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 信息内容体现了： 浏览量：

內容主要来缘于：复宏汉霖

据悉，复宏汉霖建在苏州的松江产业带网（一）确认欧共体产品的产品受权人（Qualified Person, QP）申请认证服务，仪式兑换QP下发的合乎性证明，松江产业带网（一）与设备配套的的产品经营采集安全体系合乎欧共体产品生产销售的产品经营制约（GMP）耍求。2020年4月，该产业带网就确认苏州市产品进行监督经营局的GMP申请认证服务，2020年年初和4月十几次QP财务会计的顺利圆满确认是对复宏汉霖高细则的产品采集安全体系的维持性喜爱。




中欧质量管理体系双重认证

松江基地（一）运营实力凸显

理论依据Eudralex Vol 4法律相关法律法规（欧共体GMP）还有其附表及及国际级人施药品注册公司枝术配合会（ICH）等指点的标准，QP对松江集地（一）原液、药品分娩加工线及產品管理平台模式做好了全面的的平台性核查。采用欧共体QP安全认证象征着该集地达到欧共体GMP相关内容的法律相关法律法规的标准，其分娩加工的HLX04-O（从组抗VEGF人源化单克隆抗体阳性滴注液）、HLX11（帕妥珠单抗海洋生物制品接近药）、HLX14（地舒单抗海洋生物制品接近药）等產品需要在欧洲其他国家做好临床医学现场实验。

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

我司以國际领先地位的产值优点和“汉霖”护肤品效率为整体上不断发展植入原因，目前已经方案建造三座的生孩子研学中心，方案总产值达144000L，除松江研学中心（一）之上，还涉及已投入使用操作的徐汇研学中心和建造中的松江研学中心（二）。我司的生孩子研学中心及配备的效率工作制度已可以通过NMPA、欧洲地区保健药品工作局、QP、我司國际行业合作共赢好伙伴使用的单选现地稽核及内审。各举，徐汇研学中心现存行业化产值24000L，提升我国的和欧盟国家国家GMP验证证书，是国内的第一例提升中欧双GMP验证证书代替的生孩子独立研制开发抗原海洋生物技术药的的生孩子研学中心。研学中心有我司已发售的5款护肤品能提供行业化的生孩子，并已保持我国的和欧盟国家国家双市场上供货期常态化。为满意我司之后更多的护肤品世纪上行业化的标准，我司也将一直促进推动松江研学中心（二）的建造，建设世纪顶级的海洋生物技术医药公司家产研学中心。

素，我们总部将快速拓宽产销量规划、改善制造质量水平方法装修标准、发展加工制作工艺 技术设备，减速总部向Biopharma创新，积极塑造当今生物学药厂民族风俗企业品牌。


关于复宏汉霖

复宏汉霖（2696.HK）就是一家國際化的连续科学去创新怪物工程制作otc中药饮片单位，专注于于为世界各国排名人供应可负担过重的高茶叶品质怪物工程药，货品涵盖癌肿、自身的免疫性症状、眼科医生症状等业务领域，已在全国什么时候挂牌主板上市5款货品，在欧式什么时候挂牌主板上市1款货品，13项融入症获准，4个什么时候挂牌主板上市单位注册报考赚取全国食药监局受案。自205年开办开始，复宏汉霖已建设合一化怪物工程制作otc中药饮片系统，效率及连续科学去创新的选择内在的能力惯穿加工制造、加工及商业楼营运全企业链。单位已构建进一步完善效率的世界各国排名连续科学去创新中心局，，并按照國際otc中药饮片加工性能治理治理标准的规范（GMP）标准的进行加工和性能治理监督控制，连续打牢合一化整合加工系统，在其中，东莞徐汇军事产业基地已赚取全国和欧共体otc中药饮片GMP验证，松江军事产业基地（一）也已赚取全国GMP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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