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海外获批上市自研产品，锚定全球化战略

汉利康首次海外获批，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，复宏汉霖第三款海外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，研究结果证明汉利康在质量、安全性和有效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循国际最高标准。汉利康的生产基地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。该生产基地及配套的质量管理体系已通过近百项由NMPA、欧洲药品管理局（EMA）、PIC/S成员印尼食品药品监督管理局（BPOM）和巴西国家卫生监督管理局（ANVISA）、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。

围绕汉利康，复宏汉霖积极携手Abbott、Boston Oncology、Eurofarma和FARMA DE COLOMBIA等生物制药企业合作伙伴，全力加速全球布局。未来，公司将始终怀揣“可负担的创新，值得信赖的品质”这一初心，持续推动汉利康在全球上市进程，惠及更广泛的患者群体。

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，在国际获批上市3款产品，23项适应症获批，3个上市申请分别获中国药监局和欧盟EMA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，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，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）、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，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、鳞状非小细胞肺癌、广泛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个产品在全球范围内开展30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 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.

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