Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

• H药 汉斯状®（斯鲁利单抗）是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗• H药在中国、欧洲及东南亚等30余个国家和地区获批上市，累计惠及超10万患者• H药治疗SCLC获得美国FDA、欧盟EC、瑞士Swissmedic授予孤儿药资格认定，并获韩国MFDS授予广泛期小细胞肺癌（ES-SCLC）孤儿药资格2025年4月25日，复宏汉霖（2696.HK）宣布与美时化学制药股份有限公司（台湾证券交易所股票代码：1795）全资子公司Alvogen Korea Co., Ltd.（下称“Lotus”）签署授权许可协议，授予其在韩国对公司自主开发的抗PD-1单抗H药 汉斯状®（斯鲁利单抗）包括ES-SCLC在内的多项适应症的独家商业化和半独家开发权益。2025年3月，H药用于治疗ES-SCLC获得韩国食品药品安全部（MFDS）孤儿药资格认定。Lotus专注于肿瘤、中枢神经系统、心血管系统等治疗领域，在亚洲市场拥有成熟的商业化网络和深厚的本土经验。此次合作将结合复宏汉霖全球领先的研发实力与Lotus的区域渠道优势，进一步加速H药 汉斯状®在韩国的可及性，共同推动全球领先的创新治疗方案惠及韩国当地患者。根据协议，复宏汉霖将负责H药在韩国上市后的产品生产和供应，并将从此次交易中获得500万美元的首付款、可达950万美元的监管里程碑付款、可达9,750万美元的商业化里程碑付款及两位数比例的合作区域净销售额特许权使用费。复宏汉霖首席商务发展官兼高级副总裁曹平女士表示“此次与Lotus的合作是复宏汉霖践行国际化战略走出的坚实一步。Lotus在韩国市场的卓越商业化能力与快速执行经验，将助力H药加速进入当地市场。我们期待通过双方优势资源的整合，为韩国患者提供更多高品质、可负担的创新治疗方案，并进一步深化公司在亚洲市场的布局。”Lotus首席执行官Petar Vazharov表示“我们很高兴携手复宏汉霖将极具前景的肿瘤免疫疗法斯鲁利单抗带给韩国患者。此次合作标志着我们在拓展亚洲肿瘤治疗领域的重要里程碑。MFDS近期授予的孤儿药认定，印证了H药在解决小细胞肺癌未满足临床需求方面的潜力。我们期待与复宏汉霖紧密合作，加速这款创新疗法的可及性，改善韩国患者的治疗效果。”H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、欧盟以及多个东南亚国家获批上市。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，截至目前，H药已在中国获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、ES-SCLC、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC）。除韩国外，H药治疗SCLC也已获得美国FDA、欧盟EC和瑞士Swissmedic的孤儿药资格认定，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。复宏汉霖全速推进H药在全球市场的商业化进程。截止目前，H药对外授权已覆盖美国、欧洲、东南亚、中东和北非等全球100多个国家和地区。未来，公司将携手各位合作伙伴全力推动H药的全球开发进程，令H药能够覆盖更广泛的国家和地区，为更多患者提供更广泛的治疗选择。关于美时化学制药美时化学制药股份有限公司（台湾证券交易所股票代码：1795），成立于1966年，是一家全球领先的制药公司，专注于新药和仿制药的商业化，致力于为患者提供更安全、有效且易于获得的药品。公司拥有亚洲顶尖的研发和制造平台，也是台湾唯一同时获得美国FDA、欧盟EMA、日本PDMA、中国FDA及巴西ANVISA认证的制药厂。美时在美国、欧洲、日本、中国和巴西等全球主要市场建立了合作伙伴关系，并运营超过100个制药项目，涵盖250多种商业化产品。透过自主研发和外部合作授权，美时成功引进高竞争力的肿瘤药物、复杂学名药、505(b)(2)药物、NCE药物及生物类似药，强化产品组合，进一步提升市场竞争力。 美时将继续致力于创新研发，推动全球业务拓展，为患者提供更多优质药品。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，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA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，涵盖约50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。截至目前，公司已获批上市产品包括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）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19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 Enters Exclusive License Agreement with Lotus for Anti-PD-1 mAb Serplulimab in South Korea• HANSIZHUANG (serplulimab) is the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC)• Serplulimab has been approved in 30+ markets including China, Europe, and Southeast Asia, benefiting 100,000+ patients• Orphan Drug Designation (ODD) granted to serplulimab for the treatment of SCLC by U.S. FDA, EC, and Swissmedic, and for Extensive-Stage SCLC (ES-SCLC) by Korea MFDSShanghai, China, April 25, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license agreement with the wholly-owned subsidiary of Lotus Pharmaceutical Co. Ltd. (TWSE Stock code: 1795), Alvogen Korea Co., Ltd. (“Lotus”), granting Lotus exclusive license for the commercialization and co-exclusive for the development of Henlius’ independently developed anti-PD-1 mAb HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) in South Korea for several indications including ES-SCLC. In March 2025, serplulimab was granted orphan drug designation for the treatment of ES-SCLC by the Korean Ministry of Food and Drug Safety (MFDS).Lotus has a solid track record for oncology, immunology, and central nervous system (CNS) therapies, bringing extensive regional commercialization expertise across Asia. Under the agreement, Henlius will be responsible for post-approval manufacturing and supply upon launch in South Korea and will receive a $5 million upfront payment, up to $9.5 million in regulatory milestones, up to $97.5 million in commercial sales milestones, and double-digit royalties on annual net sales from Lotus in the licensed territory.Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, “This collaboration with Lotus marks a pivotal step in Henlius’ ongoing commitment to global expansion. Lotus’ proven commercialisation expertise and agile execution capabilities in the Korean market will accelerate the introduction of serplulimab to local patients. By synergizing our complementary strengths, we aim to deliver high-quality, affordable innovative therapies to Korean patients and further solidify our strategic footprint across Asia.”Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, continued, “We are thrilled to partner with Henlius to bring serplulimab, a promising immuno-oncology therapy, to patients in South Korea. This collaboration marks a significant milestone in our continued efforts to expand our oncology footprint across Asia. The recent orphan drug designation granted by the MFDS underscores the potential of serplulimab to address critical unmet needs in small cell lung cancer. We look forward to working closely with Henlius to accelerate access to this innovative therapy and improve outcomes for patients in Korea.”Serplulimab is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in China, EU and several Southeast Asian countries. Focusing on lung and gastrointestinal cancer, the synergy of serplulimab with in-house products of the company and innovative therapies are being actively promoted. Up to date, serplulimab has been approved by the National Medicinal Products Administration (NMPA) for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). Beyond South Korea, serplulimab was granted orphan drug designations by the United States Food and Drug Administration (FDA), the European Commission (EC), and the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.In the meantime, Henlius pro-actively advances the commercialisation of serplulimab in global markets at high speed. To date, HANSIZHUANG has been licensed out to more than 100 countries and regions including the U.S., Europe, Southeast Asia, the Middle East, and North Africa. In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of serplulimab globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.About Lotus PharmaceuticalFounded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercializing both novel and generic pharmaceuticals to provide patients with better, safer, and more accessible medicines. The company boasts a best-in-class R&D and manufacturing platform in Asia, certified by leading regulatory authorities around the world, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Lotus has established partnerships in nearly every major global market, including the U.S., Europe, Japan, China, and Brazil. The company is currently developing and registering over 100 strategically selected pharmaceutical projects across Asia and the U.S., with more than 250 commercial products. Lotus invests in a diversified portfolio, consisting of high-barrier oncology, complex generics, 505(b)2, NCEs, and biosimilars, through both internal R&D investments and licensing-in partnerships to strengthen its portfolio competitiveness.About HenliusHenlius (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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. 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 about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include 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), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看