默沙东欣瑞来在华获批；亿帆医药子公司与尚德药缘达成合作

21世纪经济报道01-06

政策动向　　《医疗服务真实世界医保综合价值评价管理指南（试行）》公开征求意见　　1月5日，国家医保局发布消息显示，为加快建立全国统一的医疗服务真实世界医保综合价值评价体系，根据《关于开展真实世界医保综合价值评价试点工作的通知》（医保办发〔2025〕15号）有关要求，研究起草了《医疗服务真实世界医保综合价值评价管理指南（试行）》，向社会公开征求意见。　　药械审批　　康希诺：24价肺炎球菌多糖结合疫苗...

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Yifan Pharmaceutical subsidiary reaches cooperation with Suntech Yaoyuan","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MRK":1.91,"002019":1.88},"content_text":"政策动向　　《医疗服务真实世界医保综合价值评价管理指南（试行）》公开征求意见　　1月5日，国家医保局发布消息显示，为加快建立全国统一的医疗服务真实世界医保综合价值评价体系，根据《关于开展真实世界医保综合价值评价试点工作的通知》（医保办发〔2025〕15号）有关要求，研究起草了《医疗服务真实世界医保综合价值评价管理指南（试行）》，向社会公开征求意见。　　药械审批　　康希诺：24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）获得药物临床试验批准通知书　　1月5日，康希诺(688185.SH)公告称，康希诺生物股份公司近日收到国家药品监督管理局核准签发的关于24价肺炎球菌多糖结合疫苗（CRM197/破伤风类毒素）的《药物临床试验批准通知书》。该疫苗覆盖当前肺炎球菌主要流行血清型，采用多糖抗原与蛋白载体共价结合的方式，以及双载体技术，拟适用于2月龄（最小6周）及以上人群接种，以预防由24种肺炎球菌血清型引起的感染性疾病。目前国内外均无上市产品。　　默沙东创新药物欣瑞来®（注射用索特西普）在华获批　　默沙东1月5日宣布，全球首个且目前唯一突破性疗法激活素信号传导抑制剂（ASI）欣瑞来®（注射用索特西普）已获得中国国家药品监督管理局（NMPA）批准，适用于治疗WHO功能分级（FC）II-III级的肺动脉高压（PAH，WHO第1组）成年患者，以改善患者的运动能力和WHO功能分级。ASI是针对PAH病因治疗的新型生物制剂，此次获批是基于III期临床试验STELLAR的研究数据。　　ST人福：拟用于晚期实体瘤治疗的HW221043片临床试验获批准　　1月5日，ST人福(600079.SH)公告称，全资子公司湖北生物医药产业技术研究院有限公司近日收到国家药品监督管理局核准签发的HW221043片的《药物临床试验批准通知书》，同意本品单药在晚期实体瘤患者中开展临床试验。HW221043片拟用于晚期实体瘤的治疗，目前国内外暂无同类药物获批上市。　　恒瑞医药：子公司收到药物临床试验批准通知书　　1月5日，恒瑞医药公告，恒瑞医药收到国家药品监督管理局核准签发的关于HRS-4357注射液、HRS-5041片的《药物临床试验批准通知书》，同意开展临床试验。具体为：HRS-4357联合HRS-5041用于PSMA阳性前列腺癌治疗的安全性、耐受性及初步疗效的开放、多中心、Ib/II期临床研究。HRS-4357注射液为公司自主研发的化学药品1类放射性治疗类创新药，新增联合HRS-5041用于治疗前列腺特异性膜抗原（PSMA）阳性的前列腺癌成人患者。HRS-5041是公司开发的新型、高效、选择性的ARPROTAC小分子，拟用于治疗前列腺癌，对野生型及绝大多数突变体的AR蛋白有显著降解作用，具有克服耐药的潜力。　　资本市场　　神州细胞：向特定对象发行股票注册申请获中国证监会同意批复　　神州细胞(688520)1月5日公告，公司于近日收到中国证券监督管理委员会出具的《关于同意北京神州细胞生物技术集团股份公司向特定对象发行股票注册的批复》，同意公司向特定对象发行股票的注册申请。　　行业大事　　天臣医疗：与浪潮数科签订战略合作协议　　1月5日，天臣医疗(688013.SH)公告称，公司与浪潮数字科技（上海）有限公司签订战略合作协议，双方将共同推动医疗智能化、信息化技术在医疗器械设备与耗材的智能化制造、医疗机器人研发生产等领域的创新应用与产业化落地。该协议为框架性协议，不涉及具体金额，预计对公司2026年度及未来业绩不构成直接影响，具体影响需视下一步具体项目推进和实施情况来确定。　　中红医疗：子公司参与集中带量采购项目拟中选　　1月5日，中红医疗(300981.SZ)公告称，公司控股子公司科伦医械于近期参加省际联盟缝合线等5类医用耗材集中带量采购项目的投标工作，部分产品拟中选。中选产品包括注射器、采血管等，采购周期内，采购地区的医疗机构将优先使用公司拟中选产品，有利于扩大市场销售，提升品牌影响力。但需注意本次拟中选产品相关采购合同尚未签订，后续事项及对公司的影响程度具有不确定性。　　亿帆医药：子公司亿帆制药与尚德药缘签订《独家协议》　　1月5日，亿帆医药公告，全资子公司亿帆制药与尚德药缘签订《独家协议》，获得ACT001药物的独占性权利。亿帆制药需支付1亿元首付款、1亿元基石投资款或5000万元里程碑付款，并根据净销售额分级分成。　　亿嘉和：与麦澜德共同探索“脑机接口+具身智能机器人”技术在智能康养等场景的应用可能性　　1月5日，亿嘉和(603666.SH)在投资者关系活动中称，公司积极探索包括“脑机接口”在内的前沿技术与具身智能机器人技术融合，这是技术发展的必然趋势。公司已与麦澜德签署战略合作协议，旨在共同探索“脑机接口+具身智能机器人”技术在智能康养等场景的应用可能性，比如：1.实时情感陪护：探索通过采集分析前额叶脑电信号与心率变异性信号，尝试识别用户的情感状态，形成“监测—预警—干预”的情感闭环反馈，从而提升机器人的情感关怀能力。2.脑机控机器人：探索结合脑电信号与头部位置信息，解读用户的意图与指令（如喝水、起身等）的可能性，从而实现机器人精准协助，助力其提升生活自理能力。（文章来源：21世纪经济报道）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"corporation","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; 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