格隆汇12月30日丨康辰药业(603590.SH)公布，公司于2025年12月29日召开了职工代表大会，审议并通 过《关于选举公司第五届董事会职工董事的议案》，选举黄憗先生为公司第五届董事会职工董事。黄憗 先生将与公司2025 年第三次股东大会选举产生的董事，共同组成公司第五届董事会，任期自公司股东 大会审议通过之日起三年。 ...

特此公告。 证券代码：603590 证券简称：康辰药业 公告编号：临 2025-087 北京康辰药业股份有限公司 关于选举职工董事的公告 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"）于 2025 年 12 月 29 日召开 了职工代表大会，审议并通过《关于选举公司第五届董事会职工董事的议案》， 选举黄憗先生为公司第五届董事会职工董事（简历详见附件）。黄憗先生将与公 司 2025 年第三次股东大会选举产生的董事，共同组成公司第五届董事会，任期 自公司股东大会审议通过之日起三年。 本次选举职工董事不会导致公司董事会中兼任公司高级管理人员以及由职 工代表担任的董事人数超过公司董事总数的二分之一，符合相关法律法规、规范 性文件及《公司章程》的规定。 截至本公告日，黄憗先生持有公司股份69,000股（股权激励取得），占公司 总股本的比例为0.04%，与公司的董事、监事、高级管理人员、实际控制人及持股 5%以上的股东不存在关联关系，不存在《公司法》规定的不得担任公司的董事规 定的情形，也未受 ...

Core Viewpoint - The approval of KC1086 by the FDA marks a strategic milestone for the company, showcasing its innovative research and development capabilities [1] Group 1: Product Development - KC1086's FDA approval indicates the company's potential to enhance its product pipeline in the treatment of malignant tumors, which could significantly boost future performance [1] - The overall progress of the company's research pipeline is on track, with research expenses reaching 32.8 million yuan by Q3 2025 [1] - Multiple innovative drug projects, including KC1101 and KC5827, are entering the preclinical development stage, indicating a continuous enhancement of the product pipeline [1] Group 2: Recognition and Market Position - The company has been recognized as a high-tech enterprise, allowing it to continue benefiting from policy incentives [1] - As a leading player in the blood coagulation agent segment of the industry, the company is enriching its product pipeline through ongoing research innovation and product introduction [1] - The successful advancement of various research projects positions the company to potentially realize a diverse range of innovative outcomes in the future [1]

Investment Rating - The investment rating for the company is "Buy" [5][13] Core Insights - The company has received FDA approval for its self-developed cancer drug KC1086, marking a significant milestone in its innovation capabilities [2][3] - KC1086 is a small molecule inhibitor targeting KAT6, showing promising efficacy in preclinical studies, particularly in ER+/HER2- breast cancer models with a tumor inhibition rate exceeding 90% [2] - The company is actively advancing its R&D pipeline, with a focus on unmet clinical needs in various therapeutic areas, including hemostasis, bone metabolism, oncology, and immunology [3] - The company has been recognized as a high-tech enterprise, allowing it to benefit from favorable tax policies for the next three years [4][9] Financial Summary - As of Q3 2025, the company's R&D expenses reached 32.8 million yuan [3] - The projected revenue for 2025 is 919.53 million yuan, with a growth rate of 11.40% [9][12] - The projected net profit attributable to shareholders for 2025 is 139.26 million yuan, reflecting a significant increase of 229.87% compared to the previous year [9][12] - The company’s total market capitalization is approximately 6.36 billion yuan, with a total share capital of 159.01 million shares [6]

Group 1 - The biopharmaceutical sector increased by 0.18% on December 25, with Jindike leading the gains [1] - The Shanghai Composite Index closed at 3959.62, up 0.47%, while the Shenzhen Component Index closed at 13531.41, up 0.33% [1] - Key stocks in the biopharmaceutical sector showed various performance, with Jindike (688670) rising by 4.66% to a closing price of 22.45 [1] Group 2 - The biopharmaceutical sector experienced a net outflow of 307 million yuan from institutional investors, while retail investors saw a net inflow of 359 million yuan [2] - Notable declines included Te Bao Biological (688278), which fell by 3.14% to a closing price of 80.90 [2] - The trading volume and turnover for various stocks in the sector varied significantly, with Wan Ze Co. (000534) achieving a turnover of 488 million yuan [1][2] Group 3 - Jindike (688670) had a net inflow of 25.23 million yuan from institutional investors, while retail investors had a net outflow of 23.95 million yuan [3] - Other stocks like Zhi Xiang Jin Tai (688443) and Shen Zhou Cell (688520) also showed mixed net inflows and outflows from different investor categories [3] - The overall trend indicates a divergence in investor sentiment, with institutional investors pulling back while retail investors increased their positions [2][3]

Group 1 - Guangqi Technology's controlling shareholder proposed a share buyback of 50 million to 100 million yuan for employee stock ownership plans or equity incentives [1] - Xingyuan Zhuomai received a supplier designation from a domestic electric vehicle manufacturer to develop and supply reducer shell components, with expected sales of approximately 575 million yuan over four years from 2027 to 2030 [2] - Weigao Bio's application for clinical trials of subcutaneous human immunoglobulin has been accepted by the National Medical Products Administration, targeting primary immunodeficiency diseases [3] Group 2 - Hongda Electronics disclosed uncertainty regarding the IPO progress of its associate Jiangsu Zhanxin, in which it holds a 13.79% stake [4] - Kangchen Pharmaceutical received FDA approval to conduct clinical trials for its KC1086 project, aimed at treating advanced recurrent or metastatic solid tumors [5] - Kweichow Moutai adjusted its share buyback price ceiling to 1863.67 yuan per share, effective from December 19, 2025 [6] Group 3 - Mousse Co. announced that its controlling shareholder and actual controllers committed not to reduce their holdings within one year [7] - Tongxingbao's subsidiary signed a business contract worth 43.166 million yuan for a cloud expansion project [8] - Kaifa Electric announced plans for three shareholders to collectively reduce their holdings by 0.6999% [9] Group 4 - Longpan Technology plans to increase the production capacity of lithium iron phosphate cathode materials from 62,500 tons per year to 100,000 tons per year [10] - Zhuhai Guanyu announced plans for two shareholders to reduce their holdings by up to 3% [11] - Jiaheng Home Textiles is planning a change in control, leading to a temporary suspension of its stock [12] Group 5 - Kehua Bio's subsidiary received a medical device registration certificate for a gene polymorphism detection kit [13] - Saitex New Materials' actual controller plans to reduce holdings by up to 3% [14] - Sanhui Electric announced a shareholder's plan to reduce holdings by up to 2% [15] Group 6 - Binhua Co. plans to establish a venture capital fund with a total scale of 400 million yuan, focusing on strategic emerging industries [16] - Jindun Co. announced plans for two shareholders to reduce their holdings by up to 4% [17] - Hengdian East Magnetic's controlling shareholder plans to reduce holdings by up to 1% [18][19] Group 7 - Luxin Investment's controlling shareholder plans to reduce holdings by up to 1% [20] - Huakang Clean announced a joint bid for a hospital procurement project worth 157 million yuan [21] - Xuedilong plans to reduce its repurchased shares by up to 488,560 shares [22] Group 8 - Enhua Pharmaceutical's subsidiary signed an exclusive commercial cooperation agreement for three long-acting antipsychotic products [23] - Aier Eye Hospital plans to acquire partial equity in 39 institutions for a total of 963 million yuan [24] - Gaozheng Mining plans to acquire 100% equity of Overseas Explosives for 510 million yuan [25] Group 9 - Donghong Co. plans to repurchase shares worth 30 million to 60 million yuan for employee stock ownership plans [26] - Bear Electric's controlling shareholder plans to reduce holdings by up to 0.64% [27] - *ST Zhengping announced the initiation of pre-restructuring by the Xining Intermediate Court [28][29] Group 10 - Caesar Travel's shareholder plans to reduce holdings by up to 3% [30] - Lianchuang Electronics announced a change in controlling shareholder to Jiangxi State-owned Assets Supervision and Administration Commission [31] - Beixin Road and Bridge plans to transfer 5.33% equity in Henan Yuhang for 243 million yuan [32] Group 11 - Fenglong Co. is planning a change in control, with stock resuming trading [33]

申请事项：新药临床试验申请 证券代码：603590 证券简称：康辰药业 公告编号：临 2025-086 北京康辰药业股份有限公司 关于 KC1086 项目获得 FDA 批准开展临床试验的公告 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。 近日，北京康辰药业股份有限公司（以下简称"公司"） 获得美国食品药 品监督管理局（FDA）签发的《临床研究继续进行通知书》（Study May Proceed）， 公司申报的 KC1086 片临床试验申请正式获得 FDA 许可。 现将有关情况公告如下： 一、药品基本信息 药品名称：KC1086 片 申请人：北京康辰药业股份有限公司 审批结论：FDA 对本次申请完成评估，同意本品按拟定临床研究计划开展。 二、药品其他情况 KC1086 是由北京康辰药业股份有限公司完全自主研发的一款具有全新结构 的强效、高选择性赖氨酸乙酰转移酶 6（Lysine Acetyltransferase 6, KAT6）的小 分子抑制剂，拟用于晚期复发或转移性实体瘤的治疗。 KAT6 属于 MYST 家族组蛋白乙酰化 ...

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].