Xin Lang Zheng Quan·2025-10-17 06:37Core 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of drugs, making it increasingly difficult for generic drugs to find reference products if the original drug is withdrawn due to safety or efficacy issues [5] - Domestic pharmaceutical companies are advised to consider global regulatory dynamics and real-world data when selecting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]