上海复旦张江生物医药股份有限公司关于变更部分募集资金投资项目的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 登录新浪财经APP 搜索【信披】查看更多考评等级 股票代码：688505股票简称：复旦张江编号：临2025-035 重要内容提示： ●原项目名称：海姆泊芬美国注册项目； ●新项目名称：光动力药物创新研发持续发展项目； ●变更募集资金投向的金额：人民币18,154.61万元（该金额为截至2025年10月30日募集资金账户余额， 含利息及理财收益，实际金额以资金转出当日计算利息收入后的剩余金额为准）； ●新项目建设周期：自公司股东大会审议通过之日起至2027年12月31日； ●公司将原"海姆泊芬美国注册项目"变更至"光动力药物创新研发持续发展项目"，能够有效控制募集资 金使用风险，聚焦优势研发领域，提升资金使用效率，快速推动在研项目研发及产业化，以期尽快为公 司贡献收入； ●本次变更募投项目不会对公司当前和未来生产经营产生重大不利影响，不存在损害公司及股东利益的 情形。公司将加强对募投项目进度的监督，以提高募集资金的 ...

Core Viewpoint - Fudan Zhangjiang's application for the listing of Obeticholic Acid Tablets was not approved by the National Medical Products Administration, resulting in a loss of approximately 125 million yuan in R&D investment and highlighting systemic risks in product structure, R&D strategy, and external policy environment [1] Group 1: R&D Risks - The application for Obeticholic Acid Tablets, a Class 3 chemical generic drug, faced obstacles due to the original drug's withdrawal from markets in Europe and the U.S. due to safety concerns, which disrupted the registration path for domestic generic drugs [1] - The withdrawal of the original drug by Intercept Pharmaceuticals has led to multiple rejections of generic drug applications from various companies, including Fudan Zhangjiang [1] Group 2: Revenue Structure Challenges - Fudan Zhangjiang has four commercialized products, with Revlimid and Ella contributing approximately 70% of revenue, while the anti-tumor drug Liposomal Doxorubicin accounts for about 29.04% [3] - The core product Liposomal Doxorubicin is expected to see a price reduction of at least 35% starting May 2025, potentially leading to a more than 50% year-on-year decline in sales revenue [3] - The sales revenue of Revlimid decreased by 7% year-on-year in the first half of this year, while Ella saw a slight increase of 2%, indicating weak growth overall [3] Group 3: High R&D Investment and Uncertain Returns - Despite emphasizing that the failure of the Obeticholic Acid project will not alter the overall R&D strategy, the incident underscores the high investment, long cycle, and high risk associated with pharmaceutical R&D [4] - The company is increasing its focus on the ADC (Antibody-Drug Conjugate) platform to build a differentiated advantage, but competition in this field is intensifying [4] Group 4: Regulatory Environment - The National Medical Products Administration has tightened regulations on the entire lifecycle of drugs, making it increasingly difficult for generic drugs to find reference products if the original drug is withdrawn due to safety or efficacy issues [5] - Domestic pharmaceutical companies are advised to consider global regulatory dynamics and real-world data when selecting generic drug projects, rather than solely focusing on patent expiration and unlisted drugs in the domestic market [5] Conclusion - Fudan Zhangjiang faces multiple challenges, including aging product structures, missteps in generic drug projects, and impacts from centralized procurement policies, which complicate the path to maintaining stable existing business while accelerating the development of competitive innovative drug pipelines [6][7]