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2024-05-27

汉霖快讯 | 秘鲁获批，，，，，，，汉利康?出海“首战”告捷


复宏汉霖第三款实现外洋获批上市自研产品，，，，，，，锚定全球化战略

汉利康?首次外洋获批，，，，，，，加速惠及新兴市场国家

中国首款生物类似药，，，，，，，已惠及逾25万中国患者


近期，，，，，，，复宏汉霖自主开发和生产的汉利康?（利妥昔单抗）正式获得秘鲁药监局（Dirección General de Medicamentos, Insumos y Drogas, “DIGEMID”）批准上市，，，，，，，商品名为AUDEXA?。。。。。。汉利康?成为继汉曲优?和汉斯状?后，，，，，，，复宏汉霖第三款外洋获批上市的自主研发和生产的产品。。。。。。作为中国首个生物类似药，，，，，，，汉利康?自2019年获批上市以来已惠及超25万名中国患者。。。。。。


此次汉利康?在秘鲁获批主要基于DIGEMID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中国国家药监局（NMPA）上市注册申请（NDA）的资料。。。。。。复宏汉霖针对汉利康?开展了一系列与原研利妥昔单抗的头对头比对研究，，，，，，，包括药学比对研究、非临床比对研究和临床比对研究，，，，，，，研究效果证实汉利康?在质量、清静性和有用性等方面与原研药高度相似。。。。。。


汉利康?的研发、生产和质量控制环节遵照国际最高标准。。。。。。汉利康?的生产基地徐汇基地是海内首个获得中欧双GMP认证用于生产自主研发抗体生物药的生产基地。。。。。。该生产基地及配套的质量治理系统已通过近百项由NMPA、欧洲药品治理局（EMA）、PIC/S成员印尼食物药品监视治理局（BPOM）和巴西国家卫生监视治理局（ANVISA）、欧盟质量受权人（QP）及公司国际商业相助同伴举行的多项实地核查及审计。。。。。。


围绕汉利康?，，，，，，，复宏汉霖起劲携手Abbott、Boston Oncology、Eurofarma和FARMA DE COLOMBIA等生物制药企业相助同伴，，，，，，，全力加速全球结构。。。。。。未来，，，，，，，公司将始终怀揣“可肩负的立异，，，，，，，值得信托的品质”这一初心，，，，，，，一连推动汉利康?在全球上市历程，，，，，，，惠及更普遍的患者群体。。。。。。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的立异生物制药公司，，，，，，，致力于为全球患者提供可肩负的高品质生物药，，，，，，，产品笼罩肿瘤、自身免疫疾病、眼科疾病等领域，，，，，，，已在中国上市5款产品，，，，，，，在国际获批上市3款产品，，，，，，，23项顺应症获批，，，，，，，3个上市申请划分获中国药监局和欧盟EMA受理。。。。。。自2010年建设以来，，，，，，，复宏汉霖已建成一体化生物制药平台，，，，，，，高效及立异的自主焦点能力贯串研发、生产及商业运营全工业链。。。。。。公司已建设完善高效的全球立异中心，，，，，，，凭证国际药品生产质量治理规范（GMP）标准举行生产和质量管控，，，，，，，一直夯实一体化综合生产平台，，，，，，，其中，，，，，，，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。。。。。。


复宏汉霖前瞻性结构了一个多元化、高质量的产品管线，，，，，，，涵盖50多个分子，，，，，，，并周全推进基于自有抗PD-1单抗H药汉斯状?的肿瘤免疫团结疗法。。。。。。继海内首个生物类似药汉利康?（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优?（曲妥珠单抗，，，，，，，美国商品名：HERCESSI?，，，，，，，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，，，，，，，立异产品汉斯状?（斯鲁利单抗）已获批用于治疗微卫星高度不稳固（MSI-H）实体瘤、鳞状非小细胞肺癌、普遍期小细胞肺癌和食管鳞状细胞癌，，，，，，，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。。。。。。公司亦同步就16个产品在全球规模内开展30多项临床试验，，，，，，，对外授权周全笼罩西欧主流生物药市场和众多新兴市场。。。。。。


Henlius Rituximab Receives Marketing Approval in Peru


  • The 3rd self-developed and -manufactured product breaking into global markets -

  • HANLIKANG’s first approval beyond China to benefit patients in emerging markets -

  • The 1st biosimilar launched in China, benefiting over 250,000 Chinese patients since 2019?-

Recently, HANLIKANG (rituximab), independently developed and manufactured by Henlius, has been approved to be marketed in Peru?under the trade name AUDEXA??by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID).?HANLIKANG is the third product that has been developed and manufactured by Henlius independently and approved for overseas marketing, following HANQUYOU and HANSIZHUANG. As China's first biosimilar, HANLIKANG has so far benefited over 250,000 Chinese patients since its launch in 2019.


The approval of HANLIKANG by DIGEMID in Peru is mainly based on the review of a series of data. The application dossier is mainly based on the information submitted to China’s National Medical Products Administration (NMPA) in the New Drug Application (NDA). Henlius has conducted a set of head-to-head comparisons between HANLIKANG and the reference product, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANLIKANG and the reference product are highly similar in terms of quality, safety and efficacy.


HANLIKANG’s development, manufacturing and the quality management system are in line with global standards. Xuhui Facility, the manufacturing facility for HANLIKANG, has obtained Good Manufacturing Practice (GMP) certifications from both China and the EU, making it the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners.


Henlius has aggressively pursued international commercialisation of HANLIKANG, actively collaborating with global partners such as Abbott, Boston Oncology, Eurofarma and FARMA DE COLOMBIA to bring its therapeutics to patients around the world. In keeping with the original aspirations of “affordable innovation and reliable quality”, Henlius will?continue to promote the approval and launch of HANLIKANG in more countries and regions to accelerate the delivery of high-quality, affordable, and innovative medicines to 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, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3?marketing applications have been accepted for review in China and the EU, respectively. 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.


Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules 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: HERCESSI? in the U.S.,?Zercepac? in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S.,?HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.? ??

联系方法

媒体：PR@Henlius.com

投资者：IR@Henlius.com

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