Core Viewpoint - Kangchen Pharmaceutical (603590.SH) has received a Clinical Study Continuation Notification from the U.S. Food and Drug Administration (FDA), allowing the clinical trial application for KC1086 to proceed [1] Group 1: Company Developments - The company has developed KC1086, a small molecule inhibitor with a novel structure, targeting Lysine Acetyltransferase 6 (KAT6) [1] - KC1086 is intended for the treatment of advanced recurrent or metastatic solid tumors [1]

Core Viewpoint - Kangchen Pharmaceutical (603590.SH) has received FDA approval for its clinical trial application for KC1086 tablets, a novel small molecule inhibitor targeting Lysine Acetyltransferase 6 (KAT6) for the treatment of advanced recurrent or metastatic solid tumors [2] Company Summary - The drug KC1086 is fully developed by Kangchen Pharmaceutical and features a new structure with high potency and selectivity [2] - The clinical trial for KC1086 is currently progressing in an orderly manner [2]

Core Viewpoint - Kangchen Pharmaceutical has received FDA approval for the clinical trial application of KC1086, a novel small molecule inhibitor targeting KAT6, aimed at treating advanced recurrent or metastatic solid tumors [1][2]. Group 1: Product Development - KC1086 is a highly selective lysine acetyltransferase 6 (KAT6) inhibitor, developed entirely by Kangchen Pharmaceutical, with potential applications in cancer treatment [1]. - The KAT6 enzyme is linked to various cancers, including breast, ovarian, cervical, lung, colon, and medulloblastoma, and its inhibition may reverse tumor resistance and improve treatment outcomes [1]. Group 2: Clinical Trial Progress - KC1086 demonstrated over 90% tumor inhibition in ER+/HER2- breast cancer models and similar efficacy in other solid tumor models [2]. - The project received implied clinical trial approval from the National Medical Products Administration by the end of June 2025, with the first human clinical study for advanced solid tumor patients starting in August 2025 [2].

Core Viewpoint - Kangchen Pharmaceutical has received FDA approval for the clinical trial of its drug KC1086, a small molecule inhibitor targeting KAT6, which is intended for the treatment of advanced recurrent or metastatic solid tumors [1][2]. Group 1: Drug Development and Approval - The FDA has issued a "Study May Proceed" notification for the clinical trial application of KC1086, allowing the company to advance its research [1]. - KC1086 is a novel, highly selective small molecule inhibitor of Lysine Acetyltransferase 6 (KAT6), developed entirely by Kangchen Pharmaceutical [1]. Group 2: Mechanism and Clinical Relevance - KAT6 is part of the MYST family of histone acetyltransferases and plays a crucial role in transcription regulation, development, hematopoietic cell differentiation, cell cycle progression, and mitosis [1]. - Abnormal high expression of KAT6 has been linked to various cancers, including breast, ovarian, cervical, lung adenocarcinoma, colon and rectal adenocarcinoma, and medulloblastoma, indicating its relevance in tumorigenesis and poor prognosis [1]. Group 3: Efficacy in Preclinical Models - KC1086 has demonstrated excellent in vivo efficacy in various mouse xenograft models, achieving over 90% tumor inhibition in ER+/HER2- breast cancer models, with similar effects observed in other solid tumor models [2]. - The clinical trial for KC1086 is progressing systematically, with the first human clinical study expected to start by the end of June 2025, following the implied approval from the National Medical Products Administration [2].

Core Viewpoint - The company has received FDA approval for the clinical trial of its drug KC1086, which is a novel small molecule inhibitor designed for the treatment of advanced recurrent or metastatic solid tumors [1] Group 1 - The FDA issued a "Study May Proceed" notification, allowing the clinical trial application for KC1086 to move forward [1] - KC1086 is developed entirely by Beijing Kangchen Pharmaceutical Co., Ltd. and targets lysine acetyltransferase 6 with high selectivity and efficacy [1] - The drug is intended for use in treating advanced recurrent or metastatic solid tumors [1]

北京康辰药业股份有限公司 2025 年第三次临时股东大会 会议资料 二〇二五年十二月 1 | 2025 | 年第三次临时股东大会会议须知 5 | | --- | --- | | 2025 | 年第三次临时股东大会会议议案 6 | 北京康辰药业股份有限公司 2025 年第三次临时股东大会会议议程 一、会议时间 1、现场会议召开时间：2025 年 12 月 31 日上午 10:00 2、网络投票起止时间：自 2025 年 12 月 31 日至 2025 年 12 月 31 日。采用 上海证券交易所网络投票系统，通过交易系统投票平台的投票时间为股东大会召 开当日的交易时间段，即 9:15-9:25，9:30-11:30，13:00-15:00；通过互联网投票 平台的投票时间为股东大会召开当日的 9:15-15:00。 二、会议地点：北京市昌平区中关村生命科学园科学园路 7 号院 3 号楼公司第三 会议室 三、会议召集人：公司董事会 四、会议主持人：董事长刘建华先生 五、会议议程 2.01 关于修订《股东会议事规则》的议案 2.08 关于修订《董事及高级管理人员薪酬管理制度》的议案 2.09 关于修订《独立董事工作制 ...

证券代码：603590 证券简称：康辰药业 公告编号：临2025-085 北京康辰药业股份有限公司 关于公司通过高新技术企业重新认定的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 北京康辰药业股份有限公司（以下简称"公司"）近日收到由北京市科学技术委员会、北京市财政局、国 家税务总局北京市税务局联合颁发的编号为GS202511000053的《高新技术企业证书》，有效期三年。 本次高新技术企业的认定系公司原高新技术企业证书有效期满后的重新认定。根据《中华人民共和国企 业所得税法》及国家对高新技术企业的相关税收规定，公司自通过高新技术企业重新认定起连续三年 （即2025年、2026年、2027年）可继续享受国家高新技术企业15%的企业所得税优惠税率。公司2025年 度已按照15%的企业所得税税率进行纳税申报及预缴，本次通过高新技术企业重新认定不会对公司2025 年度经营活动产生影响。 特此公告。 北京康辰药业股份有限公司董事会 2025年12月18日 ...

（文章来源：证券日报） 证券日报网讯 12月17日晚间，康辰药业发布公告称，公司近日收到由北京市科学技术委员会、北京市 财政局、国家税务总局北京市税务局联合颁发的《高新技术企业证书》，本次高新技术企业的认定系公 司原高新技术企业证书有效期满后的重新认定。 ...

格隆汇12月17日丨康辰药业(603590.SH)公布，公司近日收到由北京市科学技术委员会、北京市财政 局、国家税务总局北京市税务局联合颁发的编号为GS202511000053的《高新技术企业证书》，有效期 三年。本次高新技术企业的认定系公司原高新技术企业证书有效期满后的重新认定。 财经频道更多独家策划、专家专栏，免费查阅>> 责任编辑：安东 ...

关于公司通过高新技术企业重新认定的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 证券代码：603590 证券简称：康辰药业 公告编号：临 2025-085 北京康辰药业股份有限公司 特此公告。 北京康辰药业股份有限公司董事会 2025 年 12 月 18 日 北京康辰药业股份有限公司（以下简称"公司"）近日收到由北京市科学技术 委 员 会、 北 京 市财 政 局 、 国家 税 务 总局 北 京 市 税务 局 联 合颁 发 的 编 号为 GS202511000053 的《高新技术企业证书》，有效期三年。 本次高新技术企业的认定系公司原高新技术企业证书有效期满后的重新认定。 根据《中华人民共和国企业所得税法》及国家对高新技术企业的相关税收规定，公 司自通过高新技术企业重新认定起连续三年（即 2025 年、2026 年、2027 年）可继 续享受国家高新技术企业 15%的企业所得税优惠税率。公司 2025 年度已按照 15% 的企业所得税税率进行纳税申报及预缴，本次通过高新技术企业重新认定不会对公 司 2025 年度经营活动 ...