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with drug registration requirements [1] - The original drug for Obeticholic Acid faced safety issues and was withdrawn from the European and American markets, which was a significant reason for the rejection of the application [1] - The company has invested approximately 125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]

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。 ...

该药物属於法尼酯X受体（Farnesoid X receptor，「FXR」）激动剂。FXR是一种在肝脏和肠道中高水 平表达的核受体，在胆酸代谢调节中起关键性作用。该药物是化学药品3类仿制药，其首个目标适应症 为原发性胆汁性胆管炎。中国作为肝胆疾病高发的国家，市场容量非常庞大。集团对于原研药物的专利 限制进行了突破，并在中国大陆获得了相应的专利授权。集团于2020年7月完成该药物人体生物等效性 研究试验，2021年7月获得药物临床试验批准通知书并于同年12月完成验证性临床试验首例患者入组， 于2024年10月向国家药监局递交该药物的上市申请并予以受理，并于2025年6月完成上市申请注册现场 核查工作。 格隆汇10月13日丨复旦张江(01349.HK)公告，公司之附属公司泰州复旦张江药业有限公司收到国家药品 监督管理局签发的《药品上市申请不予批准通知书》，奥贝胆酸片（规格：5mg、10mg）（「该药 物」）用于治疗原发性胆汁性胆管炎（PBC）的药物上市申请未获批准。 本次不予批准的原因是：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，同时鉴于目前原研上市後研究结论明确缺乏 ...

本次不予批准的原因是：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，同时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。 智通财经APP讯，复旦张江(01349)发布公告，公司的附属公司泰州复旦张江药业有限公司收到国家药品 监督管理局签发的《药品上市申请不予批准通知书》，奥贝胆酸片(规格：5mg、10mg)用于治疗原发性 胆汁性胆管炎(PBC)的药物上市申请未获批准。 ...

本次不予批准的原因是：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，同时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。 复旦张江(01349)发布公告，公司的附属公司泰州复旦张江药业有限公司收到国家药品监督管理局签发 的《药品上市申请不予批准通知书》，奥贝胆酸片(规格：5mg、10mg)用于治疗原发性胆汁性胆管炎 (PBC)的药物上市申请未获批准。 ...