Core Insights - Kangzheng Pharmaceutical Holdings Limited has signed an exclusive cooperation agreement with Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. for two innovative biological agents aimed at infectious disease prevention, obtaining exclusive commercialization rights in mainland China and exclusive licensing rights in the Asia-Pacific region, the Middle East, and North Africa [1] Group 1: Product Details - Weikangduta Monoclonal Antibody (GR2001) is a recombinant humanized monoclonal antibody that provides rapid and long-lasting protection against tetanus, outperforming human tetanus immunoglobulin (HTIG) [2] - The product targets the C-terminal heavy chain of tetanus toxin (TeNT-Hc), blocking its entry into neuronal cells, and has achieved primary efficacy endpoints in Phase III clinical trials [2] - The NDA for Weikangduta Monoclonal Antibody was accepted by the National Medical Products Administration (NMPA) on May 22, 2025, and it was included in the list of breakthrough therapies by the NMPA in May 2024 [2] Group 2: Market Potential - Sileweimi Monoclonal Antibody (GR1801) is the world's first recombinant fully human bispecific antibody for passive immunity against rabies, designed to block the rabies virus from infecting neurons before the rabies vaccine can take effect [3] - The product can be produced in a standardized and stable manner, with broad neutralization spectrum, low immunogenicity, minimal interference with vaccine-induced immunity, and controllable costs [3] - The NDA for Sileweimi Monoclonal Antibody for adults was accepted by the NMPA on January 14, 2025, and clinical trial applications for children aged 2 to 18 were approved in July 2025, with ongoing Phase III clinical trials [3] Group 3: Strategic Focus - Kangzheng Pharmaceutical is committed to developing innovative products with clinical value and differentiated advantages, addressing the limitations of existing passive immunization agents in terms of safety and accessibility [3] - The approval and market launch of Weikangduta and Sileweimi Monoclonal Antibodies are expected to provide new passive immunization options for patients exposed to tetanus and rabies, leveraging the company's existing market resources and expert networks [3]

Core Viewpoint - The company has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor project A400 (also known as EP0031) from the National Medical Products Administration (NMPA) in China, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1: Clinical Research and Development - The acceptance of the NDA is based on positive results from the KL400-I/II-01 study, which included two key Phase 2 cohorts evaluating the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for both previously treated and treatment-naive RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those who have previously undergone immunotherapy or have brain metastases [1] - A400/EP0031 has shown encouraging and manageable tolerability and safety profiles [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 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） – 1 – （股份代號：6990） 自願公告 A400/EP0031新藥上市申請獲國家藥品監督管理局受理 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 轉 染 過 程 中 重 排(RET)小分子激酶抑制劑項目A400（亦 稱 EP0031）的 一 項 新 藥 上 市 申 請(NDA)已獲中國國家藥品監督管理局(NMPA)藥 品 審評中心(CDE)受 理，用 於 治 療RET融合陽性局部晚期或轉移性非小細胞肺癌 (NSCLC)成 人 患 者。本 次 受 理 是 基 於KL ...

Group 1 - The announcement states that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1][2] - The inspection was conducted from June 16 to June 19, 2025, and concluded that the production facility complies with the Drug Production Quality Management Standards (2010 revision) [2] - The inspected facility is focused on the production of therapeutic biological products, specifically the injection of recombinant human coagulation factor VIIa [1][2] Group 2 - The product "Injection of Recombinant Human Coagulation Factor VIIa" has completed Phase III clinical trials and has submitted a marketing authorization application, which is currently under review [3] - The receipt of the GMP Compliance Inspection Notice indicates that the production facility meets national GMP requirements, allowing for potential production upon obtaining the registration certificate and final production license for the product [3] - Future production of the product may be influenced by national policies and market conditions, indicating a level of uncertainty [3]

联席主承销商：中信建投证券股份有限公司 ２０２５年９月２３日 ■ 发行人：武汉禾元生物科技股份有限公司 保荐人（联席主承销商）：国泰海通证券股份有限公司 武汉禾元生物科技股份有限公司（以下简称"禾元生物"、"发行人"或"公司"）首次公开发行股票并在科 创板上市的申请已经上海证券交易所（以下简称"上交所"）科创板上市委员会审议通过，并已经中国证 券监督管理委员会（以下简称"中国证监会"）证监许可〔２０２５〕１４６８号文同意注册。《武汉禾 元生物科技股份有限公司首次公开发行股票并在科创板上市招股意向书》及附录在上海证券交易所网站 （ｈｔｔｐ：／／ｗｗｗ．ｓｓｅ．ｃｏｍ．ｃｎ／）和符合中国证监会规定条件网站（中证网，网址 ｗｗｗ．ｃｓ．ｃｏｍ．ｃｎ；中国证券网，网址ｗｗｗ．ｃｎｓｔｏｃｋ．ｃｏｍ；证券时报网，网 址ｗｗｗ．ｓｔｃｎ．ｃｏｍ；证券日报网，网址ｗｗｗ．ｚｑｒｂ．ｃｎ）披露，并置备于发行人、 本次发行保荐人（联席主承销商）国泰海通证券股份有限公司和联席主承销商中信建投证券股份有限公 司的住所，供公众查阅。 敬请投资者重点关注本次发行流程、网上网下申购及缴款、弃购股份处理等方面，并认真阅读同日披露 于上海证 ...

Core Viewpoint - Faraday Future (FFAI.US) stock price declined over 8% to $1.625 following the announcement of a $41 million investment in Qualigen Therapeutics (QLGN.US) to support its entry into the crypto and Web3 sectors [1] Group 1 - Faraday Future's investment in Qualigen Therapeutics amounts to $41 million [1] - Following the investment announcement, Qualigen Therapeutics' stock surged over 95% to $5.55 [1] - The investment will provide Faraday Future with significant equity in Qualigen and plans to assign a management team to lead new business activities [1]

Core Viewpoint - The announcement of an exclusive cooperation agreement between Zhixiang Jintai and Kangzhe Pharmaceutical is expected to significantly enhance the company's market position and financial performance through the commercialization of two monoclonal antibodies [1][2]. Group 1: Agreement Details - Zhixiang Jintai signed an exclusive cooperation agreement with Kangzhe Pharmaceutical and its subsidiaries, which includes a total payment of up to 260 million RMB, consisting of upfront and milestone payments [1]. - The agreement grants Zhixiang Jintai exclusive commercialization rights for Weikang Duta monoclonal injection and Sileweimi monoclonal injection in mainland China and the Asia-Pacific region [1]. Group 2: Market Impact - Following the announcement, Zhixiang Jintai's stock price rose by 1.41% to 33.79 RMB per share, with a trading volume of 129 million RMB, reflecting positive market sentiment [2]. - Despite a slight decline of 0.18% in the stock price over the past seven trading days, the announcement has boosted investor confidence and increased attention on the company [2]. Group 3: Strategic Outlook - The cooperation is seen as a strategic move to enhance Zhixiang Jintai's market competitiveness and position within the biopharmaceutical industry, responding proactively to future market demands [1][4]. - The company aims to deepen resource integration with key partners, enhance R&D capabilities, and optimize product structure to drive overall transformation and long-term growth [4].

Core Viewpoint - The company, Hualan Biological, has successfully completed Phase I/II clinical trials for its recombinant Exendin-4-FC fusion protein injection, a treatment for type 2 diabetes, and is preparing to initiate Phase III trials [2] Group 1 - The company has obtained complete efficacy and safety data from the completed clinical trials [2] - Hualan Biological is applying for a new indication for overweight/obesity and has communicated with the National Medical Products Administration, which has accepted the registration application [2]

Core Viewpoint - The company, Hualan Biological Engineering, emphasizes its commitment to a stable dividend policy while sharing operational achievements with shareholders, aligning with regulatory guidelines to enhance long-term investment value and investor satisfaction [2] Group 1 - The company has consistently implemented a prudent dividend policy, ensuring that shareholders benefit from the company's stable and high-quality development [2] - The recent cash dividend plan is designed to reflect the principles of stability, sustainability, and predictability in cash dividends, responding to the policy direction of increasing dividend frequency [2] - The initiative aims to optimize the dividend schedule, thereby enhancing the company's long-term investment value and improving investor experience [2]

Summary of Key Points Core Viewpoint - On September 22, a block trade of Junshi Biosciences (君实生物-U) occurred, with a transaction volume of 1 million shares and a transaction amount of 43.13 million yuan, reflecting a discount of 0.69% compared to the closing price of the day [2] Trading Activity - The block trade was executed at a price of 43.13 yuan per share, with the buyer being the headquarters of Founder Securities Co., Ltd. and the seller being the Shanghai Pudong New District branch of CITIC Securities Co., Ltd. [2] - In the last three months, Junshi Biosciences has recorded a total of 12 block trades, amounting to a cumulative transaction value of 558 million yuan [2] Stock Performance - The closing price of Junshi Biosciences on the day of the block trade was 43.43 yuan, which represented a decline of 1.30% [2] - The stock's turnover rate for the day was 1.75%, with a total transaction amount of 582 million yuan, and a net outflow of main funds amounting to 54.32 million yuan [2] - Over the past five days, the stock has seen a cumulative decline of 8.43%, with a total net outflow of funds reaching 329 million yuan [2] Margin Trading Data - The latest margin financing balance for Junshi Biosciences is 1.431 billion yuan, which has increased by 64.72 million yuan over the past five days, reflecting a growth rate of 4.74% [2]