波动有点大！ 今日，在港股市场上，药捷安康-B（02617.HK）的股价剧烈波动。该股早盘涨幅一度超过60%，最高触及679.5港元/股， 市值一度逼近2700亿港元。 然而，今日午间，药捷安康突然公告称，不知悉股价及成交量异动原因，集团的业务营运及财务状况并无重大变动。午 后，药捷安康的股价急速跳水，跌幅一度超过60%，最低触及165港元/股，市值跌至不到700亿港元，全天振幅超过 120%。 药捷安康称，上述试验旨在评估替恩戈替尼片联合氟维司群注射液在经治失败的HR+/HER2-复发或转移性乳腺癌患者中 的安全性、疗效及药代动力学的开放标签、多中心、Ⅱ期临床研究。早期临床研究结果表明，替恩戈替尼单药在经历过 多种治疗的HR+/HER2-乳腺癌患者中显示出令人鼓舞的临床效果，且与氟维司群的联合用药具有药理学协同作用，可能 为此类患者的治疗带来新的突破。 药捷安康股价大跌 今日早盘，药捷安康大幅拉升，股价最高触及679.5港元，市值一度逼近2700亿港元。然而，午后"风云突变"，14时10分 过后，卖单持续涌现，导致公司股价持续跳水，最低触及165港元/股，跌幅一度高达60.24%。截至收盘时，药捷安康股 价 ...

Core Viewpoint - The stock of Yaojie Ankang-B (02617.HK) has surged dramatically, with a price increase of over 130% on September 11 and a total rise of 200% over the last three trading days, reaching a market capitalization of nearly HKD 997 billion within three months of its listing [2][6]. Company Performance - Yaojie Ankang-B's core product, Tinengotinib (TT-00420), has received clinical approval from the National Medical Products Administration of China for a Phase II trial targeting HR+/HER2- breast cancer patients [5][6]. - The company reported a pre-tax loss of HKD 1.23 billion for the first half of 2024, an improvement from a loss of HKD 1.6 billion in the same period of 2023 [9]. - Other income and revenue decreased by 65.1%, from HKD 10.4 million in 2024 to HKD 3.6 million in 2025, primarily due to reduced bank interest and government subsidies [9]. Market Dynamics - The stock was listed on the Hong Kong Stock Exchange on June 23, 2025, with an initial offering price of HKD 13.15 per share, raising HKD 201 million [7]. - The stock has been included in the Hong Kong Stock Connect program, effective September 8, 2025, which may enhance its trading volume and investor interest [10]. Clinical Trial Insights - The Phase II clinical trial aims to evaluate the safety, efficacy, and pharmacokinetics of Tinengotinib in combination with Fulvestrant for patients with HR+/HER2- breast cancer who have previously failed treatment [6][5]. - Early clinical results indicate promising efficacy for Tinengotinib as a monotherapy in this patient population, suggesting potential for significant market impact [9].

Group 1 - A-share market experienced a significant rally, with the ChiNext Index surpassing 3000 points for the first time in over three years, and the Sci-Tech 50 Index seeing an intraday increase of over 5% [2][4] - Key stocks in the Sci-Tech board, such as Haiguang Information and Cambricon Technologies, saw substantial gains, with Haiguang Information hitting a historical high of 220.84 yuan and a market capitalization exceeding 510 billion yuan [4][5] - The ChiNext Index recorded a rise of 4.31%, reaching 3029.58 points, with a total trading volume of approximately 419.48 billion yuan [5] Group 2 - The Hong Kong stock market showed a slight decline in the morning, with notable stocks like Semiconductor Manufacturing International Corporation and China Hongqiao Group performing well, while others like CSPC Pharmaceutical Group faced losses [6] - In the Hong Kong market, Longi Green Energy and other stocks saw significant intraday increases, with Longi Green Energy rising over 19% [6] - The announcement of clinical trial results for Tinengotinib by Yaojie Ankang-B indicated promising outcomes for breast cancer treatment, contributing to the stock's strong performance [7]

Core Viewpoint - China Biopharmaceutical has submitted a new indication application for its CDK2/4/6 inhibitor TQB3616 in combination with Fulvestrant for previously untreated HR+/HER2- locally advanced or metastatic breast cancer to the CDE, which has been accepted [1][2] Group 1: Clinical Research and Development - TQB3616-III-02 (NCT04523272) is a randomized, double-blind, parallel-controlled, multi-center Phase III clinical study aimed at evaluating the efficacy and safety of TQB3616 combined with Fulvestrant compared to placebo plus Fulvestrant in previously untreated HR+/HER2- advanced breast cancer patients [1] - The study has achieved its primary endpoint, with detailed data to be presented at an upcoming international academic conference [1] Group 2: Market Potential and Guidelines - Breast cancer is the most common malignant tumor among women, with HR+/HER2- breast cancer accounting for approximately 65%-70% of all breast cancer cases [1] - About 4%-6% of breast cancer patients are diagnosed at an advanced stage, and even early-stage patients have a 30%-40% chance of progressing to advanced disease despite standard adjuvant therapy [1] - The CSCO Breast Cancer Guidelines (2025 edition) recommend CDK4/6 inhibitors in combination with endocrine therapy for first-line treatment of HR+/HER2- advanced breast cancer [1]

Core Viewpoint - The company has submitted a new indication application for its self-developed CDK2/4/6 inhibitor TQB3616 in combination with Fulvestrant for previously untreated HR-positive, HER2-negative locally advanced or metastatic breast cancer to the National Medical Products Administration of China, which has been accepted [1] Group 1 - The application for the first-line indication further confirms the broad potential of this combination therapy in different treatment stages of advanced breast cancer [1] - The study has achieved its primary endpoint, with detailed data expected to be presented at an upcoming international academic conference [1]