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
Henlius Rituximab Receives Marketing Approval in Peru
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The 3rd self-developed and -manufactured product breaking into global markets -
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HANLIKANG’s first approval beyond China to benefit patients in emerging markets -
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The 1st biosesimilar 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 biosesimilar, 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
联系方式
媒体:PR@Henlius.com
投资者:IR@Henlius.com


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