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康方生物“双面承压”:抗癌药陷合规风波,临床数据再引争议
Xin Lang Zheng Quan· 2025-06-11 01:14
抗癌药物卡度尼利单抗竟被患者从医药代表手中大量购得?康方生物近期陷入一波未平、一波又起的双 重风波。 抗癌"研究用药"流入患者,销售合规敲警钟 近日,一则患者以79320元购买70支卡度尼利单抗的消息引发震动。据媒体报道,其中大部分药品标 注"仅供临床研究使用"。康方生物迅速回应:问题源于公司重庆销售人员伪造研究立项文件及医院伦理 批件,以"研究者发起临床研究"名义骗取公司药物,并无偿提供给患者使用。公司强调从未收取费用, 但坦承管理存在漏洞,将全面排查流程并配合监管部门。 值得玩味的是,涉事销售人员称多次赠药是因"患者支付能力有限且疗效好"。这一看似"善意"的行为, 却暴露出企业在流通环节的严重风控缺失。 临床价值是硬通货:OS争议凸显单一指标局限,真实世界需求与监管标准的博弈将持续考验药企沟通 智慧。 两起事件叠加,使康方生物面临严峻挑战: 销售合规体系亟待加固:伪造文件骗取研究用药暴露内部管控缺陷,后续调查与整改直接影响企业声誉 与监管信任。 临床数据需说服监管与市场:尽管有强生埃万妥单抗(OS趋势相似但仍获批)的先例,但Summit坦承 FDA将"OS显著获益"视为上市必要条件,为后续申报增添不确定性 ...
康方生物(09926.HK):HARMONI数据公布 国内外研究HR保持一致
Ge Long Hui· 2025-06-05 06:22
Company Update - The company announced the results of the global multicenter Phase III clinical trial HARMONi for AK112 in 2L EGFRm NSCLC, achieving a PFS HR of 0.52 and an OS HR of 0.79, indicating a successful primary endpoint for PFS and a significant trend in OS benefit [1] - The results from the international HARMONi trial are consistent with the domestic HARMONi-A trial, which reported a PFS HR of 0.46 and an OS HR of 0.80 (52% data maturity) [1] - The HARMONi clinical program enrolled 420 patients, with 38% from Europe and the US, supporting the extrapolation of domestic clinical data to global data [1] Market Context - Currently, no FDA-approved drugs have achieved statistically significant OS in 2L EGFRm NSCLC, with the OS p-value for HARMONi being 0.057 [2] - The lack of statistically significant OS data in the market indicates a substantial unmet clinical need for 2L+ EGFRm NSCLC treatments [2] - AK112 shows promise based on positive PFS and OS data, potentially addressing the needs of 2L+ EGFRm NSCLC patients [2] Financial Forecast and Valuation - The company maintains its profit forecasts for 2025 and 2026 unchanged [2] - The target price is set at HKD 120.0, indicating a 60% upside potential from the current stock price [2]
中国创新医疗器械出海势头难挡,高质量临床数据登上国际舞台
Di Yi Cai Jing· 2025-06-04 08:30
从全球范围看,医疗器械产业已逐渐成为发展速度快、贸易活跃、产品附加值高的新兴产业之一,医疗器械市场规模逐年增长,也为中国医疗器械企业提供 了广阔的出海空间。在此基础上,近年来,中国创新医疗器械成果大量涌现,正处于出海造福全球患者的关键阶段。越来越多具有全球化视野、技术先进、 合规运营、产品质量上乘的中国企业正在国际化进程中脱颖而出,逐渐展现国际影响力,包括联影、迈瑞在内的医疗器械设备巨头都开始加速出海。 越来越多具有全球化视野、技术先进、合规运营、产品质量上乘的中国企业正在国际化进程中脱颖而出,逐渐展现国际影响力,包括联影、迈瑞在内的医疗 器械设备巨头都开始加速出海。 今日A股开盘后,医疗设备巨头公司股价承压。联影医疗(688271.SH)股价一度下跌近6%,迈瑞医疗(300760.SZ)股价下跌近2%,鱼跃医疗 (002223.SZ)股价下跌近3%。 前一日消息称,欧盟拟根据《国际采购工具》对中资企业采取限制性措施,中国企业未来5年可能将被限制参与价值超过500万欧元的欧盟医疗器械公共招标 项目。 对此,外交部发言人林剑在例行记者会上回应称:"中方始终坚持高水平对外开放,坚持维护市场经济原则和贸易规则,主张 ...
Mersana Therapeutics(MRSN) - 2025 Q1 - Earnings Call Transcript
2025-05-15 13:00
Mersana Therapeutics (MRSN) Q1 2025 Earnings Call May 15, 2025 08:00 AM ET Speaker0 Good morning, and welcome to the Mersana Therapeutics First Quarter twenty twenty five Conference Call. Currently, all participants are in a listen only mode. There will be a question and answer session at the end of this call. I would now like to turn the call over to Mr. Jason Fredett, Senior Vice President, Investor Relations and Corporate Communications. Please proceed, sir. Speaker1 Thank you, operator, and good morning ...