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恒瑞医药(01276):注射用SHR-1501获纳入拟突破性治疗品种公示名单
智通财经网· 2025-09-18 09:29
Core Viewpoint - Heng Rui Medicine's subsidiary Shanghai Heng Rui Medicine Co., Ltd. has announced that its injectable SHR-1501 has been included in the list of proposed breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center, with a public announcement period of 7 days [1] Group 1: Product Information - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein with intellectual property rights, designed to stimulate the proliferation of T cells, B cells, and NK cells in the body [1] - The product enhances the immune response in the bladder when used in conjunction with BCG, achieving a synergistic anti-tumor effect [1] - Unlike IL-2, IL-15 does not stimulate the proliferation of regulatory T cells or induce T cell apoptosis [1] Group 2: Market Context - The foreign counterpart of SHR-1501, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has already been approved for sale in the United States [1] - Currently, there are no approved products targeting the same pathway in the domestic market [1] Group 3: Financial Investment - The cumulative research and development investment for injectable SHR-1501 has reached approximately 102.18 million yuan [1]