Pertuzumab

2月2日，复宏汉霖发布公告，其自主研发的Perjeta®（帕妥珠单抗）生物类似药候选药HLX11（重组抗HER2结构域II人源化单克隆抗体注射液）「HLX11）的生物制品许可申请（BLA）获美国食品药品管理局（FDA）受理，本次申请涉及的适应症如下： 与曲妥珠单抗和多西他赛联合，用于治疗既往未接受过针对转移性疾病抗HER2治疗或化疗的HER2阳性、转移性乳腺癌（MBC）患者； 与曲妥珠单抗和化疗联合，作为早期乳腺癌整体治疗方案的一部分，用于HER2阳性、局部晚期、炎性或早期乳腺癌患者（直径＞2cm或淋巴结阳性）的新辅助治疗； 用于具有高复发风险的HER2阳性早期乳腺癌患者的辅助治疗。 HLX11是复宏汉霖自主研发的帕妥珠单抗生物类似药，拟用于HER2阳性早期乳腺癌的新辅助╱辅助治疗、HER2阳性转移性乳腺癌的治疗及╱或与原研药药品标签相符的其他适应症。2024年9月，HLX11的国际多中心3期临床研究达到了主要研究终点。2024年12月，HLX11的上市注册申请获国家药品监督管理局(NMPA)受理。 2022年6月，复宏汉霖与Organon签订授权许可及供货协议，据此，复宏汉霖向Organon及其附属公司授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外的全球范围内商业化HLX11。 根据FDA发布的行业指南《证明与参照药生物相似性方面的科学考虑》，本次复宏汉霖向FDA提交的BLA基于HLX11对比Perjeta®产生的数据，包括分析相似性研究及3期临床比对研究，申请Perjeta®（帕妥珠单抗）在美国已获批上市的所有适应症。

2025年2月2日，复宏汉霖（2696.HK）宣布，公司自主研发的在研Perjeta®（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）获美国食品药品监督管理局（FDA）受理。 目前Perjeta®已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助治疗等。 复宏汉霖已于2022年与Organon达成授权许可和供应合作，授予Organon及其附属公司对包括HLX11在内的两款候选生物类似药在除中国以外的全球区域进行独家商业化的权益，协议覆盖美国、欧盟、加拿大等市场。 此次递交主要基于一系列与原研帕妥珠单抗的比对研究，包括分析相似性研究和两项临床比对研究。其中一项临床研究为在中国健康男性受试者中开展的随机、双盲、单次给药、平行对照、四臂的I期临床试验，主要研究目的为比较HLX11与美国、欧盟和中国市售的原研帕妥珠单抗静脉注射后的药物代谢动力学、安全性和免疫原性方面的生物相似性。另一临床试验为一项多中心、随机、双盲、平行对照的III期临床试验，旨在比较HLX11与欧盟市售原研帕妥珠单抗用于HER2阳性、HR阴性的早期或局部晚期乳腺癌患者新辅助治疗的疗效和安全性。此前，HLX11在中国的上市注册申请（NDA）已获国家药品监督管理局（NMPA）药品审评中心受理。 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，3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50多个分子，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）以及汉奈佳®（奈拉替尼）。公司亦同步就16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。 US FDA Accepts Biologics License Application (BLA) for HLX11, Biosimilar Candidate of Perjeta® (pertuzumab) Shanghai, China – Feb 2, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab).  Perjeta® has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer, and adjuvant treatment for certain HER2-positive early breast cancer, among other indications. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon and its affiliates the exclusive global commercialization rights to two biosimilar candidates, including HLX11. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China. The filing is based on data from a series of studies for HLX11 versus Perjeta, including analytical similarity studies and two comparative clinical studies. The first of the clinical studies was a randomized, double-blind, single-dose, parallel-controlled, four-arm phase 1 study aimed to compare the pharmacokinetics, safety and immunogenicity of HLX11 with US-, EU- and China-sourced pertuzumab administrated intravenously in healthy Chinese male subjects. The second was a multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study comparing the efficacy and safety of HLX11 with EU-sourced reference pertuzumab as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer. Previously, the new drug application for HLX11 was accepted by China’s National Medical Products Administration (NMPA). About Henlius Henlius (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, 3 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 over 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, 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 16 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