A股创新药板块上扬，润都股份、江苏吴中涨停，健友股份涨超6%，康辰药业、贝达药业等跟涨。 ...

这几只票暗盘资金正在偷偷流入，立即查看>> 创新药板块反复活跃，润都股份（002923）、江苏吴中（600200）涨停，健友股份（603707）涨超 6%，康辰药业（603590）、贝达药业（300558）上扬。 ...

证券代码：603590 证券简称：康辰药业 公告编号：临 2025-011 北京康辰药业股份有限公司 关于 KC1086 项目获得临床试验受理通知书的公告 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"）收到国家药品监督 管理局（以下简称"国家药监局"）核准签发的化学药品 1 类创新药 KC1086 片 的临床试验受理通知书，现将有关情况公告如下： 一、药品基本信息 药品名称：KC1086 片 规格： 1 mg、4 mg KC1086 展现出优异的体内外药效：在 ER+/HER2-的乳腺癌药效模型中，同 等剂量水平下 KC1086 对肿瘤生长具有更强的抑制作用，在其他实体瘤药效模型 中显示出类似的效果。KC1086 的 ADME 特性和安全性评价结果显示可有效解 决此类化合物的蓄积问题，且无明显的种属差异。 受理号：CXHL2500403、CXHL2500404 注册分类：化学药品 1 类 申请事项：境内生产药品注册临床试验 申请人：北京康辰药业股份有限公司 适应症：拟用于晚期 ...

康辰药业（603590）公告，近日收到国家药监局核准签发的化学药品1类创新药KC1086片的临床试验受 理通知书。KC1086片拟用于晚期复发或转移性实体瘤，规格为1mg、4mg。KC1086是由公司完全自主 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 Acetyltransferase6,KAT6)的小分 子抑制剂。此次申请为KC1086首次药物临床试验申请，药品注册分类为化学药品1类创新药。 ...

康辰药业 20250414 摘要 Q&A 康臣药业的治理结构和管理层变动对公司未来发展有何影响？ 康臣药业在 2023 年迎来了新的总裁牛占奇，他曾担任药恩必普的研发负责人， 并在远大健康控股公司担任执行董事。在他的领导下，公司进行了多项重要调 整。首先是商誉减值，2024 年底康臣药业对并购时形成的九千多万商誉进行了 减值，导致当年利润减少七千多万。其次，公司从 2024 年第二季度开始将销售 渠道从经销改为直销。此外，公司还进行了人员盘点和优化。这些措施预计将 提升公司的研发和销售效率，使得人均效能提高。尽管 2024 年是调整期，但预 计 2025 年及以后公司将实现显著反弹。 • 康臣药业 2024 年因商誉减值和渠道转型导致利润下降，但预计 2025 年起 将显著反弹。直销模式和人员优化有望提升研发和销售效率，提高人均效 能。 • 核心产品苏灵作为国内首款止血创新药，医保支付优势明显，预计未来销 量保持 20%以上增长。密盖息鼻喷剂虽受集采影响，但基数较低，预计 2025 年及以后收入将显著反弹。 • 创新药 ZY5,301 治疗盆腔炎后盆腔痛的三期临床试验已达阳性终点，预计 2025 年中投产，2 ...

| 财务指标 | 2022A | 2023A | 2024E | 2025E | 2026E | | --- | --- | --- | --- | --- | --- | | 营业收入（百万元） | 867 | 920 | 906 | 974 | 1,049 | | 增长率 yoy（%） | 7.0 | 6.1 | -1.5 | 7.5 | 7.7 | | 归母净利润（百万元） | 101 | 150 | 48 | 138 | 161 | | 增长率 yoy（%） | -31.4 | 48.2 | -68.3 | 189.4 | 16.9 | | EPS 最新摊薄（元/股） | 0.64 | 0.94 | 0.30 | 0.87 | 1.01 | | 净资产收益率（%） | 3.5 | 4.9 | 1.5 | 4.3 | 4.8 | | P/E（倍） | 40.2 | 27.1 | 85.6 | 29.6 | 25.3 | | P/B（倍） | 1.4 | 1.3 | 1.3 | 1.3 | 1.2 | 风险提示：新药研发不及预期风险、销售不及预期风险、产品集采降价风 险。 证券研究报告 | 首次覆盖报告 ...

证券研究报告 | 首次覆盖报告 gszqdatemark 2025 04 13 年 月 日 康辰药业（603590.SH） "苏灵""密盖息"打造双增长极，创新药产品未来可期 医保解限与手术量恢复，苏灵销量有望触底反弹。苏灵是目前国内血凝酶 制剂市场唯一国家一类创新药。2020 年-2021 年受外部环境影响手术量减 少与国谈新价影响，销量有一定下滑。随着外部环境影响衰退，院内手术 量有序恢复，同时，2023 年，苏灵凭借国家一类新药的优势和创新药政策 的红利，顺利通过医保谈判续约，并解除原医保支付范围中"限出血性疾 病治疗的二线用药，预防使用不予支付"限制，临床价值进一步显现。目 前苏灵逐渐放量，未来可期。 密盖息增长稳健，打造公司第二增长曲线。2021-2023 年密盖息业绩稳定 增长，中国泰凌医药集团有限公司和 NTPharmaPacificCompanyLtd(HK)完 成密盖息业绩承诺。随着中国老龄化的加剧，银发经济逐渐兴起，密盖息 作为治疗原发性骨质疏松及急性骨丢失性骨痛的一线治疗药物，也是预防 急性骨丢失的唯一用药，市场还有部分提升空间。 创新药管线多方向布局，打造长期发展竞争力。通过"苏灵"的 ...

Core Insights - The report highlights the significant clinical progress of KC1036, an innovative drug developed by the company, which has successfully completed the first patient enrollment in a Phase II clinical trial for treating advanced Ewing sarcoma in adolescents aged 12 and above [3][6][7] - The potential market for KC1036 is substantial, with ongoing clinical studies for multiple indications, including esophageal cancer, where the first patient was enrolled in February 2024. The estimated number of esophageal cancer patients in China was 742,000 in 2022, indicating a large potential market [7] - The company is undergoing a marketing transformation in 2024, aiming to enhance its sales capabilities through a digital marketing team, which is expected to strengthen sales for existing products and lay the groundwork for future sales of KC1036 [7] Market Performance - The Shanghai Composite Index closed at 3145.55, up by 1.58%, while the Shenzhen Component Index rose by 0.64% to 9424.68. The CSI 300 Index increased by 1.71% to 3650.76, and the ChiNext Index saw a rise of 1.83% to 1840.31 [4] - In the industry performance, the Agriculture, Forestry, Animal Husbandry, and Fishery sector led with a 7.81% increase, followed by Retail with 3.44% and Food & Beverage with 3.37%. Conversely, the Electronics sector declined by 1.69% [5]

Investment Rating - The report maintains a "Buy" rating for the company, with a market price of RMB 27.21 and a sector rating of "Outperform" [1]. Core Views - The company has successfully completed the first patient enrollment in the Phase II clinical trial of its self-developed innovative drug KC1036 for treating advanced Ewing sarcoma in adolescents aged 12 and above, indicating positive long-term development prospects [3][7]. - The potential market for KC1036 is significant, with multiple indications entering clinical trials, including esophageal cancer, which has a large patient population in China [7]. - The company is undergoing a marketing transformation aimed at enhancing sales capabilities, which is expected to strengthen the sales of existing products and support the future sales of KC1036 [7]. - The earnings forecast has been adjusted due to goodwill impairment from the acquisition of Tailin Pharmaceutical and the impact of marketing reforms, with EPS projections for 2024-2026 set at RMB 0.32, 1.12, and 1.34 respectively [7]. Financial Summary - The company's main revenue is projected to grow from RMB 867 million in 2022 to RMB 1,209 million by 2026, with a CAGR of 12.9% [6]. - EBITDA is expected to increase significantly from RMB 154 million in 2022 to RMB 316 million in 2026 [6]. - The net profit attributable to the parent company is forecasted to rise from RMB 101 million in 2022 to RMB 213 million in 2026, reflecting a substantial growth rate of 19.5% in 2026 [6]. - The company’s PE ratio is projected to decrease from 85.6 in 2024 to 20.4 in 2026, indicating improved valuation over time [6].

Investment Rating - The report assigns a "Buy" rating for the company, marking its first coverage [9][10]. Core Insights - The company, Kangchen Pharmaceutical, has established itself as a leader in the hemostatic enzyme market with its core product, Suling, which is the first high-purity hemostatic enzyme drug in China. The company is actively expanding its innovative drug pipeline, focusing on oncology and hematological diseases, with promising candidates such as KC1036 for esophageal squamous cell carcinoma and KC1086 for gynecological tumors [3][6][17]. - The traditional business is showing signs of stabilization, with Suling having lifted medical insurance restrictions in 2022, and the company is expected to enter a new growth phase [3][8]. Summary by Sections Company Overview - Kangchen Pharmaceutical, founded in 2003, focuses on the research, production, and sales of innovative drugs. It has a leading position in the hemostatic field with its product Suling and has expanded into oncology and bone metabolism through strategic acquisitions and R&D [6][17]. Innovative Drug Pipeline - The company has developed a differentiated and forward-looking innovative drug pipeline, particularly in oncology, with KC1036 targeting late-stage esophageal squamous cell carcinoma and KC1086 for gynecological tumors. The clinical data for KC1036 shows promising efficacy, with an overall response rate (ORR) of 29.2% and a disease control rate (DCR) of 83.3% [7][28][42]. Financial Projections - Revenue projections for the company are estimated at 831 million yuan, 904 million yuan, and 1.149 billion yuan for the years 2024 to 2026, respectively. The net profit attributable to shareholders is expected to be 42 million yuan, 147 million yuan, and 184 million yuan for the same period, with corresponding earnings per share (EPS) of 0.26 yuan, 0.92 yuan, and 1.15 yuan [9]. Market Potential - The market for esophageal cancer treatment is significant, with a high incidence rate in China. KC1036 is positioned to fill a gap in the treatment landscape, as there are currently no approved small molecule targeted therapies for this indication [28][30][42]. Stability of Core Products - The core products, Suling and Micagis, are expected to provide stable cash flow for the company. Suling's market performance is anticipated to improve following the lifting of insurance restrictions, while Micagis has completed goodwill impairment, further solidifying its financial stability [8][9]. R&D Investment - The company has shown a steady increase in R&D investment, reaching 176.47 million yuan in 2023, which accounts for 19.8% of its revenue, indicating a commitment to sustainable innovation [24][25].