Nihon Medi-Physics Co., Ltd.

药械追踪No.1 / 全球首个！优时比罗泽利昔珠单抗在华获批2025年3月31日，优时比（UCB）宣布自研生物制剂罗泽利昔珠单抗注射液（商品名：优迪革）获得中国国家药品监督管理局（NMPA）批准，与常规治疗药物联合用于治疗乙酰胆碱受体（AChR）或肌肉特异性受体酪氨酸激酶（MuSK）抗体阳性的成人全身型重症肌无力（gMG）患者。作为全球首个且唯一同时覆盖AChR阳性和MuSK阳性gMG的新生儿Fc受体（FcRn）拮抗剂，此次获批不仅为AChR阳性患者带来新的治疗选择，更突破了目前国内MuSK阳性患者长期缺乏有效治疗手段的困境，推动中国重症肌无力诊疗迈入精准治疗新时代。2023年发表于Lancet Neurology的关键Ⅲ期MycarinG试验结果显示，优迪革在AChR阳性和MuSK阳性 gMG患者中展示了显著的临床获益以及良好的安全性。在所有随机分组至优迪革治疗组的患者中，治疗一周后，症状快速缓解，患者日常活动能力明显提升；首个治疗周期后，总IgG降低73%（对照组下降9%），MG-ADL（重症肌无力日常生活量表）评分平均改善3.37分（对照组改善0.78分），尤其对于MuSK阳性患者疗效卓越，其MG-ADL平均改善7.28分（对照组恶化2.28分）；且观察到单次治疗后获益显著持久，在MycarinG的开放标签扩展研究中，优迪革治疗组患者一年平均接受3.4个周期的治疗（注射17.8次）。安全性方面，总体不良事件风险与安慰剂相当，以轻度或中度为主，长期安全性良好。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / GE医疗收购日本放射性药物公司Nihon Medi-Physics2025年3月31日，GE医疗宣布，已完成对日本领先放射性药物公司Nihon Medi-Physics（NMP）的收购。GE医疗曾在2004年通过收购Amersham获持NMP 50%的股份。本次自住友化学手中收购NMP的剩余50%股份后，GE医疗已实现对NMP的全资控股。NMP后续将作为GE医疗的一部分，凭借其开发和制造专有及授权放射性药物的专业知识，进一步拓展在单光子发射计算机断层成像（SPECT）和正电子发射断层成像（PET）分子成像领域的应用，助力疾病的检测和诊断。->点击文末阅读原文，解锁完整双语新闻No.2 / 诺和诺德10亿美元获Lexicon减重新药全球权益2025年3月28日，诺和诺德与Lexicon（纳斯达克股票代码：LXRX）就LX9851达成独家授权协议。LX9851是Lexicon研发的强效选择性口服小分子酰基辅酶A合成酶5（ACSL5）抑制剂。ACSL5在调节脂肪积累和能量平衡的代谢途径中发挥关键作用。LX9851可能通过激活回肠制动机制来延迟胃排空和抑制食欲，从而增加饱腹感，有望用于肥胖及相关代谢疾病。根据协议条款，Lexicon授予诺和诺德在全球范围内针对所有适应证开发、生产和商业化LX9851的独家权益，并将负责完成双方商定的LX9851新药临床研究申请（IND）所需的准备工作。诺和诺德需向Lexicon支付高达10亿美元的前期付款以及潜在的开发、监管和销售里程碑付款（包含7500万美元的前期及近期里程碑付款），并将负责提交IND申请以及LX9851的所有后续开发、生产和商业化工作。->点击文末阅读原文，解锁完整双语新闻No.3 / 8500万美元，默克行使和誉医药ABSK021全球商业化选择权2025年4月1日，和誉医药（2256.HK）发布公告称，默克已根据双方于2023年12月签订的授权协议，行使匹米替尼（ABSK021）全球商业化选择权，行权费用为8500万美元。2023年12月，和誉医药与默克就CSF-1R抑制剂匹米替尼订立独家许可协议，根据该协议条款，默克最初获得匹米替尼在中国大陆和港澳台所有适应证进行商业化的独家授权，并拥有全球商业化权利的独家选择权。默克现已行使前述选择权，因此拥有全球商业化匹米替尼的独家授权。和誉医药已于2024年2月收到了一次性、不可退还的首付款7000万美元，并已有权额外收取行权费8500万美元。此外，默克亦可选择在若干条件下共同开发匹米替尼的其他适应证。和誉医药可收取最多6.055亿美元的款项，包括首付款、开发及商业化里程碑付款，以及实际年净销售额的两位数比例销售提成。匹米替尼是由和誉医药独立研发的一种新型、口服、高选择性且高效的小分子CSF-1R抑制剂。匹米替尼在全球Ⅲ期MANEUVER研究中针对腱鞘巨细胞瘤（TGCT）的积极顶线结果已于2024年11月成功发布。在该研究中，MANEUVER研究达到了主要终点，匹米替尼组第25周的客观缓解率（ORR）达54.0%，而安慰剂组为3.2%（P<0.0001）。每日一次口服匹米替尼的耐受性良好，因治疗相关不良事件而终止治疗的比例非常低，且没有观察到胆汁淤积性肝毒性的证据。->点击文末阅读原文，解锁完整双语新闻行业政策No.1 / 上海临港签约2025年首批跨境医疗项目，发布跨境医疗方案2025年3月31日，上海临港新片区跨境医疗方案发布会暨首批项目签约揭牌仪式顺利举行。2025年首批跨境医疗项目进行签约包括医疗机构合作签约、跨境医疗服务合作签约、跨境医疗保险和结算合作签约、跨境医学教育签约等。涉及中医、口腔、心理等一批医疗服务机构和医院、医疗保险和医学教育等多领域跨境医疗合作。其中，蓝湾研究型医院项目、曙光医院滴水湖中医国际诊疗中心项目、玄合医疗健康管理中心项目、心理健康诊疗康复中心项目、口腔医院项目等5个医疗机构合作项目建成后，将成为临港新片区前沿医疗、严肃医疗、消费医疗三个资源组团的重要组成部分，相互错位、良性互动、融合发展。《临港新片区发展跨境医疗 推进国际医疗服务集聚区建设实施方案》从“推动高水平医疗服务资源集聚”“促进跨境医疗服务要素便捷流动”以及“提升医疗服务国际化水平”三个维度提出了十二项任务，积极争取跨境医疗创新突破举措在临港新片区的先行先试。同时，临港新片区跨境医疗服务中心与临港新片区药械进出口服务中心正式揭牌。临港新片区跨境医疗服务中心承担连接境外患者和临港新片区乃至上海医疗机构的桥梁作用，聚焦患者跨境医疗服务的全流程，开展境外宣介、患者导引和就医陪护等工作，提供从患者端到医疗机构端的全方位的跨境医疗服务；临港新片区药械进出口服务中心设立在洋山特殊综合保税区内，旨在推动打造公益性“一站通”服务，助力医药大健康进出口企业打通经营中的堵点、难点和痛点，加快产品及产业项目落地，推进创新研发成果转化，助力产品上市及供应链运作，促进产业高质量发展。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力 关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ xujingou@baidu.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

At the same time, GE HealthCare used the ACC meeting to announce the U.S. commercial roll out of its Flyrcado PET imaging agent for charting coronary artery disease. The fluorine-18 radiotracer was approved by the FDA last fall.\n GE HealthCare has raised the curtain on a new CT system with features designed specifically for addressing cardiovascular disease. The Revolution Vibe scanner includes what the company describes as unlimited one-beat cardiac imaging—capturing low-dose, full-organ pictures fast enough so they can be used to clearly assess moving valves and clogged arteries across the pulsing heart.Cardiac CT angiography, or CCTA, is used to help diagnose coronary artery disease, and can be employed as a first-line tool for patients suffering from chest pain. GE HealthCare said the Revolution Vibe aims to expand providers’ access to the technique. “The system is designed to encourage the broader adoption of and access to cardiac imaging, combining advanced technology with AI-powered solutions to deliver fast, accurate diagnoses and a more comfortable patient experience,” Jean-Luc Procaccini, GE HealthCare’s president and CEO of molecular imaging and computed tomography, said in a statement. The system—which has received a CE Mark approval in Europe and is currently undergoing review at the FDA—was unveiled during the annual meeting of the American College of Cardiology being held in Chicago.At the same time, GE HealthCare used the ACC meeting to announce the U.S. commercial rollout of its Flyrcado PET imaging agent for charting coronary artery disease. The fluorine-18 radiotracer was approved by the FDA last fall. The company said the injection can help deliver higher diagnostic efficacy compared to single-photon emission computed tomography, or SPECT, as well as myocardial perfusion imaging that traces the flow of blood through the heart muscle. GE HealthCare said the launch coincides with passthrough payment status from the Centers for Medicare and Medicaid Services, effective April 1, with a drug-specific billing code that will allow CMS to pay separately for the radiopharmaceutical and PET-CT scan in the outpatient setting.The company also noted that it has closed its acquisition of the Japanese radiopharmaceutical maker Nihon Medi-Physics, which was announced last December. GE HealthCare had previously split ownership of the venture 50-50 with Sumitomo Chemical. 

GE HealthCare has completed its acquisition of Sumitomo Chemical’s 50% stake in Nihon Medi-Physics (NMP), giving it full ownership. As part of GE HealthCare, NMP, already a leading radiopharmaceutical company in Japan, is positioned to enhance patient access to next-generation radiopharmaceuticals that enable detection and diagnosis of disease. CHICAGO--(BUSINESS WIRE)--Mar. 31, 2025-- GE HealthCare Technologies Inc. (GE HealthCare or the Company) (Nasdaq: GEHC) has completed its acquisition of the remaining 50% stake in Nihon Medi-Physics Co., Ltd (NMP), from Sumitomo Chemical, giving it full ownership. As part of GE HealthCare, NMP can further build on its expertise in developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. Kevin O’Neill, President & CEO of GE HealthCare’s Pharmaceutical Diagnostics (PDx) segment, who will also become President of NMP, said: “We are delighted to welcome Nihon Medi-Physics to GE HealthCare, increasing our existing footprint and offering in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country. Japan is on a path to becoming a leader in the $7 billion molecular imaging global market and a center of excellence for Asian markets. As part of GE HealthCare, NMP will play a key role in that journey, including bringing its deep expertise and scale to global innovators looking to bring next-generation radiopharmaceuticals to the Japan market and beyond.” NMP’s product portfolio includes GE HealthCare radiopharmaceuticals used to enable molecular imaging across neurology, cardiology and oncology procedures. NMP, headquartered in Tokyo, was formed in 1973 and generated revenues of 28.2B JPY (~$183M) in 2023. GE HealthCare acquired Amersham plc in 2004, and subsequently held a 50% stake in NMP. The Company expects this transaction to be neutral to Adjusted EPS in year one and accretive thereafter.