百利天恒公告，近日收到国家药品监督管理局(NMPA)正式批准签发的《药物临床试验批准通知书》， 公司自主研发的创新生物药注射用BL-M24D1（ADC）的药物临床试验获得批准。BL-M24D1是公司自 主研发的偶联了新一代毒素的ADC药物，适应症为复发或难治性血液系统恶性肿瘤和晚期实体瘤。 ...

Core Viewpoint - The company, Zhifei Biological Products Co., Ltd., and its wholly-owned subsidiaries have recently obtained an invention patent certificate from the National Intellectual Property Administration of the People's Republic of China for a vaccine and its preparation method [1] Group 1 - The patent is titled "A Vaccine and Its Preparation Method" [1]

迪哲医药-U10月21日大宗交易平台出现一笔成交，成交量6.93万股，成交金额444.31万元，大宗交易成 交价为64.08元。该笔交易的买方营业部为中信证券股份有限公司总部(非营业场所)，卖方营业部为机构 专用。 10月21日迪哲医药-U大宗交易一览 | 成交量 | 成交金额 | 成交价格 | 相对当日收盘折溢 | 买方营业部 | 卖方营 | | --- | --- | --- | --- | --- | --- | | （万股） | （万元） | （元） | 价（%） | | 业部 | | | | | | 中信证券股份有限公司总部 | 机构专 | | 6.93 | 444.31 | 64.08 | 0.00 | (非营业场所) | 用 | （文章来源：证券时报网） 进一步统计，近3个月内该股累计发生2笔大宗交易，合计成交金额为879.63万元。 证券时报·数据宝统计显示，迪哲医药-U今日收盘价为64.08元，上涨2.07%，日换手率为1.13%，成交额 为3.24亿元，全天主力资金净流入1391.87万元，近5日该股累计上涨0.22%，近5日资金合计净流入 2512.04万元。 两融数据显示，该股最新融资 ...

Core Viewpoint - Sirius Therapeutics, a four-year-old biotech company focusing on siRNA therapies, has submitted its IPO application to the Hong Kong Stock Exchange, backed by major underwriters including Goldman Sachs and HSBC. Despite its promising narrative, the company faces uncertainties regarding its commercialization path and reliance on non-recurring income [2]. Group 1: Product Pipeline and Market Potential - The company has a clear and ambitious strategic layout centered around its siRNA technology platform, targeting three major chronic disease areas: coagulation disorders, cardiovascular diseases, and obesity, each with billion-dollar market potential [3]. - The lead product, SRSD107, targets coagulation factor XI and is currently in Phase II clinical trials in Europe, with plans to initiate trials in China and Australia/New Zealand. It is positioned as a potential first-in-class therapy with the ability to provide effective anticoagulation without increasing bleeding risk [3]. - The second key product, SRSD216, targets lipoprotein(a) for treating high Lp(a) levels and related cardiovascular diseases, entering Phase IIa trials in both China and the U.S. It shows over 95% Lp(a) suppression with a long duration of effect, enhancing patient compliance [4]. - The third product, SRSD384, aims to address the obesity market by targeting the INHBE protein, promoting fat loss while preserving muscle mass, differentiating it from current GLP-1 receptor agonists [4]. Group 2: Financial Performance and Profitability - As of mid-2025, the company has not generated any product sales revenue, with reported losses of 309 million yuan and 342 million yuan for 2023 and 2024, respectively, totaling 651 million yuan in losses. However, it reported a profit of 34.46 million yuan in the first half of 2025 [5][6]. - The reported profitability is heavily reliant on non-recurring income, with other income reaching 144 million yuan in mid-2025, significantly up from 4.51 million yuan the previous year, primarily due to a strategic partnership with CRISPR Therapeutics [6]. - The partnership with CRISPR includes a cash payment of $25 million and $70 million in CRISPR shares, along with potential milestone payments of up to $800 million, contributing to the company's financial performance [6]. Group 3: Shareholder Composition and Valuation - Sirius Therapeutics boasts a strong shareholder base, including OrbiMed and Tencent, which enhances its credibility and potential for future collaborations [7][8]. - The company has raised approximately $144 million through multiple funding rounds, indicating continued market confidence. Its post-money valuation reached $253 million after a $47.5 million Series B round in April 2025 [8]. - The valuation logic is primarily based on the high growth prospects of the siRNA market, projected to reach $50.3 billion by 2040, and the synergies from its collaboration with CRISPR [8]. Group 4: Market Competition and Future Challenges - The siRNA market is highly competitive, with established players like Alnylam and Arrowhead already having products on the market. The company must prove its ability to stand out in this crowded field [11]. - The IPO represents a significant bet on cutting-edge biotechnology, emphasizing the potential for technological innovation to address major diseases [11]. - The company faces challenges in demonstrating sustainable profitability and navigating the long commercialization path, which typically requires substantial investment and time [10][12].

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct clinical trials for the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Group 1 - The clinical trial application for DR10624 injection has been approved by the U.S. FDA [1] - The approved indication for DR10624 is severe hypertriglyceridemia (SHTG) [1] - The approval allows the company to initiate clinical trials in the United States [1]

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received FDA approval for the clinical trial application of the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Company Summary - Zhejiang Daor Biotechnology Co., Ltd. is a subsidiary of the company [1] - The approved drug, DR10624, is intended for the treatment of severe hypertriglyceridemia (SHTG) [1] - The FDA approval allows the company to conduct clinical trials in the United States [1] Industry Summary - The approval of DR10624 indicates potential growth opportunities in the biotechnology sector, particularly in treatments for severe hypertriglyceridemia [1]

Core Insights - The company announced that its subsidiary, Daor Bio, received FDA notification for the clinical trial application of DR10624 injection, which is approved for clinical trials in the U.S. for severe hypertriglyceridemia indications [1] - DR10624 is a globally innovative long-acting tri-specific agonist developed independently by Daor Bio, having previously completed Phase II clinical studies with positive topline results [1] - The uncertainty surrounding the drug's development is noted, but it is stated that this will not have a significant impact on the company's recent performance [1]

本公告乃由浙江同源康醫藥股份有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資 料。 本公司董事（「董事」）會（「董事會」）欣然宣佈重點佈局的細胞周期蛋白依賴性激 酶（「CDK」）抑制劑(CDKi)領域的三款藥物TYK-00540 (CDK2/4i)、TY-2699a (CDK7i)和TY-302 (CDK4/6i)的早期臨床研究結果以壁報形式在歐洲腫瘤內科學 會（「ESMO」）年會上展示。 ESMO 2025年會於當地時間2025年10月17-21日在德國柏林召開。作為全球腫瘤 學領域最具影響力的學術盛會之一，ESMO年會吸引了眾多學界頂尖專家學者， 提供了共同探討臨床難題、分享前沿進展的舞台。 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意見，並明確表示概不就因本公告全部或任何部分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。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願性公 ...

10月21日，国产九价HPV疫苗深圳首针在深圳市龙华区妇幼保健院开打。今年5月，我国首个国产九价 HPV疫苗正式获得国家药品监督管理局批准上市，使中国成为全球第二个能够独立供应高价次HPV疫苗 的国家。 宫颈癌发病率呈现年轻化趋势 宫颈癌是威胁我国女性健康的重要疾病。根据国家癌症中心的报告，2022年我国新发的宫颈癌病例是 15.1万例，居全球首位。同时，自2000年以来，我国宫颈癌的发病率不断上升，呈年轻化趋势，25岁以 下也是中国女性感染HPV的高峰年龄段。HPV是导致女性宫颈癌的"罪魁祸首"，99.7%的宫颈癌与高危 型HPV持续感染相关。而HPV疫苗接种是公认的预防宫颈癌最安全有效的手段之一。 适用于9-45岁女性 （文章来源：南方都市报） 深圳市妇幼保健院宫颈癌防治中心主任樊静洁提到，9-45岁女性可以通过打HPV疫苗获益，有条件的适 龄女性都应该接种HPV疫苗保护自己，早打早保护。其提到，重点需要关注的是9-14岁女孩，广东省初 一女生HPV疫苗免费项目覆盖了这部分重点人群。"国产九价9-17岁免疫程序是打两针，对于低龄段的 女孩子而言，不仅节省费用，还可以少跑一趟打苗。这两年我们也在做'加速消除 ...

Core Viewpoint - Tian Tan Biological announced the initiation of Phase III clinical trials for its "Prothrombin Complex Concentrate," developed by its subsidiary Wuhan Biological Pharmaceutical, following the completion of ethical review and preparatory work for clinical enrollment [1] Group 1: Product Development - The Prothrombin Complex Concentrate is primarily used for the treatment of congenital and acquired deficiencies of coagulation factors II, VII, IX, and X, which include conditions such as Hemophilia B, anticoagulant overdose, and vitamin K deficiency [1]