Jiangsu Hengrui Pharmaceuticals(600276.SH): Injectable drug SHR-1501 included in the list of breakthrough therapies under consideration.

Jiangsu Hengrui Pharmaceuticals (600276.SH) announced that its subsidiary, Shanghai Jiangsu Hengrui Pharmaceuticals Co., Ltd., recently had its injectable drug SHR-1501 included in the list of proposed breakthrough therapeutic drugs by the National Drug Administration Drug Evaluation Center, with a 7-day public notice period. The proposed indication is the use of injectable SHR-1501 in combination with BCG vaccine for patients with non-muscle invasive carcinoma in situ (CIS) who do not respond to BCG. SHR-1501 is a fusion protein of Interleukin-15 (IL-15) developed by the company with proprietary intellectual property rights. It can stimulate the proliferation of T cells, B cells, and NK cells in the body, mobilizing the immune system to clear foreign substances (such as tumors). When used in combination with BCG, it significantly enhances the immune response in the bladder, achieving a synergistic anti-tumor effect. Compared to IL-2, IL-15 does not stimulate the proliferation of regulatory T cells or induce T cell apoptosis. A similar product, Nogapendekin Alfa Inbakicept (trade name: Anktiva), has been approved for sale in the United States but there are no similar products approved for sale domestically in China. As of now, the cumulative research and development investment for injectable SHR-1501 related projects is approximately 102.18 million yuan.