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]

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。 董事會會議通告 上海復旦張江生物醫藥股份有限公司（「本公司」）之董事會（「董事會」）謹 此公佈，將於二零二五年十月三十日（星期四）舉行董事會會議，以審議及通過 （其中包括）本公司及其附屬公司截至二零二五年九月三十日止第三季度之未經審 核業績及其發佈。 承董事會命 趙大君 主席 - 1 - 於本公告刊發日期，董事會包括以下人士： 趙大君先生（執行董事） 中國·上海 二零二五年十月十五日 * 僅供識別 - 2 - 薛 燕女士（執行董事） 沈 波先生（非執行董事） 余曉陽女士（非執行董事） 王宏廣先生（獨立非執行董事） 林兆榮先生（獨立非執行董事） 徐培龍先生（獨立非執行董事） ...

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]