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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 网站内容源头于： 浏览量：

介绍起都出自：复宏汉霖

最近，复宏汉霖坐落于昆明的松江国防教育研学基地面积（一）在欧洲联盟产品产品品质受权人（Qualified Person, QP）审核，仪式得到 QP颁发的契合性书面声明，松江国防教育研学基地面积（一）与配套设施的产品品质治理制度契合欧洲联盟产品研发产品品质治理条件（GMP）条件。2023年4月，该国防教育研学基地面积已是在昆明市产品监察治理局的GMP审核，2023年7月和五月2次QP审计局的快速在是对复宏汉霖高标淮产品品质制度的持续性认可的。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

前提Eudralex Vol 4法律规定（欧盟委员会委员会成员国GMP）十分附表同时国.际人口服药物品登陆技术水平匹配会（ICH）等具体指导遵循原则，QP对松江产业带（一）原液、剂型生孩子线及货品品质安全管理机制开始了着力的系统的性检查。顺利通过欧盟委员会委员会成员国QPv认证标识着该产业带合乎欧盟委员会委员会成员国GMP重要性的法律规定需要，其生孩子的HLX04-O（资产重组抗VEGF人源化单克隆抵抗能力打瘦脸针液）、HLX11（帕妥珠单抗生态学比如药）、HLX14（地舒单抗生态学比如药）等货品会在海外开始临床医学冲击试验。

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

工厂以国.际当先的产量长处和“汉霖”新食品质量维护为总体发展壮大释放原因，早就总体计划建筑三座的生產企业营地网，总体计划总产量达144000L，除松江企业营地网（一）外面，还以及已建成投产运营的徐汇企业营地网和建筑中的松江企业营地网（二）。工厂的生產企业营地网及配备的质量维护维护工作体系已带动NMPA、南美洲处方药维护局、QP、工厂国.际餐饮业运作协议战略合作伙伴参与的多选题实地考察复核及内部审计。表中，徐汇企业营地网当下餐饮业运作化产量24000L，赚取华人人和欧共体GMP企业身份认证，是全国第一家赚取中欧双GMP企业身份认证用作的生產服务性研发部抵抗能力微生物体药的的生產企业营地网。企业营地网其有工厂已面市的5款新食品给予餐饮业运作化的生產，并已带动华人人和欧共体双茶叶市场供货商新常态。为能够满足工厂中国未来其他新食品国际餐饮业运作化的使用需求，工厂也将保持带动松江企业营地网（二）的建筑，设计游戏世界优质的微生物体医药业企业企业营地网。

前景，我们大家将不断地拓张扩产方式 、进一步完善生育高质量工作系统、发展壮大技艺技艺，提速厂家向Biopharma进一步，全力以赴塑造现化海洋生物生物制药民簇高端品牌。


关于复宏汉霖

复宏汉霖（2696.HK）一家國際化的特色化生态学工程制药厂厂司，秉承于为中内地国家爱美者展示 可的压力的高好品质生态学工程药，厂品遍布癌症、工作中免疫系统妇科的疾病、眼科整形妇科的疾病等层面，已中内地大陆国家面市5款厂品，在欧洲国家面市1款厂品，13项融入症将建，二个面市注测个人申请拿到中内地国家otcotc药品监督标淮化管理局授理。自20多年组建起来，复宏汉霖已竣工成集成化生态学工程制药厂厂大公司，效率能及特色化的自由本质特性 贯通研制开发、产出销售的及商业区营销推广全高新产业发展链。司已确立落实效率能的中内地国家特色化重心，安装國際otcotc药品产出销售的質量标淮化管理技术规范（GMP）标淮确定产出销售的和質量监督控制，源源不断扎实成集成化综合评估产出销售的大公司，但其中，东莞徐汇军事产业园已拿到中内地国家和欧盟国家otcotc药品GMP申请实名认证，松江军事产业园（一）也已拿到中内地国家GMP申请实名认证。


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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