Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a new drug application for its product, a monoclonal antibody injection for HER2-positive breast cancer, by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed a monoclonal antibody injection, Pertuzumab, which has received regulatory acceptance for marketing [1] - The product is classified as a Class 3.3 therapeutic biological product and is indicated for HER2-positive breast cancer [1] - Pertuzumab is a recombinant humanized anti-HER2 monoclonal antibody injection that requires administration every three weeks [1] Group 2: Product Mechanism and Clinical Trials - The product works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that Pertuzumab is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, with comparable safety and tolerability [1]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a listing application for its drug, trastuzumab injection, by the National Medical Products Administration of China, aimed at treating HER2-positive breast cancer [1] Company Summary - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed trastuzumab injection, which is a recombinant humanized anti-HER2 monoclonal antibody [1] - The drug is administered once every three weeks and works by specifically binding to the extracellular dimerization domain II of HER2, blocking dimerization with other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients, demonstrating that the drug is equivalent to the reference drug in terms of efficacy [1] Clinical Trial Summary - The clinical trial results indicate that trastuzumab injection is effective for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, showing equivalence to the reference drug [1] - The safety and tolerability of the drug are reported to be good and comparable to the reference drug [1]

Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from 951.985 billion yuan at the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings in Hong Kong stocks indicates a structural transformation in asset allocation, driven by the attractiveness of technology and value stocks [1] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main reasons: valuation advantages compared to A-shares, the convenience and low cost of ETF trading, and risk diversification benefits [2] - The top Hong Kong stocks that public funds increased their holdings in include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [2]

Group 1 - Public funds have significantly increased their allocation to Hong Kong stocks, with the investment market value reaching 1.362211 trillion yuan by the end of Q3 2025, a 43.09% increase from the end of Q2 2025 [1] - The market value of equity and index funds in Hong Kong stocks reached 1.231653 trillion yuan and 701.284 billion yuan, reflecting increases of 45.02% and 73.07% respectively [1] - The surge in public fund holdings indicates a structural transformation in asset allocation, driven by the enhanced attractiveness of Hong Kong stocks, particularly in the technology and banking sectors [1][2] Group 2 - The influx of funds into Hong Kong ETFs is attributed to three main factors: valuation advantages compared to A-shares, trading convenience and low fees of ETFs, and risk diversification benefits [2] - The most favored Hong Kong stocks by public funds include SenseTime-W, Alibaba Health, China Biologic Products, and others, primarily in the information technology and healthcare sectors, aligning with the constituents of the Hang Seng Technology Index and the Hong Kong Pharmaceutical Index [2] - A total of 38 cross-border ETFs attracted a net inflow of 49.561 billion yuan in Q3, with a year-to-date net inflow of 72.642 billion yuan as of November 12 [3] Group 3 - The acceleration of fund flows into ETFs is expected to enhance market liquidity and pricing efficiency, supporting the stable development of the Hong Kong stock market [4]

Major Events - Hong Kong Stock Exchange (00388) plans to make a strategic investment in Xunqing Settlement Holdings Limited [1] - Lai Kai Pharmaceutical-B (02105) signs an exclusive licensing agreement with Qilu Pharmaceutical for LAE 002 (AFURESERTIB) in China [1] - TECHSTARACQ-Z (07855) is expected to inherit the company Tuda Tong's listing on the main board of the Stock Exchange on December 10 [1] - Superstar Legend (06683) intends to establish a joint venture with Yushu Technology to develop consumer-grade IP robots and IP derivative products [1] - Beijing Enterprises Holdings (00392) plans to acquire 100% equity of Beijing Beiran Special Equipment Inspection and Testing Co., Ltd. for 54.6 million yuan [1] - CSPC Pharmaceutical Group (01093) has its application for the marketing of Pertuzumab Injection accepted by the National Medical Products Administration [1] - Rongli Construction (09639) plans to collaborate with CATL to develop efficient energy storage systems and solutions [1] Operating Performance - BeiGene (06160) reports a net profit attributable to shareholders of 1.139 billion yuan for the first three quarters, turning from loss to profit year-on-year [1] - Tencent Music-SW (01698) reports a net profit attributable to equity holders of 2.15 billion yuan in the third quarter, a year-on-year increase of 36.0% [1] - Zhou Li Fu (06168) sees a 32% year-on-year increase in e-commerce revenue for the first ten months, with net profit rising 71% year-on-year [1] - China Resources Land (01109) reports a cumulative contract sales amount of approximately 169.6 billion yuan for the first ten months, a year-on-year decrease of 16.6% [1]

Core Viewpoint - The application for the marketing authorization of the drug "Patuzumab Injection" developed by the subsidiary of the company, Shijiazhuang Yiling Pharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration of China for the treatment of HER2-positive breast cancer [1] Group 1: Product Information - The product is a recombinant humanized anti-HER2 monoclonal antibody injection, administered once every three weeks [1] - It works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The product also mediates antibody-dependent cell-mediated cytotoxicity [1] Group 2: Clinical Trial and Efficacy - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that the product is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] - The safety and tolerability of the product are good and comparable to the reference drug [1] Group 3: Development and Research Compliance - The development of the product follows the guidelines for biosimilar drug research, confirming its high similarity in quality, safety, and efficacy to the reference drug through a series of rigorous studies [1] - The studies include pharmaceutical, non-clinical, human pharmacokinetics, clinical efficacy, and safety assessments, ensuring there are no clinically meaningful differences [1]

Core Viewpoint - The announcement indicates that the application for the listing of the drug Pertuzumab injection, developed by the subsidiary of the company, has been accepted by the National Medical Products Administration of the People's Republic of China, targeting HER2-positive breast cancer [1] Group 1 - The drug Pertuzumab injection is classified under Category 3.3 of therapeutic biological products [1] - The indication for the drug is specifically for HER2-positive breast cancer [1]

Core Viewpoint - The application for the listing of the drug Patuzumab Injection developed by the subsidiary of the company has been accepted by the National Medical Products Administration of China, targeting HER2-positive breast cancer [1] Group 1: Product Details - Patuzumab Injection is a recombinant humanized anti-HER2 monoclonal antibody administered every three weeks [1] - The drug works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The product also mediates antibody-dependent cell-mediated cytotoxicity [1] Group 2: Clinical Trial and Approval - The application is based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that the product is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer [1] - The safety and tolerability of the product are comparable to the reference drug [1] Group 3: Research and Development Compliance - The development of the product follows the guidelines for biosimilar drug research, confirming its high similarity in quality, safety, and efficacy to the reference drug through a series of rigorous studies [1] - The studies include pharmaceutical, non-clinical, human pharmacokinetics, clinical efficacy, and safety assessments [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。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 代表董事會 石藥集團有限公司 主席 蔡東晨 香港，2025年11月12日 自願公告 帕妥珠單抗注射液的上市申請 獲國家藥品監督管理局受理 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布，本公司附屬公司石藥集團巨石生物製藥有限公司開發的帕妥珠單抗注射液（「該產品」） 的上市申請已獲中華人民共和國國家藥品監督管理局受理。該產品按照治療用生物製品3.3 類申報，其適應症為HER2陽性乳腺癌。 該產品為一款重組人源化抗HER2單克隆抗體注射液，患者每3周需使用一次。該產品通過 特異性結合HER2的細胞外二聚化結構域II，阻斷HER2與HER2或其他HER ...

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.48% on November 11, with a trading volume of 854 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 10, 2024, the fund's latest share count was 9.675 billion, with a total size of 8.015 billion yuan, reflecting a significant increase in both share count and size compared to the previous year [1] Fund Performance - The fund's share count increased by 2347.04% and its size increased by 2021.31% from 3.95 million shares and 378 million yuan on December 31, 2024 [1] - Over the past 20 trading days, the cumulative trading amount reached 24.964 billion yuan, with an average daily trading amount of 1.248 billion yuan [1] - Year-to-date, the cumulative trading amount for 207 trading days was 244.556 billion yuan, with an average daily trading amount of 1.181 billion yuan [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 65.68% during the management period [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant percentages of the portfolio allocated to these stocks [2] - The largest holdings by percentage include BeiGene at 10.62%, CanSino Biologics at 10.55%, and Innovent Biologics at 10.21% [2]