Core Viewpoint - Fudan Zhangjiang's stock price has decreased by 1.97% this week, closing at 8.94 yuan, with a total market capitalization of 9.267 billion yuan as of October 17, 2025 [1] Company Announcements Summary - Fudan Zhangjiang signed a structured deposit agreement with Ping An Bank, investing 220 million yuan in a principal-protected floating income product with a term of 79 days and an expected annualized return of 0.45%-1.90%, linked to the Shanghai gold price [2] - The company's wholly-owned subsidiary, Taizhou Fudan Zhangjiang, had its application for the listing of Obeticholic Acid Tablets (5mg, 10mg) for the treatment of primary biliary cholangitis rejected by the National Medical Products Administration. The project has incurred approximately 125 million yuan in R&D costs, which have been accounted for in the financial statements, but the rejection will not significantly impact the company's current financial status [2][5] - Fudan Zhangjiang entered into two structured deposit agreements with the Bank of China, totaling 170 million yuan, with terms of 63 and 78 days, linked to GBP/USD and EUR/USD exchange rates, respectively, and expected annualized returns ranging from 0.35% to 1.70% [3] - The company also signed a structured deposit agreement with China Merchants Bank, totaling 100 million yuan, with a term of 76 days, linked to gold prices, and expected annualized returns of 1.00%-1.65% [3]

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]

Core Insights - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that the application for the drug Obeticholic Acid Tablets for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1][2] Group 1: Company Developments - The drug Obeticholic Acid, developed by Intercept Pharmaceuticals, was initially approved by the FDA in May 2016 for PBC patients who are intolerant to or do not respond to Ursodeoxycholic Acid (UDCA) [2] - Fudan Zhangjiang completed the bioequivalence study for Obeticholic Acid in July 2020 and finished the on-site inspection for the registration application in June 2025 [1] - The total R&D investment for the Obeticholic Acid project reached approximately RMB 125 million (unaudited) as of the announcement date [1] Group 2: Regulatory Challenges - The application for Obeticholic Acid was rejected because the reference drug did not receive regular approval in foreign markets, and there was insufficient evidence to support the drug's benefits outweighing risks [1] - Intercept Pharmaceuticals voluntarily withdrew Obeticholic Acid from the U.S. market in September 2023 at the request of the FDA, which also suspended all clinical trials involving the drug [2]

Group 1 - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that the application for the drug Ocaliva (Obeticholic Acid) for the treatment of primary biliary cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] - The drug is a generic version of a conditionally approved overseas drug, and the original reference formulation has not received regular approval abroad, leading to concerns about the risk-benefit profile of the drug [1] - The company has invested approximately RMB 125 million in the research and development of this drug as of the announcement date [1] Group 2 - Ocaliva, developed by Intercept Pharmaceuticals, is a Farnesoid X receptor (FXR) agonist that received accelerated approval from the FDA in May 2016 for PBC patients who are intolerant to or unresponsive to Ursodeoxycholic acid (UDCA) [2] - On September 11, 2023, Intercept Pharmaceuticals voluntarily withdrew Ocaliva from the U.S. market at the request of the FDA, which also suspended all clinical trials involving the drug [2]

Core Viewpoint - Fudan Zhangjiang's application for the drug Ocaliva (Obeticholic Acid) has been rejected by the National Medical Products Administration due to safety concerns and lack of sufficient evidence to support its approval as a generic drug [1][4]. Group 1: Company Updates - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notification of non-approval for its drug application for Obeticholic Acid, which is intended for treating primary biliary cholangitis (PBC) [1]. - The company has invested approximately 125 million yuan in the development of Obeticholic Acid [1]. - The rejection of the drug application is not expected to have a significant impact on the company's current financial status [1]. Group 2: Industry Context - Obeticholic Acid, originally developed by Intercept Pharmaceuticals, was first approved by the FDA in May 2016 and subsequently received conditional approval in Europe [2]. - The global sales of Obeticholic Acid showed steady growth from 2016 to 2021, reaching approximately $363 million in 2021 before stabilizing around $300 million in subsequent years [2]. - Safety concerns regarding Obeticholic Acid have led to multiple warnings and restrictions, including its classification under a "black box warning" by the FDA due to reports of severe liver damage and increased risk of liver transplant and death [3]. - The European Medicines Agency recommended the withdrawal of Obeticholic Acid's marketing authorization in 2023, and Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. market in September 2023 [3]. - There are currently no approved Obeticholic Acid products in China, and the safety risks associated with the original drug have created uncertainty for domestic generic drug prospects [4]. - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics, with some projects being halted after significant investments [5].

Core Viewpoint - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that its application for the drug Ocaliva (Obeticholic Acid Tablets) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1][2]. Group 1: Drug Development and Approval - The application for Ocaliva is a Class 3 generic drug, with the first target indication being PBC. Fudan Zhangjiang has made breakthroughs in patent restrictions and obtained relevant patent authorization in mainland China [2]. - The drug was included in the second batch of encouraged generic drugs in China in 2021, but no generic versions have been approved domestically yet [4]. - Other companies, including Chengdu Kanghong Pharmaceutical Group and Jiangsu Hengrui Medicine, are also involved in the development of Ocaliva [4]. Group 2: Financial Impact and R&D Investment - Fudan Zhangjiang has invested approximately 125 million yuan in the development of Ocaliva, which will not significantly impact the company's current financial status [3]. - The company has experienced a continuous decline in revenue and net profit over the past three and a half years, with revenues of 1.031 billion yuan, 851 million yuan, and 709 million yuan from 2022 to 2024, representing year-on-year declines of 9.57%, 17.5%, and 16.61% respectively [7]. - R&D expenses have been increasing, reaching 314 million yuan in 2024, accounting for 44% of revenue [8]. Group 3: Market Context and Competitors - The original drug for Ocaliva was conditionally approved in foreign markets but has faced significant safety and efficacy controversies, leading to its withdrawal from the U.S. market by Intercept Pharmaceuticals [3]. - Other companies, including Zhengda Tianqing Pharmaceutical Group, have also faced setbacks with their applications for Ocaliva [5][6].

Core Viewpoint - Fudan Zhangjiang's subsidiary failed to obtain approval from the National Medical Products Administration for its drug Obecholic Acid Tablets, which is intended for the treatment of Primary Biliary Cholangitis (PBC) [1] Company Summary - The drug Obecholic Acid Tablets is classified as a Class 3 chemical generic drug and acts as a Farnesoid X receptor agonist to regulate bile acid metabolism for PBC treatment [1] - Fudan Zhangjiang completed the human bioequivalence study for the drug in July 2020 and submitted the application for market approval in October last year, which was accepted [1] - The company invested a total of 125 million yuan (approximately 17.5 million USD) in the drug development, which has been fully accounted for in the respective financial periods [1] Financial Performance - In the first half of the year, the company reported revenue of 390 million yuan (approximately 54.5 million USD), a year-on-year decrease of 4.42% [1] - The net profit attributable to the parent company was 5.71 million yuan (approximately 800,000 USD), representing a significant year-on-year decline of 91.89% [1]

Core Viewpoint - The failure of the generic drug application for Obeticholic Acid by Fudan Zhangjiang highlights the high-risk nature of the pharmaceutical industry, particularly in the context of drug approvals and market entry [2][3]. Company Summary - Fudan Zhangjiang Biopharmaceutical Co., Ltd. announced that its subsidiary, Taizhou Fudan Zhangjiang, received a notice of disapproval from the National Medical Products Administration for its application of Obeticholic Acid tablets, which were intended for the treatment of Primary Biliary Cholangitis (PBC) [2]. - The company had invested approximately 125 million yuan in the development of Obeticholic Acid tablets as of the announcement date [4]. - The disapproval was attributed to the lack of sufficient evidence supporting the drug's benefits over risks, particularly due to the original drug's performance in the market, which has raised concerns about severe liver damage [4][6]. - Despite the setback, the company plans to continue increasing its R&D investments and accelerate the progress of other projects to maintain revenue contributions and enhance its core competitiveness [6]. Industry Summary - The pharmaceutical industry is characterized by high risks, with many companies facing challenges in drug development and approval processes [4]. - The original drug, Obeticholic Acid, has faced scrutiny and regulatory actions, including a recommendation for withdrawal of its market authorization by the European Medicines Agency and a voluntary market withdrawal in the U.S. [3]. - Other companies, such as Zai Lab, have also encountered difficulties with FXR agonists, indicating broader challenges within this segment of the pharmaceutical market [5].

Core Viewpoint - Fudan Zhangjiang (01349.HK) has entered into agreements with Bank of China to subscribe to structured deposit products totaling RMB 170 million using temporarily idle funds raised from its A-share public offering [1] Related Events - Fudan Zhangjiang (01349.HK) has subscribed to structured deposit products from Bank of China [1] - Fudan Zhangjiang (688505.SH) faced a setback as its drug application for Obecholic Acid Tablets for the treatment of primary biliary cholangitis was not approved [1]

Core Insights - Fudan Zhangjiang's subsidiary failed to obtain approval from the National Medical Products Administration (NMPA) for the drug Obecholic Acid Tablets, which is intended for the treatment of primary biliary cholangitis (PBC) [1] - The drug is classified as a Class 3 generic chemical drug and is a Farnesoid X receptor agonist that regulates bile acid metabolism [1] - The NMPA's rejection was primarily due to the lack of sufficient evidence supporting the drug's benefits outweighing risks, as the reference drug has not received regular approval abroad [1] Company Performance - Fudan Zhangjiang reported a revenue of 390 million yuan in the first half of the year, a year-on-year decline of 4.42% [2] - The company's net profit attributable to shareholders was 5.71 million yuan, a significant drop of 91.89% year-on-year [2] - Since 2022, the company's net profit has been on a downward trend, with declines of 35.3% in 2022, 21.3% in 2023, and a projected 63.4% drop in 2024 [2] Investment Context - Despite a 20% increase in stock price this year, Fudan Zhangjiang's current stock price is only about 20% of its historical high point since its listing in July 2020 [2] - The company has invested a total of 125 million yuan (unaudited) in the development of Obecholic Acid, which has been fully accounted for in the respective accounting periods [1]