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Mar 9, 2026
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.
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Dec 5, 2025
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
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Nov 24, 2025
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
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Oct 16, 2025
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
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