HLX11是公司自主研发的帕妥珠单抗生物类似药。2022年6月，公司与Organon LLC(Organon & Co.的全 资附属公司)签订协议，向其授出一项独家许可，供其及其附属公司于除中国境内及港澳台地区以外全 球范围内商业化HLX11。2024年12月，HLX11的上市注册申请(NDA)获国家药品监督管理局 (NMPA)受 理。2025年3月，HLX11的上市许可申请(MAA)获欧洲药品管理局(EMA)受理。2025年5月，HLX11的上 市注册申请(NDS)获加拿大卫生部 (Health Canada)受理。根据IQVIA MIDASTM的最新数据(由IQVIA提 供，IQVIA是全球医药健康产业专业信息和战略咨询服务提供商)，2024年度，帕妥珠单抗产品于全球 范围内的销售额约为33.04亿美元。 POHERDY®获批上市之后，集团累计已有七款产品于海外获批上市，其中，四款产品于美国获批上 市。本次获批，代表国际主流市场对于公司产品的又一认可，将进一步推进公司国际化布局的进程，提 升公司产品的国际影响力。集团将联合合作伙伴Organon LLC于条件具备后推进当地商业化销售。 智通财经APP讯，复 ...

Core Insights - EirGenix Inc. has entered into a second global exclusive licensing agreement with Sandoz AG for the commercialization of its breast cancer biosimilar EG1206A, covering all territories except specific Asian markets [1][2] - The agreement includes up to USD 152 million in upfront and milestone payments, along with profit sharing and sales incentives post-launch [1][2] - EG1206A has received positive feedback from the U.S. FDA and EMA, allowing for an abbreviated development pathway without Phase III trials [2] Company Developments - EirGenix has successfully developed multiple biosimilar products using reverse engineering technologies, enhancing its global competitiveness [5] - The company is accelerating the development of four HER2-targeted antibody programs and expanding its product pipeline and CDMO services [5] - EirGenix's production capacity and facilities have attracted attention from international pharmaceutical companies, indicating strong growth potential [5] Market Context - There are approximately 2.3 million breast cancer patients globally, with 20% diagnosed with HER2-positive disease, indicating a significant market for EG1206A [3] - The combination therapy of Trastuzumab and Pertuzumab is the current standard of care, with potential market expansion for EG1206A as new treatment options emerge [3] - Roche's Perjeta® generated global sales of approximately USD 4 billion in 2024, highlighting the lucrative market for HER2-targeted therapies [3][4] Strategic Partnership - The partnership with Sandoz strengthens the existing collaboration, following a previous agreement for EG12014, which is already approved in Europe and under review in the U.S. [2] - Sandoz is a leader in affordable medicines, with a portfolio of around 1,300 products and net sales of USD 10.4 billion in 2024 [4]