--- title: "Junshi receives China’s NMPA acceptance for toripalimab injection" type: "News" locale: "en" url: "https://longbridge.com/en/news/278544178.md" description: "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." datetime: "2026-03-10T10:43:55.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/278544178.md) - [en](https://longbridge.com/en/news/278544178.md) - [zh-HK](https://longbridge.com/zh-HK/news/278544178.md) generator: "portal-rs" --- # Junshi receives China’s NMPA acceptance for toripalimab injection The injection is independently developed by Junshi Biosciences as a subcutaneous option based on the already marketed toripalimab injection. Credit: Ake Studio / Shutterstock.com. 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. ### Go deeper with GlobalData - ![ReportsLogo](/wp-content/themes/goodlife-wp-B2B/assets/img/report.png) Reports #### LOA and PTSR Model - Toripalimab in Bone Sarcoma - ![ReportsLogo](/wp-content/themes/goodlife-wp-B2B/assets/img/report.png) Reports #### LOA and PTSR Model - Toripalimab in Cervical Cancer ##### Go deeper with GlobalData The gold standard of business intelligence. Find out more #### Discover B2B Marketing That Performs Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms. Find out more 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). GlobalData Strategic Intelligence # US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Results 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. ### Related Stocks - [44018.HK](https://longbridge.com/en/quote/44018.HK.md) - [159506.CN](https://longbridge.com/en/quote/159506.CN.md) - [512290.CN](https://longbridge.com/en/quote/512290.CN.md) - [516500.CN](https://longbridge.com/en/quote/516500.CN.md) - [BBH.US](https://longbridge.com/en/quote/BBH.US.md) - [01877.HK](https://longbridge.com/en/quote/01877.HK.md) - [513060.CN](https://longbridge.com/en/quote/513060.CN.md) - [520690.CN](https://longbridge.com/en/quote/520690.CN.md) - [IBB.US](https://longbridge.com/en/quote/IBB.US.md) - [FBT.US](https://longbridge.com/en/quote/FBT.US.md) - [520880.CN](https://longbridge.com/en/quote/520880.CN.md) - [588860.CN](https://longbridge.com/en/quote/588860.CN.md) - [560600.CN](https://longbridge.com/en/quote/560600.CN.md) - [IBBQ.US](https://longbridge.com/en/quote/IBBQ.US.md) - [510660.CN](https://longbridge.com/en/quote/510660.CN.md) - [516930.CN](https://longbridge.com/en/quote/516930.CN.md) - [159102.CN](https://longbridge.com/en/quote/159102.CN.md) - [588250.CN](https://longbridge.com/en/quote/588250.CN.md) - [516820.CN](https://longbridge.com/en/quote/516820.CN.md) - [159849.CN](https://longbridge.com/en/quote/159849.CN.md) - [588130.CN](https://longbridge.com/en/quote/588130.CN.md) - [BIB.US](https://longbridge.com/en/quote/BIB.US.md) - [159992.CN](https://longbridge.com/en/quote/159992.CN.md) - [SBIO.US](https://longbridge.com/en/quote/SBIO.US.md) - [IHE.US](https://longbridge.com/en/quote/IHE.US.md) - [688180.CN](https://longbridge.com/en/quote/688180.CN.md) - [513120.CN](https://longbridge.com/en/quote/513120.CN.md) - [513700.CN](https://longbridge.com/en/quote/513700.CN.md) - [159892.CN](https://longbridge.com/en/quote/159892.CN.md) - [159837.CN](https://longbridge.com/en/quote/159837.CN.md) - [688238.CN](https://longbridge.com/en/quote/688238.CN.md) - [159316.CN](https://longbridge.com/en/quote/159316.CN.md) - [512010.CN](https://longbridge.com/en/quote/512010.CN.md) - [LXEO.US](https://longbridge.com/en/quote/LXEO.US.md) - [159615.CN](https://longbridge.com/en/quote/159615.CN.md) - [XBI.US](https://longbridge.com/en/quote/XBI.US.md) - [159859.CN](https://longbridge.com/en/quote/159859.CN.md) - [PBE.US](https://longbridge.com/en/quote/PBE.US.md) ## Related News & Research - [Junshi Biosciences terminates 2026 A-share employee stock ownership scheme](https://longbridge.com/en/news/297027904.md) - [Lexeo Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (Rmat) Designation For Lx2020](https://longbridge.com/en/news/294966104.md) - [China to Foster New Pillar Industries in New Energy, Robotics, Biomedicine](https://longbridge.com/en/news/297036513.md) - [SBIO: U.S. Programmatic and EMEA drove 49% of Q2 sales, with margins rising to 61% and profitability expected in H2 2026](https://longbridge.com/en/news/296517769.md) - [EverGen Infrastructure Reports Q2 2026 Results | EVGIF Stock News](https://longbridge.com/en/news/297122882.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**