Junshi Biosciences Announces NMPA Acceptance of New Drug Applications for Toripalimab Injection (Subcutaneous) Across 12 Indications

>The NDAs for toripalimab injection (subcutaneous injection [code: JS001sc]), for 12 indications in the treatment of tumors has been accepted by the NMPA. JS001sc is the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to enter the marketing application stage.

Junshi Biosciences Announces Acceptance of the NDA for Roconkibart (IL-17A) for the Treatment of Moderate to Severe Plaque Psoriasis

>The NDA for the company’s product, roconkibart injection (anti-IL-17A mAb, product code: JS005), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy has been accepted by the NMPA

Junshi Biosciences Announces Primary Endpoints Met in JS001sc’s Phase 3 Study for the 1ST-line Treatment of NSQ-NSCLC

>JS001sc-002-III-NSCLC study has met its primary endpoints. JS001sc-002-III-NSCLC is a multi-center, open-label, randomized Phase 3 clinical study comparing toripalimab injection (subcutaneous injection) (code: JS001sc) or toripalimab injection (code: JS001) in combination with chemotherapy for the first-line treatment of recurrent or metastatic NSQ-NSCLC

FDA Approved IND Application of Phase 2/3 Clinical Study of JS207 (PD-1/VEGF) for the Neoadjuvant Treatment of NSCLC Patients

>FDA recently approved IND application of Phase 2/3 Clinical Study of JS207 (PD-1/VEGF) for the neoadjuvant treatment of patients with stage Ⅱ/Ⅲ, resectable, AGA-negative NSCLC