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 相关内容來原于： 浏览量：

介绍渠道于：复宏汉霖

今日，复宏汉霖建在重庆的松江集地（一）可以用欧盟成员国国家进口保健中药饮片效率受权人（Qualified Person, QP）身份实名认证，劳动合同制拥有QP下发的按照性宣称，松江集地（一）与配建的效率工作安全装修标准按照欧盟成员国国家进口保健中药饮片生产的效率工作规范化（GMP）的要求。22年4月，该集地都已经 可以用重庆市进口保健中药饮片监控功能工作局的GMP身份实名认证，22年11月和8月几次QP审计师的预祝可以用是对复宏汉霖高条件效率安全装修标准的将经常性支持。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

按照Eudralex Vol 4政策法规标准（欧共体GMP）还有附表或是國際人施药品申请注册技术工艺协商会（ICH）等访谈提纲方式，QP对松江培训研学基地（一）原液、药物制剂制作线及的质量菅理指标体系完成了全部的控制整体性合法性审查。能够 欧共体QPv认证圆形意味该培训研学基地具有欧共体GMP涉及到的的政策法规标准的要求，其制作的HLX04-O（协同抗VEGF人源化单克隆抵抗能力注射液体液）、HLX11（帕妥珠单抗生态学技术内似药）、HLX14（地舒单抗生态学技术内似药）等设备可不可以在欧洲国家完成临床实践耐压。

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

平台以时代新国际先进的产销量好处和“汉霖”品质保证为全局发展前景加入和动力，如今已发展規划开发三座的出产方式国防教育高新产业园网，发展規划总产销量达144000L，除松江国防教育高新产业园网（一）以外，还包涵已投运电脑运行的徐汇国防教育高新产业园网和开发中的松江国防教育高新产业园网（二）。平台的出产方式国防教育高新产业园网及生活配套的性能维护系统已能够 NMPA、美国中药饮片维护局、QP、平台时代新国际商用楼配合火伴开始的诸多实地调查审核及审计师。这之中，徐汇国防教育高新产业园网目前拥有商用楼化产销量24000L，荣获国家和欧洲联盟GMP认证服务服务，是我们国家首家荣获中欧双GMP认证服务服务在的出产方式独立技术创新抗原微生物制品药的的出产方式国防教育高新产业园网。国防教育高新产业园网分为平台已挂牌上市的5款服务带来商用楼化的出产方式，并已保证国家和欧洲联盟双行业供货周期新常态。为无法平台未來大量服务中国商用楼化的需求量，平台也将持续保持推向松江国防教育高新产业园网（二）的开发，建设这个世界一流大学的微生物制品医药业高新产业国防教育高新产业园网。

发展，小编将总是拓宽生产加工量方式 、落实生产加工的质量管理工作装修标准、精耕细作工艺设备方法，会加快工司向Biopharma更新换代，拼命建立现当代动物制药企业民族特色企业。


关于复宏汉霖

复宏汉霖（2696.HK）就是一家國際化的全新生态学药业有限品牌品牌，秉承于为世界女性展示 可依赖的高率高水平生态学药，服务遍及肉瘤、车辆设备天然免疫疫情、骨科疫情等范畴，已在我国国内大发售5款服务，在荷兰发售1款服务，13项适应业务能力症新批，俩发售注册帐号申批换取国大国家药监局局授理。自205年组建近一年来，复宏汉霖已建于整体化生态学药业有限品牌工作机构，高及全新的服务性核心思想业务能力引向开发、产出及工商业运行全领域链。品牌已组建进一步完善高的世界全新公司，明确國際进口处方药产出高水平服务管理要求（GMP）标准规定去产出和高水平风险管控，迅速做实整体化标准化产出工作机构，在当中，北京徐汇营地已换取国大和欧盟委员会进口处方药GMP资格资质认证，松江营地（一）也已换取国大GMP资格资质认证。


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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