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]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. (科济药业-B) has conducted share buybacks, indicating a strategy to enhance shareholder value amidst market fluctuations [2] Summary by Category Share Buyback Details - On October 23, Kintor Pharmaceutical repurchased 205,000 shares at prices ranging from HKD 16.470 to HKD 16.700, totaling HKD 3.3982 million [2] - The stock closed at HKD 16.550 on the same day, reflecting a decline of 1.78%, with total trading volume of HKD 26.4818 million [2] - Year-to-date, the company has completed two buybacks, acquiring a total of 455,000 shares for a cumulative amount of HKD 7.6679 million [2] Buyback Breakdown - Buyback details include: - Date: October 23, 2025; Shares repurchased: 205,000; Highest price: HKD 16.700; Lowest price: HKD 16.470; Total amount: HKD 3.3982 million [2] - Date: October 21, 2025; Shares repurchased: 250,000; Highest price: HKD 17.150; Lowest price: HKD 16.990; Total amount: HKD 4.2698 million [2]

Group 1 - The company Kintor Pharmaceutical Co., Ltd. (stock code 02171) announced a share buyback plan [1] - The company will spend HKD 3.3982 million to repurchase 205,000 shares [1]

Group 1 - The company, 科济药业-B (02171.HK), announced a share buyback on October 23, spending HKD 3.4 million to repurchase 205,000 shares [1]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. announced a share buyback plan, indicating confidence in its stock value and future prospects [1] Group 1 - The company plans to repurchase 205,000 shares at a total cost of HKD 3.3982 million [1] - The buyback is scheduled for October 23, 2025, reflecting a strategic move to enhance shareholder value [1]

FF305 呈交日期： 2025年10月23日 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 科濟藥業控股有限公司 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 02171 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | | | 已發 ...