重磅！首个“中国籍”曲妥珠单抗于欧盟获批上市

本文转载自复宏汉霖 作者Henlius，点击阅读原文链接

2020年7月29日，复宏汉霖（2696.HK）联合合作伙伴Accord Healthcare Limited（“Accord”）共同宣布，欧盟委员会（European Commission，EC）已批准复宏汉霖自主开发和生产的曲妥珠单抗（HLX02，欧盟商品名：Zercepac®）于欧盟上市，该药获得了原研药在欧盟批准的所有适应症：1）HER2阳性早期乳腺癌；2）HER2阳性转移性乳腺癌；3）HER2阳性转移性胃癌。复宏汉霖曲妥珠单抗成为首个登陆欧洲市场的“中国籍”单抗生物类似药，开辟了中国医药企业参与单抗生物类似药“世界杯”比赛的先河。

重磅！首个“中国籍”曲妥珠单抗于欧盟获批上市

欧盟是世界上最早制定生物类似药指导原则的地区，亦是全球生物类似药最主要的成熟市场。2020年5月，欧洲药品管理局（European Medicines Agency, EMA）人用医药产品委员会（Committee for Medicinal Products for Human Use, CHMP）在对Zercepac®进行了一系列严格审评后得出了积极审评意见，并推荐EC批准Zercepac®的上市销售许可申请。EMA公布的最终审评决定显示，“依照欧盟对生物类似药的要求，Zercepac®具有与参照药Herceptin®高度相似的结构、纯度和生物活性。此外，HER2阳性转移性乳腺癌患者的临床研究结果显示，Zercepac®与Herceptin®的临床疗效等效。这些数据足以证明Zercepac®与参照药对于获批适应症具有相似的疗效和安全性。[1] 随着HLX02（欧盟商品名：Zercepac®）在欧洲获批，其商业化将由Accord负责，可在全部欧盟成员国以及欧洲经济区国家挪威、冰岛和列支敦士登上市销售。根据IQVIA MIDASTM数据估计，2019年原研曲妥珠单抗及其生物类似药于欧盟及挪威、冰岛和列支敦士登的销售额达到了13.7亿美金。

复宏汉霖曲妥珠单抗获得国际权威药监机构的认可，得益于公司长期对产品质量的严格要求。在公司两位联合创始人刘世高博士和姜伟东博士的坚持与带领下，HLX02（欧盟商品名：Zercepac®）的开发与生产过程均对标国际质量标准，同时遵照中国及欧盟生物类似药相关法规进行研制，与原研曲妥珠单抗开展了多项头对头比对研究，包括质量对比研究、非临床相似性研究、临床1期和国际多中心临床3期研究。HLX02（欧盟商品名：Zercepac®）的生产基地已获得了欧盟GMP认证，也是国内首个获得欧盟GMP认证用于生产自主研发抗体生物药的GMP工厂，打破了国产单抗生物药在海外上市的GMP壁垒，对产品成功登陆欧洲市场起到至关重要的作用。

HLX02（欧盟商品名：Zercepac®）国际多中心临床3期研究主要研究者徐兵河教授表示：

“

很荣幸看到复宏汉霖自主研制的生物类似药疗效和安全性得到国际权威药监机构的肯定，我国开展的生物类似药临床试验也同样获得了EMA的认可，是国内临床试验历程中的一次重大飞跃。期待看到越来越多国家和地区HER2阳性乳腺癌及胃癌患者获得‘中国籍’曲妥珠单抗的治疗，在HER2靶向治疗中贡献中国‘好声音’。

”

复宏汉霖联合创始人、首席执行官刘世高博士表示：

“

我们始终’以优质生物药，造福全球病患’为使命，此次曲妥珠单抗欧盟获批是公司国际化战略的重要里程碑，标志着我们在生物药的研发和生产方面达到国际质量标准。我们会尽快携手合作伙伴Accord推进Zercepac®在欧洲的后续工作，并进一步拓展在其他地区的可及性，为全球更多患者带去高品质单抗生物药治疗选择。

”

Accord副总裁（EMENA地区）Paul Tredwell先生表示：

“

Accord 抗肿瘤产品管线正在不断扩展，目前已经能够为欧洲的患者提供30余种高品质、可负担的治疗药物。Zercepac®是来自复宏汉霖的高品质生物药，也是Accord负责营销的首个单抗药物，其获批为Accord抗肿瘤产品管线注入了新的活力。我们会继续巩固将高品质复杂生物药推进上市的能力，以不断提升患者可及性，为医疗体系提供更多选择。

”

未来，复宏汉霖将持续践行“可负担的创新·值得信赖的品质”的核心理念，深耕肿瘤治疗领域，拓展更多产品的国际化布局，同时积极推动创新生物药和生产工艺的开发，努力成为全球最受信赖和景仰的创新生物医药公司。

关于Accord Healthcare

Accord总部位于英国，是欧洲增长最快的制药公司之一。Accord广阔的市场覆盖在欧洲仿制药与生物类似药公司中处于领先地位，营销和分销网络已覆盖全球80多个国家。

广阔的全球布局使得Accord得以为不同国家的卫生系统提供重要且可负担的药物供给，帮助全世界的医生改善患者的生活。通过采取灵活创新的商业模式，Accord不断追求产品质量与可及性的提升并将始终力求为全世界患者带来更多获益。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫疾病等领域。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司在中国上海、中国台北和美国加州均设有研发中心，按照国际GMP标准进行生产和质量管控，位于上海徐汇的生产基地已获得中国和欧盟GMP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HLX10的肿瘤免疫联合疗法。继成功推出首个国产生物类似药汉利康®（利妥昔单抗）后，HLX02（曲妥珠单抗，欧盟商品名：Zercepac®）在欧盟获批上市，成为首个登陆欧盟的“中国籍”单抗生物类似药。同时，HLX02有望于今年在国内同步上市，成为首个国产曲妥珠单抗。截止目前，公司已成功上市2个产品，1个产品（阿达木单抗）也有望于今年上市，并同步就10个产品、8个联合治疗方案于全球范围内开展20多项临床试验，产品对外授权覆盖全球近100个国家和地区。

Henlius and Accord Healthcare Receive EMA Approval for Zercepac®, trastuzumab biosimilar

Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced the European Commission (EC) has approved Zercepac®(HLX02), a trastuzumab biosimilar developed and manufactured by Henlius, for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer. The approval was based on a series of robust studies including comparative quality studies, preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac®(HLX02), demonstrating comparable efficacy and safety to the reference product, Herceptin®.

Zercepac® (HLX02) is the first China-developed monoclonal antibody (mAb) biosimilar that has successfully entered the EU market. Under the leadership of Henlius’ co-founders Dr. Scott Liu and Dr. Weidong Jiang, the development and manufacturing process of Zercepac® (HLX02) is in line with international standard to ensure it meet the requirements to serve patients around the globe. During the development process of Zercepac® (HLX02), Henlius strictly followed the NMPA and EMA biosimilar guidelines and has taken multiple head-to-head comparisons between Zercepac®(HLX02) and the reference trastuzumab , including comparative quality studies, preclinical studies, a Phase 1 clinical study and a global multi-certre Phase 3 clinical study. Manufacturing site of Zercepac® and its quality management system have obtained EU GMP certificates. Henlius’ Xuhui Facility has become China’s first EU certified GMP site to manufacture a self-developed antibody biosimilar. This also means that Henlius is breaking the GMP barriers for China-developed mAb biologics to be launched on international market, laying a solid foundation for the successful approval of Zercepac® (HLX02).

Professor Binghe Xu, principal investigator of the international multi-centre Phase 3 clinical study of Zercepac® (HLX02), said, “I’m very glad to see that an international drug regulatory authority has acknowledged the efficacy and safety of Henliu’s self-developed biosimilar, which also means our clinical trial is of international standard. I’m looking forward to seeing more HER2 positive breast cancer and gastric cancer patients benefiting from China-developed trastuzumab in more countries and regions.”

Dr. Scott Liu, co-founder and CEO of Henlius, said “Henlius’ mission is to improve patients’ lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence. The approval of Zercepac® in the EU is a significant milestone of our global strategy. This achievement announces that our capability in the development and manufacturing of biologics has reached international standards. In the future, Henlius will provide more high quality biologics as new treatment options to benefit patients worldwide.”

Paul Tredwell, Accord VP Speciality Brands, EMENA said, “Zercepac® is an exciting new addition to our growing oncology portfolio which now provides access to over 30 high-quality, cost effective oncology treatments to patients across Europe. With Zercepac®, our first mAb, we firmly establish our expertise in bringing high quality complex medicines to market – to ensure improved patient access, and to provide cost effective alternatives to overstretched health systems.”

Looking forward, Henlius will keep on with its core values of “Affordable Innovation · Reliable Quality” and continue its dedication in the field of oncology. Henlius will actively promote the discovery and development of novel biologics as well as process innovation to realize its vision of becoming the most trusted and admired biotech company in the world.

About Accord Healthcare

Headquartered in the United Kingdom, Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world.

This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide.

The approach of Accord is agile and inventive, always seeking to improve products and patients’ access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.

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 and autoimmune diseases. 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 commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. After 汉利康® (HLX01, rituximab) was launched commercially, HLX02 (Zercepac® in the EU, trastuzumab) is approved in the EU as the first Chinese mAb biosimilar entering the EU market. Meanwhile, HLX02 will also potentially be lauched within 2020 in China, becoming the first Chinese trastuzumab biosimialr. Up to date, in addition to 2 products launched successfully and 1 product (HLX03 adalimumab) to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.

参考资料

[1] European Medicines Agency. Human medicine European public assessment report (Zercepac). https://www.ema.europa.eu/en/medicines/human/EPAR/zercepac