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of drugs, making it increasingly difficult for generic drugs to find reference products if the original drug is withdrawn due to safety or efficacy issues [5] - Domestic pharmaceutical companies are advised to consider global regulatory dynamics and real-world data when selecting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].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示概不因本公告全部或任何部份內容而產生或因依賴該等內容而 引致的任何損失承擔任何責任。 須予披露的交易 認購招商銀行結構性存款產品 認購結構性存款產品 近日，本公司與招商銀行訂立招商銀行結構性存款產品協議 I，本公司之全資附屬公司泰州復旦 張江與招商銀行訂立招商銀行結構性存款產品協議 II，據此，本集團同意以日常營運產生的自有 閑置資金向招商銀行認購總金額為人民幣 1.00 億元的結構性存款產品。 上市規則的涵義 根據上市規則第 14.22 條，招商銀行結構性存款產品協議項下的交易需合併計算。在訂立招商銀 行結構性存款產品協議時，就招商銀行結構性存款產品協議項下產品的總認購金額合計而言，一 項或多項適用百分比率（定義見上市規則第 14.07 條）超過 5%但均低於 25%，故根據上市規則第 14章，该等交易構成本公司之須予披露的交易，須遵守上市規則第14章有關申報及公告之規定， 惟獲豁免遵守獨立股東批准之規定。 概述 近日，本公司與招商銀行訂立招商銀行結構性存款產品協議 I，本公司之全資附屬公 ...

格隆汇10月15日丨复旦张江(01349.HK)公布，将于2025年10月30日(星期四)举行董事会会议，以审议及 通过(其中包括)公司及其附属公司截至2025年9月30日止第三季度的未经审核业绩及其发布。 ...

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 (01349.HK) has entered into a structured deposit product agreement with China Merchants Bank, indicating a strategic move to utilize idle funds for investment purposes [1] Group 1 - The company’s wholly-owned subsidiary, Taizhou Fudan Zhangjiang, has signed a structured deposit product agreement with China Merchants Bank [1] - The total amount agreed for the structured deposit product is RMB 100 million [1] - The funds used for this investment are derived from the company’s daily operational idle funds [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示概不因本公告全部或任何部份內容而產生或因依賴該等內容而 引致的任何損失承擔任何責任。 須予披露的交易 認購招商銀行結構性存款產品 認購結構性存款產品 本集團與招商銀行訂立之两份結構性存款產品協議（有關結構性存款產品均由本集團以日常營運產 生的自有閑置資金認購）的主要條款大致相同，載列如下： | | | | 產品期限： | 協議 | | 期限 | | --- | --- | --- | --- | | | 招商銀行結構性存款產品協議 | I | 76 天 | | | 招商銀行結構性存款產品協議 | II | 76 天 | 招商銀行結構性存款產品協議 I 及招商銀行結構性存款產品協議 II 之實際年 化收益率按如下情況計算： 近日，本公司與招商銀行訂立招商銀行結構性存款產品協議 I，本公司之全資附屬公司泰州復旦 張江與招商銀行訂立招商銀行結構性存款產品協議 II，據此，本集團同意以日常營運產生的自有 閑置資金向招商銀行認購總金額為人民幣 1.00 億元的結構性存款產品。 上市規則的涵義 根據上市 ...

Core Viewpoint - Fudan Zhangjiang (01349.HK) announced that it will hold a board meeting on October 30, 2025, to review and approve the unaudited performance for the third quarter ending September 30, 2025, for the company and its subsidiaries [1] Summary by Category - Company Announcement - The board meeting is scheduled for October 30, 2025 [1] - The meeting will focus on the unaudited performance for the third quarter ending September 30, 2025 [1] - Financial Reporting - The performance report will include results from both the company and its subsidiaries [1]