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 玩法来原于： 浏览量：

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今日，复宏汉霖建在西安的松江基底（一）实现欧洲共同体医疗进口非处方药质理受权人（Qualified Person, QP）身份实名认证，已正式收获QP批准的完全合适性宣称，松江基底（一）与服务设施的质理标准的化菅理采集网络体系完全合适欧洲共同体医疗进口非处方药出产质理标准的化菅理规范性（GMP）规范要求。2030年4月，该基底现已实现西安市医疗进口非处方药进行监督标准的化菅理局的GMP身份实名认证，2030年11月和10月三次QP审核的顺利完成实现是对复宏汉霖高重量的质理采集网络体系的维持性认可度。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

前提条件Eudralex Vol 4法律条例（澳大利亚联盟GMP）各种绪论各种國际人用药治疗品申请工艺配合会（ICH）等免费指导规则，QP对松江中心（一）原液、药制剂生产方式制造线及高质量监管工作体系实行了着力的系统化性查看。用澳大利亚联盟QP审核标志logo着该中心遵循澳大利亚联盟GMP有关的的法律条例标准，其生产方式制造的HLX04-O（整体上市抗VEGF人源化单克隆抗原肌内注射液）、HLX11（帕妥珠单抗动物如此药）、HLX14（地舒单抗动物如此药）等成品能够在澳大利亚实行临床经过多次实验发现经过多次实验发现。

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

新品牌的以国.际金精英型的产出能力其优势和“汉霖”口感为总布局转型吸取的动力，陆续发展规划方案的构建三座产出集散地，发展规划方案总产出能力达144000L，除松江集散地（一）模版，还涉及已建成投产加载的徐汇集散地和的构建中的松江集散地（二）。新品牌的产出集散地及整套搭配的重量菅理标准体系已采用NMPA、西方非处方药菅理局、QP、新品牌的国.际金工餐饮业加盟盟友做的诸多现地清查及财务审计。这之中，徐汇集散地目前拥有工餐饮业化产出能力24000L，取得全国有和欧洲联盟GMP身份验证服务，是全国内地首位取得中欧双GMP身份验证服务采用产出专业化研发团队抵抗能力怪物药的产出集散地。集散地均可为新品牌的已发行的5款服务提高工餐饮业化产出，并已体现全国有和欧洲联盟双茶叶市场供应商状态。为具备新品牌的未来的发展更好服务全国工餐饮业化的要，新品牌的也将维持促进改革松江集散地（二）的的构建，制造世界级优质的怪物药业家产集散地。

未来十年，自己将反复户外拓展培训工作量设计、成熟工作質量管理方法模式、深耕细作生产工艺技木，快速公司向Biopharma觉醒，奋力打造出近现代生态学药业有限公司中国民族项目。


关于复宏汉霖

复宏汉霖（2696.HK）一家國际化的转型升级海洋生物学制品制药企业企业新公司，专注于打造于为全.球提高提供了可经济负担的高效果经营海洋生物学制品药，类企业物品重叠肺部肿瘤、内在免疫细胞肠道慢性病、眼科医生肠道慢性病等方面，已在国主板什么时候主板上市5款类企业物品，在非洲主板什么时候主板上市1款类企业物品，13项自我调节症新批，多个主板什么时候主板上市注册帐号审请可以赚取国国家药监局局结案。自2015年公司设立后，复宏汉霖已建于三合一化海洋生物学制品制药企业企业工作平台网站，优质及转型升级的綜合性本质能力素质紧扣研究开发、出产及商业圈市场运营全文化产业发展链。新公司已搭建持续不断完善优质的全.球转型升级中央，假设按照國际保健货品出产效果经营经营规程（GMP）标准单位对其进行出产和效果经营安全控制，持续不断夯实基层基础三合一化綜合出产工作平台网站，在这当中，沪徐汇工厂已可以赚取国和欧洲共同体保健货品GMP企业资格认证，松江工厂（一）也已可以赚取国GMP企业资格认证。


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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