China's NMPA Accepts Junshi Biosciences' NDAs for Toripalimab Subcutaneous Injection

Key Facts

1The Chinese NMPA accepted New Drug Applications (NDAs) for toripalimab subcutaneous injection across 12 indications.

2JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to reach the marketing application stage in China.

3Junshi Biosciences is listed on the Hong Kong Stock Exchange (1877) and the Shanghai Stock Exchange (688180).

Shanghai Junshi Biosciences announced that China's National Medical Products Administration (NMPA) has accepted its New Drug Applications (NDAs) for a subcutaneous formulation of toripalimab. The applications cover 12 different tumor indications, marking a significant milestone in the company's oncology pipeline development. Notably, JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to reach the marketing application stage in China. This regulatory acceptance is a critical step toward commercializing a more convenient delivery method compared to traditional intravenous options. Junshi Biosciences, listed on both the Hong Kong and Shanghai stock exchanges, expects this formulation to provide a competitive edge in the PD-1 market. The move highlights the company's ongoing commitment to innovation within the rapidly evolving Chinese pharmaceutical sector.