CIRC (01763) Subsidiary Secures Clinical Trial Approval for BNCT Boron Drug

Stock News12-19

CIRC (01763) announced that its subsidiary, Shenzhen Zhonghe Haidewei Biotechnology Co., Ltd. (Haidewei), has received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration for clinical trials of its self-developed 2.2-class improved new drug "Boron [10B] Phenylalanine Injection" (BNCT boron drug: Boron Neutron Capture Therapy). The approval notice number is 2025LP03425.

Haidewei's domestically developed "Boron [10B] Phenylalanine Injection" demonstrates significant clinical advantages for treating radiation- and chemotherapy-insensitive, recurrent, refractory, invasive, mid-to-late stage, and locally metastatic head and neck tumors. The treatment features a short course (requiring only 1-2 sessions) and low toxicity, representing a cutting-edge innovation in modern precision oncology. It provides patients with a novel therapeutic option and drives innovation in the field of cancer treatment.

The approval of Haidewei's clinical trial application marks a breakthrough in the company's BNCT drug-device collaborative R&D efforts, officially entering a new phase of clinical translation. This development injects new momentum into precision oncology under China's "Healthy China" strategy and contributes a "Chinese solution" to global cancer treatment.

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