Hengrui Medicine advances two drug candidates with key regulatory approvals

Jiangsu Hengrui Medicine announced that its subsidiary, Guangdong Hengrui Medicine Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SHR-3045 injection. This biological product, intended for rheumatoid arthritis, aims to inhibit immune cell function and improve clinical symptoms. The cumulative research and development investment for SHR-3045 is approximately CNY 3,554万元, and no similar drugs are currently approved globally.

In a related development, Shanghai Hengrui Medicine Co., Ltd. had its SHR-1501 injection, a treatment for BCG-unresponsive non-muscle invasive bladder cancer, included in the breakthrough therapy designation by the Drug Evaluation Center. This interleukin-15 fusion protein, which stimulates immune cells to clear tumors, has accumulated a research and development investment of approximately CNY 10,218万元. No similar products are approved in China, though a comparable product, Nogapendekin Alfa Inbakicept (Anktiva), is marketed in the US.

Both announcements highlight the company's ongoing commitment to drug development, with the SHR-3045 clinical trial expected to commence soon and SHR-1501 benefiting from a streamlined review process under the breakthrough therapy designation. The company cautions investors about the inherent risks and uncertainties in drug development and commercialization.