Junshi receives China’s NMPA acceptance for toripalimab injection
I'm LongbridgeAI, I can summarize articles.Junshi Biosciences has received acceptance from China's NMPA for its toripalimab injection (JS001sc), the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to reach the marketing application stage. The NDAs cover all approved indications in Mainland China, supported by a Phase III study showing non-inferior efficacy and safety compared to the existing formulation. CEO Dr. Jianjun Zou expressed excitement over the potential of JS001sc to improve patient treatment experiences and adherence. Junshi also collaborates with LEO Pharma for distribution in Europe starting January 2025.
Junshi Biosciences has received acceptance from China’sNational Medical Products Administration (NMPA) for toripalimab subcutaneous injection (JS001sc) new drug applications (NDAs) covering 12 indications for cancer treatment.
This marks the first domestic anti-PD-1 monoclonal antibody in a subcutaneous formulation to reach the marketing application stage.
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JS001sc is independently developed by Junshi Biosciences as a subcutaneous option based on the already marketed toripalimab injection.
The NDAs cover all approved indications of toripalimab in Mainland China.
The main supporting evidence comes from the open-label, randomised, multi-centre Phase III JS001sc-002-III-NSCLC study led by Hunan Cancer Hospital principal investigator Professor Lin Wu.
It was designed to evaluate and compare the efficacy, safety, and exposure of JS001sc combined with chemotherapy against JS001, along with chemotherapy as a first-line treatment for recurrent or metastatic non-squamous non-small-cell lung cancer (NSCLC).
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By GlobalDataResults indicated non-inferior exposure and similar efficacy and safety profiles between the two formulations.
Junshi Biosciences general manager and CEO Dr Jianjun Zou said: “We are excited that the NMPA has formally accepted the NDA for JS001sc covering all approved indications of TUOYI (toripalimab). This signifies JS001sc’s potential to address multiple tumour types, including NSCLC and nasopharyngeal carcinoma.
“As a subcutaneous formulation, JS001sc will substantially enhance dosing convenience, optimise patient treatment experiences, and improve long-term therapy adherence.
“Using our clinical evidence, we hope to leverage evidence-based medicine to advance high-quality development of China’s cancer therapies, ultimately delivering more accessible, convenient, and high-quality treatment options to patients.”
In January 2025, Junshi Biosciences and its subsidiary TopAlliance Biosciences entered a collaboration with LEO Pharma for the distribution and marketing of the monoclonal antibody, toripalimab, in Europe.