复宏汉霖质量再获认可！松江生产基地通过欧盟QP认证，符合欧盟GMP要求

发布时间:2022-06-21 主要内容的来出自于： 浏览量：

方式渠道于：复宏汉霖

不过近期，复宏汉霖在北京的松江国防教育营地（一）按照欧洲经济共同体制剂质理受权人（Qualified Person, QP）认真，即日起收获QP核发的贴合性声明公告，松江国防教育营地（一）与配备的质理方法规范标准贴合欧洲经济共同体制剂生產质理方法规范化（GMP）追求。明年4月，该国防教育营地都已经按照北京市制剂远程监控方法局的GMP认真，明年就在今年1月份和3月几次QP审计工作的顺利完成按照是对复宏汉霖高规范标准质理规范标准的不断地性喜爱。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

根据Eudralex Vol 4有关系法律相关法律法规（欧州经济共同体GMP）还有其附则已经国际英文人药物治疗品登陆高技术组织协调会（ICH）等培训条件，QP对松江园区面积（一）原液、药品工作销售线及物品品质处理安全体系开始了全部的程序性核查。使用欧州经济共同体QP认证服务标准着该园区面积适用欧州经济共同体GMP有关系的有关系法律相关法律法规需求，其工作销售的HLX04-O（合拼抗VEGF人源化单克隆抗原打瘦脸针液）、HLX11（帕妥珠单抗怪物有些相似药）、HLX14（地舒单抗怪物有些相似药）等物品能能在欧州开始诊疗实验。

松江基地（一）是复宏汉霖第二个商业化生产基地，按照中国、欧盟和美国的质量标准建设，共拥有产能24000L。2022年5月，该基地获得中国国家药品监督管理局（NMPA）批准用于汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）的商业化生产，为满足日益增长的产品需求提供有力保障。此外，基地不断优化生产工艺、精益应用先进生产技术，实现生产的高度协同和降本增效，为产品创造更多附加值，持续提升市场竞争力，引领企业高质量可持续发展。

满足全球产能需求

持续完善生产体系建设

有限有限总部以全球排名前沿的服务开发量强势和“汉霖”服务为整体布局进步灌入和动力，此前筹划建造三座服务开发工厂，筹划总服务开发量达144000L，除松江工厂（一）之中，还主要包括已开工自动运行的徐汇工厂和建造中的松江工厂（二）。有限有限总部服务开发工厂及整套搭配的安全性能标准化工作制度已完成NMPA、欧洲其他国家保健药品标准化工作局、QP、有限有限总部全球排名餐饮业合伙同伴去的好多项实地调研清查及财务审计。中仅，徐汇工厂总数餐饮业化服务开发量24000L，取得全球排名和欧盟委员会成员国GMP认证证书证书，是目前在我国首份取得中欧双GMP认证证书证书采用服务开发个性化服务开发免疫抗体菌物药的服务开发工厂。工厂均可为有限有限总部已纳斯达克上市的5款服务提高餐饮业化服务开发，并已保证全球排名和欧盟委员会成员国双贸易市场供应必然。为实现有限有限总部中国未来多服务全球排名餐饮业化的实际需求，有限有限总部也将定期促进推动松江工厂（二）的建造，提升环境完善的菌物医疗机械产业发展工厂。

以后，我将连续不断户外拓展训练研发能力设计、完整研发質量治理装修标准、发展技艺系统，快速总部向Biopharma物种进化，竭尽全力提升现代化微生物化工中国的民族知名品牌。


关于复宏汉霖

复宏汉霖（2696.HK）一家展览化的信息化怪物医药化工新集团，强院于为世界十大求美者供应可财政负担的高的成品质怪物药，的成品所覆盖肿癌、自身业务免役消化道慢性病、护眼消化道慢性病等业务领域，已在国家销售5款的成品，在南美洲销售1款的成品，13项转变症将建，多个销售祖册办理可以领取国家保健otc药品监督安全管理局授理。自2015年创办近一年来，复宏汉霖已建设完工系统化化怪物医药化工网上品台，快速益及信息化的自主化主要实力紧扣研制开发、制作的及行业集团运营全流通业链。新集团已建造逐渐完善快速益的世界十大信息化安全管理中心，假设按照展览保健otc药品制作的质安全管理技术规范（GMP）规范实施制作的和质管理，逐渐夯实基础系统化化整体制作的网上品台，这当中，沈阳徐汇示范园区已可以领取国家和欧洲共同体保健otc药品GMP认可，松江示范园区（一）也已可以领取国家GMP认可。


复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、10个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。



Henlius’ Songjiang First Plant Received QP Declaration of Its GMP Equivalence to EU GMP


Recently, Henlius’ Songjiang First Plant in Shanghai received QP Declaration on its Good Manufacturing Practice (GMP) equivalence to European Union (EU) GMP. It declared that the quality management system of Songjiang First Plant is in line with EU GMP. In April 2022, Songjiang First Plant has obtained the GMP certification by Shanghai Medical Products Administration. In January and May 2022 respectively, this plant has passed two inspections by the EU QP, underscoring Henlius’ high-standard quality management system.


Advantages built with dual certifications from EU and China


According to EudraLex Volume 4 and its Annex and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), QP has conducted the on-site inspections on the drug substance (DS) line, drug product (DP) line and quality management system of Songjiang First Plant. The GMP equivalence to EU GMP of Songjiang First Plant also means that the investigational medical products manufactured in the plant, which include HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection), HLX11 (pertuzumab biosimilar) and HLX14 (denosumab biosimilar), could be used in clinical trials in Europe.


Songjiang First Plant is the second commercial manufacturing plant of the company. It was constructed according to the quality system standards of China, the EU and the United States, with a total manufacturing capacity of 24000L. In May 2022, it has been approved for the commercial manufacturing of HANQUYOU (trastuzumab, trade name in Europe: Zercepac®) by the NMPA, so as to meet the growing demands for the product. Looking beyond, Henlius will further bring down the cost and enhance manufacturing efficiency to sharpen competitive edges and drive market penetration, lending great support to its global footprint.


Meeting global capacity demand with ever-improving manufacturing platform


With the advantages of leading manufacturing capacity and high quality, Henlius has constructed and planned 3 manufacturing facilities with a total manufacturing capacity of 144,000L. In addition to Songjiang First Plant, Xuhui Facility has been put into operation, and Songjiang Second Plant is under construction. The company's manufacturing facility and its quality management system have obtained GMP certificates of China and EU and passed many inspections by QP and business partners. Among them, Xuhui Facility has commercial manufacturing capacity of 24,000L, which has obtained GMP certifications of China and EU, making it the first plant that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies in China. The facility could manufacture 5 commercial products and meet China and EU market demand with stable supply. To further secure capacity for global footprint, Henlius will advance the construction of Songjiang Second Plant, making it a first-class biopharmaceutical facility in the world.


While ramping up the capacity progress, Henlius will continue polishing quality management system and advance state-of-the-art technologies for efficient supply with reliable quality, gathering pace on the way of evolution to a biopharma.


About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.


Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 10 combination therapies.

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