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"。 ...

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」。 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着临床优势，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。 格隆汇12月19日丨中国同辐(01763.HK)宣布，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，Boronneutroncapturetherapy)临床试验申请获批(通知 书编号：2025LP03425)。 ...

Core Viewpoint - China National Nuclear Corporation's subsidiary, Shenzhen Zhongke Haidewei Biotechnology Co., Ltd., has received acceptance for its application of "Injectable Boron [10B] Phenylalanine" from the National Medical Products Administration, marking a significant step in the development of innovative cancer treatments in China [1] Group 1 - The injectable boron [10B] phenylalanine is designed for patients with tumors that are resistant to radiotherapy and chemotherapy, including recurrent, refractory, infiltrative, advanced, and locally metastatic cancers, showcasing significant clinical advantages [1] - The treatment requires only 1-2 sessions, has low toxicity and side effects, and integrates diagnosis and treatment, representing a breakthrough in modern precision oncology [1] - The submission of the IND application for BNCT boron drug signifies a breakthrough in the collaborative research and development of domestic BNCT technology, entering a new phase of clinical transformation [1] Group 2 - This development aligns with the "Healthy China" strategy, injecting new momentum from nuclear technology into precision cancer treatment and contributing a "Chinese solution" to global cancer therapy [1]

Core Viewpoint - China National Nuclear Corporation's subsidiary, Shenzhen Zhongke Haidewei Biotechnology Co., Ltd., has received acceptance for its application of "Injection Boron [B] Falan" from the National Medical Products Administration (NMPA), marking a significant step in the development of innovative cancer treatments in China [1] Group 1: Product Development - The "Injection Boron [10B] Falan" is designed for treating tumors that are resistant to radiotherapy and chemotherapy, including recurrent, refractory, infiltrative, advanced, and locally metastatic cancers, showcasing significant clinical advantages [1] - The treatment requires only 1-2 sessions, has low side effects, and integrates diagnosis and treatment, representing a breakthrough in modern precision oncology [1] Group 2: Industry Impact - The submission of the IND application for the BNCT boron drug signifies a breakthrough in the collaborative research and development of domestic BNCT technology, entering a new phase of clinical transformation [1] - This advancement contributes to the "Healthy China" strategy by injecting new momentum from nuclear technology into precision cancer treatment and offers a "Chinese solution" to global cancer treatment challenges [1]