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 products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1: Product Development - SHR-1501 is a self-developed interleukin-15 (IL-15) fusion protein that stimulates the proliferation of T cells, B cells, and NK cells, enhancing the immune response to eliminate foreign substances such as tumors [1] - The proposed indication for SHR-1501 is in combination with Bacillus Calmette-Guérin (BCG) for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG [1] - The combination of SHR-1501 with BCG is expected to significantly enhance the immune response in the bladder, achieving a synergistic anti-tumor effect [1] Group 2: Market Context - Currently, there are no approved products in China targeting the same mechanism as SHR-1501, while a similar product, Nogapendekin Alfa Inbakicept (marketed as Anktiva), has been approved for sale in the United States [1] - The cumulative research and development investment for SHR-1501 has reached approximately 10.218 million yuan [1]