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]

Group 1: Financial Performance - Everbright Bank plans to grant a comprehensive credit limit of RMB 29 billion to CITIC Financial Asset Management for a period of 12 months, constituting a related party transaction [1] - Xinhua Insurance expects a net profit of RMB 29.986 billion to RMB 34.122 billion for the first three quarters of 2025, representing a year-on-year increase of 45% to 65% [2] - Salt Lake Co. anticipates a net profit of RMB 4.3 billion to RMB 4.7 billion for the first three quarters of 2025, a year-on-year increase of 36.89% to 49.62% [3] - Chujiang New Materials forecasts a net profit of RMB 350 million to RMB 380 million for the first three quarters of 2025, reflecting a year-on-year increase of 2057.62% to 2242.56% [6] - Juchip Technology expects a net profit of RMB 151 million for the first three quarters of 2025, a year-on-year increase of 112.94% [7] - Zhongshi Technology projects a net profit of RMB 230 million to RMB 270 million for the first three quarters of 2025, a year-on-year increase of 74.16% to 104.45% [10] - Feirongda anticipates a net profit of RMB 275 million to RMB 300 million for the first three quarters of 2025, a year-on-year increase of 110.80% to 129.96% [11] Group 2: Corporate Actions - Yiyi Co. is planning to acquire a pet food company and has suspended its stock trading, with an announcement of the transaction expected within 10 trading days [5] - Northern Rare Earth received a warning letter from the Inner Mongolia Securities Regulatory Bureau for failing to disclose non-operating fund occupation by a related party [4] - Han Jian He Shan won a bid for a land drainage project worth RMB 207 million, which accounts for 26.29% of the audited revenue for 2024 [14] - ST Weihai is a candidate for a construction project with a bid amount of RMB 313 million, which is expected to account for 12.60% of the audited total revenue for 2024 [15][16]

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 認購平安銀行結構性存款產品 認購結構性存款產品 近日，本公司與平安銀行訂立平安銀行結構性存款產品協議，同意以日常營運產生的自有閑置資 金向平安銀行認購金額為人民幣 2.20 億元的結構性存款產品。 上市規則的涵義 在訂立平安銀行結構性存款產品協議時，就平安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，本公司與平安銀行訂立平安銀行結構性存款產品協議，同意以日常營運產生的自有閑置資金 向平安銀行認購金額為人民幣 2.20 億元的結構性存款產品。 - 1 - 產品成立日期： 二零二五年十月十三日 訂約方： （1）本公司；及 （2）平安銀行。 產品名稱： ...

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。 股票代码：688505 股票简称：复旦张江 编号：临 2025-032 上海复旦张江生物医药股份有限公司 自愿披露关于奥贝胆酸片用于治疗原发性胆汁性胆管炎 药品上市申请未获批准的公告 药品名称：奥贝胆酸片 二、药物的其他情况 上海复旦张江生物医药股份有限公司（以下简称"公司"）全资子公司泰州 复旦张江药业有限公司（以下简称"泰州复旦张江"）于近日收到国家药品监督 管理局（以下简称"国家药监局"）下发的《药品上市申请不予批准通知书》，泰 州复旦张江申报的用于治疗原发性胆汁性胆管炎（PBC）的奥贝胆酸片（规格： 5mg、10mg）（以下简称"该药物"）因不符合药品注册的有关要求，注册申请未 获批准。 一、药物的基本情况 该药物为境外附条件批准上市境内未上市药品的仿制药，参比制剂原研在国 外未获得常规批准，鉴于目前原研上市后研究结论明确缺乏确证的获益、且存在 严重风险而无法支持奥贝胆酸用于境外已批准适应症的获益大于风险，认为现有 资料无法充分支持该药物按照 3 类仿制药常规批准的技 ...

该药物为境外附条件批准上市境内未上市药品的仿制药，参比制剂原研在国外未获得常规批准，鉴于目 前原研上市后研究结论明确缺乏确证的获益、且存在严重风险而无法支持奥贝胆酸用于境外已批准适应 症的获益大于风险，认为现有资料无法充分支持该药物按照3类仿制药常规批准的技术要求。 截至本公告披露日，该项目累计研发投入约人民币1.25亿元（未经审计）。按照相关会计准则及公司会 计政策，上述研发投入均于发生时计入相应会计期间损益。该药物注册申请未获批准不会对公司当期财 务状况产生重大影响。 格隆汇10月13日丨复旦张江(688505.SH)公布，全资子公司泰州复旦张江药业有限公司（简称"泰州复旦 张江"）于近日收到国家药品监督管理局（简称"国家药监局"）下发的《药品上市申请不予批准通知 书》，泰州复旦张江申报的用于治疗原发性胆汁性胆管炎（PBC）的奥贝胆酸片（规格：5mg、10mg） 因不符合药品注册的有关要求，注册申请未获批准。 ...