股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 科濟藥業控股有限公司 呈交日期: 2025年11月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02171 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 200,000,000,000 | USD | | 0.00000025 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 200,000,000,000 | USD | | 0.00000025 | USD | | 50,000 | ...

Core Insights - The annual adjustment of the National Medical Insurance (NMI) catalog has progressed, with negotiations for the 2025 NMI drug catalog and commercial insurance innovative drug catalog taking place from October 30 to November 3, involving 120 domestic and foreign companies [1] - The introduction of the commercial insurance innovative drug catalog is a significant highlight, marking its first establishment, with 141 submissions and 121 passing the preliminary review [1][2] - The NMI's focus is on "basic protection," which has led to high-value innovative drugs like CAR-T therapies not being included in the basic catalog, while the commercial insurance catalog aims to cover high-innovation drugs that exceed basic insurance limits [2] Group 1 - The NMI negotiations involved 127 drugs for the basic catalog and 24 for the commercial insurance catalog, with the new catalogs expected to be released in early December and implemented on January 1 [1] - The commercial insurance innovative drug catalog respects the market position of commercial insurance companies, differing from the NMI catalog adjustments [2] - Five CAR-T therapies are in the preliminary review for the commercial insurance catalog, indicating a growing acceptance of high-value therapies in the market [2][3] Group 2 - The support from commercial insurance for high-value innovative products like CAR-T therapies is seen as essential for risk-sharing among patients and promoting industry development [3] - There is a need for national involvement to enhance the role of commercial insurance in rare disease coverage, as profitability concerns may limit insurance companies' willingness to cover patients with pre-existing conditions [3] - The potential for innovative drugs included in both NMI and commercial insurance catalogs to experience rapid revenue growth is highlighted, benefiting patients and leading to increased flexibility for related companies [4]

Group 1 - MSCI announced the results of the November index review, with adjustments effective after the market close on November 24 [1] - The MSCI Global Small Cap Index will include 22 new stocks, such as Gilead Sciences (01672) and Meili Tianyuan Healthcare (02373) [1] - 17 stocks will be removed from the MSCI Global Small Cap Index, including China Gold International (02099) and China Nonferrous Mining (01258) [1] Group 2 - The MSCI Hong Kong Index will add 7 new stocks, including Chow Sang Sang (00116) and MGM China (02282) [2] - Stocks removed from the MSCI Hong Kong Index include Kintor Pharmaceutical (02171) and HKT Trust (00215) [2][3]

Group 1 - MSCI announced the results of the November index review, with adjustments effective after the market close on November 24 [1] - A total of 22 stocks were added to the MSCI Global Small Cap Index, including companies such as Genscript Biotech (01672) and Youzan (08083) [1] - 17 stocks were removed from the MSCI Global Small Cap Index, including China Gold International (02099) and Longi Green Energy (601869) [1] Group 2 - The MSCI Hong Kong Index included 7 new stocks, such as Chow Sang Sang (00116) and MGM China (02282) [2] - The MSCI Hong Kong Index removed stocks like Kintor Pharmaceutical (02171) and HKT Trust (00215) [2][3]

Core Insights - The National Medical Insurance Negotiation concluded on November 4, with 120 companies participating, involving 127 off-list drugs and 24 drugs for commercial insurance innovation [1] Group 1: Introduction of Commercial Health Insurance Innovation Drug Directory - The "Commercial Health Insurance Innovation Drug Directory" was introduced for the first time this year, building on the existing medical insurance directory adjustment mechanism [2] - A total of 121 drug names passed the formal review for the commercial health insurance innovation drug directory, with 79 drugs applying for both the basic medical insurance and the commercial health insurance directories [2] Group 2: CAR-T Therapy and Pricing Negotiations - The high-priced CAR-T therapies are highlighted as a significant focus in the commercial health insurance innovation drug directory [4] - Five CAR-T therapies have passed the formal review for the commercial insurance directory, with three also applying for the basic medical insurance directory [5] - The only CAR-T therapy priced below one million yuan is the one from Huyuan Biotechnology, priced at 999,000 yuan per injection, and negotiations for this therapy have reportedly gone smoothly [5][6] Group 3: Market Dynamics and Future Implementation - The introduction of the commercial health insurance innovation drug directory is seen as a key step to break the payment deadlock, potentially lowering patient out-of-pocket expenses and expanding the patient population [6] - The new basic medical insurance drug directory and the first commercial health insurance innovation drug directory are expected to be released in early December, with implementation starting on January 1 of the following year [6]

Core Viewpoint - Kexing Pharmaceutical Holdings Limited has announced promising clinical data for its universal CAR-T products CT0596 and CT1190B, indicating good safety and efficacy signals for treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma [1][2] Group 1: Clinical Data and Product Development - The clinical data for CT0596 and CT1190B shows encouraging results in treating relapsed/refractory multiple myeloma and non-Hodgkin lymphoma, respectively [1][2] - Kexing's universal CAR-T products can significantly reduce production costs by over 80% compared to autologous CAR-T therapies, addressing issues of high costs and patient accessibility [2] - The company has developed proprietary technology platforms, THANK-uCAR® and the upgraded THANK-u Plus®, to enhance the accessibility of CAR-T therapies and minimize immune rejection [3] Group 2: Market Context and Competitive Landscape - The current autologous CAR-T therapies are highly customized, leading to prices exceeding 1 million yuan, with only 20% of eligible patients in the U.S. able to access treatment, and an even lower percentage in China [2] - Kexing Pharmaceutical is positioned as a leading player in the domestic CAR-T therapy market, with significant achievements in the autologous CAR-T field [4] - The company aims to launch its first universal CAR-T product within the next 4-5 years, expanding treatment options for patients [3]

Core Insights - Kintor Pharmaceutical (02171.HK) announced clinical data for its universal BCMA CAR-T product CT0596 and universal CD19/CD20 CAR-T product CT1190B, both showing promising safety and efficacy signals for treating relapsed/refractory multiple myeloma (R/R MM) and non-Hodgkin lymphoma (R/R NHL) respectively [1][2] Group 1: Product Development - CT0596 is a universal CAR-T cell therapy targeting BCMA, currently undergoing investigator-initiated clinical trials for R/R MM and plasma cell leukemia (PCL), with plans to submit an IND application in the second half of 2025 [1] - CT1190B targets CD19/CD20 and is involved in clinical trials for treating relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc) [2] Group 2: Company Overview - Kintor Pharmaceutical is a biopharmaceutical company focused on developing innovative CAR-T cell therapies to address unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [2] - The company has established end-to-end capabilities in CAR-T cell research and development, from target discovery to commercial-scale production, positioning itself as a leading global player in CAR-T therapy [2] - Kintor currently has 10 CAR-T pipeline products, including 4 autologous CAR-T and 6 universal CAR-T, all of which are self-developed with global rights [2]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. (02171.HK) experienced a significant intraday increase of over 8%, with a current rise of 6.31%, trading at HKD 17.52, and a transaction volume of HKD 51.9354 million [2] Company Summary - Kintor Pharmaceutical's stock price showed a notable increase during trading, indicating positive market sentiment towards the company [2] - The trading volume reached HKD 51.9354 million, reflecting active investor interest [2]

Core Viewpoint - The stock of Kintor Pharmaceutical (02171) has seen a significant increase, rising over 8% during trading, with a current price of HKD 17.52 and a trading volume of HKD 51.9354 million. This surge is linked to the ongoing negotiations for the 2025 National Medical Insurance pricing, which may positively impact CAR-T therapies, including Kintor's Zewokaiolun injection [1]. Group 1 - The negotiations for the 2025 National Medical Insurance are currently in their fourth day, with representatives from HeYuan Bio expressing that discussions have been smooth, although final results will depend on the National Healthcare Security Administration's announcement [1]. - There are currently seven CAR-T products approved in China, all priced over one million yuan, with five undergoing review through the commercial insurance directory, including Kintor's Zewokaiolun injection [1]. - Inclusion of CAR-T therapies in the commercial insurance directory is expected to enhance patient accessibility, reduce financial burdens, alleviate pricing pressure on pharmaceutical companies, expand market share, and ensure reasonable returns for high-value innovative therapies [1].

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]