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 ...

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].

Investment Rating - The report maintains a "Recommendation" rating for the company, indicating an expectation that the stock will outperform the market by 10% to 20% over the next six months [14]. Core Views - The innovative value of KC1036 is expected to be reassessed, with the company preparing for a lighter load in 2025 after recognizing goodwill impairment in 2024. The report anticipates that the progress in innovation will support this reassessment [8][9]. - The company has made significant advancements in the clinical trials of KC1036, a first-in-class drug with independent intellectual property rights, targeting multiple indications including advanced esophageal squamous cell carcinoma and thymic cancer [8]. - The report highlights a substantial unmet clinical need in the treatment of advanced esophageal squamous cell carcinoma, suggesting a broad market opportunity given the high incidence of the disease in China [8]. Financial Summary - The company is projected to achieve a net profit of 44 million to 55 million yuan in 2024, a decline of 63% to 73% year-on-year, primarily due to goodwill impairment [8]. - Revenue forecasts for 2024, 2025, and 2026 are 868 million yuan, 990 million yuan, and 1,131 million yuan respectively, with a year-on-year growth of -5.7%, 14.1%, and 14.3% [7][12]. - The net profit for 2025 is expected to rebound to 133 million yuan, reflecting a significant recovery from the anticipated low in 2024 [7][12]. Clinical Development Progress - KC1036 has shown promising progress in clinical trials, with nearly 300 subjects enrolled across various studies. Key milestones include the completion of the first subject enrollment for the phase II trial in adolescents with advanced juvenile sarcoma [4][8]. - The report notes that the company is also advancing other projects, including KC1086 and KC3001, with potential IND submissions expected in 2025 [8].

Core Points - Beijing Kangchen Pharmaceutical Co., Ltd. has completed the industrial and commercial change registration and obtained a new business license [1][2] - The company held a board meeting on October 29, 2024, to discuss amendments to certain provisions of its articles of association [1] - The updated business registration information includes a registered capital of 1,593.56477 million yuan and a legal representative named Liu Jianhua [1] Company Information - The company is classified as a joint-stock company (listed, natural person investment or control) [1] - The registered address is located at No. 11, Xingsheng South Road, Economic Development Zone, Miyun District, Beijing [1] - The business scope includes the production of lyophilized powder injections, biochemical raw materials, tablets (including anti-tumor drugs), biopharmaceutical development and research, technology promotion services, and technology transfer and consulting services (excluding intermediary services) [1][2]

证券代码：603590 证券简称：康辰药业 公告编号：临 2025-010 北京康辰药业股份有限公司 关于完成工商变更登记并换发营业执照的公告 近日，公司完成了工商变更登记手续并取得了由北京市密云区市场监督管理 局换发的《营业执照》，变更后的工商登记信息如下： 名称：北京康辰药业股份有限公司 统一社会信用代码：91110228754175237Y 类型：股份有限公司（上市、自然人投资或控股） 住所：北京市密云区经济开发区兴盛南路 11 号 法定代表人：刘建华 注册资本：15935.6477 万元 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 2024 年 10 月 29 日召开 2024 年第二次临时股东大会，审议通过了《关于变更公司注册资本暨修订<公司 章程>部分条款的议案》，具体内容详见公司分别于 2024 年 9 月 30 日、10 月 30 日在指定信息披露媒体披露的相关公告（公告编号：临 2024-057、临 2024-060）。 成立日期：2003 年 09 月 0 ...

特此公告。 北京康辰药业股份有限公司董事会 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 2024 年 10 月 29 日召 开的第四届董事会第十三次会议、第四届监事会第十一次会议审议通过《关于使 用闲置募集资金进行现金管理的议案》，同意公司使用额度不超过人民币 3 亿元 的闲置募集资金适时进行现金管理，该额度自公司董事会审议通过之日起 12 个 月内有效，并在有效期内可循环滚动使用。具体内容详见公司于 2024 年 10 月 30 日在上海证券交易所网站及指定信息披露媒体披露的《康辰药业关于使用闲 置募集资金进行现金管理的公告》（公告编号：临 2024-065）。 截至本公告披露日，公司使用部分闲置募集资金购买的保本型产品已赎回， 募集资金本金及理财收益已归还至募集资金账户，具体情况如下： 证券代码：603590 证券简称：康辰药业 公告编号：临 2025-009 北京康辰药业股份有限公司 关于使用部分闲置募集资金进行现金管理赎回的公告 2025 年 3 月 15 日 单位： ...

北京康辰药业股份有限公司 关于股东股份解除冻结的公告 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。 重要内容提示： 证券代码：603590 证券简称：康辰药业 公告编号：临 2025-008 截至本公告披露日，刘建华先生所持公司原冻结 9,463,485 股股份已解除 冻结。刘建华先生及其一致行动人所持公司股份无被冻结情况。 北京康辰药业股份有限公司（简称"公司"）近日通过中国证券登记结算有 限责任公司系统查询，获悉公司控股股东刘建华先生所持公司原冻结 9,463,485 股股份已解除司法冻结，截至本公告日，刘建华先生及其一致行动人所持公司股 份无被冻结情况，现将有关事项公告如下： 特此公告。 北京康辰药业股份有限公司董事会 2025年3月14日 股东名称 刘建华 本次解除冻结股份 9,463,485股 占其所持股份比例 18.63% 占公司总股本比例 5.94% 解除冻结时间 2025年3月11日 持股数量 50,786,760股 持股比例 31.87% 剩余被冻结股份数量 0 剩余被冻结股份数量占其所持股份比例 0 剩余 ...