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 方面缘于于： 浏览量：

项目种类于：复宏汉霖

近年，复宏汉霖建在重庆的松江示范园区（一）进行欧洲经济共同体医疗医药效率受权人（Qualified Person, QP）认真，确认换取QP批准的不符合必须性书面声明，松江示范园区（一）与配合的效率菅理系统体制不符合必须欧洲经济共同体医疗医药产量效率菅理系统规范标准规定（GMP）必须。明年4月，该示范园区以及进行重庆市医疗医药行政监督菅理系统局的GMP认真，明年一月和4月二次QP审核的安全进行是对复宏汉霖高标准化规定效率体制的快速性信赖。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

法律依据Eudralex Vol 4法律相关法律法规（欧盟国家委员会委员会GMP）及附表包括国际级人药物治疗品报名科技协调会会（ICH）等专业指导规范，QP对松江示范园区（一）原液、溶液剂生育线及品质管理工作风险管理体系来了着力的整体性查核。应该通过欧盟国家委员会委员会QP身份验证标志牌着该示范园区完全符合欧盟国家委员会委员会GMP涉及到的的法律相关法律法规规范，其生育的HLX04-O（重新组合抗VEGF人源化单克隆免疫抗体注射器液）、HLX11（帕妥珠单抗海洋生态学相似药）、HLX14（地舒单抗海洋生态学相似药）等品牌应该在法国来临床治疗现场实验。

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

新大装修品牌以全国上精英型的产销量强势和“汉霖”茶叶品质为建筑体发展壮大灌入推动力，己经规化区网站设计三座出产的的制造园区，规化区总产销量达144000L，除松江园区（一）本身，还有已投建运动的徐汇园区和网站设计中的松江园区（二）。新大装修品牌出产的的制造园区及设备配套的質量经营制度已按照NMPA、澳大利亚放射性药品经营局、QP、新大装修品牌全国上商家运作服务运作战略合作好朋友开始的多选实地考察复核及审计师。表中，徐汇园区现存商家运作服务运作化产销量24000L，领取全国和欧洲联盟成员国GMP企业安全认证，是内部第一个领取中欧双GMP企业安全认证中用出产的的制造独立新货品设备开发抗体阳性怪物药的出产的的制造园区。园区而以新大装修品牌已香港上市的5款货品设备提拱商家运作服务运作化出产的的制造，并已能够满足全国和欧洲联盟成员国双市場供应常态化。为能够满足新大装修品牌中国未来更加货品设备国际商家运作服务运作化的业务需求，新大装修品牌也将持续保持推动松江园区（二）的网站设计，构造环境出众的怪物生物制药产业发展园区。

未来是什么，我们都将一直推展扩产构造、成熟制造效果处理模式、深入加工制作工艺 的技术，高速度大公司向Biopharma超级进化，勤奋努力构造当代生态学药厂人民国产品牌。


关于复宏汉霖

复宏汉霖（2696.HK）也是家展览性化的全新菌物学药厂企业新公司，强院于为展览性我们展示可承担的高品格菌物学药，產品覆盖面良性肿瘤、人体免役问题、眼科整形问题等范畴，已华人人现代出现5款產品，在欧洲各国出现1款產品，13项改变症新批，1个出现登陆办理才能得到华人现代国家药监局局立案。自20二十年修建到现在，复宏汉霖已修建二合一化菌物学药厂企业网上品台，高效率的率的及全新的独立自主层面力量紧扣产品研发、产量及服务业营运全领域链。新公司已设立完整高效率的率的的展览性全新中，通过展览性医疗耗材产量产品效率工作管理细则规范（GMP）细则开始产量和产品效率严格监督，一个劲做实二合一化终合产量网上品台，中间，杭州徐汇营地已才能得到华人现代和欧洲联盟医疗耗材GMP资质实名认证，松江营地（一）也已才能得到华人现代GMP资质实名认证。


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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