复宏汉霖汉曲优®于澳大利亚获批上市

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关键词：复宏汉霖上市获批

资讯来源：药时代

发布时间： 2022-07-27

2022年7月25日，复宏汉霖（2696.HK）宣布，公司商业合作伙伴Cipla Limited（“Cipla”）收到相关注册证书，复宏汉霖自主开发和生产的150mg/瓶规格汉曲优 ^®（曲妥珠单抗，欧洲商品名：Zercepac ^®）获得澳大利亚药品管理局（Therapeutic Goods Administration, TGA）批准上市，商品名为Tuzucip ^®和Trastucip ^®，覆盖原研曲妥珠单抗在澳大利亚获批的所有适应症。目前，复宏汉霖正与Cipla在澳大利亚合作，此次获批将有助于双方携手将汉曲优 ^®带给更多澳大利亚的患者。

加速出海领航，全球20国上市

汉曲优 ^®是复宏汉霖按照中国、欧盟和美国等生物类似药法规自主研发的曲妥珠单抗生物类似药，于2020年7月及8月先后获得欧盟委员会与中国国家药监局（NMPA）批准上市，为首个中国自主研发的中欧双批单抗药物。作为国产生物药“出海”代表，Zercepac ^®（150mg）已于英国、德国、西班牙、法国、意大利等约20个欧洲国家和地区成功上市，其60mg及420mg规格也在欧盟获得批准。

复宏汉霖针对汉曲优开展了一系列的头对头比对研究，包括质量对比研究、临床前研究及临床I期和国际多中心临床III期研究等，证明了汉曲优 ^®与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。此次汉曲优 ^®获批主要基于澳大利亚TGA对一系列研究数据的审查，相关申报资料主要基于该产品递交欧盟委员会营销授权申请（Market Authorization Application，MAA）的资料，获批适应症包括：1）HER2阳性的早期乳腺癌；2）HER2阳性的局部晚期乳腺癌；3）HER2过表达的转移性乳腺癌；4）HER2阳性的晚期胃腺癌或胃食管交界腺癌。

拓展商业价值，惠及全球患者

2018年，公司与Cipla签署授权许可及供货协议，授予Cipla对汉曲优 ^®在包括澳大利亚在内的多个国家进行独家开发和商业化的权利，并由复宏汉霖在中国的生产基地独家供货。汉曲优 ^®的生产和质量控制环节遵循国际最高标准，所在的徐汇基地是国内首个获得中欧双GMP认证用于生产自主研发抗体生物药的生产基地，且该生产基地及配套的质量管理体系还通过了由NMPA、欧洲药品管理局（EMA）、欧盟质量受权人（QP）及公司国际商业合作伙伴进行的多项实地核查及审计。2022年5月，汉曲优 ^®变更生产场地的补充申请获NMPA批准，获批的松江基地（一）规划产能24,000L，可全部应用于汉曲优 ^®商业化生产，强力支撑产品持续放量。

目前，汉曲优 ^®150mg规格已完成中国境内所有省份的招标挂网和医保准入，60mg规格已完成中国境内23个省份的招标挂网和30个省份的医保准入，在中国迄今已惠及近7万名患者。此外，公司亦携手全球商业合作伙伴Cipla、Accord、Abbott、Eurofarma、Mabxience和雅各臣药业等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球90多个国家和地区。展望未来，复宏汉霖将充分发挥公司全球联动、整合创新的优势，继续推动公司全方位向国际化Biopharma进化战略的落地，同时也将通过搭建更多新的战略合作伙伴关系，进一步提升汉曲优 ^®在全球更多国家和地区的可及性和影响力，为更多患者带来希望。

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可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在欧洲上市1款产品，13项适应症获批，2个上市注册申请获得中国药监局受理。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。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国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^®，澳大利亚商品名： Tuzucip ^® 和Trastucip ^® ）、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。

关于Cipla

全球制药公司Cipla成立于1935年，专注于灵活、可持续增长和仿制药的开发，并在印度、南非、北美和其他关键监管和新兴市场不断优化其产品组合。Cipla在呼吸学、抗逆转录病毒、泌尿学、心脏病学和中枢神经系统方面的优势得到了普遍认可。通过遍布于世界各地的47处生产基地，Cipla利用其国际顶尖的技术平台生产出50多种剂型的1500多种产品，满足了全球范围内80多个市场的需求。其销量在印度制药行业排名第三（IQVIA MAT，2022年5月），南非私营制药市场排名第三（IQVIA YTD, 2022年5月），同时也是美国市场中最知名的仿制药企业之一。在过去的80年间，Cipla一直将改变病患的用药状况作为工作的导向。2001年，Cipla在非洲以每天不到1美元的价格提供了艾滋病的抗逆转录病毒三重疗法，这一行业范例的举措被广泛认为对抵抗艾滋病运动贡献了更多的包容性、可及性和可负担性。作为一个具有高度责任感的企业，Cipla围绕“关爱生命”这一目标所践行的人道主义策略和其在所到之处建立的良好关系网络，成为全球医疗卫生机构、同行业以及所有利益相关者信赖的合作伙伴。

Henlius HANQUYOU Received TGA Approval in Australia

Shanghai, China, Jul, 25^th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company’s business partner Cipla Limited (“Cipla”) has received the relevant registration certificates from the Therapeutic Goods Administration of Australia (“TGA”) for the approval of Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®) with the specification of 150mg/vial in Australia under the trade names Tuzucip^® and Trastucip^®, covering all indications of the reference trastuzumab approved in Australia. At present, Henlius is working with Cipla in Australia and this approval will help both parties bring HANQUYOU to more patients in Australia.

Henlius independently developed HANQUYOU in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), US Food and Drug Administration (USFDA) and other international biosimilar guidelines. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively, and became the first Chinese mAb biosimilar to enter both the European Union (EU) and China markets. In particular, Zercepac^® (150mg/vial) has launched in about 20 European countries and regions, including the United Kingdom, Germany, Spain, France, and Italy, and the dosage forms of 60mg/vial and 420mg/vial were also approved for marketing in the EU.

Henlius has taken multiple head-to-head comparisons between HANQUYOU and the reference trastuzumab, including comparative quality studies, preclinical studies, a phase 1 clinical study and a global multi-certre phase 3 clinical study. These data proved that HANQUYOU and reference trastuzumab are highly similar in terms of quality, safety and efficacy. The approval of HANQUYOU by TGA of Australia was mainly based on the review of a series of studies. The relevant application materials are mainly based on the information in the Marketing Authorization Application (MAA) in relation to the product submitted to the EU. HANQUYOU has been approved in Australia for the treatment of HER2-positive early breast cancer, HER2-positive locally advanced breast cancer, HER2-overexpressing metastatic breast cancer and HER2-positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction.

In 2018, Henlius granted Cipla the exclusive rights to develop and commercialize HANQUYOU in several countries including Australia and is solely responsible for the production and supply of HANQUYOU for Cipla in the licensed territories. The manufacturing facilities for HANQUYOU and the quality management system are in line with global standards. Among them, the Xuhui Facility has obtained Good Manufacturing Practice (GMP) certifications from China and the EU, making it the first plant that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies in China. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency, the EU qualified person, and multiple international business partners. In May 2022, Songjiang First Plant has been approved for the commercial manufacturing of HANQUYOU by the NMPA with a total capacity of 24,000L, to support the growing global demands for the product.

To date, the 150mg form of HANQUYOU has completed the tendering process on the procurement platform and was included in the medical insurance procurement platform for all provinces in the Chinese mainland while the 60mg form has completed the tendering process on the procurement platform in 23 provinces and was included into the medical insurance procurement platform in 30 provinces in the Chinese mainland, benefiting nearly 70,000 patients. In addition, the company has actively collaborated with global partners such as Cipla, Accord, Abbott, Eurofarma, Mabxience, Jacobson, etc. to bring HANQUYOU to patients in over 90 countries and regions, covering the United States, Canada, Europe, and many emerging markets. Looking forward, Henlius will give full play to the company's footprints in innovation and globalization, continue to promote the implementation of the company's all-round evolution strategy towards a global Biopharma and boost the accessibility and influence of Henlius' products in the global market by reaching out to more strategic partners and bring hope to more patients.

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 ^®, trade names in Australia: Tuzucip ^®and Trastucip ^®), 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.

About Cipla

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT May’22), 3rd largest in the pharma private market in South Africa (IQVIA MAT May’22), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.

联系方式

媒体：PR@Henlius.com

投资者：IR@Henlius.com

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