汉贝泰®首次海外获批，获得玻利维亚AGEMED批准上市

复宏汉霖第四款海外获批自研产品，持续拓展新兴市场

携手Eurofarma，三款合作产品均实现合作区域获批上市

近期，复宏汉霖自主开发和生产的汉贝泰®(贝伐珠单抗注射液)正式获得玻利维亚国家药品与卫生技术局(Agencia Estatal de Medicamentos y Tecnologías en Salud，AGEMED)批准上市，商品名为LONGIVA。这一里程碑标志着汉贝泰®成为继汉曲优®(曲妥珠单抗)、H药 汉斯状®(斯鲁利单抗)、汉利康®(利妥昔单抗)后，复宏汉霖第四款在海外获批上市的自主研发和生产的产品，进一步推动了公司的全球化进程。

此次获批是基于复宏汉霖与巴西及拉美地区领先的制药公司Eurofarma的独家商业化合作。2022年，复宏汉霖与Eurofarma达成合作，授权其在16个拉美地区国家对公司自主开发的利妥昔单抗汉利康®、曲妥珠单抗汉曲优®、贝伐珠单抗汉贝泰®三款产品进行开发、生产和商业化权益。依托复宏汉霖领先的产品品质和Eurofarma强大的本地化能力，汉曲优®和汉利康®已在玻利维亚等拉美国家获批上市。此次汉贝泰®获AGEMED批准上市，标志着双方合作的三款产品在合作区域均已实现获批，充分体现了双方紧密合作的丰硕成果。

汉贝泰®的研发、生产和质量控制环节遵循国际最高标准。此次汉贝泰®在玻利维亚获批主要基于AGEMED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品监督管理局(NMPA)上市许可申请(NDA)的资料。复宏汉霖针对汉贝泰®开展了一系列与原研贝伐珠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，研究结果证明汉贝泰®在质量、安全性和有效性等方面与原研药高度相似。公司生产基地及配套的质量管理体系已通过约百项由NMPA、欧洲药品管理局(EMA)、美国食品药品监督管理局(FDA)、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。

未来，复宏汉霖将始终坚守“可负担的创新，值得信赖的品质”这一初心，持续推动更多产品在全球获批上市，以惠及更广泛的患者群体。

• HANBEITAI (bevacizumab) receives first overseas approval from Bolivia's AGEMED

• The 4th self-developed product of Henlius approved overseas, continuing to expand into emerging markets

• In collaboration with Eurofarma, all three partnered products have been approved for marketing in the partnered regions

Recently, HANBEITAI (bevacizumab), independently developed and produced by Henlius, has been officially approved by Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for marketing in Bolivia under the trade name LONGIVA. This milestone marks HANBEITAI as the fourth self-developed and -manufactured product of Henlius to be approved for overseas marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), and HANLIKANG (rituximab). This further propels the company's globalization process.

The approval is based on the exclusive commercial cooperation between Henlius and Eurofarma, a leading pharmaceutical company in Brazil and Latin America. In 2022, Henlius entered into a license agreement with Eurofarma for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG, HANQUYOU, and HANBEITAI. Leveraging Henlius' leading product quality and Eurofarma's strong local capabilities, HANQUYOU and HANLIKANG have already been approved for marketing in Latin American countries including Bolivia. The approval of HANBEITAI by AGEMED signifies that all three partnered products have been successfully approved in the partnered territories, highlighting the fruitful outcomes of the close collaboration.

HANBEITAI’s development, manufacturing and the quality management system are in line with global standards. The approval of HANBEITAI by AGEMED in Bolivia 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 HANBEITAI and the reference bevacizumab, including analytical similarity studies, non-clinical studies and clinical studies. The results showed that HANBEITAI and the reference product are highly similar in terms of quality, safety and efficacy. Henlius’ three production sites – Xuhui Facility, Songjiang First Plant and Songjiang Second Plant – along with their quality management systems, have successfully passed approximately 100 inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners.

Moving forward, Henlius remains committed to its mission of "Affordable innovation, Reliable Quality", continuing to drive the global approval and marketing of more products to benefit a broader patient population.