Core Viewpoint - Fudan Zhangjiang (688505) has entered into two structured deposit agreements with Bank of China, utilizing temporarily idle funds from its A-share public offering, totaling RMB 170 million [1] Group 1: Stock Performance - As of October 14, 2025, Fudan Zhangjiang's stock closed at RMB 9.02, down 0.88% from the previous trading day [1] - The stock opened at RMB 9.09, reached a high of RMB 9.19, and a low of RMB 8.97, with a trading volume of RMB 56.688 million and a turnover rate of 0.88% [1] Group 2: Structured Deposit Agreements - The company has signed two structured deposit agreements with Bank of China, with a total investment of RMB 170 million [1] - Agreement I involves an investment of RMB 40 million for 63 days, linked to the GBP/USD spot exchange rate, with an expected annualized return of 0.5500%-1.7000% [1] - Agreement II involves an investment of RMB 130 million for 78 days, linked to the EUR/USD spot exchange rate, with an expected annualized return of 0.3500%-1.5575% [1] Group 3: Disclosure and Approval - The transactions are disclosed under listing rules and are exempt from independent shareholder approval [1] - The board believes the transactions are conducted on normal commercial terms and are in the overall interest of the company and its shareholders [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].

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 認購中國銀行結構性存款產品 認購結構性存款產品 近日，本公司與中國銀行訂立中國銀行結構性存款產品協議 I 及中國銀行結構性存款產品協議 II，同意以 A 股公開發行所得暫時閑置募集資金向中國銀行認購總金額為人民幣 1.70 億元的結構 性存款產品。 上市規則的涵義 在訂立中國銀行結構性存款產品協議時，就中國銀行結構性存款產品協議項下產品的認購金額而 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，本公司與中國銀行訂立中國銀行結構性存款產品協議 I 及中國銀行結構性存款產品協議 II， 同意以 A 股公開發行所得暫時閑置募集資金向中國銀行認購總金額為人民幣 1.70 億元的結構性存 款產品。 - ...

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 Viewpoint - Fudan Zhangjiang (01349) 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] Group 1 - The company has signed two structured deposit product agreements with Bank of China [1] - The total amount for the structured deposit products is RMB 170 million [1] - The funds used for this investment are temporarily idle funds from the company's A-share public offering [1]

Core Viewpoint - Fudan Zhangjiang (01349) has entered into agreements with Bank of China to invest a total of RMB 170 million in structured deposit products using temporarily idle funds raised from the public offering of A-shares [1] Group 1 - The company has signed two structured deposit product agreements with Bank of China [1] - The total amount of investment in these structured deposit products is RMB 170 million [1] - The funds used for this investment are temporarily idle funds from the public offering of A-shares [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 認購中國銀行結構性存款產品 認購結構性存款產品 近日，本公司與中國銀行訂立中國銀行結構性存款產品協議 I 及中國銀行結構性存款產品協議 II，同意以 A 股公開發行所得暫時閑置募集資金向中國銀行認購總金額為人民幣 1.70 億元的結構 性存款產品。 上市規則的涵義 在訂立中國銀行結構性存款產品協議時，就中國銀行結構性存款產品協議項下產品的認購金額而 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，本公司與中國銀行訂立中國銀行結構性存款產品協議 I 及中國銀行結構性存款產品協議 II， 同意以 A 股公開發行所得暫時閑置募集資金向中國銀行認購總金額為人民幣 1.70 億元的結構性存 款產品。 - ...

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]

Core Points - The application for the generic drug developed by Fudan Zhangjiang, which cost 125 million yuan, was rejected due to safety concerns related to its reference drug, which has been withdrawn from the European and American markets [1][2] - The original drug, Ocaliva, has faced multiple safety warnings since 2017, leading to its withdrawal from the market and suspension of all related clinical trials [3][4] - The domestic market for the generic version of Ocaliva is now highly uncertain due to the original drug's safety issues and market withdrawal [4][5] Company Summary - Fudan Zhangjiang's subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., received a notice from the National Medical Products Administration stating that the application for Obechol acid tablets was not approved due to non-compliance with drug registration requirements [1][5] - The company has invested approximately 125 million yuan in the development of Obechol acid tablets, but the rejection of the application is not expected to have a significant impact on its current financial status [1][5] - Other domestic companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obechol acid generics, with several applications still pending approval [5] Industry Summary - Obechol acid, originally developed by Intercept Pharmaceuticals, was first approved in 2016 for treating primary biliary cholangitis (PBC) but has since faced serious safety concerns leading to its market withdrawal [2][3] - The prevalence of PBC in China has been increasing, reaching 21.05 per 100,000 in 2022, indicating a potential market for treatments despite the current setbacks [2] - The domestic market for Obechol acid generics is now fraught with uncertainty, as the original drug's safety risks have raised doubts about the viability of its generic counterparts [4][5]

Core Viewpoint - Fudan Zhangjiang (688505.SH) announced that its subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notice from the National Medical Products Administration stating that the application for the marketing authorization of Ocaliva (Obeticholic Acid Tablets) for the treatment of primary biliary cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] Group 1: Drug Approval and Market Impact - The primary reason for the rejection of the marketing application is the safety issues associated with the original drug, which led to its withdrawal from the European and American markets [1][2] - Fudan Zhangjiang has invested approximately 125 million yuan in the development of Obeticholic Acid Tablets, but the company stated that the rejection will not have a significant impact on its current financial status [1][3] Group 2: Original Drug Background - The original drug, Ocaliva, developed by Intercept Pharmaceuticals, was first approved by the FDA in May 2016 and received conditional approval in Europe in December 2016 [2] - The global sales of Ocaliva showed steady growth from 2016 to 2021, reaching approximately 363 million USD in 2021, but stabilized around 300 million USD in subsequent years [2] Group 3: Safety Concerns and Regulatory Actions - Since 2017, there have been multiple safety alerts regarding Ocaliva, including reports of severe liver damage and even death, leading to the FDA placing a "black box warning" on the drug [3] - In October 2023, the European Medicines Agency recommended the withdrawal of Ocaliva's marketing authorization, which was officially revoked in September 2024 [3] Group 4: Domestic Generic Drug Landscape - Currently, there are no approved domestic versions of Obeticholic Acid, and the safety risks associated with the original drug have created significant uncertainty for its generic prospects in China [4][5] - Several domestic pharmaceutical companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics [5][6]