Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences) announced that China’s National Medical Products Administration (NMPA) has formally accepted the supplemental new drug application (sNDA) for toripalimab injection in subcutaneous form (code: JS001sc). The filing covers first-line treatment of HER2-expressing, locally advanced or metastatic urothelial carcinoma when used with disitamab vedotin, and simultaneously seeks approval for all 13 indications already authorized for the intravenous formulation (TUOYI®, JS001).
JS001sc, supplied as a 180 mg/1 ml pre-filled syringe, is the first domestically developed anti-PD-1 monoclonal antibody in subcutaneous formulation to enter the Chinese NDA stage. Phase III data disclosed earlier showed non-inferior drug exposure, efficacy and safety versus the intravenous version in first-line treatment of non-squamous non-small cell lung cancer.
Regulatory acceptance triggers a statutory review under Article 32 of the Administrative License Law, but Junshi Biosciences cautions that approval and subsequent commercialization remain subject to customary R&D and market uncertainties.
The company will provide further updates in accordance with disclosure requirements.
Comments