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康辰药业:KC1036纳入药审中心“星光计划”试点项目
Xin Lang Cai Jing· 2025-09-05 07:53
康辰药业9月5日公告,近日,公司1类创新药KC1036被国家药监局药品审评中心纳入"儿童抗肿瘤药物 研发鼓励试点计划(星光计划)"。后续公司将向药审中心积极汇报实施框架中所要求的相关工作进展 或结果,共同推进KC1036在儿童尤文肉瘤疾病领域的临床研发和上市。康辰药业同日公告,公司控股 股东刘建华拟通过集中竞价、大宗交易方式,减持公司股份合计不超过478.07万股,即不超过公司股份 总数的3%。 ...
康辰药业(603590.SH):KC1036纳入药审中心“星光计划”试点项目
智通财经网· 2025-09-05 07:44
KC1036是公司自主研发的化学药品1类创新药,公司拥有该产品的全球知识产权。KC1036通过抑制 VEGFR2、AXL等多靶点实现抗肿瘤活性。目前KC1036已开展多项I~Ⅲ期临床研究,已有超过300例 成人肿瘤患者接受KC1036治疗,并在消化道系统肿瘤、胸腺肿瘤等多个适应症表现出突出的抗肿瘤活 性、以及良好的安全性和耐受性。 本次公司KC1036作为首批首个入选"星光计划"的创新药品种,代表药审中心对KC1036创新性和在青少 年尤文肉瘤患者获益性上的认可,更推动公司关注中国儿童肿瘤患者的临床需求。后续公司将向药审中 心积极汇报实施框架中所要求的相关工作进展或结果,共同推进KC1036在儿童尤文肉瘤疾病领域的临 床研发和上市。 智通财经APP讯,康辰药业(603590.SH)发布公告,近日,公司1类创新药KC1036被国家药品监督管理局 药品审评中心(简称"药审中心")纳入"儿童抗肿瘤药物研发鼓励试点计划(星光计划)"。 ...
康辰药业(603590):业绩稳健恢复,创新产品有序推进
GOLDEN SUN SECURITIES· 2025-09-05 07:36
证券研究报告 | 半年报点评 gszqdatemark 2025 09 05 年 月 日 康辰药业(603590.SH) 业绩稳健恢复,创新产品有序推进 公司发布 2025 年半年报。2025 年上半年,公司实现营业收入 4.61 亿元, 同比+13.8%;归母净利润 0.9 亿元,同比+15%;扣非归母净利润 0.96 亿元,同比+29.2%。2025Q2,公司实现营业收入 2.49 亿元,同比+20.9%; 归母净利润 0.47 亿元,同比+24%;扣非归母净利润 0.52 亿元,同比 +50.3%。 营销改革成效显现,苏灵增幅明显。营销方面,公司转型区域达到 19 个 省,得益于高效的数字化推广模式,上半年自营区域继续保持高速增长, 从而使上半年公司销售费用率降至 44.35%,同比下降 3.49pct。从产品来 看,苏灵上半年销售收入 3.26 亿元,同比增长 18.77%;密盖息上半年销 售收入 1.34 亿元,同比增长 3.37%。 创新药产品持续推进,多点开花未来可期。通过自研与外引双轮驱动,加 快形成梯队式产品管线新格局:1)KC1086 为公司首个从靶点选择、分子 设计、化合物合成、先导化合 ...
康辰药业(603590):业绩持续改善 自主创新能力得到验证
Xin Lang Cai Jing· 2025-09-03 00:39
盈利预测和估值。根据公司经营情况,我们对盈利预测进行调整,预计2025 年至2027 年公司营业收入 分别为9.11 亿元、10.63 亿元和12.14 亿元,同比增速分别为10.4%、16.7%和14.2%;归母净利润分别为 1.69 亿元、2.03 亿元和2.42 亿元,同比增速分别为299.8%、20.2%和19.2%,以9 月1 日收盘价计算,对 应PE 分别为58.3 倍、48.6 倍和40.7 倍,维持"买入"评级。 风险提示:"苏灵"和"密盖息"放量速度低于预期;创新药研发失败。 创新药研发迎来新突破,自主创新能力得到验证。2025 年上半年,公司的KC1086(KAT6 抑制剂)在 获批临床后,迅速进入临床I 期研究。对于HR+/HER2-的晚期乳腺癌患者,在使用CDK4/6 抑制剂后会 出现进展和耐药,目前对于CDK4/6 抑制剂联合内分泌治疗进展的患者缺乏标准的后续治疗方案,我们 认为KAT6 抑制剂未来有望成为CDK4/6 抑制剂治疗失败患者的潜在重要疗法,KC1086 作为Fast-Follow 型创新药具有广阔的市场前景。KC1036 针对成人消化系统肿瘤、胸腺肿瘤和儿童尤文肉瘤等多 ...
康辰药业(603590):KC1086完成首例患者入组 自营转型效果持续体现
Xin Lang Cai Jing· 2025-08-30 00:53
平安观点: 事项: 加大对优锐开曼投资,拓展公司创新药及原研药国际合作。近期公司公告拟以1.5亿元参与优锐开曼E轮 融资,其中租金出资5000万,现金出资1亿元,投资完成后公司对优锐开曼持股比例提升至7.98%。优 锐开曼重点管线恩司芬群(PDE3/4双靶点抑制剂)已于2024年获FDA批准用于COPD治疗;2025年5月 中国大陆COPD三期临床达到主要终点,计划下半年递交NDA。本次投资完成后,公司将借助优锐开曼 的业务平台和业务资源,拓展公司创新药及原研药国家合作的商业化运营。 公司公布2025年半年报,实现收入4.61亿元,同比增长13.79%;实现归母净利润0.91亿元,同比增长 14.95%;实现扣非后归母净利润0.96亿元,同比增长29.21%。公司业绩符合预期。 KC1086完成首例患者入组,公司研发体系走向成熟。25H1公司持续推进研发,核心产品KC1036 (AXL、VEGFR2多靶点抑制剂)累计有超过300例患者入组,2期阶段性临床结果显示,单药治疗 ESCC的ORR达到26.1%。新产品KC1086(KAT6靶点)于近期完成首例患者入组,在多种小鼠移植瘤 CDX/PDX模型种展现出优异 ...
康辰药业(603590):KC1086完成首例患者入组,自营转型效果持续体现
Ping An Securities· 2025-08-29 07:47
Investment Rating - The report maintains a "Recommended" investment rating for the company [1][9]. Core Insights - The company achieved a revenue of 461 million yuan in the first half of 2025, representing a year-on-year growth of 13.79%, and a net profit attributable to shareholders of 91 million yuan, up 14.95% year-on-year [4]. - The core product KC1036 has shown promising results in clinical trials, with an overall response rate (ORR) of 26.1% for single-agent treatment of esophageal squamous cell carcinoma (ESCC) [8]. - The company is actively investing in Uruy Cayman, with a planned investment of 150 million yuan to enhance its international collaboration in innovative and original drugs [8]. Financial Performance Summary - The company forecasts net profits of 133 million yuan, 177 million yuan, and 214 million yuan for 2025, 2026, and 2027 respectively, indicating a recovery in its core business and ongoing innovation pipeline [9]. - The gross margin is projected to remain stable around 89.7% for the coming years, with net profit margins improving from 5.1% in 2024 to 16.8% by 2027 [12]. - The company's total assets are expected to decrease slightly from 3,920 million yuan in 2024 to 3,723 million yuan in 2027, while maintaining a low debt ratio of around 9.7% by 2027 [11][12].
康辰药业: 天风证券股份有限公司关于北京康辰药业股份有限公司使用自有资金支付募投项目所需资金并以募集资金等额置换的核查意见
Zheng Quan Zhi Xing· 2025-08-27 11:12
天风证券股份有限公司 《上海证券交易所股票上市规则》 《上海证券交易 所上市公司自律监管指引第 1 号——规范运作》等有关法律法规和规范性文件的 要求,对康辰药业使用自有资金支付募投项目所需资金并以募集资金等额置换相 关事项进行了核查,具体情况如下: 一、募集资金基本情况 经中国证券监督管理委员会《关于核准北京康辰药业股份有限公司首次公开 发行股票的批复》(证监许可[2018]1084 号)的核准,公司向社会公众首次公开 发行人民币普通股股票(A 股)4,000 万股,发行价格为每股人民币 24.34 元,募 集资金总额为人民币 97,360.00 万元,扣除各项发行费用后的实际募集资金净额 为人民币 89,142.5937 万元。上述募集资金已于 2018 年 8 月 20 日全部到账,广 东正中珠江会计师事务所(特殊普通合伙)对公司本次公开发行新股的资金到位 情 况 进 行 了 审 验 , 并 于 2018 年 8 月 20 日 出 具 了 验 资 报 告 ( 广 会 验 字 [2018]G16002320621 号)。募集资金到账后,公司对募集资金采取了专户存储制 度,开立了募集资金专项账户,募集资金全 ...
康辰药业: 康辰药业2025年半年度报告
Zheng Quan Zhi Xing· 2025-08-27 11:07
非流动性资产处置损益,包括已计提资产减值 准备的冲销部分 计入当期损益的政府补助,但与公司正常经营 业务密切相关、符合国家政策规定、按照确定 的标准享有、对公司损益产生持续影响的政府 补助除外 除同公司正常经营业务相关的有效套期保值业 务外,非金融企业持有金融资产和金融负债产 生的公允价值变动损益以及处置金融资产和金 融负债产生的损益 北京康辰药业股份有限公司2025 年半年度报告 计入当期损益的对非金融企业收取的资金占用 费 委托他人投资或管理资产的损益 2,538,452.19 对外委托贷款取得的损益 因不可抗力因素,如遭受自然灾害而产生的各 项资产损失 单独进行减值测试的应收款项减值准备转回 企业取得子公司、联营企业及合营企业的投资 成本小于取得投资时应享有被投资单位可辨认 净资产公允价值产生的收益 同一控制下企业合并产生的子公司期初至合并 日的当期净损益 非货币性资产交换损益 债务重组损益 企业因相关经营活动不再持续而发生的一次性 费用,如安置职工的支出等 因税收、会计等法律、法规的调整对当期损益 产生的一次性影响 因取消、修改股权激励计划一次性确认的股份 支付费用 对于现金结算的股份支付,在可行权日 ...
中银晨会聚焦-20250409
Bank of China Securities· 2025-04-09 01:02
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]
宏信证券晨会:每日信息速递-20250319
Hongxin Security· 2025-02-17 03:28
Investment Rating - The report assigns a "Buy" rating, indicating an expectation that the stock will outperform the CSI 300 Index by more than 20% over the next six months [48]. Core Insights - The report highlights that the Chinese economy is showing signs of recovery, with significant increases in both loans and deposits in January 2024, with RMB loans increasing by 5.13 trillion and deposits by 4.32 trillion [3][4]. - The mechanical industry in China is projected to grow steadily, with a 6% increase in value added for large-scale mechanical industries in 2024, supported by favorable policies and demand recovery [24][25]. - The smartphone market is experiencing robust growth, with a 22.1% year-on-year increase in domestic smartphone shipments in December 2024, driven largely by 5G devices [27]. Summary by Sections Financial Sector - In January 2024, household loans increased by 443.8 billion, while corporate loans rose by 4.78 trillion, indicating a strong demand for credit [4][5]. - By the end of January 2024, the total RMB loan balance reached 260.77 trillion, reflecting a year-on-year growth of 7.5% [6]. Mechanical Industry - The mechanical industry is expected to maintain a stable growth trajectory, with 72 out of 122 monitored products showing production increases [25]. - The report notes a significant rise in the production of electric machinery and generator sets, with a 16% increase in generator set production [25][27]. Technology and Telecommunications - The domestic smartphone market saw shipments of 34.528 million units in December 2024, with 5G phones accounting for 88.1% of total shipments [27]. - The report emphasizes the importance of digital transformation in the mechanical industry, with over 80% of large enterprises adopting digital design tools [27]. Logistics and Trade - The report discusses the launch of a pilot program for logistics data sharing across 16 cities, aimed at reducing logistics costs and improving efficiency [19][20]. - The initiative is expected to enhance data interoperability among various transport modes and improve supply chain transparency [21][22]. Consumer Market - Shanghai's government plans to implement six major actions to boost consumption in 2025, including initiatives for upgrading consumer goods and enhancing service quality [31][32]. - The focus will be on promoting new consumption models, such as live commerce and digital trade, to stimulate economic activity [33][34].