注射用硼[10B]法仑
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中国同辐附属公司中核海得威BNCT硼药获批临床
Zhi Tong Cai Jing· 2025-12-19 12:11
Core Viewpoint - China Nuclear Industry's subsidiary, Shenzhen Zhongke Haidewei Biotechnology Co., Ltd., has received approval for clinical trial application of its self-developed drug "Injection Boron [10B] Faron" for Boron Neutron Capture Therapy (BNCT), marking a significant advancement in cancer treatment [1] Group 1: Drug Development - The approved drug targets head and neck tumors that are resistant to radiotherapy and chemotherapy, particularly in cases that are recurrent, difficult to treat, infiltrative, and locally metastatic [1] - The treatment regimen is notably short, requiring only 1-2 sessions, and has low toxicity and side effects, representing a significant clinical advantage [1] Group 2: Innovation and Strategic Impact - The approval signifies a breakthrough in the collaborative research and development of BNCT drugs and devices, entering a new phase of clinical transformation [1] - 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]
中国同辐(01763.HK)附属中核海得威“BNCT硼药”获批临床
Ge Long Hui· 2025-12-19 12:07
Core Viewpoint - China Nuclear Industry's subsidiary, Shenzhen Zhongke Haidewei Biotechnology Co., Ltd., has received approval for clinical trial application of its self-developed 2.2 class improved new drug, "Injectable Boron [10B] Falun" (BNCT boron drug), marking a significant advancement in the field of tumor treatment [1] Group 1 - The drug targets head and neck tumors that are resistant to radiotherapy and chemotherapy, showing significant clinical advantages, including a short treatment course of only 1-2 sessions and low toxicity [1] - This approval signifies a breakthrough in the collaborative research and development of BNCT drug-device integration, entering a new phase of clinical transformation [1] - The development aligns with the "Healthy China" strategy, injecting new momentum from nuclear technology into precise tumor treatment and contributing a "Chinese solution" to global cancer treatment [1]
中国同辐附属公司中核海得威BNCT硼药提交IND申请
Zhi Tong Cai Jing· 2025-10-17 14:30
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]
中国同辐(01763.HK)附属中核海得威BNCT硼药提交IND申请
Ge Long Hui· 2025-10-17 14:29
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]