中国同辐(01763)附属公司中核海得威BNCT硼药获批临床

智通财经
Dec 19, 2025

智通财经APP讯,中国同辐(01763)发布公告,近日,国家药品监督管理局药品审评中心(CDE)官网信息显示公司附属公司深圳市中核海得威生物科技有限公司(中核海得威)自主研发的2.2类改良新药“注射用硼[10B]法仑”(BNCT硼药:硼中子俘获疗法,Boron neutron capture therapy)临床试验申请获批(通知书编号:2025LP03425)。

中核海得威自研的国产“注射用硼[10B]法仑”针对对放化疗不敏感、复发性、难治性、浸润性、中晚期、局部转移的头颈部肿瘤具有显著临床优势,且治疗疗程短(仅需1-2次)、毒副作用低,代表了现代肿瘤精准医学的发展方向和前沿创新,为患者提供了全新的治疗选择,推动了肿瘤治疗领域的创新与突破。

此外,中核海得威“注射用硼[10B]法仑”临床试验申请获批标志着中核海得威BNCT药械协同研发领域取得突破性成果,正式迈入临床转化新阶段,为“健康中国”战略下的精准肿瘤治疗注入核科技新动能,为全球肿瘤治疗贡献“中国方案”。

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