Junshi Biosciences Achieves Regulatory Milestone with First Domestic Subcutaneous Anti-PD-1 Antibody Application in China
核心洞察
China's National Medical Products Administration has accepted new drug applications for JS001sc (搜索), the first domestic anti-PD-1 (搜索) monoclonal antibody in subcutaneous formulation to reach marketing application stage.
The application covers 12 tumor indications and is supported by a Phase 3 clinical study demonstrating non-inferior drug exposure compared to intravenous administration with comparable efficacy and safety.
The subcutaneous formulation addresses urgent clinical needs for more convenient immunotherapy administration, potentially reducing dosing time and improving patient treatment experiences across multiple cancer types.
Shanghai Junshi Biosciences has achieved a significant regulatory milestone with China's National Medical Products Administration (NMPA) accepting new drug applications for toripalimab injection subcutaneous formulation (JS001sc (搜索)) across 12 tumor indications. This marks the first domestic anti-PD-1 (搜索) monoclonal antibody in subcutaneous formulation to enter the marketing application stage in China.
Addressing Critical Clinical Need
The development addresses a substantial unmet medical need in China's cancer treatment landscape. According to GLOBOCAN 2022 data, China recorded 4.8247 million new cancer cases and 2.5742 million cancer-related deaths in 2022. While immunotherapy represented by anti-PD-1 (搜索) monoclonal antibodies has become a cornerstone treatment for various malignant tumors including lung cancer, breast cancer, liver cancer, esophageal cancer, and nasopharyngeal carcinoma, most immunotherapy drugs in China are currently administered intravenously, requiring lengthy infusion times and imposing significant inconveniences on patients.
Phase 3 Clinical Evidence
The NDA submission is primarily based on the JS001sc (搜索)-002-III-NSCLC Study (NCT06505837), a multi-center, open-label, randomized phase 3 clinical study led by Professor Lin WU from Hunan Cancer Hospital. The study compared the exposure, efficacy and safety of JS001sc plus chemotherapy versus JS001 plus chemotherapy for first-line treatment of recurrent or metastatic non-squamous non-small-cell lung cancer (NSCLC).
The results demonstrated that JS001sc (搜索)'s exposure was non-inferior to that of JS001 with comparable efficacy and safety profiles. This represents the first phase 3 clinical study of a domestic anti-PD-1 (搜索) monoclonal antibody in subcutaneous formulation.
Professor Lin WU emphasized the clinical significance: "The JS001sc (搜索)-002-III-NSCLC study, as China's first Phase 3 clinical trial of a domestically developed PD-1 (搜索) monoclonal antibody in a subcutaneous formulation, confirmed that the subcutaneous administration method achieved statistical non-inferiority in drug exposure compared with intravenous administration, while demonstrating comparable efficacy and safety."
Broad Therapeutic Coverage
The 12 indications covered in the JS001sc (搜索) NDAs encompass all currently approved indications of toripalimab injection in Chinese Mainland. According to Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, JS001sc has potential to address multiple tumor types, including NSCLC, nasopharyngeal carcinoma, esophageal cancer, renal cancer, and liver cancer.
Clinical Impact and Future Implications
The subcutaneous formulation is expected to significantly enhance treatment convenience and patient outcomes. Professor Wu noted that the development "provides a novel administration pathway for cancer immunotherapy at the clinical level" and is "expected to significantly reduce dosing time, optimize healthcare resource allocation, and offer new technical support for advancing hierarchical medical systems and home-based treatment management."
Dr. ZOU highlighted the patient-centered approach: "As a subcutaneous formulation, JS001sc (搜索) will substantially enhance dosing convenience, optimize patient treatment experiences, and improve long-term therapy adherence."
Company Background
Junshi Biosciences, founded in December 2012, operates as an innovation-driven biopharmaceutical company with a diversified R&D pipeline comprising over 50 drug candidates across five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases. The company has achieved five product approvals in China and international markets, with toripalimab representing China's first domestically produced and independently developed anti-PD-1 (搜索) monoclonal antibody, approved in over 40 countries and regions including China, the US, and Europe.