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Type","Name","Indications","Pre-Clinical","Phase I","Phase II","Phase III","BLA","Commercializtion","Future Milestone"],"content":[{"type":"Recombinant Vaccine","productName":"LZ901","indications":[["Herpes zoster",100,100,99,0,0,0,"Complete Phase II in Q2 2023 and expected to initiate Phase III in Q2 2023"],["Herpes zoster",100,50,0,0,0,0,"Complete Phase I in Q1 2024 and expected to initiate Phase II in Q1 2024"]]},{"type":"Monoclonal Antibody","productName":"K3","indications":[["Rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis",100,100,100,0,0,0,"Initiate Phase III in Q2 2023 and expected to submit a BLA in Q4 2024"]]},{"type":"Bispecific Antibody","productName":"K193","indications":[["Relapsed/Refractory B-cell lymphoma/leukemia",100,80,0,0,0,0,"Complete Phase I in Q2 2023 and expected to initiate Phase II in Q1 2024"]]},{"type":"Recombinant Vaccine","productName":"Recombinant Varicella Vaccine","indications":[["Varicella",100,0,0,0,0,0,"Initiate Phase I in Q3 2023 and expected to initiate Phase II in Q3 2024"]]},{"type":"Recombinant Vaccine","productName":"Recombinant Rabies Vaccine","indications":[["Rabies",80,0,0,0,0,0,"Request pre-IND meeting with the NMPA in Q4 2023"]]},{"type":"Bispecific Antibody","productName":"K333","indications":[["Myeloid leukemia",80,0,0,0,0,0,"Request pre-IND meeting with the NMPA in the second half of 2024"]]},{"type":"Bispecific Antibody","productName":"K1932","indications":[["Relapsed/Refractory B-cell lymphoma",80,0,0,0,0,0,"Request pre-IND meeting with the NMPA in the second half of 2024"]]}]},"cn":{"header":["类型","产品名称","适应症","临床前研究","I期临床","II期临床","III期临床","上市许可申请","已上市","预期时间表"],"content":[{"type":"重组疫苗","productName":"LZ901","indications":[["带状疱疹",100,100,99,0,0,0,"已完成临床II期，预计2023年Q2进入III期临床"],["带状疱疹",100,50,0,0,0,0,"预计于2024年Q1完成临床I期"]]},{"type":"单抗","productName":"K3","indications":[["强直性脊柱炎、类风湿性关节炎、银屑病",100,100,100,0,0,0,"预计于2023年Q2进入III期，2024年Q4提交BLA"]]},{"type":"双抗","productName":"K193","indications":[["复发性/难治性B细胞淋巴瘤/白血病",100,80,0,0,0,0,"预计于2023年Q2完成I期"]]},{"type":"重组疫苗","productName":"重组水痘疫苗","indications":[["水痘",100,0,0,0,0,0,"预计于2023年Q3进入I期"]]},{"type":"重组疫苗","productName":"重组狂犬疫苗","indications":[["狂犬病",80,0,0,0,0,0,"预计于2023年Q4提交Pre-IND申请"]]},{"type":"双抗","productName":"K333","indications":[["髓系白血病",80,0,0,0,0,0,"预计于2024年H2提交Pre-IND申请"]]},{"type":"双抗","productName":"K1932","indications":[["复发性/难治性B细胞淋巴瘤",80,0,0,0,0,0,"预计于2024年H2提交Pre-IND申请"]]}]}},"processList":{"en":{"list":[{"intro":"0/8","desc":"Products/Indications"},{"intro":"1","desc":"BLA"},{"intro":"2","desc":"Candidates"},{"intro":"2+1","desc":"Clinical Studies"}],"desc":"Since Luzhu Biotech inception, we have strategically focused on internally developing innovative human vaccines, including bacterial-based vaccines and recombinant vaccines, and therapeutic biologics, such as monoclonal antibodies and bispecific antibodies, targeting a broad spectrum of infectious diseases, cancer, and autoimmune diseases. Leveraging our technology platforms and strong research and development capabilities, we established a diversified and advanced product pipeline. "},"cn":{"list":[{"intro":"0/8","desc":"上市产品/适应症"},{"intro":"1","desc":"上市注册申请在中国获受理"},{"intro":"2","desc":"临床在研产品"},{"intro":"2+1","desc":"临床试验"}],"desc":"自绿竹生物创立以来，我们已战略性集中于内部开发创新型人类疫苗（包括细菌性及重组疫苗）及治疗性生物制剂（例如单克隆抗体及双特异性抗体），针对广泛的传染病、癌症及自身免疫性疾病。依靠自身的技术平台和强大的研发能力，我们建立了多元化及先进的产品管线。"}},"productInRdList":{"en":[{"title":"Recombinant Herpes Zoster Vaccine (LZ901)","info":["LZ901 is a recombinant herpes zoster vaccine and core product independently developed by our group. It has become the world's first herpes zoster vaccine with a tetramer molecular structure, used to prevent herpes zoster caused by varicella zoster virus (VZV). Compared with the naturally occurring VZV antigen, its molecular structure has a double Fc region for antigen presenting cells (APCs) to bind to. LZ901 actively presents VZV antigen to immune cells to trigger an immune response. In addition, LZ901 has demonstrated high immunogenicity, efficacy, and safety in preclinical studies and clinical trials conducted in China, while inducing specific humoral and cellular immunity.","Our group completed the Phase II clinical trial of LZ901 in China in May 2023. The experimental results have statistical and clinical significance, and demonstrate good safety. In terms of immunogenicity research, the geometric mean concentration (GMC), geometric mean titer (GMT), and positivity rate of antibodies in the high-dose experimental group of LZ901 were significantly higher than those in the low-dose experimental group. On the other hand, the antibody GMC, GMT, and positivity rate of the LZ901 high-dose and low-dose experimental groups were significantly higher than those of the placebo experimental group. In terms of safety research, adverse events (AEs) in the trial mainly occurred within 0-7 days. The incidence rates of Grade I, II, and III AEs in the trial vaccine were approximately 23.74%, 6.02%, and 1.00%, respectively. The reported incidence rates of adverse events in the high-dose, low-dose, and placebo groups were approximately 29.0%, 23.0%, and 13.0%, respectively. During the phase II clinical trial of LZ901 in China, no grade IV or severe adverse events were observed.","Based on the Phase II clinical trial data (which provides accurate evidence for Phase III clinical trials), our group has launched a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial of LZ901 in China in September 2023. The participants in the Phase I and Phase II clinical trials of LZ901 in China are aged 50 years and above. The group has expanded the enrollment scope of participants in the Phase III clinical trials of LZ901 to adults aged 40 years and above in China, and completed the enrollment of a total of 26000 healthy participants aged 40 years and above in Jiangsu, Shandong, Hubei, and Shanxi provinces in January 2024. Our Group held a mid-term summary meeting for the Phase III clinical trial of LZ901 in June 2024, and based on the interim analysis of the Phase III clinical trial, a BLA for LZ901 was submitted to the NMPA in January 2025, which was subsequently accepted in February 2025.","In addition, our group received IND approval for LZ901 from the FDA in July 2022. Our group initiated phase I clinical trials of LZ901 and completed subject enrollment in the United States in February 2023 and July 2023, respectively. Our Group has completed the on-site research on LZ901 Phase I clinical trial in the U.S. in the first half of 2024, and expects to complete the Phase I clinical trial for LZ901 in the U.S. in the second quarter of 2025."],"isFold":false},{"title":"recombinant human anti-tumor necrosis factor-α monoclonal antibody injection (K3)","info":["K3 is a recombinant human anti-tumor necrosis factor (TNF) independently developed by our group- α Monoclonal antibody injection product under development, Humira ® The biological analogue of Adalimumab is mainly used to treat various autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Our group initiated Phase I clinical trials in China in September 2018 (where K3 showed pharmacokinetics consistent with Adalimumab), and completed Phase I clinical trials in December 2019. Our group plans to launch phase III clinical trials of K3 in China in the second half of 2024 and complete them by 2025. Our group expects K3 to achieve product commercialization in 2026, thereby expanding the market for Adalimumab biosimilars in China."],"isFold":true},{"title":"K193 Antibody Injection (CD19-CD3)","info":["K193 is a self-developed bispecific antibody injection (B-lymphocyte antigen CD19 \"CD19\") - Differentiation Group 3 (\"CD3\") in the group for the treatment of B-cell leukemia and lymphoma. K193 is the world's first CD19/CD3 bispecific antibody with an asymmetric structure. K193 has Fabite, a self-developed bispecific antibody development platform based on our group's own research ® Compared with other similar products on the market, the innovative molecular structure developed by our mammalian expression technology platform is less prone to polymerization and decreased activity. In preclinical studies, K193 has shown high in vivo and in vitro anti-tumor activity, and its optimized formula is stable and convenient to use. The unique principle of action of K193 endows it with strong ability to treat various types of B-cell leukemia and lymphoma. The safe and controllable administration method of K193 also reduces the pressure impact on patients caused by medication. In December 2019, our group launched the Phase I clinical trial of K193 in China."],"isFold":true},{"title":"Recombinant Varicella Vaccine","info":["Recombinant Varicella Vaccine is our independently developed recombinant varicella vaccine candidate, is an adjusted dosage of LZ901 for the prevention of chickenpox caused by VZV. Recombinant Varicella Vaccine prevents childhood chickenpox and has a wide range of applications. It is expected to partially replace live attenuated vaccines of the OKA strain of VZV as an alternative vaccination method, reduce the chance of children suffering from VZV infection, and reduce the risk of developing shingles in adults. Unlike other marketed live-attenuated vaccines that contain weakened forms of VZV which may lay dormant in the patient and reactivate causing shingles, Recombinant Varicella Vaccine does not contain VZV and does not carry the risk of developing into shingles."],"isFold":true},{"title":"Recombinant RSV vaccine","info":["Recombinant RSV vaccine, which has a primary indication of RSV-induced lower respiratory tract disease, is currently undergoing preclinical studies."],"isFold":true},{"title":"Recombinant HSV-1 Vaccine","info":["Recombinant HSV-1 vaccine, which has a primary indication of oral herpes or cold sores, is currently undergoing preclinical studies."],"isFold":true},{"title":"Recombinant HSV-2 Vaccine","info":["Recombinant HSV-2 vaccine, which has a primary indication of genital herpes, is currently undergoing preclinical studies."],"isFold":true},{"title":"K333 Antibody Injection (CD33-CD3)","info":["K333 is our proprietary bispecific antibody injection (CD33-CD3) product candidate for the treatment of myeloid leukemia, is a bispecific antibody that binds to human CD33 and CD3."],"isFold":true},{"title":"K1932 Antibody Injection (CD19-CD3)","info":["K1932 is our proprietary bispecific antibody injection (CD19-CD3) product candidate for the treatment of B cell lymphoma, is based on the molecular structure of K193. Compared with K193, K1932 has a much longer half-life in the human body. Patients administered K1932 following the first stage administration of K193 have lower risk of experiencing a cytokine storm, which allows for dose escalation. After the induction period of K193, K1932 can be administered on a weekly basis, which greatly improves the medication experience of B cell lymphoma patients."],"isFold":true}],"cn":[{"title":"重组带状疱疹疫苗（LZ901）","info":["LZ901是本集团自主研发的在研重组带状疱疹疫苗及核心产品，已经成为全球首款具有四聚体分子结构的带状疱疹疫苗，用于预防由水痘－带状疱疹病毒（「VZV」）引起的带状疱疹。与天然存在的VZV抗原相比，其分子结构具有双倍的Fc区供抗原呈递细胞（「APC」）结合。LZ901主动向免疫细胞呈递VZV抗原以触发免疫反应。此外，LZ901于在中国进行的临床前研究及临床试验中表现出高免疫原性、有效性和安全性，同时诱导出特异性体液和细胞免疫。","本集团已于2023年5月在中国完成LZ901的II期临床试验。试验结果具有统计学和临床意义，并表现出良好的安全性。免疫原性研究方面，LZ901高剂量试验组的抗体几何平均浓度（「GMC」）、几何平均滴度（「GMT」）和阳转率均显著高于低剂量试验组。另一方面，LZ901高、低剂量试验组的抗体GMC、GMT和阳转率均显著高于安慰剂试验组。安全性研究方面，试验中的不良事件（「AE」）主要发生在0-7天内，试验疫苗发生的I级、II级和III级AE发生率分别约为23.74%、6.02%和1.00%。高剂量试验组、低剂量试验组及安慰剂试验组报告的AE发生率分别约为29.0%、23.0%及13.0%。于中国进行LZ901的II期临床试验期间，并无观察到IV级AE及严重AE。","凭借II期临床试验数据（为III期临床试验提供了确切依据），本集团已于2023年9月在中国启动LZ901的多中心、随机、双盲、安慰剂对照III期临床试验。在中国参加LZ901的I期及II期临床试验的受试者年龄为50岁及以上，而本集团已在中国将LZ901的III期临床试验的受试者入组范围扩大至40岁及以上的成年人，并于2024年1月在江苏、山东、湖北及山西四省完成共26,000名40岁及以上健康受试者的入组。本集团于2024年6月召开了LZ901的Ⅲ期临床试验中期总结会议，并根据Ⅲ期临床试验的中期分析结果，于2025年1月向国家药监局提交了LZ901的BLA，并随后于2025年2月获受理。","此外，本集团已于2022年7月从FDA收到LZ901的IND批准。本集团分别于2023年2月及2023年7月在美国启动LZ901的I期临床试验及完成受试者入组。本集团已于2024年上半年在美国完成LZ901的Ⅰ期临床试验的现场研究，并预期于2025年第二季度在美国完成LZ901的I期临床试验。"],"isFold":false},{"title":"重组人抗肿瘤坏死因子-α单克隆抗体注射剂（K3）","info":["K3是本集团自主研发的重组人抗肿瘤坏死因子（「TNF」）-α单克隆抗体注射剂在研产品，是Humira®（阿达木单抗）的生物类似药，主要用于治疗各种自身免疫性疾病，如类风湿性关节炎、强直性脊柱炎和斑块状银屑病。 本集团于2018年9月在中国启动I期临床试验（当中K3显示出与阿达木单抗一致的药代动力学），并已于2019年 12月完成I期临床试验。本集团计划于2024年下半年在中国启动K3的III期临床试验、于2025年完成III期临床试 验。本集团预计K3于2026年实现产品商业化，从而扩展中国的阿达木单抗生物类似药市场。"],"isFold":true},{"title":"K193抗体注射液（CD19-CD3）","info":["K193是本集团自主研发的用于治疗B细胞白血病和淋巴瘤的双特异性抗体注射液（ B淋巴细胞抗原CD19 「CD19」）－ 分化群3（「CD3」） 在研产品。K193是全球首款具有不对称结构的CD19/CD3双特异性抗体。K193具有基于本集团自研的双特异性抗体开发平台Fabite®及本集团哺乳动物表达技术平台开发的创新分子结构，与市场上其他类似产品相比，它不容易发生聚合和活性下降。在临床前研究中，K193显示出很高的体内和体外抗肿瘤活性，其优化的配方稳定且使用方便。K193独特的作用原理使其具有较强的治疗各种类型B细胞白血病和淋巴瘤的能力。K193安全可控的给药方式也减少了患者因用药而产生的压力影响。于2019年12月，本集团在 中国启动了K193的I期临床试验。"],"isFold":true},{"title":"重组水痘疫苗","info":["重组水痘疫苗是我们自主研发的在研重组水痘疫苗，是一种调整剂量的LZ901，用于预防由VZV引起的水痘。重组水痘疫苗预防儿童水痘，应用广泛。重组水痘疫苗预计会作为一种替代接种方法部分替代VZV OKA株减毒活疫苗，降低儿童患VZV感染的几率，减少成人患带状疱疹的风险。与其他市售减毒活疫苗不同，重组水痘疫苗不含VZV，亦没有发展成带状疱疹的风险，前者含有可能潜伏在患者体内并重新激活而引起带状疱疹的减毒形式的VZV。"],"isFold":true},{"title":"重组RSV疫苗","info":["重组RSV疫苗是我们开发的主要针对适应症为RSV引起的下呼吸道疾病的产品，目前正在进行临床前研究。"],"isFold":true},{"title":"重组HSV-1疫苗","info":["重组HSV-1疫苗是我们开发的主要针对适应症为HSV-1引起的口唇部疱疹的产品，目前正在进行临床前研究。"],"isFold":true},{"title":"重组HSV-2疫苗","info":["重组HSV-2疫苗是我们开发的主要针对适应症为HSV-2引起的生殖器疱疹的产品，目前正在进行临床前研究。"],"isFold":true},{"title":"K333抗体注射液（CD33-CD3）","info":["K333是我们专有的用于治疗髓系白血病的双特异性抗体注射液（CD33-CD3）在研产品，是结合人CD33和CD3的双特异性抗体。"],"isFold":true},{"title":"K1932抗体注射液（CD19-CD3）","info":["K1932是我们专有的用于治疗B细胞淋巴瘤的基于K193的分子结构的双特异性抗体注射液（CD19-CD3）在研产品。与K193相比，K1932 在人体内的半衰期要长得多。于注射K193的第一阶段后给予K1932的患者发生细胞因子风暴的风险较低，允许增加剂量。在K193的诱导期结束后，可以每週给药K1932，大大提高了B细胞淋巴瘤患者的用药体验。"],"isFold":true}]},"productDetail":{"aqun":{"title":"A群脑膜炎球菌多糖IgG抗体试剂盒","profile":"https://forweb105.oss-cn-beijing.aliyuncs.com/aqun.jpeg","intro":"本试剂盒在微孔条上预包被经特殊处理的A群脑膜炎球菌多糖，配以酶标记抗人IgG结合物及TMB显色剂等其它试剂，采用间接酶联免疫法原理检测人血清或血浆中的A群脑膜炎球菌多糖抗体(IgG)的含量。","composition":[["A群脑膜炎球菌多糖预包酶标板","12×8"],["A群脑膜炎球菌抗体参比品","0.5 μg/0.5 ml/支"],["A群脑膜炎球菌抗体阳性对照血清","1支"],["A群脑膜炎球菌抗体阴性对照血清","1支"],["抗人IgG酶结合物","0.2 ml×1支"],["浓缩洗涤液(20×)","50 ml×1瓶"],["显色剂A液","6 ml×1瓶"],["显色剂B液","6 ml×1瓶"],["终止液","6 ml×1瓶"],["说明书","1份"],["封板膜","1张"]],"manual":[["操作步骤",["1、配液：将50ml浓缩洗涤液（20×）用蒸馏水或去离子水稀释至1000ml备用，此洗涤液同时作为稀释液使用。","2、参比品的稀释: 每支冻干参比品溶于0.5 ml稀释液，即为1.0 μg/ml。将参比品稀释为0.12μg/ml、0.10μg/ml、0.08μg/ml、0.06μg/ml、0.04μg/ml、0.02μg/ml、0.01μg/ml、0.005μg/ml浓度的系列，备用（详见附件1） 。","3、样品稀释：先将样品作1∶100稀释（精确取10μl血清加入990μl洗涤液中混匀）备用。","4、加样：第1行（空白对照A1）和阴性、阳性对照孔（各1~2孔）、参比品各浓度的孔不加稀释液。每份待检标本做<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800四个稀释度。","5、参比品加样：将8个稀释度的参比品各取100μl加到酶标板相应的孔内。空白对照孔不加样品。","6、阳性对照、阴性对照各加1-2孔，每孔100μl。","7、置37℃孵育60分钟。","8、洗涤：将孔内液体甩干，用洗涤液充分洗涤4遍，甩干。","9、加酶：每支冻干抗人IgG酶结合物溶于0.2ml洗涤液，完全溶解后用洗涤液作1∶120倍稀释。每孔（包括空白对照孔）加入已稀释酶标试剂100μl，置37℃孵育30分钟。","10、洗涤：将孔内液体甩干，用洗涤液充分洗涤5遍，甩干。","11、显色：显色剂A、B液等体积混匀后每孔加入100μl，37℃避光显色10分钟，之后每孔加终止液50μl。","12、测定：设定酶标仪波长为450nm（建议用双波长检测参比波长≥600nm），用空白孔调零点后测定各孔吸光值。"]],["结果判定",["1、阳性对照A450nm > 0.50 ，阴性对照A450nm < 0.20试验成立。","2、以标准品抗体浓度作为横坐标、吸光值作为纵坐标作直线回归方程，方程式为y= a + bx。","3、将待检样品的吸光值(y)代入方程中计算出不同稀释度时血清样品的抗体含量（ Xμg/ml）。","4、将抗体含量乘以对应的样品稀释度求出血清抗体含量的均值。","5、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量。","6、计算样品抗体含量时，最好选择样品吸光值在0.3~1.0之间的代入方程式，此时计算结果较为真实。"]],["注意事项",["1、试剂盒从冷藏环境中取出后，在室温平衡15-30分钟方可使用。","2、未用完的预包酶标微孔条用封板膜封存在冷藏环境，7-10天内用完。","3、抗人酶结合物加入稀释后可以置37℃保温5分钟便于完全溶解；溶解后未用完酶结合物置-20℃保存。","4、酶标板洗涤时各孔均需加满洗液，防止非特异性抗体、游离酶残留。","5、加样时应先加样品，后加标准品，再加阴性对照、阳性对照。整个加样过程应在15分钟内完成。","6、终止液为2M硫酸，使用时应注意安全。","7、操作应按说明书严格进行，不同批次试剂不得混用。","8、人群流行病学调查可做4个稀释度或2个稀释度（<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800）。","9、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量，吸光值低于检测线性范围的，应降低血清稀释倍数重新测定，血清可做1:25 及1:50稀释用于测定。","10、每次测定均应同时作标准曲线。","11、每个试剂盒测定的标准曲线只能用于本试剂盒酶标板测定的血清，不能用于其他试剂盒测定结果的计算。"]],["存储条件和有效期",["1、储存条件：2-8℃。","2、有效期：12个月。"]]],"attachment":[["<strong>A群脑膜炎球菌抗体参比品稀释</strong>","1、先用0.5 ml稀释液溶解抗血清，参比品抗体浓度为1.0μg/ml；","2、取7-8个洁净的玻璃小瓶或小试管，按下表稀释：","<table><tbody><tr><td rowspan='2'></td><td colspan='8' valign='middle'>参比品抗体浓度（μg/ml）</td></tr><tr><td>0.12</td><td>0.10</td><td>0.08</td><td>0.06</td><td>0.04</td><td>0.02</td><td>0.01</td><td>0.005</td></tr><tr><td>稀释液（μl）</td><td>440</td><td>450</td><td>460</td><td>470</td><td>480</td><td>980</td><td>1980</td><td>1990</td></tr><tr><td>溶解后的参比血清（μl）</td><td>60</td><td>50</td><td>40</td><td>30</td><td>20</td><td>20</td><td>20</td><td>10</td></tr></tbody></table>","3、上述稀释的一系列参比品各取100μl加入预包酶标板上。"],["人血清A群脑膜炎球菌多糖抗体（IgG）测定ELISA工作曲线（此图仅供示例用）","<img src='/statics/aqun2.png'>"],["提示：同一份血清同时检测A群流脑抗体和其它群流脑抗体时，建议采用深孔的96孔的稀释板。","1、参比品稀释则用洁净小瓶或小管稀释。","2、在深孔稀释板稀释后移到A群流脑、其它群流脑预包板时需要仔细操作，不同的血清之间应更换吸尖。","3、世界卫生组织推荐的A群脑膜炎球菌多糖抗体(IgG)保护性水平为2μg/ml，未经广泛的流行病学调查结果确证，仅供参考。"]]},"bqun":{"title":"b型流感嗜血杆菌多糖IgG抗体试剂盒","profile":"https://forweb105.oss-cn-beijing.aliyuncs.com/bqun.jpeg","intro":"本试剂盒在微孔条上预包被经特殊处理的b-型流感嗜血杆菌多糖，配以碱性磷酸酶标记抗人IgG及p-硝基苯基磷酸盐(PNP)溶液显色剂等其它试剂，采用间接酶联免疫法原理检测人血清或血浆中的b-型流感嗜血杆菌多糖(IgG)抗体含量。","composition":[["b-型流感嗜血杆菌多糖预包板","96孔"],["b-型流感嗜血杆菌抗体参比品","0.5 μg/0.5 ml/支"],["b-型流感嗜血杆菌抗体阳性对照血清","1支"],["b-型流感嗜血杆菌抗体阴性对照血清","1支"],["羊抗人IgG碱性磷酸酶结合物","10 ml×1支"],["浓缩洗涤液(20×)","50 ml×1瓶"],["底物缓冲液","10 ml×1瓶"],["底物(PNP)","5mg/片×2片"],["终止液","6 ml×1瓶"],["说明书","1份"],["封板膜","1张"]],"manual":[["操作步骤",["1、配液：将50ml浓缩洗涤液（20×）用蒸馏水或去离子水稀释至1000ml备用，此洗涤液同时作为稀释液使用。","2、参比品的稀释: 每支冻干参比品溶于1.667 ml稀释液，即为0.3 μg/ml。将参比品稀释为0.300μg/ml、0.100μg/ml、0.0333μg/ml、0.0111μg/ml、0.0037μg/ml、0.0012μg/ml、0.0004μg/ml、0.0001μg/ml浓度的系列，备用（详见附件1）。 （即1∶3倍倍比稀释：0.4ml稀释液＋0.2ml上个稀释倍数参比品）","3、样品稀释：先将样品作1∶50稀释（精确取20μl血清加入980μl洗涤液中混匀）备用。","4、加样：第1行（空白对照A1）和阴性、阳性对照孔（各1~2孔）、参比品各浓度的孔不加稀释液。每份待检标本做<strong style='color: red'>1∶50</strong>、1∶150、<strong style='color: red'>1∶450</strong>、1∶1350四个稀释度。","5、参比品加样：将8个稀释度的参比品各取100μl加到酶标板相应的孔内。空白对照孔不加样品。","6、阳性对照、阴性对照各加1-2孔，每孔100μl。","7、置25℃孵育120分钟。","8、洗涤：将孔内液体甩干，用洗涤液充分洗涤4遍，甩干。","9、直接加入液体酶：每孔（包括空白对照孔）加入液体酶标试剂100ml，置25℃孵育2小时。","10、洗涤：将孔内液体甩干，用洗涤液充分洗涤5遍，甩干。","11、显色：将铝铂袋中2片底物（p-硝基苯基磷酸盐）用药勺取出后溶解于10.0ml底物缓冲液中，完全溶解后，每孔加入100ml，25℃显色2小时后每孔加终止液50ml，放置5分钟后测定。","12、测定：设定酶标仪波长为405nm（建议用双波长检测参比波长≥600nm）用空白孔调零点后测定各孔OD值。"]],["结果判定",["1、空白孔吸光值＜0.1，阳性对照吸光值 > 0.50 ，阴性对照吸光值 ＜ 0.25试验成立。","2、以参比品抗体浓度作为横坐标、吸光值作为纵坐标,作四参数对数分析法（y = b+(a-b)/(1+xc)^d ）计算，回归方程的拟合度R2≥0.95。","3、待检样品各稀释度的吸光值(y)在标准曲线对应范围内的值代入方程，计算出不同稀释度时血清样品的抗体含量（ X mg/ml）。","4、将抗体含量乘以对应的样品稀释度求出血清抗体含量的均值。","5、最好选择样品吸光值在0.3~1.5之间的代入方程式，此时计算结果较为真实。样品吸光值超出方程范围的吸光值不得代入方程计算抗体含量。"]],["注意事项",["1、试剂盒从冷藏环境中取出后，在室温平衡15-30分钟方可使用。","2、未用完的预包酶标微孔条用封板膜封存在冷藏环境，7-10天内用完。","3、抗人酶结合物加入稀释后可以置37℃保温5分钟便于完全溶解；溶解后未用完酶结合物置-20℃保存。","4、酶标板洗涤时各孔均需加满洗液，防止非特异性抗体、游离酶残留。","5、加样时应先加样品，后加标准品，再加阴性对照、阳性对照。整个加样过程应在15分钟内完成。","6、终止液为3M氢氧化钠，使用时应注意安全。","7、操作应按说明书严格进行，不同批次试剂不得混用。","8、人群流行病学调查可做4个稀释度或2个稀释度（<strong style='color: red'>1∶50</strong>、1∶150、<strong style='color: red'>1∶450</strong>、1∶1350）。","9、样品吸光值超出拟合方程范围的吸光值不得代入方程计算抗体含量。样品的抗体浓度通过多个稀释度的平均值计算得到，且不同稀释浓度得出的抗体浓度的变异系数（CV）大于30％，需要检查数据中是否有不合适的结果（如重复性不好，和/或非线性），如果没有发现明显的原因，则要重新测定。","10、每次测定均应同时作标准曲线。","11、每个试剂盒测定的标准曲线只能用于本试剂盒酶标板测定的血清，不能用于其他试剂盒测定结果的计算。"]],["存储条件和有效期",["1、储存条件：2-8℃。","2、有效期：12个月。"]]],"attachment":[["<strong>b型流感嗜血杆菌多糖IgG抗体参比品稀释</strong>","1、先用1.667 ml稀释液溶解抗血清，参比品抗体浓度为0.300μg/ml；","2、取8个洁净的玻璃小瓶或小试管，按下表稀释，从抗体浓度为0.300μg/ml开始进行1∶3倍倍稀释，示意图如下：","<img src='/statics/bqun2.png'>","3、上述稀释的一系列参比品各取100μl加入预包酶标板上。"],["人血清b型流感嗜血杆菌多糖IgG抗体试剂盒（IgG）测定ELISA工作曲线（此图仅供示例用）","<img src='/statics/bqun3.png'>","Fit type : Four parameter logistic : y = b+(a-b)/(1+xc)^d","Fit type : a=0.087 b=3.003 c=0.025 d=1.292 R2=0.995"]]},"cqun":{"title":"C群脑膜炎球菌多糖IgG抗体试剂盒","profile":"https://forweb105.oss-cn-beijing.aliyuncs.com/cqun.jpeg","intro":"本试剂盒在微孔条上预包被经特殊处理的C群脑膜炎球菌多糖，配以酶标记抗人IgG结合物及TMB显色剂等其它试剂，采用间接酶联免疫法原理检测人血清或血浆中的C群脑膜炎球菌多糖抗体(IgG)的含量。","composition":[["C群脑膜炎球菌多糖酶标板","12×8"],["C群脑膜炎球菌抗体参比品","2.5 μg/0.5 ml/支"],["C群脑膜炎球菌抗体阳性对照血清","1支"],["C群脑膜炎球菌抗体阴性对照血清","1支"],["抗人IgG酶结合物","0.2 ml×1支"],["浓缩洗涤液(20×)","50 ml×1瓶"],["显色剂A液","6 ml×1瓶"],["显色剂B液","6 ml×1瓶"],["终止液","6 ml×1瓶"],["说明书","1份"],["封板膜","1张"]],"manual":[["操作步骤",["1、配液：将50ml浓缩洗涤液（20×）用蒸馏水或去离子水稀释至1000ml备用，此洗涤液同时作为稀释液使用。","2、参比品的稀释: 每支冻干参比品溶于5 ml稀释液，即为1.0 μg/ml。将参比品稀释为0.12μg/ml、0.10μg/ml、0.08μg/ml、0.06μg/ml、0.04μg/ml、0.02μg/ml、0.01μg/ml、0.005μg/ml浓度的系列，备用（详见附件1） 。","3、样品稀释：先将样品作1∶100稀释（精确取10μl血清加入990μl洗涤液中混匀）备用。","4、加样：第1行（空白对照A1）和阴性、阳性对照孔（各1~2孔）、参比品各浓度的孔不加稀释液。每份待检标本做<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800四个稀释度。","5、参比品加样：将8个稀释度的参比品各取100μl加到酶标板相应的孔内。空白对照孔不加样品。","6、阳性对照、阴性对照各加1-2孔，每孔100μl。","7、置37℃孵育60分钟。","8、洗涤：将孔内液体甩干，用洗涤液充分洗涤4遍，甩干。","9、加酶：每支冻干抗人IgG酶结合物溶于0.2ml洗涤液，完全溶解后用洗涤液作1∶120倍稀释。每孔（包括空白对照孔）加入已稀释酶标试剂100μl，置37℃孵育30分钟。","10、洗涤：将孔内液体甩干，用洗涤液充分洗涤5遍，甩干。","11、显色：显色剂A、B液等体积混匀后每孔加入100μl，37℃避光显色10分钟，之后每孔加终止液50μl。","12、测定：设定酶标仪波长为450nm（建议用双波长检测参比波长≥600nm），用空白孔调零点后测定各孔吸光值。"]],["结果判定",["1、阳性对照A450nm > 0.50 ，阴性对照A450nm ＜ 0.20试验成立。","2、以标准品抗体浓度作为横坐标、吸光值作为纵坐标作直线回归方程，方程式为y= a + bx。","3、将待检样品的吸光值(y)代入方程中计算出不同稀释度时血清样品的抗体含量（ Xμg/ml）。","4、将抗体含量乘以对应的样品稀释度求出血清抗体含量的均值。","5、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量。","6、计算样品抗体含量时，最好选择样品吸光值在0.3~1.0之间的代入方程式，此时计算结果较为真实。"]],["注意事项",["1、试剂盒从冷藏环境中取出后，在室温平衡15-30分钟方可使用。","2、未用完的预包酶标微孔条用封板膜封存在冷藏环境，7-10天内用完。","3、抗人酶结合物加入稀释后可以置37℃保温5分钟便于完全溶解；溶解后未用完酶结合物置-20℃保存。","4、酶标板洗涤时各孔均需加满洗液，防止非特异性抗体、游离酶残留。","5、加样时应先加样品，后加标准品，再加阴性对照、阳性对照。整个加样过程应在15分钟内完成。","6、终止液为2M硫酸，使用时应注意安全。","7、操作应按说明书严格进行，不同批次试剂不得混用。","8、人群流行病学调查可做4个稀释度或2个稀释度（<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800）。","9、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量，吸光值低于检测线性范围的，应降低血清稀释倍数重新测定，血清可做1:25 及1:50稀释用于测定。","10、每次测定均应同时作标准曲线。","11、每个试剂盒测定的标准曲线只能用于本试剂盒酶标板测定的血清，不能用于其他试剂盒测定结果的计算。"]],["存储条件和有效期",["1、储存条件：2-8℃。","2、有效期：12个月。"]]],"attachment":[["<strong>C群脑膜炎球菌抗体参比品稀释</strong>","1、先用2.5 ml稀释液溶解抗血清，参比品抗体浓度为1.0μg/ml；","2、取7-8个洁净的玻璃小瓶或小试管，按下表稀释：","<table><tbody><tr><td rowspan='2'></td><td colspan='8'>参比品抗体浓度（μg/ml）</td></tr><tr><td>0.12</td><td>0.10</td><td>0.08</td><td>0.06</td><td>0.04</td><td>0.02</td><td>0.01</td><td>0.005</td></tr><tr><td>稀释液（μl）</td><td>440</td><td>450</td><td>460</td><td>470</td><td>480</td><td>980</td><td>1980</td><td>1990</td></tr><tr><td>溶解后的参比血清（μl）</td><td>60</td><td>50</td><td>40</td><td>30</td><td>20</td><td>20</td><td>20</td><td>10</td></tr></tbody></table>","3、上述稀释的一系列参比品各取100μl加入预包酶标板上。"],["人血清C群脑膜炎球菌多糖抗体（IgG）测定ELISA工作曲线（此图仅供示例用）","<img src='/statics/cqun2.png'>"],["提示：","同一份血清同时检测C群流脑抗体和其它群流脑抗体时，建议采用深孔的96孔的稀释板。","1、参比品稀释则用洁净小瓶或小管稀释。","2、在深孔稀释板稀释后移到C群流脑、其它群流脑预包板时需要仔细操作，不同的血清之间应更换吸尖。","3、世界卫生组织推荐的C群脑膜炎球菌多糖抗体(IgG)保护性水平为2μg/ml，未经广泛的流行病学调查结果确证，仅供参考。"]]},"wqun":{"title":"W<sub>135</sub>群脑膜炎球菌多糖IgG抗体试剂盒","profile":"https://forweb105.oss-cn-beijing.aliyuncs.com/wqun.jpeg","intro":"本试剂盒在微孔条上预包被经特殊处理的W<sub>135</sub>群脑膜炎球菌多糖，配以酶标记抗人IgG结合物及TMB显色剂等其它试剂，采用间接酶联免疫法原理检测人血清或血浆中的W<sub>135</sub>群脑膜炎球菌多糖抗体(IgG)的含量。","composition":[["W<sub>135</sub>群脑膜炎球菌多糖酶标板","12×8"],["W<sub>135</sub>群脑膜炎球菌抗体参比品","0.65 μg/0.5 ml/支"],["W<sub>135</sub>群脑膜炎球菌抗体阳性对照血清","1支"],["W<sub>135</sub>群脑膜炎球菌抗体阴性对照血清","1支"],["抗人IgG酶结合物","0.2 ml×1支"],["浓缩洗涤液(20×)","50 ml×1瓶"],["显色剂A液","6 ml×1瓶"],["显色剂B液","6 ml×1瓶"],["终止液","6 ml×1瓶"],["说明书","1份"],["封板膜","1张"]],"manual":[["操作步骤",["1、配液：将50ml浓缩洗涤液（20×）用蒸馏水或去离子水稀释至1000ml备用，此洗涤液同时作为稀释液使用。","2、参比品的稀释: 每支冻干参比品溶于0.65 ml稀释液，即为1.0 μg/ml。将参比品稀释为0.12μg/ml、0.10μg/ml、0.08μg/ml、0.06μg/ml、0.04μg/ml、0.02μg/ml、0.01μg/ml、0.005μg/ml浓度的系列，备用（详见附件1） 。","3、样品稀释：先将样品作1∶100稀释（精确取10μl血清加入990μl洗涤液中混匀）备用。","4、加样：第1行（空白对照A1）和阴性、阳性对照孔（各1~2孔）、参比品各浓度的孔不加稀释液。每份待检标本做<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800四个稀释度。","5、参比品加样：将8个稀释度的参比品各取100μl加到酶标板相应的孔内。空白对照孔不加样品。","6、阳性对照、阴性对照各加1-2孔，每孔100μl。","7、置37℃孵育60分钟。","8、洗涤：将孔内液体甩干，用洗涤液充分洗涤4遍，甩干。","9、加酶：每支冻干抗人IgG酶结合物溶于0.2ml洗涤液，完全溶解后用洗涤液作1∶120倍稀释。每孔（包括空白对照孔）加入已稀释酶标试剂100μl，置37℃孵育30分钟。","10、洗涤：将孔内液体甩干，用洗涤液充分洗涤5遍，甩干。","11、显色：显色剂A、B液等体积混匀后每孔加入100μl，37℃避光显色10分钟，之后每孔加终止液50μl。","12、测定：设定酶标仪波长为450nm（建议用双波长检测参比波长≥600nm），用空白孔调零点后测定各孔吸光值。"]],["结果判定",["1、阳性对照A450nm > 0.50 ，阴性对照A450nm ＜ 0.20试验成立。","2、以标准品抗体浓度作为横坐标、吸光值作为纵坐标作直线回归方程，方程式为y= a + bx。","3、将待检样品的吸光值(y)代入方程中计算出不同稀释度时血清样品的抗体含量（ Xμg/ml）。","4、将抗体含量乘以对应的样品稀释度求出血清抗体含量的均值。","5、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量。","6、计算样品抗体含量时，最好选择样品吸光值在0.3~1.0之间的代入方程式，此时计算结果较为真实。"]],["注意事项",["1、试剂盒从冷藏环境中取出后，在室温平衡15-30分钟方可使用。","2、未用完的预包酶标微孔条用封板膜封存在冷藏环境，7-10天内用完。","3、抗人酶结合物加入稀释后可以置37℃保温5分钟便于完全溶解；溶解后未用完酶结合物置-20℃保存。","4、酶标板洗涤时各孔均需加满洗液，防止非特异性抗体、游离酶残留。","5、加样时应先加样品，后加标准品，再加阴性对照、阳性对照。整个加样过程应在15分钟内完成。","6、终止液为2M硫酸，使用时应注意安全。","7、操作应按说明书严格进行，不同批次试剂不得混用。","8、人群流行病学调查可做4个稀释度或2个稀释度（<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800）。","9、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量，吸光值低于检测线性范围的，应降低血清稀释倍数重新测定，血清可做1:25 及1:50稀释用于测定。","10、每次测定均应同时作标准曲线。","11、每个试剂盒测定的标准曲线只能用于本试剂盒酶标板测定的血清，不能用于其他试剂盒测定结果的计算。"]],["存储条件和有效期",["1、储存条件：2-8℃。","2、有效期：12个月。"]]],"attachment":[["<strong>W<sub>135</sub>群脑膜炎球菌抗体参比品稀释</strong>","1、先用0.65 ml稀释液溶解抗血清，参比品抗体浓度为1.0μg/ml；","2、取7-8个洁净的玻璃小瓶或小试管，按下表稀释：","<table><tbody><tr><td rowspan='2'></td><td colspan='8'>参比品抗体浓度（μg/ml）</td></tr><tr><td>0.12</td><td>0.10</td><td>0.08</td><td>0.06</td><td>0.04</td><td>0.02</td><td>0.01</td><td>0.005</td></tr><tr><td>稀释液（μl）</td><td>440</td><td>450</td><td>460</td><td>470</td><td>480</td><td>980</td><td>1980</td><td>1990</td></tr><tr><td>溶解后的参比血清（μl）</td><td>60</td><td>50</td><td>40</td><td>30</td><td>20</td><td>20</td><td>20</td><td>10</td></tr></tbody></table>","3、上述稀释的一系列参比品各取100μl加入预包酶标板上。"],["人血清W<sub>135</sub>群脑膜炎球菌多糖抗体（IgG）测定ELISA工作曲线（此图仅供示例用）","<img src='/statics/wqun2.jpg'>"],["提示：同一份血清同时检测W<sub>135</sub>群流脑抗体和其它群流脑抗体时，建议采用深孔的96孔的稀释板。","1、参比品稀释则用洁净小瓶或小管稀释。","2、在深孔稀释板稀释后移到W<sub>135</sub>群流脑、其它群流脑预包板时需要仔细操作，不同的血清之间应更换吸尖。","3、世界卫生组织推荐的W<sub>135</sub>群脑膜炎球菌多糖抗体(IgG)保护性水平为2μg/ml，未经广泛的流行病学调查结果确证，仅供参考。"]]},"yqun":{"title":"Y群脑膜炎球菌多糖IgG抗体试剂盒","profile":"https://forweb105.oss-cn-beijing.aliyuncs.com/yqun.jpeg","intro":"本试剂盒在微孔条上预包被经特殊处理的Y群脑膜炎球菌多糖，配以酶标记抗人IgG结合物及TMB显色剂等其它试剂，采用间接酶联免疫法原理检测人血清或血浆中的Y群脑膜炎球菌多糖抗体(IgG)的含量。","composition":[["Y群脑膜炎球菌多糖酶标板","12×8"],["Y群脑膜炎球菌抗体参比品","1.3 μg/0.5 ml/支"],["Y群脑膜炎球菌抗体阳性对照血清","1支"],["Y群脑膜炎球菌抗体阴性对照血清","1支"],["抗人IgG酶结合物","0.2 ml×1支"],["浓缩洗涤液(20×)","50 ml×1瓶"],["显色剂A液","6 ml×1瓶"],["显色剂B液","6 ml×1瓶"],["终止液","6 ml×1瓶"],["说明书","1份"],["封板膜","1张"]],"manual":[["操作步骤",["1、配液：将50ml浓缩洗涤液（20×）用蒸馏水或去离子水稀释至1000ml备用，此洗涤液同时作为稀释液使用。","2、参比品的稀释: 每支冻干参比品溶于2.6 ml稀释液，即为1.0 μg/ml。将参比品稀释为0.12μg/ml、0.10μg/ml、0.08μg/ml、0.06μg/ml、0.04μg/ml、0.02μg/ml、0.01μg/ml、0.005μg/ml浓度的系列，备用（详见附件1） 。","3、样品稀释：先将样品作1∶100稀释（精确取10μl血清加入990μl洗涤液中混匀）备用。","4、加样：第1行（空白对照A1）和阴性、阳性对照孔（各1~2孔）、参比品各浓度的孔不加稀释液。每份待检标本做<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800四个稀释度。","5、参比品加样：将8个稀释度的参比品各取100μl加到酶标板相应的孔内。空白对照孔不加样品。","6、阳性对照、阴性对照各加1-2孔，每孔100μl。","7、置37℃孵育60分钟。","8、洗涤：将孔内液体甩干，用洗涤液充分洗涤4遍，甩干。","9、加酶：每支冻干抗人IgG酶结合物溶于0.2ml洗涤液，完全溶解后用洗涤液作1∶120倍稀释。每孔（包括空白对照孔）加入已稀释酶标试剂100μl，置37℃孵育30分钟。","10、洗涤：将孔内液体甩干，用洗涤液充分洗涤5遍，甩干。","11、显色：显色剂A、B液等体积混匀后每孔加入100μl，37℃避光显色10分钟，之后每孔加终止液50μl。","12、测定：设定酶标仪波长为450nm（建议用双波长检测参比波长≥600nm），用空白孔调零点后测定各孔吸光值。"]],["结果判定",["1、阳性对照A450nm > 0.50 ，阴性对照A450nm ＜ 0.20试验成立。","2、以标准品抗体浓度作为横坐标、吸光值作为纵坐标作直线回归方程，方程式为y= a + bx。","3、将待检样品的吸光值(y)代入方程中计算出不同稀释度时血清样品的抗体含量（ Xμg/ml）。","4、将抗体含量乘以对应的样品稀释度求出血清抗体含量的均值。","5、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量。","6、计算样品抗体含量时，最好选择样品吸光值在0.3~1.0之间的代入方程式，此时计算结果较为真实。"]],["注意事项",["1、试剂盒从冷藏环境中取出后，在室温平衡15-30分钟方可使用。","2、未用完的预包酶标微孔条用封板膜封存在冷藏环境，7-10天内用完。","3、抗人酶结合物加入稀释后可以置37℃保温5分钟便于完全溶解；溶解后未用完酶结合物置-20℃保存。","4、酶标板洗涤时各孔均需加满洗液，防止非特异性抗体、游离酶残留。","5、加样时应先加样品，后加标准品，再加阴性对照、阳性对照。整个加样过程应在15分钟内完成。","6、终止液为2M硫酸，使用时应注意安全。","7、操作应按说明书严格进行，不同批次试剂不得混用。","8、人群流行病学调查可做4个稀释度或2个稀释度（<strong style='color: red'>1∶100</strong>、1∶200、<strong style='color: red'>1∶400</strong>、1∶800）。","9、样品吸光值超出直线回归方程范围的吸光值不得代入方程计算抗体含量，吸光值低于检测线性范围的，应降低血清稀释倍数重新测定，血清可做1:25 及1:50稀释用于测定。","10、每次测定均应同时作标准曲线。","11、每个试剂盒测定的标准曲线只能用于本试剂盒酶标板测定的血清，不能用于其他试剂盒测定结果的计算。"]],["存储条件和有效期",["1、储存条件：2-8℃。","2、有效期：12个月。"]]],"attachment":[["<strong>Y群脑膜炎球菌抗体参比品稀释</strong>","1、先用2.6 ml稀释液溶解抗血清，参比品抗体浓度为1.0μg/ml；","2、取7-8个洁净的玻璃小瓶或小试管，按下表稀释：","<table><tbody><tr><td rowspan='2'></td><td colspan='8'>参比品抗体浓度（μg/ml）</td></tr><tr><td>0.12</td><td>0.10</td><td>0.08</td><td>0.06</td><td>0.04</td><td>0.02</td><td>0.01</td><td>0.005</td></tr><tr><td>稀释液（μl）</td><td>440</td><td>450</td><td>460</td><td>470</td><td>480</td><td>980</td><td>1980</td><td>1990</td></tr><tr><td>溶解后的参比血清（μl）</td><td>60</td><td>50</td><td>40</td><td>30</td><td>20</td><td>20</td><td>20</td><td>10</td></tr></tbody></table>","3、上述稀释的一系列参比品各取100μl加入预包酶标板上。"],["人血清Y群脑膜炎球菌多糖抗体（IgG）测定ELISA工作曲线（此图仅供示例用）","<img src='/statics/yqun2.png'>"],["提示：同一份血清同时检测Y群流脑抗体和其它群流脑抗体时，建议采用深孔的96孔的稀释板。","1、参比品稀释则用洁净小瓶或小管稀释。","2、在深孔稀释板稀释后移到Y群流脑、其它群流脑预包板时需要仔细操作，不同的血清之间应更换吸尖。","3、世界卫生组织推荐的Y群脑膜炎球菌多糖抗体(IgG)保护性水平为2μg/ml，未经广泛的流行病学调查结果确证，仅供参考。"]]}},"news":{"cn":[{"id":"24","date":"2024-11-15T14:59:27","title":"简讯：我公司取得中国国家知识产权局下发的双特异性抗体K333的发明专利证书","content":["公司收到中国国家知识产权局于2024年11月15日下发的“一种结合人CD33和CD3的双特异性抗体”发明专利证书，专利号为ZL202410503481.1。","","该专利证书的取得有利于进一步完善公司知识产权保护体系，促进技术创新，提升公司的核心竞争力。",""],"link":"/news/24","image":"/statics/banner2.jpeg","isNew":true},{"id":"23","date":"2024-09-18T13:18:02","title":"简讯：我公司于韩国取得核心产品重组带状疱疹疫苗LZ901的发明专利注册证书","content":["公司收到韩国知识产权局于2024年8月21日下发的“重组水痘带状疱疹病毒（VZV）疫苗”发明专利注册证书，专利号为10-2698706。","","目前，公司核心产品重组带状疱疹疫苗LZ901已于中国、俄罗斯、日本、澳大利亚、美国以及韩国依次取得发明专利证书。",""],"link":"/news/23","image":"/statics/banner1.jpeg","isNew":true},{"id":"22","date":"2024-09-13T13:42:53","title":"简讯：我公司于2024年9月12日圆满举行中期业绩发布会","content":["公司2024年中期业绩发布会于2024年9月12日圆满召开，多家行业机构参与线上会议并踊跃提问。管理层结合公司管线进展及当下市场情况，就投资者提出问题详细解答。未来，绿竹生物将进一步拓展与投资者交流的广度与深度，积极回馈广大投资者的支持与信任，推动公司高质量发展。",""],"link":"/news/22","image":"/statics/banner3.jpeg","isNew":false},{"id":"21","date":"2024-07-05T13:36:17","title":"简讯：我公司于美国及澳大利亚取得核心产品重组带状疱疹疫苗LZ901的发明专利注册证书","content":["公司收到美国专利和商标局于2024年5月28日下发的“重组水痘带状疱疹病毒(VZV)疫苗”发明专利注册证书。此外，公司已于2024年4月4日收到澳大利亚专利注册下发的“重组水痘带状疱疹病毒(VZV)疫苗”发明专利注册证书。","","目前，公司核心产品重组带状疱疹疫苗LZ901已于中国、俄罗斯、日本、澳大利亚及美国取得发明专利。",""],"link":"/news/21","image":"/statics/banner3.jpeg","isNew":false},{"id":"20","date":"2024-02-01T11:32:17","title":"简讯：我公司于2024年1月完成H股全流通","content":["我公司于2024年1月31日在联交所网站发布公告，宣布我公司共59,729,296股非上市股份的H股全流通计划已分别取得中国证监会的备案通知及联交所的上市批准，并于2024年1月31日完成转换，该等已转换H股将于2024年2月1日上午九时开始在联交所上市。","","请见2024年1月31日发布的公告信息：","","https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0131/2024013100753_c.pdf",""],"link":"/news/20","image":"/statics/banner2.jpeg","isNew":false},{"id":"19","date":"2024-02-01T11:14:49","title":"简讯：我公司于2024年1月完成于中国的LZ901三期临床试验受试者入组","content":["我公司于2024年1月18日在联交所网站发布了自愿性公告，宣布我公司核心产品带状疱疹疫苗LZ901已在中国完成三期临床试验受试者入组，且超过98%的受试者已接受两剂LZ901注射液或安慰剂注射液。该三期临床试验目前已经进入病例积累阶段，在满足主要临床终点指标后将进行试验中期数据揭盲。","","请见2024年1月18日发布的公告信息：","","https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0118/2024011800892_c.pdf",""],"link":"/news/19","image":"/statics/banner2.jpeg","isNew":false},{"id":"18","date":"2023-10-13T11:37:11","title":"简讯：我公司于2023年9月启动核心产品重组带状疱疹疫苗LZ901在中国的三期临床试验并完成首批受试者入组","content":["我公司于2023年9月28日在联交所网站发布了自愿性公告，宣布我公司核心产品LZ901的多中心、随机、双盲、安慰剂对照设计，用于评价在40岁及以上成人中预防带状疱疹保护效力、安全性的Ⅲ期临床试验已于中国正式启动，并已完成首批受试者入组。","","本次临床试验将在江苏、山东、湖北及山西共四个省份开展，计划入组约26,000例40岁及以上健康受试者。","","请见2023年9月28日发布的公告信息：","","https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0928/2023092800726_c.pdf"],"link":"/news/18","image":"/statics/banner1.jpeg","isNew":false},{"id":"17","date":"2023-10-13T11:34:51","title":"简讯：我公司于日本取得核心产品重组带状疱疹疫苗LZ901的发明专利注册证书","content":["我公司收到日本知识产权局于2023年8月25日下发的“一种重组水痘带状疱疹病毒疫苗”发明专利注册证书。目前，我公司核心产品重组带状疱疹疫苗LZ901已于中国、俄罗斯及日本取得发明专利。"],"link":"/news/17","image":"/statics/banner1.jpeg","isNew":false},{"id":"16","date":"2023-05-30T17:00:00","title":"简讯：我公司于2023年5月完成核心产品带状疱疹疫苗LZ901在中国的临床二期试验","content":["我公司于2023年5月30日在联交所网站发布了自愿性公告，宣布于中国进行的LZ901的II期临床试验已于2023年5月成功完成。试验结果具有统计学和临床意义，并表现出良好的安全性。","本公司正在中国推进LZ901的多中心、随机、双盲及安慰剂对照III期临床试验，并争取尽早开始。","请见2023年5月30日发布的公告信息：","https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0530/2023053000375_c.pdf",""],"link":"/news/16","image":"/statics/banner2.jpeg","isNew":false},{"id":"15","date":"2023-02-13T00:00:00","title":"简讯：我公司于2023年2月13日递交了港股IPO申请表格","content":["我公司于2023年2月13日递交了港股IPO申请表格，本次更新公布了公司在研核心产品--重组带状疱疹疫苗（LZ901）的Ⅰ期临床试验数据。","请见2023年2月13日发布信息：","https://www1.hkexnews.hk/app/appindex.html?lang=zh",""],"link":"/news/15","image":"/statics/banner1.jpeg","isNew":false},{"id":"14","date":"2022-11-11T00:00:00","title":"简讯：我公司获得中国证监会关于首次公开发行境外上市外资股批复","content":["我公司于2022年11月11日获得中国证监会关于首次公开发行境外上市外资股（H股）及境内未上市股份全流通的批复。","我们将根据香港联交所的聆讯进度安排及资本市场状况择机发行。",""],"link":"/news/14","image":"/statics/banner1.jpeg","isNew":false},{"id":"13","date":"2022-04-19T00:00:00","title":"绿竹生物应用龙沙GS Xceed<sup>®</sup>基因表达系统研发重组带状疱疹疫苗和双特异性抗体","content":["瑞士巴塞尔和中国北京，2022年4月19日——威尼斯37000cm官网（绿竹生物）与龙沙（制药、生物技术和营养行业的全球开发和生产合作伙伴）已签署研究和商业许可协议，授权绿竹生物使用龙沙GS Xceed®基因表达系统和GS piggyBac®转座子技术。绿竹生物是一家生物制药公司，致力于研发用于预防、控制和治疗人类疾病的疫苗和治疗性双特异性抗体。","绿竹生物LZ901重组带状疱疹疫苗获得临床试验批件，适合50岁以上易感成人接种。LZ901疫苗由在CHO细胞中表达的重组水痘带状疱疹病毒糖蛋白E制成，不含防腐剂和抗生素。此外，绿竹生物的K193抗体注射液目前也进入临床试验阶段，它是一种同时靶向人CD19和CD3的双特异性抗体，主要用于治疗复发性或难治性B细胞非霍奇金淋巴瘤以及复发性或难治性B细胞白血病。LZ901疫苗和K193抗体均采用龙沙GS Xceed®基因表达系统表达。","与龙沙签署授权协议之后，绿竹生物即可利用GS Xceed®基因表达系统，研发可扩展、稳定且可靠的表达工艺。绿竹生物充分认识到，运用龙沙GS Xceed®基因表达系统可以稳定表达其研发的疫苗和治疗性双特异性抗体。目前，GS Xceed®基因表达系统工具箱还包括GS piggyBac®转座子技术，该技术优先靶向基因组的高转录活性区域。","https://pharma.lonza.com/offerings/specialized-capabilities/expressions-technologies/GS-piggyBac","龙沙授权许可和制剂服务部门负责人Peter Droc表示：“绿竹生物的创新候选药物进入临床试验阶段，标志着在新一代抗体分子和疫苗研发领域迈进了一大步。龙沙致力于开发有助于适应行业趋势的表达系统。我们采用灵活多变的模式，适合各种产品类型，便于用户在内部使用经授权的技术平台。”","绿竹生物首席执行官孔健指出：“龙沙GS Xceed®基因表达系统是一种易于使用的哺乳动物细胞蛋白表达系统。我们已经通过该系统成功表达和生产了多种重组双特异性抗体和病毒蛋白。GS Xceed®系统表达的病毒抗原有优异的免疫活性，糖基化类型很好地涵盖了现有的病毒蛋白类型。此外，免疫学研究结果表明，利用龙沙GS Xceed®表达系统研发的重组带状疱疹疫苗可以刺激动物的免疫系统，从而产生良好的细胞免疫和体液免疫。”","<b>关于LONZA</b>","龙沙是全球制药、生物技术与营养市场的优秀合作伙伴。 我们致力于助力客户推出创新药物辅助治疗一系列的疾病，成就更健康的世界。为达成这一使命，我们将先进生产制造、科学专业技术、卓越工艺及技术洞察力完美结合。我们全方位的产品与服务帮助客户在医疗保健行业的发现与创新成果实现商业化。","1897年，龙沙诞生于瑞士的阿尔卑斯山脉地区。发展至今，业务已遍及全球五大洲。 我们拥有约16,000名全职员工，由他们组成的高效团队及每一名员工都为我们的业务和所在地区及国家做出意义非凡的改变。2021年，公司销售额达54亿瑞士法郎，核心业务的息税折旧摊销前利润（EBITDA）达17亿瑞士法郎。更多详情，请访问: https://www.lonza.com","<b>关于绿竹生物</b>","威尼斯37000cm官网（绿竹生物）成立于2001年11月，致力于在人类医学领域取得卓越成就。绿竹生物专注研发用于预防、控制和治疗人类疾病的疫苗和治疗性双特异性抗体，拥有一支强大的研发团队，利用先进一流的技术开发和生产满足临床需求的各类生物制品。","绿竹生物成立后的首个10年内，成功研发出了3种多糖蛋白结合疫苗、2种多糖疫苗和1种病毒灭活疫苗，此6种疫苗产品均转让给了北京智飞绿竹生物制药有限公司。公司自2009年开始进行人用单克隆抗体、双特异性抗体药物、重组病毒疫苗的研究，之后陆续获得了相应候选药物的临床批件。公司将充分利用已经建立的定向抗原呈递技术开发多种病毒性疫苗，同时利用自主开发的双功能抗体平台技术（注册商标Fabite®），开发多种用于人类血液系统恶性肿瘤治疗用的双特异性抗体药物。",""],"link":"/news/13","image":"/statics/banner2.jpeg","isNew":false},{"id":"12","date":"2021-08-30T00:00:00","title":"绿竹生物完成3.5亿人民币B轮融资","content":["2021年8月30日，威尼斯37000cm官网宣布完成3.5亿人民币的B轮融资。本轮融资由建银国际、两家A+H股上市公司泰格医药和丽珠医药旗下的投资主体，及其他多家投资机构进行战略投资。","此轮融资资金将主要用于公司自主创新药物重组带状疱疹疫苗的临床试验研究，以及用于治疗复发性/难治性B细胞白血病（ALL）和治疗复发性/难治性B细胞非霍奇金淋巴瘤（NHL）的双功能抗体CD19-CD3的临床研究以及人用疫苗生产基地的建设。",""],"link":"/news/12","image":"/statics/banner3.jpeg","isNew":false},{"id":"11","date":"2021-08-03T00:00:00","title":"获得“重组带状疱疹疫苗（CHO细胞）”药物临床试验批准通知书","content":["2021年8月3日获得“重组带状疱疹疫苗（CHO细胞）”药物临床试验批准通知书，通知书编号：2021LP01212。","重组带状疱疹疫苗（CHO细胞）用于预防带状疱疹病毒感染，适用于40岁以上易感成人。","本品系由重组CHO细胞表达的水痘带状疱疹病毒糖蛋白E，经细胞培养、分离和纯化、病毒灭活后获得的蛋白，加入氢氧化铝佐剂制成。为乳白色混悬液体，可因沉淀而分层，易摇散。不含防腐剂和抗生素。",""],"link":"/news/11","image":"/statics/banner3.jpeg","isNew":false},{"id":"10","date":"2019-04-19T00:00:00","title":"获得“K193抗体注射液”药品临床试验通知书","content":["2019年4月19日获得“K193抗体注射液”药品临床试验通知书，K193抗体是针对人CD19和CD3双特异性抗体，主要用于治疗复发性或难治性B细胞非霍奇金淋巴瘤以及复发性或难治性白血病（ALL）。","K193抗体是在LONZA公司的最新一代GS Xceed表达载体在CHO K1 SV GS-KO细胞中表达的。K193细胞的克隆筛选过程一直在化学成分限定培养基中（CD CHO）进行，未使用任何含血清或动物来源成分的培养基，不存在任何外源因子污染的来源；摇瓶培养、罐培养所使用的培养基均为化学成分限定培养基；纯化工艺采用了亲和色谱、低pH孵育灭活病毒、离子交换色谱去除DNA和HCP，最后经除病毒纳米滤膜过滤病毒，添加不含蛋白质的特殊稳定剂，稀释到适当浓度后制成注射液。K193抗体注射液中单体含量达到98%（二聚体含量小于5%）。每剂K193抗体注射液中DNA的残留量不到1pg，HCP的残留量小于0.01%。产品生产工艺经严格的验证可以有效地去除病毒的污染，尽最大的可能性保证了药物使用的安全性。",""],"link":"/news/10","image":"/statics/banner1.jpeg","isNew":false},{"id":"9","date":"2018-12-27T00:00:00","title":"关于提名2019年度国家科学技术奖项目的公示","content":["由我单位与北京智飞绿竹生物制药有限公司共同完成的“一种新型流脑-流感嗜血杆菌联合疫苗的开发及应用”项目提名2019年度国家科学技术进步奖二等奖。根据《国家科学技术奖励工作办公室关于2019年度国家科学技术奖提名工作的通知》（国科奖字【2018】41号）要求，现将该项目进行公示。","自本公示之日起7日内，如对公示内容有异议，请您在异议期内以书面形式或电话联系外事企发部。逾期不予受理。","联系人：张琰平","联系电话：010-61568563、13601305699","联系地址：北京通州工业开发区广通街3号",""],"link":"/news/9","image":"/statics/banner1.jpeg","isNew":false},{"id":"8","date":"2018-11-29T00:00:00","title":"成立全资子公司—绿竹生物制药（珠海市）有限公司","content":["2018年11月29日，公司在珠海市金湾区成立全资子公司绿竹生物制药（珠海市）有限公司，占地面积105亩。",""],"link":"/news/8","image":"/statics/banner2.jpeg","isNew":false},{"id":"7","date":"2017-12-29T00:00:00","title":"获得“肠道病毒71型灭活疫苗”药物临床试验批件","content":["公司于2007年开始EV71灭活疫苗的研究，是国内最早开展EV71疫苗研究的机构，2011年申报临床研究，2018年12月29日NMPA批准进入I/II期临床研究。采用VERO细胞培养，精制纯化的灭活EV71疫苗，纯度达700U/μg以上，此项目已转让给智飞生物(300122.SZ)，目前处于II期临床研究阶段。",""],"link":"/news/7","image":"/statics/banner2.jpeg","isNew":false},{"id":"6","date":"2017-11-07T00:00:00","title":"生物类似药抗人肿瘤坏死因子-α单抗注射液获得临床批件","content":["抗人肿瘤坏死因子-α单抗注射液，为修美乐（Humira，阿达木单抗）的生物类似药，主要用于类风湿关节炎的治疗，此外还能治疗强直性脊柱炎，斑块型银屑病、银屑病关节炎、溃疡性结肠炎等多种自身免疫性疾病。","自2010年开始研究该产品，为本公司开发的第1个全人源单抗药物， 2016年7月份申报了新药临床试验；本项目已完成的实验证明按照阿达木单抗的质检标准进行检验K3单抗各项指标均符合规定，达到了阿达木同等的质量要求，已完成的动物实验的结果表明也表明K3单抗与阿达木单抗无差异。2017年11月份获得CFDA批准的药物临床试验批件。","阿达木单抗（修美乐）是欧美批准的第一个全人源单抗，是目前在用的各种抗体制剂中安全性最好的单克隆抗体制剂，由于该抗体的氨基酸序列完全来源于人抗体库，在人体内应用时被人体的免疫系统视为自身的蛋白质，产生抗体的机会降到了最低，优良的分子设计最大限度的提升了该抗体在人体内使用时的安全性。它与其他的TNF-拮抗剂相比，还有剂量小、注射次数少、效果好、可自行注射等优点。",""],"link":"/news/6","image":"/statics/banner3.jpeg","isNew":false},{"id":"5","date":"2017-04-13T00:00:00","title":"生物类似药人源化抗VEGF单抗注射液获得临床批件","content":["人源化抗VEGF单抗注射液，为安维汀（Avastin，贝伐珠单抗）仿制药，主要用于治疗肺癌、结肠癌、直肠癌。该产品自2015年7月申报临床研究，2017年4月13日获得临床研究批件（生物类似药只进行I、III期临床研究）。","安维汀国内已有进口，但其昂贵的治疗费用大大限制了国内患者获得这一先进治疗方案的机会。",""],"link":"/news/5","image":"/statics/banner3.jpeg","isNew":false},{"id":"4","date":"2010-03-01T00:00:00","title":"A群C群脑膜炎球菌－b型流感嗜血杆菌多糖结合疫苗","content":["2002-2006年期间本公司和北京绿竹生物制药有限公司联合研究开发了AC群脑膜炎球菌-b型流感嗜血杆菌多糖结合疫苗，2006年1月注册新药临床研究，2007年6月完成I/II期临床研究。","2007年国家“863计划”现代医学技术专题课题。","2010年该产品正在进行III期临床研究。",""],"link":"/news/4","image":"/statics/banner1.jpeg","isNew":false},{"id":"3","date":"2008-05-01T00:00:00","title":"b型流感嗜血杆菌多糖（Ig）抗体酶联免疫检测试剂盒","content":["2004~2006年期间本公司研究开发b型流感嗜血杆菌多糖（Ig）抗体检测试剂盒（EILSA法）。采用间接酶联免疫吸附法，碱性磷酸酶标记抗人Ig抗体，定量检测人群血清中b型流感嗜血杆菌多糖（Ig）抗体含量检测。该试剂盒灵敏度为3.7毫微克/ ml。参比品含量与吸光值作四参数对数分析法，回归方程的拟合度R2≥0.95。产品的有效期长达12个月。",""],"link":"/news/3","image":"/statics/banner1.jpeg","isNew":false},{"id":"2","date":"2004-08-01T00:00:00","title":"A群/C群脑膜炎球菌多糖（Ig）抗体酶联免疫检测试剂盒","content":["2002~2003年期间本公司研究开发A群脑膜炎球菌多糖（Ig）抗体检测试剂盒（ELISA法）、C群脑膜炎球菌多糖（Ig）抗体检测试剂盒（ELISA法），采用间接酶联免疫吸附法，该试剂盒主要用于人群血清中A群／C群脑膜炎球菌多糖（Ig）抗体水平检测。A群脑膜炎球菌多糖（Ig）抗体检测试剂盒与血清杀菌力试验（SBA法）相比较，灵敏度为96.9，特异性为90.0％，一致性95.8％，阳性质控品的变异系数为4.3~5.3%。","2004年进一步优化条件，现为定量检测，灵敏度为10毫微克／ml。系列参比品的直线回归方程的相关系数＞0.98，产品的有效期长达12个月。主要用于人群血清中A群／C群脑膜炎球菌多糖（Ig）抗体含量检测。",""],"link":"/news/2","image":"/statics/banner2.jpeg","isNew":false},{"id":"1","date":"2001-11-09T00:00:00","title":"以人为本，精益求精","content":["2001年11月，北京绿竹生物技术有限责任公司注册成立，公司位于北京市通州工业开发区广通街3号。",""],"link":"/news/1","image":"/statics/banner1.jpeg","isNew":false}],"en":[{"id":"24","date":"2024-11-15T14:59:27","title":"Luzhu Biotech has obtained the Certificate of Invention Patent issued by China National Intellectual Property Administration for its bispecific antibody product K333","content":["Luzhu Biotech has received the Certificate of Invention Patent for \"a bispecific antibody that combines human CD33 and CD3\" issued by China National Intellectual Property Administration on November 15, 2024, with the patent number ZL202410503481.1.","","The obtaining of the patent certificate will further improve the company's intellectual property protection system, promote technological innovation, and enhance the company's core competitiveness.",""],"link":"/news/24","image":"/statics/banner2.jpeg","isNew":true},{"id":"23","date":"2024-09-18T13:18:02","title":"Luzhu Biotech has obtained the certificate of invention patent for its core product recombinant herpes zoster vaccine LZ901 in the Republic of Korea.","content":["Luzhu Biotech has received the certificate of invention patent for “Recombinant Varicella-Zoster Virus (VZV) Vaccine” issued by the Korean Intellectual Property Office on August 21, 2024. The patent number is 10-2698706.","","At present, Luzhu Biotech has obtained invention patent certificates for its core product recombinant VZV vaccine (LZ901) in China, Russia, Japan, Australia, the United States, and the Republic of Korea.",""],"link":"/news/23","image":"/statics/banner1.jpeg","isNew":true},{"id":"22","date":"2024-09-13T13:42:53","title":"Interim Results Conference of Luzhu Biotech was held successfully on September 12, 2024","content":["The Interim Results Conference of Luzhu Biotech was successfully held on September 12, 2024, with variety of professional institutions participating in the online conference and raising questions enthusiastically. The management team answered the questions raised by investors in detail, taking into account the progress of the Company's pipeline and the current market situation. The Company will continue to communicate with investors in great breadth and depth, actively return the support and trust of investors, and promote the company's high-quality development.",""],"link":"/news/22","image":"/statics/banner3.jpeg","isNew":false},{"id":"21","date":"2024-07-05T13:36:17","title":"Luzhu Biotech has successfully completed the registration of invention patent for its core product recombinant herpes zoster vaccine LZ901 in the US and Australia","content":["Luzhu Biotech has received the invention patent registration license for “Recombinant Varicella-Zoster Virus(VZV) Vaccine” issued by the United States Patent and Trademark Office on the date of May 28th, 2024. In addition, on April 4th, 2024, Luzhu Biotech has also received the registration license for “Recombinant Varicella-Zoster Virus(VZV) Vaccine” issued by the Patent Office of Australia.","","Currently, Luzhu Biotech has obtained invention patent registration license for its core product recombinant varicella-zoster virus vaccine LZ901 in China, Russia, Japan, Australia and the US.",""],"link":"/news/21","image":"/statics/banner3.jpeg","isNew":false},{"id":"20","date":"2024-02-01T11:32:17","title":"Luzhu Biotech has completed the H share full circulation","content":["Luzhu Biotech issued an announcement to the Hong Kong Stock Exchange on January 31, 2024, announcing that the H share full circulation programme of an aggregate of 59,729,296 unlisted","shares of Luzhu Biotech has received the filing notice issued by the CSRC and the listing approval granted by the Stock Exchange respectively, and the H share conversion was completed on January 31, 2024 and the listing of such converted H shares on the Stock Exchange will commence at 9:00 a.m. on February 1, 2024.","","Please refer to the announcement released on January 31, 2024:","","https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0131/2024013100752.pdf",""],"link":"/news/20","image":"/statics/banner2.jpeg","isNew":false},{"id":"19","date":"2024-02-01T11:14:49","title":"Luzhu Biotech has completed the enrollment of subjects for phase III clinical trial of LZ901 in the PRC","content":["Luzhu Biotech has completed the enrollment of subjects for phase III clinical trial of LZ901 in the PRC","","Luzhu Biotech issued a voluntary announcement to the Hong Kong Stock Exchange on January 18, 2024, announcing that LZ901, the core product of Luzhu Biotech, has completed the enrollment of subjects for its Phase III clinical trial in the People’s Republic of China, and more than 98% subjects have received two doses of LZ901 injection or placebo injection, as the case may be. The Phase III clinical trial will now proceed to case collection, and will proceed to interim unblinding work of the trial data after the primary endpoints of the trial are being met.","","Please refer to the announcement released on January 18, 2024:","","https://www1.hkexnews.hk/listedco/listconews/sehk/2024/0118/2024011800891.pdf",""],"link":"/news/19","image":"/statics/banner2.jpeg","isNew":false},{"id":"18","date":"2023-10-13T11:37:11","title":"Luzhu Biotech initiated a Phase Ⅲ clinical trial of its core product recombinant herpes zoster vaccine LZ901 in China in September 2023 and the enrollment of first group of subjects has been completed","content":["Luzhu Biotech issued a voluntary announcement to the Hong Kong Stock Exchange on September 28th , 2023, announcing that the multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical trial of LZ901, the core product of Luzhu Biotech, has been initiated in the People’s","Republic of China, to evaluate the efficacy and safety profile of LZ901 for the prevention of herpes zoster in adults aged 40 years and older, with the first group of subjects having been enrolled.","","The clinical trial will be conducted in four provinces including Jiangsu, Shandong, Hubei and Shanxi, with a planned enrollment of approximately 26,000 healthy subjects aged 40 years and older.","","Please refer to the announcement released on September 28th , 2023:","","https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0928/2023092800725.pdf",""],"link":"/news/18","image":"/statics/banner1.jpeg","isNew":false},{"id":"17","date":"2023-10-13T11:34:51","title":"Luzhu Biotech has newly secured registration of the invention patent for its core product recombinant herpes zoster vaccine LZ901 in Japan","content":["Luzhu Biotech has received the registration license for “A recombinant varicella-zoster virus vaccine” issued by the Department of Intellectual Property of Japan on the date of August 25th, 2023. Currently, the invention patent for the core product recombinant herpes zoster vaccine LZ901 of Luzhu Biotech has been granted in the People’s Republic of China, Russia and Japan."],"link":"/news/17","image":"/statics/banner1.jpeg","isNew":false},{"id":"16","date":"2023-05-30T17:00:00","title":"Luzhu Biotech completed the phase II clinical trial of the core product Recombinant Herpes Zoster Vaccine (LZ901) in China","content":["Our company issued a voluntary announcement to the Hong Kong Stock Exchange on May 30, 2023, announcing that the phase II clinical trial of LZ901 in China has been successfully completed in May 2023.","The test results were statistically and clinically significant, and showed good safety profile. The company is promoting the multi-center, randomized, double-blind and placebo-controlled phase III clinical trial of LZ901 in China, and strives to start as soon as possible.","Please refer to the information released on May 30, 2023.","https://www1.hkexnews.hk/listedco/listconews/sehk/2023/0530/2023053000375_c.pdf",""],"link":"/news/16","image":"/statics/banner2.jpeg","isNew":false},{"id":"15","date":"2023-02-13T00:00:00","title":"Luzhu Biotech submitted the Hong Kong Stock Exchange IPO application form on February 13, 2023.","content":["Luzhu Biotech submitted the Hong Kong Stock Exchange IPO application form on February 13, 2023. This update announces the Phase I clinical trial data of our core product under development - Recombinant Shingles Vaccine (LZ901).","Please refer to the information released on February 13, 2023.","https://www1.hkexnews.hk/app/appindex.html?lang=zh",""],"link":"/news/15","image":"/statics/banner1.jpeg","isNew":false},{"id":"14","date":"2022-11-11T00:00:00","title":"Luzhu Biotech has received approval from the China Securities Regulatory Commission for the initial public offering of overseas-listed foreign shares","content":["Beijing Luzhu Biotechnology Co., Ltd. has received approval from the China Securities Regulatory Commission for the initial public offering of overseas-listed foreign shares (H shares) and the full circulation of unlisted shares domestically on November 11th, 2022.","We will arrange the issuance based on the progress of the Hong Kong Stock Exchange's hearing and the capital market conditions.",""],"link":"/news/14","image":"/statics/banner1.jpeg","isNew":false},{"id":"13","date":"2021-08-30T00:00:00","title":"Luzhu Biotech Develops Recombinant Herpes Zoster Vaccine and Bispecific Antibody using Lonza’s GS Xceed<sup>®</sup> Gene Expression System","content":["Basel, Switzerland and Beijing, China, 19 April 2022 – Beijing Luzhu Biotechnology Co., Ltd. (Luzhu Biotech), and Lonza, a global development and manufacturing partner to pharma, biotech and nutritional industries, have entered a research and commercial license agreement for Luzhu to use Lonza’s GS Xceed® Gene Expression System with GS piggyBac® transposon technology. Luzhu Biotech is a biopharmaceutical company committed to research and development of a diverse pipeline of drug candidates for human disease prevention, control, and treatment.","Luzhu Biotech obtained clinical trial approval for its LZ901 Recombinant Herpes Zoster Vaccine used to prevent the infection of herpes zoster virus and suitable for susceptible adults over 50 years old. Made from recombinant varicella zoster virus glycoprotein E expressed in CHO cells, the LZ901 vaccine is free of preservatives and antibiotics. Luzhu Biotech is also in a clinical trial with its K193 Antibody Injection, a bispecific antibody against human CD19 and CD3 mainly used for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma and relapsed or refractory B cell leukemia. Both the LZ901 vaccine and K193 antibody are expressed using Lonza’s GS Xceed® technology.","The licensing agreement with Lonza ensures Luzhu Biotech’s access to the GS Xceed® Gene Expression System, providing for the development of scalable, robust, and reliable expression processes. Luzhu Biotech noted stable expression of their vaccine and therapeutic bispecific antibody using Lonza's GS Gene Expression System®. The GS Xceed® Expression System toolbox now also includes GS piggyBac® transposon technology that preferentially targets stable regions of the genome associated with highly expressed genes.","https://pharma.lonza.com/offerings/specialized-capabilities/expressions-technologies/GS-piggyBac","Peter Droc, Head of Licensing and Drug Product Services, Lonza, commented: “Luzhu Biotech’s innovative candidates moving to clinical trials is a great step forward in next-generation molecules and vaccine development. At Lonza, we are committed to developing a toolbox of expression systems that help accommodate industry trends. Our flexible model suits all business types such that they can license the technology platform for use in-house.”","Jian Kong, CEO of Luzhu Biotech, commented: “Lonza's GS Xceed expression system is an easy-to-use mammalian cell protein expression system. We have successfully expressed and produced a variety of recombinant bispecific antibodies and viral proteins by this system. The viral antigens expressed by the GS Xceed® system show superior immunogenicity and the glycosylation type covers the kinds of viral proteins already available quite well. Immunological results also showed that the recombinant herpes zoster vaccine utilizing Lonza’s GS Xceed® Expression System could stimulate the immune system of animals to induce good cellular immunity and humoral immunity.”","<b>About Lonza</b>","Lonza is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.","Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021. Find out more at www.lonza.com.","<b>About Luzhu</b>","Established in November 2001, Beijing Luzhu Biotechnology Co., Ltd.(Luzhu Biotech) aims to excel in human medicine. With a focus on the research and development of vaccine and therapeutic bispecific antibody for human disease prevention, control and treatment, Luzhu Biotech has a strong research team that utilizes state-of-the-art technologies to develop and produce various biological products that meet clinical needs.","Within 10 years since its establishment, Luzhu Biotech has successfully developed 3 polysaccharide protein conjugate vaccines, 2 polysaccharide vaccines and 1 virus inactivated vaccine, all of which have been licensed to Beijing Zhifei Luzhu Biopharmaceuticals Co., Ltd. In 2009, Luzhu Biotech began the research on human monoclonal antibodies, bispecific antibodies, and recombinant virus vaccines, subsequently obtaining clinical approvals for their candidates. Using well-established targeted antigen presentation technologies to develop a variety of viral vaccines, and Fabite®, a bifunctional antibody platform technology developed in-house, Luzhu Biotech will continue to develop a variety of bispecific antibodies for the treatment of human hematological malignancies.",""],"link":"/news/13","image":"/statics/banner2.jpeg","isNew":false},{"id":"12","date":"2021-08-30T00:00:00","title":"Luzhu Biotech completed Series B financing of CNY 350 million","content":["On August 30, 2021, Beijing Luzhu Biotechnology Co., Ltd. announced the completion of Series B financing of CNY 350 million. This round of financing was strategically invested by CCB international, the investment entities of two A+H-share listed companies, Tigermed and Livzon Pharmaceutical, and followed by a number of investment firms.","The fund raised during this round of financing will mainly be used for the clinical trial of our innovative Recombinant Herpes Zoster Vaccine and our bispecific CD19-CD3 antibody, used for the treatment of relapsed/refractory B-cell leukemia (ALL) and non-Hodgkin's lymphoma (NHL). The fund will also be used for the construction of a human vaccine production plant.",""],"link":"/news/12","image":"/statics/banner3.jpeg","isNew":false},{"id":"11","date":"2021-08-03T00:00:00","title":"Luzhu Biotech obtained clinical trial approval for 'Recombinant Herpes Zoster Vaccine (CHO cells)'","content":["On August 3, 2021, Luzhu Biotech obtained clinical trial approval for 'Recombinant Herpes Zoster Vaccine (CHO cells)' (Approval number is 2021LP01212).","Recombinant Herpes Zoster Vaccine (CHO cells) is used to prevent the infection of herpes zoster virus and is suitable for susceptible adults over 40 years old.","This product is made of recombinant varicella zoster virus glycoprotein E expressed in CHO cells, obtained after cell culture, protein isolation and purification, virus inactivation and aluminum hydroxide adjuvant addition. It is a milky suspension, which may precipitate but easy to resuspend by shaking. The vaccine is free of preservatives and antibiotics.。",""],"link":"/news/11","image":"/statics/banner3.jpeg","isNew":false},{"id":"10","date":"2019-04-19T00:00:00","title":"Obtained clinical trial approval for 'K193 Antibody Injection'","content":["On April 19, 2019, Luzhu Biotech obtained clinical trial approval for 'K193 Antibody Injection'. K193 antibody is a bispecific antibody against human CD19 and CD3 and is mainly used for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma and relapsed or refractory leukemia (ALL).","The K193 antibody was expressed in CHO K1 SV GS-KO cells using LONZA's latest generation of GS Xceed vector. Cloning and selection of K193-producing cells, as well as large scale K193 production in bioreactors, were carried out in chemically defined CD CHO medium that is free of serum, animal-derived components, or contaminating factors. K193 was purified using affinity chromatography, followed by low pH incubation to inactivate the virus, ion exchange chromatography to remove DNA and host cell proteins, and ultrafiltration to remove the virus. A special protein-free stabilizer is added to the purified antibody, and the mixture is diluted to an appropriate concentration for injection. The monomer content in K193 antibody injection reached 98% (dimer and higher aggregates < 5%). In each dose of K193 Antibody Injection, residual DNA and host cell proteins was < 1pg and < 0.01%, respectively. This rigorously validated production process effectively removes contaminating virus to ensure safety of the drug.",""],"link":"/news/10","image":"/statics/banner1.jpeg","isNew":false},{"id":"9","date":"2018-12-27T00:00:00","title":"Announcement on the nomination of the 2019 National Science and Technology Award","content":["The project entitled 'Development and Application of a novel Meningococcal-Haemophilus Influenzae Conjugate Vaccine' jointly completed by Luzhu Biotech and Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd., was nominated for the second prize of the 2019 National Science and Technology Progress Award. Details of the project are now given per the requirements stated in the 'Notice of the National Science and Technology Award Office on the Nomination of the National Science and Technology Award in 2019' (National Award [2018] No. 41).","Within 7 days from the date of this announcement, if you have any objections, please contact the Department of External Affairs in writing or by phone. Objections after the 7-day period will not be accepted.","Contacts: Yanping Zhang","Tel.: 010-61568563、13601305699","Add.: No. 3 Guangtong Street, Industrial Development Zone, Tongzhou District, Beijing",""],"link":"/news/9","image":"/statics/banner1.jpeg","isNew":false},{"id":"8","date":"2018-11-29T00:00:00","title":"Luzhu Biotech established a wholly-owned subsidiary—Luzhu Biopharmaceuticals (Zhuhai) Co., Ltd.","content":["At the end of 2018, Luzhu Biopharmaceuticals (Zhuhai) Co., Ltd. a wholly-owned subsidiary, was established in Jinwan District, Zhuhai City, covering an area of 70,000 square meters. The subsidiary focuses on the production of vaccines and biologics, and is committed to building a high-standard and modern biopharmaceutical industrialization base.",""],"link":"/news/8","image":"/statics/banner2.jpeg","isNew":false},{"id":"7","date":"2017-12-29T00:00:00","title":"Luzhu Biotech obtained clinical trial approval for Inactivated Enterovirus 71 Vaccine","content":["Luzhu Biotech, being the first in China to do so, began the study of Inactivated EV71 Vaccine in 2007. Clinical trial application was submitted in 2011, which was approved on December 29, 2018 by NMPA for Phase I/II clinical study. The purified Inactivated EV71 vaccine, cultured in Vero cells, has a purity of over 700U/g. This project has been licensed to Zhifei Biopharma (300122.SZ) and Phase II clinical trial is currently ongoing.",""],"link":"/news/7","image":"/statics/banner2.jpeg","isNew":false},{"id":"6","date":"2017-11-07T00:00:00","title":"Luzhu Biotech obtained clinical trial approval for Biosimilar Anti-human Tumor Necrosis Factor-α Monoclonal Antibody Injection","content":["Anti-human Tumor Necrosis Factor-α (TNF) Monoclonal Antibody Injection, a biosimilar of Humira (adalimumab), is mainly used for the treatment of rheumatoid arthritis, in addition to the treatment of ankylosing spondylitis and plaque psoriasis, psoriatic arthritis, ulcerative colitis and many other autoimmune diseases.","Development of K3, the first fully human monoclonal antibody developed in Luzhu Biotech, began in 2010. The clinical trial application for this innovative drug was submitted in July 2016; Our data showed that K3 met all specifications of adalimumab. Animal studies also showed that K3 and adalimumab had similar efficacy. Clinical trial approval was obtained from CFDA (renamed as NMPA) in November 2017.","Adalimumab (Humira) is the first fully human monoclonal antibody approved in Europe and the United States. Fully human monoclonal antibody is the safest among other antibody preparations currently in use. Since the antibody has an amino acid sequence completely derived in the human antibody library, the human immune system regards it as its own protein so that the chance of producing blocking antibodies is minimized. The excellent molecular design maximizes the safety of the antibody in human. Compared with other TNF-antagonists, it has the advantages of lower dose, fewer injections, more efficacious, and self-injectable.",""],"link":"/news/6","image":"/statics/banner3.jpeg","isNew":false},{"id":"5","date":"2017-04-13T00:00:00","title":"Luzhu Biotech obtained clinical trial approval for Biosimilar Humanized Anti-VEGF Monoclonal Antibody Injection","content":["Humanized Anti-VEGF Monoclonal Antibody Injection, which is a generic drug of Avastin (bevacizumab), is mainly used to treat lung, colon, and rectal cancer. The clinical trial application for this product was submitted in July 2015, which received approval on April 13, 2017 (biosimilar drugs only undergo phase I and III clinical study).","Avastin is available in China, but its high treatment costs greatly limit the number of patients who can afford this treatment regime.",""],"link":"/news/5","image":"/statics/banner3.jpeg","isNew":false},{"id":"4","date":"2010-03-01T00:00:00","title":"Group A/C Meningococcal - Haemophilus Influenzae Type b Polysaccharide Conjugate Vaccine","content":["During 2002-2006, Luzhu Biotech and Beijing Luzhu Biopharmaceuticals Co., Ltd. jointly developed the Group A/C Meningococcal-Haemophilus Influenzae Type b Polysaccharide Conjugate Vaccine. The clinical study for this vaccine was registered in January 2006, and the phase I/II clinical studies were completed in June 2007.","In 2007, this product was included in the modern medical technology section of national '863 Program'.","The product underwent phase III clinical study in 2010.",""],"link":"/news/4","image":"/statics/banner1.jpeg","isNew":false},{"id":"3","date":"2008-05-01T00:00:00","title":"Enzyme-linked immunoassay kit for haemophilus influenzae type b polysaccharide (Ig) antibody","content":["From 2004 to 2006, Luzhu Biotech developed a detection kit for haemophilus influenzae type b polysaccharide (Ig) antibody (ELISA). The amount of haemophilus influenzae type b polysaccharide (Ig) antibody in serum was detected quantitatively using indirect ELISA and alkaline phosphatase-labeled anti-human Ig antibody. Sensitivity of the kit was 3.7 ng/ml. Absorbance of the standards were analyzed using four-parameter logistics, and the fit of the regression was R2≥0.95. The product has a long shelf life of 12 months.",""],"link":"/news/3","image":"/statics/banner1.jpeg","isNew":false},{"id":"2","date":"2004-08-01T00:00:00","title":"Enzyme-linked immunoassay kit for Group A/C Meningococcal Polysaccharide (Ig) Antibody","content":["From 2002 to 2003, Luzhu Biotech developed detection kits for Group A Meningococcal Polysaccharide (Ig) Antibody (ELISA) and Group C Meningococcal Polysaccharide (Ig) Antibody (ELISA) using indirect ELISA. This kit is used to detect the level of group A and group C meningococcal polysaccharide (Ig) antibodies in human serum. Compared with the serum bactericidal assay (SBA), sensitivity of the detection kit for Group A Meningococcal Polysaccharide (Ig) Antibody was 96.9, specificity was 90.0%, consistency was 95.8%, and the coefficient of variation of the positive control was 4.3~ 5.3%.","After further optimization in 2004, detection is now quantitative, with a sensitivity of 10 ng/ml. Correlation coefficient of linear regression of the standard curve was > 0.98, and the shelf life of this product is 12 months.",""],"link":"/news/2","image":"/statics/banner2.jpeg","isNew":false},{"id":"1","date":"2001-11-09T00:00:00","title":"Excel in Human Medicine","content":["In November 2001, Beijing Luzhu Biotechnology Co., Ltd. was registered and established. Its headquarters is located at No. 3 Guangtong Street, Industrial Development Zone, Tongzhou District, Beijing.",""],"link":"/news/1","image":"/statics/banner1.jpeg","isNew":false}]},"charterList":{"cn":[{"title":"薪酬委员会职权范围","file":"https://forweb105.oss-cn-beijing.aliyuncs.com/%E8%96%AA%E9%85%AC%E5%A7%94%E5%91%98%E4%BC%9A%E8%81%8C%E6%9D%83%E8%8C%83%E5%9B%B4.pdf","date":"2022-02-28T00:00:00"},{"title":"提名委员会职权范围","file":"https://forweb105.oss-cn-beijing.aliyuncs.com/%E6%8F%90%E5%90%8D%E5%A7%94%E5%91%98%E4%BC%9A%E8%81%8C%E6%9D%83%E8%8C%83%E5%9B%B4.pdf","date":"2022-02-28T00:00:00"},{"title":"审核委员会职权范围","file":"https://forweb105.oss-cn-beijing.aliyuncs.com/%E5%AE%A1%E6%A0%B8%E5%A7%94%E5%91%98%E4%BC%9A%E8%81%8C%E6%9D%83%E8%8C%83%E5%9B%B4.pdf","date":"2022-02-28T00:00:00"}],"en":[{"title":"Terms of Reference of the Remuneration 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