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 玩法来自于： 浏览量：

项目种类于：复宏汉霖

不久前，复宏汉霖坐落郑州的松江产业研学工厂（一）根据欧洲共同体委员会放射性医疗医疗药品安全性能受权人（Qualified Person, QP）v实名认证，正试刷出QP出具的适合性声明范文，松江产业研学工厂（一）与配合的安全性能的控制系统适合欧洲共同体委员会放射性医疗医疗药品产量安全性能的控制正确（GMP）必须。22年4月，该产业研学工厂已根据郑州市放射性医疗医疗药品监查的控制局的GMPv实名认证，22年3月和的五月份三次QP财务会计的太顺利根据是对复宏汉霖高细则安全性能系统的快速性认证。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

重要依据Eudralex Vol 4法律规定（欧洲各国经济共同体GMP）还有附表已经时代国际人用药量品注冊水平协商会（ICH）等制定方案的原则，QP对松江研学国防教育基地（一）原液、药物制剂的生产的线及安全性能标准化管理标准体系实施了完全的平台性复核。能够 欧洲各国经济共同体QP身份验证标志图案着该研学国防教育基地适合欧洲各国经济共同体GMP有关于的法律规定追求，其的生产的的HLX04-O（重组方案抗VEGF人源化单克隆抗体阳性注入液）、HLX11（帕妥珠单抗菌物技术一样药）、HLX14（地舒单抗菌物技术一样药）等的产品就可以在欧洲各国实施临床上冲击试验。

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

新子机构以国际联盟级进取的加工能力优劣势和“汉霖”品性为大体壮大植入能源，早已开发计划开发三座加工加工军事幼儿园，开发计划总加工能力达144000L，除松江军事幼儿园（一）囿于，还包扩已投建加载的徐汇军事幼儿园和开发中的松江军事幼儿园（二）。新子机构加工加工军事幼儿园及智能化的质量管理方法制度管理方法制度标准已保持NMPA、欧州处方药管理方法制度局、QP、新子机构国际联盟级餐饮业工司合作挚友实施的多实景调查核实及财务会计。这里面，徐汇军事幼儿园目前有餐饮业化加工能力24000L，可以才能得到全国和欧洲联盟GMP认真，是全国第一个可以才能得到中欧双GMP认真适用加工加工自行研发部抗体阳性微生物制品药的加工加工军事幼儿园。军事幼儿园可以给新子机构已挂牌上市的5款货品提拱餐饮业化加工加工，并已保持全国和欧洲联盟双市场上供货商新常态。为充分满足新子机构未来生活更大货品时代十大餐饮业化的所需，新子机构也将持续性引领松江军事幼儿园（二）的开发，做大做强时代超一流的微生物制品制药品牌军事幼儿园。

的前景，咱们将连续不断扩展扩产平面布置、健全生产的质理方法体系中、精耕细作方法科技，加快速度公司向Biopharma最终进化，尽力做大做强现在生物体制药企业民族风俗公司。


关于复宏汉霖

复宏汉霖（2696.HK）一家国际级性化的多元化海洋菌物药厂总部，坚持信息化驱动于为环球患病者打造可不良影响的高品控海洋菌物药，护肤品履盖癌肿、自己的免疫系统疾病症状症状、眼科医生疾病症状症状等范围，已在我国的发售5款护肤品，在欧洲各国发售1款护肤品，13项习惯症新批，2发售注册帐号个人申请提升我国的国家药监局局业务办理。自20十五年创办近一年来，复宏汉霖已开建一起化海洋菌物药厂品台，更高效益及多元化的专业化核心思想力深入新产品研发、研发及服务业推广全制造业链。总部已建立起成熟更高效益的环球多元化中心局，依据国际级性进口货品研发的品质方法技术规范（GMP）标准通过研发和的品质把控，不停夯实基层基础一起化综合管理研发品台，在这其中，伤害徐汇集地已提升我国的和欧盟成员国进口货品GMP安全认可，松江集地（一）也已提升我国的GMP安全认可。


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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