Junshi Biosciences’ Subcutaneous Toripalimab NDAs Accepted in China

Shanghai Junshi Biosciences Co., Ltd. Class H ( (HK:1877) ) has issued an announcement.

Shanghai Junshi Biosciences has received acceptance from China’s National Medical Products Administration for new drug applications covering 12 tumor-related indications of its toripalimab subcutaneous injection, JS001sc. The formulation is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous form to reach the marketing application stage and is designed to offer more convenient administration compared with existing intravenous options.

The applications are supported by a phase III clinical study in first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer, which showed JS001sc to be non-inferior to the intravenous version in exposure, efficacy and safety. If ultimately approved, the product could enhance Junshi’s competitive position in China’s immuno-oncology market by addressing an urgent clinical need for more convenient cancer immunotherapy, though the company cautions that significant development and commercialization risks remain.

The most recent analyst rating on (HK:1877) stock is a Hold with a HK$22.50 price target. To see the full list of analyst forecasts on Shanghai Junshi Biosciences Co., Ltd. Class H stock, see the HK:1877 Stock Forecast page.

More about Shanghai Junshi Biosciences Co., Ltd. Class H

Shanghai Junshi Biosciences Co., Ltd. is a China-based biopharmaceutical company focused on innovative oncology treatments, particularly immunotherapies such as anti-PD-1 monoclonal antibodies. The company targets the rapidly growing cancer market in Chinese Mainland, where immunotherapy has become a cornerstone in managing a wide range of malignant tumors.

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