股票代码：688505 股票简称：复旦张江 公告编号：临 2025-033 上海复旦张江生物医药股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 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、准确性和完整性依法承担法律责任。 投资者可于 2025 年 10 月 24 日（周五）至 10 月 30 日（周四）16:00 前登录 上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 ir@fd-zj.com 进 行提问。公司将在说明会上对投资者普遍关注的问题进行回答。 上海复旦张江生物医药股份有限公司（以下简称"公司"）将于 2025 年 10 月 31 日于上海证券交易所网站（www.sse.com.cn）披露《上海复旦张江生物医药股 份有限公司 2025 年第三季度报告》。为便于广大投资者全面深入地了解公司 2025 年第三季度经营成果及财务状况，公司计划于 2025 年 10 月 31 日上午 11:00-12:00 举行 2025 年第三季度业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以网络互动形式召开， ...

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。 趙大君先生（執行董事） 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） 中國·上海 二零二五年十月二十三日 海外監管公告 本公告乃上海復旦張江生物醫藥股份有限公司（「本公司」）根據香港聯合交易所有 限公司證券上市規則第 13.10(B)條刊發。 茲載列本公司於上海證券交易所網站刊發的《上海復旦張江生物醫藥股份有限公司關 於召開 2025 年第三季度業績說明會的公告》，僅供參閱。該文件及其披露內容乃根據 中國法律法規及境內相關監管要求而編制及刊發。 承董事會命 趙大君 主 席 於本公告刊發日期，董事會包括以下人士： * 僅供識別 股票代码：688505 股票简称：复旦张江 公告编号：临 2025-033 上海复旦张江生物医药股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 本公司董 ...

Core Insights - The article highlights the current premium rates of AH shares, with Northeast Electric (00042) leading at a premium rate of 881.82% [1] - The bottom three in terms of premium rates are Ningde Times (03750) at -17.23%, China Merchants Bank (03968) at 1.09%, and Hengrui Medicine (01276) at 1.64% [1] - The article also discusses the deviation values of these stocks, indicating significant discrepancies between their A-shares and H-shares [1] Premium Rate Rankings - The top three AH shares by premium rate are: 1. Northeast Electric (00042) with a premium rate of 881.82% and a deviation value of 68.11% [1] 2. Hongye Futures (03678) with a premium rate of 248.18% and a deviation value of 18.60% [2] 3. Zhejiang Shibao (01057) with a premium rate of 247.12% and a deviation value of 23.76% [1] - The bottom three AH shares by premium rate are: 1. Ningde Times (03750) with a premium rate of -17.23% and a deviation value of -2.71% [1] 2. China Merchants Bank (03968) with a premium rate of 1.09% and a deviation value of -3.46% [1] 3. Hengrui Medicine (01276) with a premium rate of 1.64% and a deviation value of 4.78% [1] Deviation Value Rankings - The top three AH shares by deviation value are: 1. Northeast Electric (00042) with a deviation value of 68.11% [1] 2. Shandong Molong (00568) with a deviation value of 29.50% [1] 3. Changfei Optical Fiber (06869) with a deviation value of 28.06% [1] - The bottom three AH shares by deviation value are: 1. Shanghai Electric (02727) with a deviation value of -27.72% [2] 2. China Foreign Transport (00598) with a deviation value of -17.01% [2] 3. COSCO Shipping Energy (01138) with a deviation value of -15.18% [2]

Core Insights - The article highlights the top and bottom AH share premium rates, with Northeast Electric (00042) leading at 918.87% and Ningde Times (03750) at -17.09% [1][2] Summary by Category Top AH Share Premium Rates - Northeast Electric (00042) has a premium rate of 918.87% with a deviation value of 109.61% [2] - Hongye Futures (03678) follows with a premium rate of 246.28% and a deviation value of 16.95% [2] - Zhejiang Shibao (01057) ranks third with a premium rate of 241.04% and a deviation value of 19.03% [2] Bottom AH Share Premium Rates - Ningde Times (03750) has the lowest premium rate at -17.09% with a deviation value of -2.80% [2] - Heng Rui Pharmaceutical (01276) has a premium rate of -1.38% and a deviation value of 1.69% [2] - China Merchants Bank (03968) has a premium rate of 0.51% with a deviation value of -4.32% [2] Top AH Share Deviation Values - Northeast Electric (00042) leads with a deviation value of 109.61% [2] - Changfei Optical Fiber (06869) has a deviation value of 31.51% [2] - Shandong Molong (00568) follows with a deviation value of 26.68% [2] Bottom AH Share Deviation Values - Shanghai Electric (02727) has the lowest deviation value at -25.42% [3] - China National Foreign Trade Transportation Group (00598) has a deviation value of -16.00% [3] - COSCO Shipping Energy Transportation (01138) has a deviation value of -14.18% [3]

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].

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 ...