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which cost 125 million yuan, was rejected due to safety concerns related to its reference drug, which has been withdrawn from the European and American markets [1][2] - The original drug, Ocaliva, has faced multiple safety warnings since 2017, leading to its withdrawal from the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]

Group 1 - Jiuan Medical plans to repurchase shares worth no less than 300 million yuan and no more than 600 million yuan, with a maximum repurchase price of 53.5 yuan per share, to maintain company value and shareholder rights [1] - The current share price of 38.19 yuan represents a discount of approximately 28% compared to the repurchase cap, signaling potential valuation recovery [1] - The repurchased shares are intended to be sold within 12 months after the announcement, providing short-term price stability and future funding flexibility for business transformation [1] Group 2 - Lingbei's drug Bexicaserin has been recognized as a breakthrough therapy by the National Medical Products Administration (NMPA) in China for treating developmental epileptic encephalopathy (DEE) [2] - Bexicaserin is a novel oral 5-HT2C receptor agonist designed to reduce cardiovascular risks, marking a significant milestone in Lingbei's development in China [2] Group 3 - Four Rings Pharmaceutical has announced an investment in Swiss medical aesthetics company Suisselle SA, strengthening their long-term partnership [3] - This investment allows Four Rings to maintain exclusive rights to the CELLBOOSTER® product in China and participate deeply in its operations and development [3] - The collaboration aims to accelerate the promotion and sales of Four Rings' self-developed aesthetic products in Europe and other overseas markets [3] Group 4 - Fudan Zhangjiang's application for the drug Obechol acid tablets for treating primary biliary cholangitis was not approved by the NMPA due to non-compliance with registration requirements [4] - The project has incurred approximately 125 million yuan in R&D investment, which will not significantly impact the company's current financial status [4] - The company needs to review the reasons for the rejection and optimize its pipeline to enhance future R&D efficiency [4] Group 5 - Sunshine Nuohuo's BTP4507 has received approval for clinical trials from the NMPA, targeting primary hypertension patients with inadequate response to monotherapy [5] - BTP4507 is a compound formulation designed to address multiple hypertension targets, catering to the needs of over 300 million hypertensive patients in China [5] - If successful in clinical trials, this drug could open new growth avenues for the company, although it will face competition from similar combination therapies [5]

Core Points - 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 drug application for Obeticholic Acid Tablets was not approved due to non-compliance with drug registration requirements [1] - The original drug for Obeticholic Acid faced safety issues and was withdrawn from the European and American markets, which was a significant reason for the rejection of the application [1] - The company has invested approximately 125 million yuan in the development of Obeticholic Acid Tablets, but the rejection will not have a significant impact on its current financial status [1] Industry Overview - Obeticholic Acid was first approved by the FDA in May 2016 for treating primary biliary cholangitis (PBC) and received conditional approval in Europe in December 2016 [2] - The prevalence of PBC in China has been increasing, reaching 21.05 per 100,000 in 2022 [2] - Global sales of Obeticholic Acid grew steadily from approximately $250 million in 2019 to $363 million in 2021, stabilizing around $300 million in subsequent years [2] - Safety concerns have led to multiple warnings from the FDA, including a "black box warning" and restrictions on its use in patients with liver cirrhosis [2] - In October 2023, the European Medicines Agency recommended the withdrawal of Obeticholic Acid's market authorization, and Intercept Pharmaceuticals voluntarily withdrew the drug from the U.S. market [3] - Several domestic pharmaceutical companies, including Hengrui Medicine and Zai Lab, are also facing setbacks in their applications for Obeticholic Acid generics due to the original drug's safety risks [4][5]

Core Points - Fudan Zhangjiang announced that its wholly-owned subsidiary, Taizhou Fudan Zhangjiang Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration stating that the application for the marketing authorization of Obecholic Acid Tablets (5mg, 10mg) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [2] Company Summary - Taizhou Fudan Zhangjiang's application for Obecholic Acid Tablets was rejected by the regulatory authority [2] - The drug was intended for the treatment of Primary Biliary Cholangitis (PBC) [2] - The rejection indicates potential challenges in meeting regulatory standards for drug registration [2] Industry Summary - The news highlights the regulatory scrutiny faced by pharmaceutical companies in the drug approval process [2] - The incident may reflect broader trends in the industry regarding compliance with drug registration requirements [2] - The rejection could impact the company's future product pipeline and market strategy [2]

Group 1: Financial Performance - Xinhua Insurance expects a net profit of 29.986 billion to 34.122 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 45% to 65% due to reforms and improved investment returns [2] - Feirongda anticipates a net profit of 275 million to 300 million yuan for the first three quarters of 2025, reflecting a growth of 110.80% to 129.96% driven by increased R&D in AI and cooling technologies [2] - Lingyi Zhizao forecasts a net profit of 1.890 billion to 2.120 billion yuan for the first three quarters of 2025, marking a growth of 34.10% to 50.42% attributed to new product launches and increased overseas revenue [5] - Yilake Co. expects a net profit of 4.300 billion to 4.700 billion yuan for the first three quarters of 2025, with a significant increase of 36.89% to 49.62% driven by rising potassium chloride prices [6] - Bojun Technology projects a net profit increase of 50% to 80% for the first three quarters of 2025 [9] Group 2: Regulatory and Corporate Actions - Fudan Zhangjiang's application for the drug Obeticholic Acid for primary biliary cholangitis was not approved by the National Medical Products Administration, with a total R&D investment of approximately 125 million yuan [3] - Northern Rare Earth received a warning letter from the Inner Mongolia Securities Regulatory Bureau for failing to disclose non-operating fund occupation by an affiliate, totaling 8.9485 million yuan [7] - Tianji Co. announced that its major shareholders reduced their holdings by 2.9996% and have terminated their reduction plan ahead of schedule [8] Group 3: Market Trends and Developments - The demand for AI server cooling solutions and related materials has increased, contributing to Feirongda's revenue growth [2] - The overall market for potassium chloride has seen price increases, positively impacting Yilake Co.'s profitability [6] - The consumer electronics market is recovering, leading to increased demand for thermal management materials, benefiting Feirongda's market share [2]

Core Viewpoint - Fudan Zhangjiang (688505) 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 Obecholic Acid Tablets (5mg, 10mg) for the treatment of Primary Biliary Cholangitis (PBC) was not approved due to non-compliance with drug registration requirements [1] Group 1 - The drug Obecholic Acid is a generic version of a conditionally approved drug overseas that has not been conventionally approved in China [1] - The original drug has not demonstrated clear benefits post-approval, and there are significant risks that prevent supporting the benefits of Obecholic Acid for the approved indications [1] - The existing data was deemed insufficient to meet the technical requirements for conventional approval as a Class 3 generic drug [1]

Company Announcements - Northern Rare Earth received a warning letter from the Inner Mongolia Securities Regulatory Bureau due to undisclosed non-operating fund occupation by related parties, amounting to 8.9485 million yuan, which has been fully repaid [2] - Aosheng Electronics reported that revenue from controllable nuclear fusion-related products will account for less than 1% of its main business revenue in the first half of 2025 [2] - Yiyi Co. is planning to acquire a pet food company, leading to a stock suspension [3] - Sanmei Co. expects a net profit increase of 172%-193% year-on-year for the first three quarters, driven by a significant rise in the average price of fluorinated refrigerants [4] - Feirongda anticipates a net profit increase of 111%-130% year-on-year for the first three quarters, with growth in AI server cooling-related business revenue [4] - Zhongshi Technology expects a net profit increase of 74%-104% year-on-year for the first three quarters, benefiting from increased shipments of thermal materials and components [4] - Juxin Technology forecasts a net profit increase of 113% year-on-year for the first three quarters, with sales revenue from edge AI processor chips increasing significantly [4] - Chuangjiang New Materials expects a staggering net profit increase of 2058%-2243% year-on-year for the first three quarters [4] - New China Life Insurance anticipates a net profit increase of 45%-65% year-on-year for the first three quarters [4] Investment & Contracts - Fostda plans to invest 1 billion yuan in the construction of an intelligent manufacturing project for marine engineering and equipment [11] Shareholding Changes - Dongxin Co. has set an initial transfer price of 82.5 yuan per share for its inquiry transfer, which is a 16% discount from the closing price [11] - China Jushi has obtained a commitment letter for a stock repurchase loan of up to 630 million yuan [12] - Tianji Co. has reduced its holdings by 2.9996% of the company's shares and has terminated its reduction plan early [3] Performance & Operations - Yingweike reported a net profit of 183 million yuan for the third quarter, an increase of 8.35% year-on-year [13] - Chenguang Biological expects a net profit increase of 344%-402% year-on-year for the first three quarters [14] - Meili Ecology's subsidiary won a bid for a 2.375 billion yuan urban renewal project in Shenzhen [18] Stock Price Movements - Hezhu Intelligent has not generated any revenue related to nuclear fusion concepts [19] - Jinli Yongci confirmed that its recent stock price fluctuations are not due to undisclosed significant matters [20] Other Developments - Heng Rui Medicine's subsidiary received approval for clinical trials of SHR-1905 injection [24] - Renfu Medicine received a drug registration certificate for Dapoxetine Hydrochloride Tablets, which are expected to generate approximately 1.1 billion yuan in sales in 2024 [26]