复宏汉霖自主开发和生产的汉曲优®在菲律宾、泰国获批
内容来源：复宏汉霖
近期，复宏汉霖自主开发和生产的汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）接连在泰国和菲律宾获得批准上市，商品名分别为TRAZHER®和Hertumab®，用于HER2阳性乳腺癌和胃癌的治疗。此前，汉曲优®已在新加坡、柬埔寨等东南亚国家成功获批上市。截至目前，该产品已在全球超过40个国家和地区获批上市。
乳腺癌是东南亚发病率最高的恶性肿瘤，2022年该区域乳腺癌新发病例近17万例[1]。HER2过表达的乳腺癌约占乳腺癌总数的15%-20%[2]。另一方面，胃癌患者的HER2过表达比率约为12%-23%[3]。曲妥珠单抗是治疗HER2阳性乳腺癌和胃癌的基石类药物，并作为一线治疗方案被纳入美国国家综合癌症网络（NCCN）指南、中国临床肿瘤协会（CSCO）诊疗指南、欧洲肿瘤内科学会（ESMO）指南等-6。目前，复宏汉霖正与KGbio在多个东南亚国家合作推进汉曲优®在该区域市场的商业化进程，为当地患者提供更多高效、安全的治疗选择，助力推动当地医疗水平的不断进步，提升优质生物药在新兴市场的可及性。
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，并有望成为首个在中国、欧盟、美国获批的“中国籍”生物类似药。其美国上市许可申请已获得美国FDA受理，预计将于2024年获批。自上市以来，汉曲优®（欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）已成功于中国、英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯、新加坡等超过40个国家和地区获批上市，覆盖亚洲、大洋洲、拉丁美洲和欧洲，并进入中国、英国、法国和德国等多个国家的医保目录。截至目前，汉曲优®（欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）已惠及逾17万名患者。
汉曲优®的生产和质量控制环节遵循国际最高标准，其生产基地及配套的质量管理体系相继获得中欧双GMP认证，通过了由中国国家药监局（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，并于2023年接受了美国FDA的批准前检查（Pre-licensing Inspection, PLI）。复宏汉霖现有48,000升商业化产能，可为公司已上市产品提供商业化生产，并已实现全球产品常态化供应，全面覆盖中国、欧洲、东南亚及拉丁美洲。公司亦持续推进产能扩增，2026年公司总商业化产能预计可达144,000升，有望进一步满足日益增长的全球市场需求。
围绕汉曲优®，复宏汉霖亦前瞻性地开展了国际商业化布局，携手Accord、Abbott、Eurofarma、Elea和KGbio等国际一流的生物制药企业，在进军欧美主流生物药市场的同时，加快落子新兴市场，对外授权已覆盖全球约100个国家和地区。未来，复宏汉霖将继续推进汉曲优®在更多国家和地区的获批上市，以高品质生物药造福全球患者。
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Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines
Recently, Henlius' self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions.
Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022 [1]. About 15% to 20% of breast tumours are HER2-positive breast cancers. [2]. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23% [3]. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a first-line treatment option in the National Comprehensive Cancer Network (NCCN) guidelines, the Chinese Society of Clinical Oncology (CSCO) guidelines, and the European Society of Medical Oncology (ESMO) guidelines -6. Currently, Henlius is working with KGbio in most Southeast Asia to promote the commercialisation of HANQUYOU in the regional market, to provide more efficient and safe treatment options for local patients, to boost regional healthcare, and to enhance the accessibility of high-quality biologics in emerging markets.
Henlius independently developed HANQUYOU in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other international biosimilar guidelines. It was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively. It is the first China-developed mAb approved both in China and Europe and is expected to be the first China-developed biosimilar approved in China, Europe, and the United States (U.S) with the U.S. FDA’s acceptance of the BLA filing which is expected to be approved in 2024. Since its approval, HANQUYOU has been successfully approved in more than 40 countries and regions, including the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, Singapore, etc., covering Asia, Oceania, Latin America, and Europe, and it is reimbursed nationally in countries and regions including China, the United Kingdom (UK), France and Germany. To date, HANQUYOU has benefited more than 170,000 patients.
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. Also, the facility has successfully passed the on-site inspections and audits conducted by the NMPA, the EMA, the EU qualified person, and multiple international business partners and received the Pre-licencing Inspection (PLI) conducted by the U.S. FDA in 2023. A total commercial capacity of 48,000 Liters allows the company to supply products stably to markets beyond China, including Europe, Southeast Asia and Latin America. The company’s total capacity is expected to hit 144,000 Liters in 2026 to address the ever-increasing global market needs.
Henlius has aggressively pursued international commercialisation of HANQUYOU, actively collaborating with global partners such as Accord Healthcare, Abbott, Eurofarma, Elea and KGbio to bring its therapeutics to patients in the U.S., Europe, and other emerging markets, covering about 100 countries and regions. In the future, Henlius will continue to promote the approval and launch of HANQUYOU in more countries and regions to accelerate the delivery of high-quality, affordable, and innovative medicines to patients worldwide.
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