枸橼酸伏维西利胶囊

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轩竹生物通过港交所聆讯将上市;弘星相和完成近亿元Pre-A轮融资
Mei Ri Jing Ji Xin Wen· 2025-09-19 00:47
| 2025年9月19日星期五丨 港交所官网显示,轩竹生物通过港交所聆讯即将上市,中金公司(601995)为独家保荐人。招股书显 示,轩竹生物是一家以创新为驱动的中国生物制药公司。公司早已建立起一个全面的内部研发平台,支 持开发多样化且均衡的管线。 点评:作为四环医药孵化的创新药企,轩竹生物管线丰富,涵盖消化、肿瘤、NASH领域,还有多款商 业化产品。此次上市有望助力其加速研发进程,在激烈的医药市场竞争中抢占先机。 NO.3弘星相和完成近亿元Pre-A轮融资 弘星相和宣布完成近亿元人民币的Pre-A轮融资。本轮融资由北极光创投领投,东卫基金、DCG Holdings、鼎赋投资、未来启创基金跟投,天使轮股东星药太浩基金持续加码。本轮融资资金将主要用 于丰富并推进现有管线的临床前及临床POC(概念验证)研究,同时全面布局AI(人工智能)平台、生物类 器官平台在药物研发与评价中的应用,着力于靶点和分子成药性评估、分子和试验设计。 NO.1复宏汉霖CDK4/6抑制剂在中国获批新适应证 复宏汉霖宣布,创新型CDK4/6抑制剂枸橼酸伏维西利胶囊新增适应证的药品注册申请获得中国国家药 品监督管理局(NMPA)批准。本次获批 ...
轩竹生物通过港交所聆讯将上市;弘星相和完成近亿元Pre-A轮融资丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-18 23:14
每经记者|甄素静 每经编辑|张海妮 | 2025年9月19日 星期五 丨 港交所官网显示,轩竹生物通过港交所聆讯即将上市,中金公司为独家保荐人。招股书显示,轩竹生物 是一家以创新为驱动的中国生物制药公司。公司早已建立起一个全面的内部研发平台,支持开发多样化 且均衡的管线。 点评:作为四环医药孵化的创新药企,轩竹生物管线丰富,涵盖消化、肿瘤、NASH领域,还有多款商 业化产品。此次上市有望助力其加速研发进程,在激烈的医药市场竞争中抢占先机。 NO.3 弘星相和完成近亿元Pre-A轮融资 弘星相和宣布完成近亿元人民币的Pre-A轮融资。本轮融资由北极光创投领投,东卫基金、DCG Holdings、鼎赋投资、未来启创基金跟投,天使轮股东星药太浩基金持续加码。本轮融资资金将主要用 于丰富并推进现有管线的临床前及临床POC(概念验证)研究,同时全面布局AI(人工智能)平台、生 物类器官平台在药物研发与评价中的应用,着力于靶点和分子成药性评估、分子和试验设计。 点评:此次融资的顺利完成,标志着弘星相和的创新研发模式及早期研发阶段成果获得了国际资本、产 业基金和多地政府的共同青睐,为公司创新管线的丰富与推进提供了强劲动力。 ...
中泰国际每日晨讯-20250916
ZHONGTAI INTERNATIONAL SECURITIES· 2025-09-16 04:53
2025 年 9 月 16 日 星期二 每日大市点评 9 月 15 日,港股大盘高台窄幅波动,恒生指数最终上升 58 点或 0.2%,收报 26,446 点。恒生科指上升 0.9%,收报 6,043 点。大市成交金额减少至 2,902 多亿港元,港股通净流入 144.7 亿,继续支撑大市。盘面上,市场表现分化,下跌板块及 个股占大多数,但 AI 相关及生物医药都相对强势。阿里巴巴(9988 HK)再升 2.3%。宁德时代(3750 HK)升 7.4%,一度创上 市新高,中国神华(1088 HK)、兖矿能源(1171 HK)分别升 2.3%及 5.5%。泡泡玛特(9992 HK)在纳入恒指后持续下跌,昨日 股价再跌 6.4%。中国 8 月各项经济数据反映经济增长动能放缓,消费温和增长、投资显著放缓、地产下行压力不改、居 民及企业缺少信贷意愿,再通胀路途崎岖不平。值得注意的是,8 月中国信贷脉冲指数出现九个月以来首次下降,这一领 先指标的转弱或对港股市场构成压力。另一方面,恒生指数与 MSCI 中国指数的盈利预期持续遭到下调。若后续未有更强 有力的政策支持,港股市场可能面临较大上行阻力甚至出现回调压力。 宏观动态 ...
9月15日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-15 10:34
Group 1 - Yihau New Materials plans to reduce its shareholding by up to 1% of the company's total shares, amounting to 165,500 shares, due to personal funding needs [1] - Fuxing Pharmaceutical's subsidiary has received approval for a new indication for its drug, which is used in the treatment of certain types of breast cancer [1][2] - Shantui Co. has submitted its H-share issuance application to the China Securities Regulatory Commission, which has been accepted [3] Group 2 - Sierte's chairman plans to increase his shareholding by an amount between 3 million to 6 million yuan [4] - Borui Pharmaceutical's BGM0504 tablet has received approval for clinical trials in overweight and obese adults [5] - Ganyue Expressway reported vehicle toll service revenue of 349 million yuan for August [6] Group 3 - Chip Microelectronics has submitted its H-share issuance application to the China Securities Regulatory Commission, which has been accepted [7] - Lingrui Pharmaceutical's director plans to reduce his shareholding by up to 200,000 shares, representing 0.0353% of the total shares [8] - Jiahu Energy has adjusted its share repurchase price limit to 11.63 yuan per share [10] Group 4 - Spring Airlines reported a year-on-year increase of 12.23% in passenger turnover for August [11] - Kaida has received an invention patent for a self-calibrating sensor technology [12] - Chuanheng Co. has obtained a new utility model patent aimed at improving industrial waste utilization [14] Group 5 - Huashi Technology received a government subsidy of 2.21 million yuan, accounting for 22.71% of its latest audited net profit [15] - Shanghai Pharmaceuticals' controlling shareholder plans to increase its H-share holdings by up to 74 million shares [16] - Hongrun Construction has won a bid for a significant segment of the Shanghai Metro Line 21 project, valued at 126 million yuan [18] Group 6 - Sanfangxiang plans to invest 100 million yuan to establish a wholly-owned subsidiary focused on green technology [19] - Lao Fengxiang's subsidiaries plan to jointly invest in luxury goods sales and gold refining companies [20][21] - China Eastern Airlines reported an 8.72% year-on-year increase in passenger turnover for August [22] Group 7 - Inner Mongolia First Machinery has signed a railway freight car procurement contract worth 186 million yuan [22] - Jiuqiang Bio has received five invention patents related to diagnostic reagents [24] - Longmag Technology plans to invest 210 million yuan in its second phase project in Vietnam [25] Group 8 - Galaxy Magnetics plans to acquire 100% equity of Kyoto Longtai, with its stock suspended for trading [26] - Jinlong Co.'s controlling shareholder will have 30 million shares auctioned [27] - Haishi Co.'s controlling shareholder has released the pledge on 29.97 million shares [28] Group 9 - Qiu Tianwei plans to reduce its shareholding by up to 1.17% of the total shares [29] - Xiaocheng Technology's directors plan to reduce their shareholding by a total of 0.08% [30] - Victory Co. reported that Sunshine Life Insurance has reduced its shareholding by 4.4 million shares [31] Group 10 - Xindong Technology plans to distribute a cash dividend of 0.156 yuan per share [32] - Huaqin Technology plans to distribute a cash dividend of 0.13 yuan per share [33] - Kexing Pharmaceutical's controlling shareholder intends to transfer 5% of the company's shares [35] Group 11 - Guojin Securities has completed the repayment of its second short-term financing bond for 1.0205 billion yuan [38] - Chunhui Intelligent Control's application for asset acquisition has been accepted by the Shenzhen Stock Exchange [39] - Chaohongji has submitted its H-share issuance application to the Hong Kong Stock Exchange [40] Group 12 - Tianyue Advanced has fully exercised its over-allotment option, involving 716,180 H-shares [40] - Chengfeng Technology's vice president has resigned due to internal adjustments [41] - Yingpais plans to establish a 100 million yuan technology sports industry investment fund [43]
上海复星医药(02196.HK):枸橼酸伏维西利胶囊新增适应症获注册批准
Ge Long Hui· 2025-09-15 09:57
截至2025年8月,集团现阶段针对该药品的累计研发投入约为人民币6.17亿元(未经审计)。 上海复星医药(02196.HK)公告,近日,上海复星医药(集团)股份有限公司(以下简称"公司")控股子公司 锦州奥鸿药业有限责任公司就枸橼酸伏维西利胶囊(商品名:复妥宁,项目代号:FCN-437c;以下简 称"该药品")新增适应症的药品注册申请获国家药品监督管理局批准。本次获批适应症为用于激素受体 (HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联 合使用作为初始内分泌治疗。 该药品为本集团(即本公司及控股子公司/单位,下同)拥有自主知识产权的创新型小分子CDK4/6抑制 剂,是一种口服、强效、高选择性、全新结构的创新小分子药物,于2018年被列入国家"重大新药创 制"科技重大专项。除本次获批的新适应症外,该药品另一适应症(联合氟维司群用于既往接受内分泌治 疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子2(HER2)阴性的复发或转移性成年乳腺癌患 者)已于2025年5月获批于中国境内(不包括港澳台地区,下同)上市。 根据IQVIAMIDAS最新数据1,2024年 ...
复星医药:枸橼酸伏维西利胶囊新增适应症获批准
Xin Lang Cai Jing· 2025-09-15 09:55
复星医药公告,控股子公司锦州奥鸿药业有限责任公司就枸橼酸伏维西利胶囊新增适应症的药品注册申 请获国家药品监督管理局批准。本次获批适应症为用于激素受体(HR)阳性、人表皮生长因子受体2 (HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗。 ...
复星医药(600196.SH):枸橼酸伏维西利胶囊新增适应症药品注册申请获批
智通财经网· 2025-09-15 08:52
智通财经APP讯,复星医药(600196.SH)发布公告,近日,公司控股子公司锦州奥鸿药业有限责任公司 就枸橼酸伏维西利胶囊(商品名:复妥宁,项目代号:FCN-437c;以下简称"该药品")新增适应症的药品 注册申请获国家药品监督管理局批准。本次获批适应症为用于激素受体(HR)阳性、人表皮生长因子受 体2(HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗。 该药品为集团拥有自主知识产权的创新型小分子CDK4/6抑制剂,是一种口服、强效、高选择性、全新 结构的创新小分子药物,于2018年被列入国家"重大新药创制"科技重大专项。 ...
复星医药(600196.SH):枸橼酸伏维西利胶囊药品获注册批准
Ge Long Hui A P P· 2025-09-15 08:45
该药品为本集团(即本公司及控股子公司/单位,下同)拥有自主知识产权的创新型小分子 CDK4/6 抑 制剂,是一种口服、强效、高选择性、全新结构的创新小分子药物,于2018年被列入国家"重大新药创 制"科技重大专项。 格隆汇9月15日丨复星医药(600196.SH)公布,公司控股子公司锦州奥鸿药业有限责任公司就枸橼酸伏维 西利胶囊(商品名:复妥宁,项目代号:FCN-437c;以下简称"该药品")新增适应症的药品注册申请 获国家药品监督管理局批准。本次获批适应症为用于激素受体(HR)阳性、人表皮生长因子受体2 (HER2)阴性局部晚期或转移性乳腺癌成人患者:与芳香化酶抑制剂联合使用作为初始内分泌治疗。 ...
我省全链条支持医药产业创新发展
Liao Ning Ri Bao· 2025-07-10 01:42
Group 1 - The core viewpoint of the articles highlights the rapid development and regulatory support for the medical device industry in Liaoning Province, which has led to increased investment and innovation from companies like Pengyue Technology [1][2][3] - Pengyue Technology has invested over 100 million yuan in Liaoning and anticipates an annual output value exceeding 2 billion yuan once both production bases are operational [1] - The provincial drug regulatory authority has implemented priority review and approval for innovative medical devices, resulting in an average approval time of only 12 working days, a 90% reduction in processing time [1][2] Group 2 - The province has introduced procedures to streamline the registration and production licensing of medical devices, which has led to a reduction of 262 inspections and saved 3,668 working days [2] - In the field of innovative drug development, three innovative drugs have been included in a support list, with Jinzhou Aohong Pharmaceutical's product being the first national Class 1 new drug approved this year [2] - The province has seen a significant increase in the approval of medical devices, with 10 third-class and 72 second-class medical devices approved this year, marking a year-on-year growth of 7.6% [3]
医药生物行业周报:创新药密集上市,关注后续医保谈判
Donghai Securities· 2025-06-03 09:43
Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][37]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 2.21% in the week from May 26 to May 30, ranking second among 31 industries in the Shenwan index and outperforming the CSI 300 index by 3.29 percentage points. Year-to-date, the sector has risen by 6.61%, ranking sixth among the 31 industries and outperforming the CSI 300 index by 9.02 percentage points [4][13][15]. - The current PE valuation for the pharmaceutical and biotechnology sector is 27.98 times, which is at the historical median level, with a valuation premium of 137% compared to the CSI 300 index. The top three sub-sectors in terms of growth are chemical pharmaceuticals, biological products, and medical services, with increases of 3.83%, 3.14%, and 2.46% respectively [4][22][15]. - A total of 373 stocks (77.9%) in the sector rose last week, while 97 stocks (20.3%) declined. The top five gainers were Shuyou Shen (60.41%), Huason Pharmaceutical (41.97%), Changshan Pharmaceutical (35.91%), Huana Pharmaceutical (32.62%), and Yifang Biological (30.51%) [4][27]. Market Performance - The pharmaceutical and biotechnology sector's performance is highlighted by the approval of 11 innovative drugs by the National Medical Products Administration (NMPA) on May 29, which enhances treatment options for patients and showcases the increasing innovation capability of China's pharmaceutical industry [5][29]. - The 2025 American Society of Clinical Oncology (ASCO) annual meeting showcased several domestic innovative drug projects, indicating that local companies are gaining international recognition for their innovative capabilities [5][32]. Investment Recommendations - The report suggests focusing on the innovative drug sector as it is the most certain and leading sub-sector within the pharmaceutical and biotechnology industry. Additionally, it recommends exploring investment opportunities in medical devices, traditional Chinese medicine, chain pharmacies, and medical services [6][35]. - Recommended stocks include Beida Pharmaceutical, Te Bao Biological, Qianhong Pharmaceutical, Ling Rui Pharmaceutical, and Lao Bai Xing. Stocks to watch include Kelong Pharmaceutical, Rongchang Biological, Kaili Medical, Huaxia Eye Hospital, and Baipu Sais [6][35].