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:2023-06-21 资源来历于： 浏览量：

文章体现了于：复宏汉霖

最近，复宏汉霖坐落沈阳的松江研学国防教育中心（一）经由欧共体国家非处方药线高服务线质量受权人（Qualified Person, QP）资质资格认证，已正式赢得QP颁发的复合性申明，松江研学国防教育中心（一）与模块化的线高服务线质量的工作管理系统标系统复合欧共体国家非处方药制作线高服务线质量的工作管理系统规范性（GMP）符合要求。2030年4月，该研学国防教育中心以及经由沈阳市非处方药督查的工作管理系统局的GMP资质资格认证，2030年一月份和7月几次QP审计工作的顺利图片经由是对复宏汉霖高标线高服务线质量标系统的延续性支持。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

标准Eudralex Vol 4政策规范（拉丁美洲联盟GMP）已经其绪论已经时代国际人用药治疗品注测技能协商会（ICH）等免费指导理论依据，QP对松江营地（一）原液、剂型产出线及企业产品质量管控指标体系实现了全方面的体系性查核。能够拉丁美洲联盟QP资格认证标记着该营地完全符合拉丁美洲联盟GMP重要性的政策规范要，其产出的HLX04-O（并购重组抗VEGF人源化单克隆抗体阳性打针液）、HLX11（帕妥珠单抗海洋生物工程累似药）、HLX14（地舒单抗海洋生物工程累似药）等企业产品都可以在拉丁美洲实现临床检验应力测试。

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

新单位以时代国外前沿的产值优缺点和“汉霖”高品质为整个發展植入趋势，如今已发展筹划建没三座产量工业园，发展筹划总产值达144000L，除松江工业园（一）除此之外，还涉及到已投运运动的徐汇工业园和建没中的松江工业园（二）。新单位产量工业园及匹配的效率工作管理制度制度已顺利通过NMPA、澳洲处方药工作管理制度局、QP、新单位时代国外商用圈楼性的合伙好伙伴对其进行的每项实地调查审查及审计师。这里面，徐汇工业园目前商用圈楼性的化产值24000L，换取我国的和欧共体GMP资格身份验证，是我国国内首届换取中欧双GMP资格身份验证代替产量选择科研抗体阳性生态学药的产量工业园。工业园分为新单位已主板上市的5款食品具备商用圈楼性的化产量，并已完成我国的和欧共体双贸易市场要货状态。为符合新单位在未来大量食品中国十大商用圈楼性的化的使用需求，新单位也将持续时间着力推进松江工业园（二）的建没，开发中国出众的生态学医疗工业工业园。

未来的，小编将迅速户外拓展培训加工能力分布、建全加工质量水平标准化管理采集体系、深耕细作工艺设计系统，减速大公司向Biopharma进化升级，拼命建立意式海洋生物制药厂民族文化品脾。


关于复宏汉霖

复宏汉霖（2696.HK）就是家国际级上化的随时升级信息化怪物学制品药业有限工厂工厂，专注于于为全.球性的人具备可负税的高品行怪物学制品药，物料遮盖肉瘤、自身的免役发病、眼科整形发病等层面，已在美国内地发售5款物料，在德国发售1款物料，13项适合症将建，3个发售注册工厂办理可以赢得我国的内地国家药监局局结案。自206年制定之初，复宏汉霖已开工建设混合式化怪物学制品药业有限工厂工作渠道，高品质处理及随时升级信息化的随时升级处理处工作能力推动开发、研发制造加工及商业性工厂运营全领域链。工厂已制定建立完善高品质处理的全.球性随时升级信息化重心，采用国际级上产品研发制造加工品质处理处理规范化（GMP）条件对其进行研发制造加工和品质处理监管，总是夯实基础混合式化宗合研发制造加工工作渠道，另外，沈阳徐汇国防教育培训基地已可以赢得我国的内地和欧洲共同体产品GMPv身份验证，松江国防教育培训基地（一）也已可以赢得我国的内地GMPv身份验证。


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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