近日，康弘药业宣布其自主研发的布瑞哌唑片（Brexpiprazole Tablets）获得中国国家药品监督管理局（NMPA）批准注册。该药物是一种新型非典型抗精神病药，主要用于治疗精神分裂症和作为重度抑郁症（MDD）的辅助疗法。布瑞哌唑通过调节多巴胺和5-羟色胺系统，在改善阳性与阴性症状的同时，具有较低的副作用风险，尤其在体重增加、代谢异常及锥体外系反应方面表现更优。此次获批标志着康弘药业在中枢神经系统（CNS）疾病领域迈出关键一步，不仅丰富了公司创新药产品线，也为中国精神疾病患者提供了新的治疗选择。布瑞哌唑原研由大冢制药与灵北制药联合开发，已在美、日、欧等多个国家和地区上市。康弘药业通过技术攻关实现国产化，有望显著降低患者用药成本，并提升药物可及性。未来，康弘药业表示将继续推进该品种的临床研究与市场推广，并探索其在其他适应症中的潜力，进一步巩固其在精神神经领域的研发优势。
Recently, Kanghong Pharmaceutical announced that its self-developed Brexpiprazole Tablets have received marketing approval from China’s National Medical Products Administration (NMPA). Brexpiprazole is a novel atypical antipsychotic primarily indicated for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder (MDD). By modulating dopamine and serotonin systems, brexpiprazole effectively addresses both positive and negative symptoms while demonstrating a favorable safety profile—particularly with lower risks of weight gain, metabolic disturbances, and extrapyramidal side effects.This approval marks a significant milestone for Kanghong in the central nervous system (CNS) therapeutic area, enriching its innovative drug portfolio and offering Chinese patients a new treatment option for psychiatric conditions. Originally co-developed by Otsuka Pharmaceutical and Lundbeck, brexpiprazole has already been launched in the U.S., Japan, Europe, and other regions. Kanghong’s successful domestication of the drug through independent R&D is expected to substantially reduce treatment costs and improve accessibility for patients in China.Looking ahead, Kanghong Pharmaceutical stated it will continue advancing clinical studies and commercialization efforts for brexpiprazole, while also exploring its potential in additional indications to further strengthen its leadership in CNS drug development.
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