H药汉斯状®领衔，复宏汉霖携创新研发成果连续五年参展BIO International Convention
文章主要来源：复宏汉霖
复宏汉霖立足患者需求，致力于凭借强大的产品研发、前沿的生产与质量体系及卓越的商业化能力，携手价值链上的伙伴积极布局拓展全球生物药市场，为全球患者提供可负担的高品质生物药。H药 汉斯状®（斯鲁利单抗）是全球首个用于治疗小细胞肺癌（SCLC）的抗PD-1单抗，该产品治疗SCLC已获得美国FDA和欧盟EC的孤儿药资格认定。2023年3月，H药联合化疗一线治疗ES-SCLC的上市许可申请（MAA）获得EMA受理。此外，公司在美国启动了一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验，并计划于2024年在美国递交上市申请，有望惠及全球更广泛的肿瘤患者群体。公司另一款抗肿瘤核心产品汉曲优®（曲妥珠单抗）是中国首个自主研发的中欧双批单抗药物。作为国产生物药“出海”代表，汉曲优®在英国、法国、德国、瑞士、澳大利亚、新加坡、阿根廷、沙特阿拉伯等30多个国家获批上市，同时，汉曲优®的上市许可申请已获得美国FDA受理，有望进一步覆盖欧美主流生物药市场。
研发方面，公司协同中美两地创新中心及全球产品开发团队，持续加码创新，夯实丰富的多元化产品管线，已累计在全球范围内获得超过100项临床试验批准，并同步在中国、欧盟、美国和澳大利亚等国家和地区开展30多项临床试验。生产方面，公司严格遵照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，现有商业化产能共计48000升。公司商业化生产基地及配套的质量管理体系已获得中国和欧盟药品生产质量管理规范（GMP）认证，可为公司已上市产品提供商业化生产，并已实现中国和欧盟市场常态化供应，强力支撑产品在全球的持续放量。商业化方面，公司搭建了超过1000人的自主商业化团队负责汉曲优®和H药 汉斯状®等核心肿瘤产品在中国市场的商业化推广，同时前瞻性地布局海外市场，积极与Abbott, Accord Healthcare, Getz Pharma, Eurofarma, Organon和HAHA体育 医药等国际制药企业达成战略商业化合作，产品对外授权覆盖美国、欧盟、日本等主流生物药市场和新兴市场。凭借在全球合作增长方面的卓越表现和优秀的品牌声誉，复宏汉霖在Global Generics & Biosimilars Awards 2022（GGB Awards，2022全球仿制药与生物类似药奖）榜单中斩获 “Business Development of the Year”（年度商务拓展奖）。
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Henlius Shines for Five Consecutive Years at BIO International Convention
Having the goals of providing innovation and affordability for patient-centric unmet medical needs, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as collaborating with capable partnerships to accelerate these goals. One highlight was the global presence of HANSIZHUANG (serplulimab), the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). HANSIZHUANG was granted Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC. In March 2023, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for HANSIZHUANG for the first-line treatment of ES-SCLC. Patients have also been dosed in a head-to-head bridging trial of HANSIZHUANG versus first-line standard-of-care atezolizumab for ES-SCLC in the U.S. The company plans to submit a Biologics License Application (BLA) for HANSIZHUANG in the U.S. in 2024. Additionally, the company prides itself on its trastuzumab biosimilar HANQUYOU (trade name in Europe: Zercepac®, trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb approved in both China and Europe. It is now approved in more than 30 countries, including China, the United Kingdom (UK), France, Germany, Switzerland, Australia, Singapore, Argentina, and Saudi Arabia. In February 2023, the Biologics License Application (BLA) for HANQUYOU has been accepted by the FDA, which will further expand the product's footprint in major markets of biologics in the U.S. and Europe.
Synergising its innovation centres in China and the US and global product development teams, the company continues to build on the momentum to expand an even more diversified innovation product pipeline and has conducted more than 30 clinical trials in China, the EU, the US, Australia, etc. with more than 100 clinical trial approvals worldwide. In terms of manufacturing, the company strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. It has a total commercial manufacturing capacity of 48,000 L. The company's commercial production facility and supporting quality management system have been certificated by China and the EU GMP. At present, a stable supply has been achieved in the Chinese and the EU markets, strongly supporting the continued expansion of the products globally. In terms of commercialization, Henlius has built a top-tier in-house commercial team of over 1000 sales forces for the local commercialization of the company's core oncology products such as HANQUYOU and HANSIZHUANG. In addition, Henlius has actively partnered with other global companies such as Abbott, Accord Healthcare, Getz Pharma, Eurofarma, Organon, and Fosun Pharma to expand into mature and emerging markets, including the U.S., EU, and Japan. In recognition of its remarkable global partnership growth and brand reputation, Henlius received the ‘Business Development of the Year’ award from Generics Bulletin in 2022. Looking forward, Henlius will maintain its focus on unmet medical and market needs; develop more high-quality, affordable and innovative biologics; advance its global R&D, production, and commercialization capabilities; expand international collaborations, and accelerate building a global presence to benefit patients worldwide.About BIO International Convention
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