KELUN PHARMA(002422)
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四川科伦药业股份有限公司 关于子公司在2025年欧洲肿瘤内科学会大会上 公布多项创新药物研究成果的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-21 10:42
Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced significant clinical research results from its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., at the 2025 European Society for Medical Oncology (ESMO) conference, highlighting advancements in targeted antibody-drug conjugates (ADCs) for various cancers [1]. Group 1: Clinical Research Results Overview - Two studies on sac-TMT (LKB5) were selected for Late Breaking Abstract (LBA) oral presentations, demonstrating its efficacy in treating EGFR mutation-positive non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer (BC) [2][3]. - In the OptiTROP-Lung04 study, sac-TMT showed a median progression-free survival (PFS) of 8.3 months compared to 4.3 months for chemotherapy, reducing the risk of disease progression or death by 51% [2][3]. - The OptiTROP-Breast02 study reported a median PFS of 8.3 months for sac-TMT versus 4.1 months for investigator's choice chemotherapy, with a hazard ratio (HR) of 0.35 [4][5]. Group 2: Safety and Efficacy - Both studies indicated similar rates of treatment-related adverse events (TRAEs) between sac-TMT and chemotherapy, with no TRAEs leading to treatment discontinuation in the sac-TMT group [3][5]. - The objective response rate (ORR) for sac-TMT was 60.6% in NSCLC and 41.5% in BC, significantly higher than the chemotherapy groups [2][5]. - The studies support the approval of sac-TMT by the National Medical Products Administration (NMPA) for specific cancer treatments [3][5]. Group 3: Additional Research and Drug Information - The study on SKB315, targeting Claudin18.2 in advanced solid tumors, showed an ORR of 37.5% and a median PFS of 8.2 months [6]. - The innovative drugs sac-TMT and botu-tuzumab (舒泰莱) are designed to target specific cancer types, with sac-TMT being the first TROP2 ADC approved for lung cancer indications [8][10]. - Kelun Botai has initiated multiple clinical studies for these drugs, indicating a robust pipeline for cancer treatment [9][11].
10月21日医疗健康R(480016)指数涨1.04%,成份股华大智造(688114)领涨
Sou Hu Cai Jing· 2025-10-21 10:00
Core Points - The Medical Health R Index (480016) closed at 7852.45 points, up 1.04%, with a trading volume of 22.052 billion yuan and a turnover rate of 0.74% [1] - Among the index constituents, 40 stocks rose while 9 fell, with WuXi AppTec leading the gainers at 4.27% and Pian Zai Huang leading the decliners at 0.91% [1] Index Constituents Summary - The top ten constituents of the Medical Health R Index include: - WuXi AppTec (603259) with a weight of 14.37%, latest price at 102.04, and a market cap of 304.463 billion yuan [1] - Hengrui Medicine (600276) with a weight of 11.45%, latest price at 66.00, and a market cap of 438.055 billion yuan [1] - Mindray Medical (300760) with a weight of 8.07%, latest price at 223.57, and a market cap of 271.066 billion yuan [1] - United Imaging Healthcare (688271) with a weight of 4.32%, latest price at 143.03, and a market cap of 117.879 billion yuan [1] - Pian Zai Huang (600436) with a weight of 3.59%, latest price at 185.38, and a market cap of 111.843 billion yuan [1] - Aier Eye Hospital (300015) with a weight of 3.21%, latest price at 12.33, and a market cap of 114.982 billion yuan [1] - Kelun Pharmaceutical (002422) with a weight of 2.54%, latest price at 36.05, and a market cap of 57.610 billion yuan [1] - Changchun High & New Technology (000661) with a weight of 2.35%, latest price at 120.28, and a market cap of 49.067 billion yuan [1] - Fosun Pharma (600196) with a weight of 2.28%, latest price at 29.28, and a market cap of 78.190 billion yuan [1] - Sinopharm (002001) with a weight of 2.22%, latest price at 23.27, and a market cap of 71.519 billion yuan [1] Capital Flow Analysis - The net inflow of main funds into the Medical Health R Index constituents totaled 634 million yuan, while retail funds saw a net outflow of 105 million yuan [1] - Detailed capital flow for key stocks includes: - WuXi AppTec with a net inflow of 353.9 million yuan from main funds [2] - Sinopharm with a net inflow of 90.036 million yuan from main funds [2] - Hengrui Medicine with a net inflow of 76.418 million yuan from main funds [2] - Other stocks like Changchun High & New Technology and Fosun Pharma also experienced varying levels of net inflow and outflow [2]
科伦药业博度曲妥珠单抗获批,2款ADC新药+罗替高汀贴片首仿来袭
Ge Long Hui· 2025-10-21 04:06
Core Insights - The approval of the new drug injection trastuzumab botidotin by Kelun Pharmaceutical marks a significant milestone in the company's product portfolio, targeting HER2-positive breast cancer patients who have previously undergone treatment [1][3] - Kelun Pharmaceutical's launch of the rotigotine patch represents the first domestic generic version of a drug that has dominated the Parkinson's disease treatment market, breaking the original manufacturer's monopoly [6][9] - The company has demonstrated a strong performance in the pharmaceutical sector, with over 40 generic drugs approved this year, enhancing its competitiveness in both domestic and international markets [11] Drug Approvals - The injection trastuzumab botidotin is a HER2 ADC monoclonal antibody developed by Kelun Biotech, approved for patients with unresectable or metastatic HER2-positive breast cancer who have received prior HER2-targeted therapies [3] - The rotigotine patch, originally developed by UCB Pharma, is the first transdermal patch for treating Parkinson's disease, with global sales exceeding $300 million in 2023, accounting for approximately 22% of the market share for Parkinson's treatments [6][9] Market Position - Kelun Pharmaceutical has successfully launched two ADC drugs, trastuzumab botidotin and another drug, enhancing its position in the ADC market, which is a key focus area for the company [4] - The approval of the rotigotine patch not only diversifies Kelun's product offerings but also positions the company as a significant player in the Parkinson's disease treatment market, previously dominated by UCB Pharma [6][9] Clinical Development - Kelun has a robust pipeline with nine ADC drugs in various stages of clinical trials, indicating a strong commitment to innovation and development in the oncology sector [4] - The company has also received approvals for additional new drugs, including injection formulations that further expand its therapeutic range [11]
化学制药板块10月20日涨0.32%,富祥药业领涨,主力资金净流出6.23亿元
Zheng Xing Xing Ye Ri Bao· 2025-10-20 08:30
Market Overview - The chemical pharmaceutical sector increased by 0.32% on October 20, with Fuxiang Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3863.89, up 0.63%, while the Shenzhen Component Index closed at 12813.21, up 0.98% [1] Top Gainers - Fuxiang Pharmaceutical (300497) closed at 10.48, up 5.43% with a trading volume of 302,100 shares and a transaction value of 316 million [1] - Changshan Pharmaceutical (300255) closed at 50.98, up 4.60% with a trading volume of 280,800 shares [1] - Kelong Pharmaceutical (002422) closed at 36.47, up 4.56% with a trading volume of 188,600 shares and a transaction value of 681 million [1] Top Losers - Anglikang (002940) closed at 41.66, down 7.05% with a trading volume of 214,800 shares [2] - Asia-Pacific Pharmaceutical (002370) closed at 7.35, down 5.16% with a trading volume of 1,918,400 shares [2] - Yifan Pharmaceutical (002019) closed at 13.11, down 4.45% with a trading volume of 271,200 shares and a transaction value of 358 million [2] Fund Flow Analysis - The chemical pharmaceutical sector experienced a net outflow of 623 million from institutional investors, while retail investors saw a net inflow of 672 million [2] - The top stock with the highest net inflow from institutional investors was Xingqi Eye Medicine (300573) with 206 million [3] - Kelong Pharmaceutical (002422) had a net inflow of 99.67 million from institutional investors [3]
2025年1-8月中国化学药品原药产量为247.7万吨 累计增长3.1%
Chan Ye Xin Xi Wang· 2025-10-20 03:41
Core Viewpoint - The report by Zhiyan Consulting highlights the growth and future trends in China's chemical pharmaceutical industry, indicating a steady increase in production and market dynamics from 2025 to 2031 [1]. Industry Summary - According to the National Bureau of Statistics, the production of chemical pharmaceutical raw materials in China reached 263,000 tons in August 2025, with a cumulative production of 2,477,000 tons from January to August 2025, reflecting a growth of 3.1% [1]. - The report provides insights into the supply and demand situation in the chemical pharmaceutical industry, projecting future trends and market conditions [1]. Company Summary - Listed companies in the report include Heng Rui Medicine, East China Medicine, Lizhu Group, Baiyunshan, North China Pharmaceutical, Haizheng Pharmaceutical, Fosun Pharmaceutical, Kelun Pharmaceutical, Enhua Pharmaceutical, and Xianju Pharmaceutical, indicating a diverse range of players in the market [1]. - The report emphasizes the importance of industry research and consulting services in aiding investment decisions, showcasing Zhiyan Consulting's expertise in providing comprehensive industry solutions [1].
科伦药业:两款ADC药物获突破性成果
Guo Ji Jin Rong Bao· 2025-10-20 02:01
Core Insights - The company announced significant clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference, showcasing advancements in cancer treatment [1] Group 1: Clinical Research Results - The drug sac-TMT demonstrated a median progression-free survival (PFS) of 8.3 months in the randomized, multicenter Phase 3 OptiTROP-Lung04 study for treating EGFR-mutant non-small cell lung cancer (NSCLC), significantly improving compared to the chemotherapy group, with a 51% reduction in the risk of disease progression or death [1] - In the randomized, multicenter Phase 3 OptiTROP-Breast02 study for locally advanced or metastatic hormone receptor-positive and HER2-negative breast cancer, sac-TMT significantly extended the median PFS to 8.3 months, with an objective response rate of 41.5% [1] - The drug bodu-TM compared to emtansine (T-DM1) in a randomized Phase 3 study for HER2-positive metastatic breast cancer showed a significant extension of median PFS to 11.1 months, with an objective response rate reaching 76.9% [1]
科伦药业子公司在2025年欧洲肿瘤内科学会大会上公布多项创新药物研究成果
Zhi Tong Cai Jing· 2025-10-20 00:32
Core Viewpoint - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., presented multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1 - The clinical research results include data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (Jiatailai), targeting trophoblast cell surface antigen 2 (TROP2) [1] - The company also presented data on A166 (Shutailai), a HER2-targeted ADC [1] - Additionally, results related to Claudin18.2 (CLDN18.2) ADC SKB315 were shared [1]
科伦药业(002422.SZ)子公司在2025年欧洲肿瘤内科学会大会上公布多项创新药物研究成果
智通财经网· 2025-10-20 00:32
Core Insights - The company announced that its subsidiary, Sichuan Kelun-Botai Biopharmaceutical Co., Ltd., presented multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1 - The clinical research results included data on targeted antibody-drug conjugates (ADCs) such as sac-TMT (Jiatailai®), targeting trophoblast cell surface antigen 2 (TROP2) [1] - The results also covered data on A166 (Shutailai®), a HER2-targeted ADC [1] - Additionally, data on SKB315, a Claudin18.2 (CLDN18.2) ADC, was presented [1]
科伦药业:子公司在2025年欧洲肿瘤内科学会大会上公布多项创新药物研究成果
Zheng Quan Shi Bao Wang· 2025-10-20 00:29
Core Viewpoint - The announcement by Kelun Pharmaceutical regarding the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference highlights the company's advancements in targeted antibody-drug conjugates (ADCs) [1] Group 1: Clinical Research Results - Kelun Pharmaceutical's subsidiary, Sichuan Kelun Biotech Co., Ltd., presented data on several ADCs, including sac-TMT targeting TROP2, A166 targeting HER2, and SKB315 targeting Claudin18.2 [1]
健讯Daily|《医疗器械管理法》立法调研在京开展;翰森ADC药物卖给罗氏
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-20 00:09
Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' kidney function [4] - Kelun Pharmaceutical's subsidiary obtained approval for its targeted antibody-drug conjugate, Boduocizumab, for treating HER2-positive breast cancer patients who have received prior anti-HER2 therapies, showing significant improvement in progression-free survival [5] Financial Reports - Wowo Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenues of 625 million yuan [7] - Pianzaihuang's third-quarter net profit decreased by 28.82% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector and declining gross margins [8] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Purui Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [11] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted antibody-drug conjugate for colorectal cancer [12][13] - Maipu Medical plans to acquire 100% of Guangzhou Yijie Medical Technology for 335 million yuan and raise additional funds [15] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [18]