复宏汉霖曲妥珠单抗国内获批首个中欧双批国产单抗生物类似药！

Henlius 复星 2022-07-04

内容来源于：复宏汉霖

2020年8月14日，复宏汉霖（2696.HK）宣布，其自主开发和生产的曲妥珠单抗汉曲优^®（HLX02，欧盟商品名：Zercepac^®）正式获国家药品监督管理局（National Medical Products Administration, NMPA）批准上市。7月27日，该药已获欧盟委员会（European Commission，EC）批准上市登陆欧洲市场，由此成为首个中欧双批的国产单抗生物类似药，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。汉曲优^®通用名为注射用曲妥珠单抗（规格150mg/瓶，不含防腐剂），获得原研在中国已获批准的所有适应症：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。曲妥珠单抗已于2017年被纳入国家医保目录，根据国家医疗保障局发布的《基本医疗保险用药管理暂行办法》，《基本医疗保险药品目录》（以下简称《药品目录》）实行通用名管理，《药品目录》内药品的同通用名药品自动属于基本医疗保险基金支付范围。

汉曲优^®（HLX02，欧盟商品名：Zercepac^®）相继在欧盟和中国成功获批，得益于复宏汉霖联合创始人刘世高博士和姜伟东博士对产品品质的长期坚持，开发与生产过程均对标国际质量标准，为其顺利上市奠定了坚实的基础。公司严格遵照中国及欧盟生物类似药相关法规，针对汉曲优^®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期研究等，研究结果证明汉曲优^®在质量、安全性和有效性方面与原研曲妥珠单抗均高度相似。在汉曲优^®的工艺开发与生产过程中，复宏汉霖坚持践行质量源于设计（quality by design，QbD）的先进理念并采用一次性生产技术进行生产，可降低污染风险、提高生产效率。汉曲优^®的生产基地及配套的质量管理体系已通过NMPA、欧洲药品管理局（EMA）、欧盟质量受权人（QP）以及国际商业合作伙伴进行的多项实地核查及审计，获得了中国与欧盟GMP认证。为加快推进汉曲优^®的商业化进程，让中国“质”造的高品质生物药切实惠及更多患者，复宏汉霖积极开拓了创新的商业化模式，并建立起一支专业、高效的国际化商业运营团队。随着汉曲优^®的获批上市，复宏汉霖也将继续以患者利益为核心，联合社会各界不断提升HER2阳性患者的规范化诊疗，加快推进各地医保落地，最终实现“不让一个HER2阳性患者落下”的宏愿。

汉曲优^®国际多中心临床3期研究主要研究者徐兵河教授表示：

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汉曲优^®为中国首个开展国际多中心3期临床研究的生物类似药，其临床相似性研究数据十分优异，研究证实汉曲优^®与原研曲妥珠单抗无临床统计学差异。汉曲优^®的获批上市将进一步提升曲妥珠单抗在中国的可及性，不断强化HER2阳性乳腺癌及胃癌患者的规范化治疗。

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复宏汉霖总裁张文杰先生表示：

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汉曲优^®是公司上市的第二款产品，也是公司首款获得国外药监机构批准上市的产品，该产品的成功获批离不开所有参与该项目临床研究的医护人员、患者及各级药监机构、主管部门给予的大力支持。我们希望汉曲优^®能够广泛惠及中国广大城市和乡村HER2阳性乳腺癌和胃癌患者，也有信心为这些患者带来新的希望和治疗选择。

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复宏汉霖联合创始人、首席执行官刘世高博士表示：

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复宏汉霖作为国内生物制药行业的领军企业，自主研制的中国首个生物类似药汉利康^®（利妥昔单抗）已于2019年获批上市。现在我们又非常自豪地看到汉曲优^®惠及国内患者，中国和国际监管机构对于汉曲优^®的认可是复宏汉霖始终坚守国际品质的成果，我们将继续秉持‘以优质生物药，造福全球病患’的使命，践行企业社会责任，为患者和社会带去福祉。

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复星国际联席首席执行官、复星医药董事长、复宏汉霖董事长陈启宇先生表示：

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汉曲优^®的成功上市是公司十年辛勤耕耘的重大成果，衷心感谢汉霖团队为产品在中国和欧盟上市做出的杰出贡献及社会各界的信任与支持。我们会始终重视创新研发，并将质量放在最核心的位置，推动更多高品质产品造福社会，向引领世界生物医药产业发展的目标矢志前行。

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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，积极推动更多中国“质”造，国际品质生物药的研发与商业化，让全球病患能够用得到复宏汉霖研制的高品质生物药，成为全球最受信赖和景仰的创新生物医药公司。

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。截至目前，公司已成功上市国内首个生物类似药汉利康^®（利妥昔单抗），首个中欧双批的国产单抗生物类似药汉曲优^®（曲妥珠单抗，欧盟商品名：Zercepac^®），HLX03阿达木单抗上市申请正在审评中，并获得优先审评审批资格，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。

China’s First Trastuzumab Biosimilar 汉曲优^® Approved by NMPA

Shanghai, China, 14^th August, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the trastuzumab biosimilar 汉曲优^® (HLX02, EU brand name: Zercepac^®), developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). On 27^th July, Zercepac^® has also been approved by the European Commission (EC), making HLX02 the first China-developed mAb biosimilar to be approved both in China and in the EU. The common name of 汉曲优^® is trastuzumab injection (150mg/vial, without preservative) and it is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, which corresponds to all the indications approved in China of the trastuzumab originator. Trastuzumab has been included in China’s National Reimbursement Drug List (NRDL) in 2017. According to the "Interim Measures for the Administration of Drugs in the NRDL", drugs in the NRDL are managed by their common names, and drugs with common names that have been listed in the NRDL will automatically enter the NRDL.

Under the leadership of Henlius’ co-founders Dr. Scott Liu and Dr. Weidong Jiang, the development and manufacturing process of 汉曲优^® (HLX02, EU brand name: Zercepac^®) is also in line with international standards to ensure it meet the requirements to serve patients around the globe. During the development process of 汉曲优^®, Henlius strictly followed the NMPA and European Medicines Agency (EMA) biosimilar guidelines and has taken multiple head-to-head comparisons between 汉曲优^® and the reference trastuzumab. Results from analytical studies, preclinical studies, a Phase 1 clinical study and a global multi-centre Phase 3 clinical study showed that 汉曲优^® is highly similar to the reference trastuzumab in terms of quality, safety and efficacy. Henlius has implemented the concept of QbD （quality by design) in process development for 汉曲优^® and has adopted single-use technology for its manufacturing, leading to decreased risk of contamination and increased production efficiency. Manufacturing site of 汉曲优^® and its quality management system have passed multiple on-site inspections and audits by NMPA, EMA, EU Qualified Persons (QP) and international business partners of Henlius, and have obtained China and EU GMP certificates. To accelerate the commercialisation of 汉曲优^®, Henlius has built a professional and efficient international commercial team and established an innovative commercial model. With the launch of 汉曲优^®, Henlius will always put patients in the first place and continue cooperating with various partners to improve the diagnosis and treatment of HER2-positive patients, to gradually approach the goal of leaving no HER2 positive patient behind.

Professor Binghe Xu, principal investigator of the international multi-centre Phase 3 clinical study of 汉曲优^®, said, "汉曲优^® is the first China-developed biosimilar that has been evaluated in an international multi-centre Phase 3 clinical study. The Phase 3 study confirmed that there is no clinically meaningful difference between 汉曲优^® and reference trastuzumab. The approval of 汉曲优^® will improve the accessibility of trastuzumab in China and further strengthen the standardised treatment of patients with HER2-positive breast and gastric cancer."

Mr. Wenjie Zhang, President of Henlius, said, “汉曲优^® is the second product successfully approved for launch of Henlius and the first product that has received recognition from international drug regulatory agency. We are very grateful to all the physicians, nurses, patients and regulatory authorities that have contributed to or supported the studies of 汉曲优^®. We hope that 汉曲优^® will benefit HER2-positive breast cancer and gastric cancer patients both in urban and rural areas in China, and bring patients new hope and additional treatment options.”

Dr. Scott Liu, co-founder and CEO of Henlius, said, “As the leading company in the biologics industry of China, Henlius’ self-developed rituximab biosimilar 汉利康^® was approved by the NMPA in 2019, making it the first biosimilar in China. Now we are proud that 汉曲优^® can benefit Chinese patients. The recognition of 汉曲优^® by domestic and international regulatory authorities is the results of insisting the quality standards of Henlius, and Henlius will continue making efforts in providing affordable and effective therapies for patients worldwide and taking corporate responsibility to benefit our society.”

Mr. Qiyu Chen, co-CEO of Fosun International, Chairman of Fosun Pharma and Chairman of Henlius, said, "The approval of HLX02 both in China and in the EU is the result of ten-year's hardworking of Henlius. We sincerely appreciate the great contributions made by Henlius team and the trust and support from our society. We will value innovaton and quality as our core competency and bring quality products to more patients, and we will also keep pushing forward the development of the biopharmaceutical industry."

Looking forward, with its core values of “Affordable Innovation · Reliable Quality”, Henlius will actively accelerate the R&D and commercialisation of more biosimilars and innovative biologics that are developed and made in China and are of international quality, highlighting the company’s vision of becoming the most trusted and admired biotech company in the world.

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, 汉曲优^® (HLX02, trastuzumab, EU brand name: Zercepac^®) also has been approved in the EU and China, becoming the first China-developed mAb biosimilar approved both in the EU and China. 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.

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