Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients

SHANGHAI, China, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (the “sNDA”) for toripalimab (trade name: TUOYI, product code: JS001) in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB non-small cell lung cancer (“NSCLC”) has been approved by the National Medical Products Administration. This is the first approved perioperative therapy for lung cancer in China and the second worldwide.

Lung cancer is currently the world’s second most prevalent malignant tumor, with the highest mortality rate. According to the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000, accounting for 17.9% of all new cancer cases in China. In the same year, the number of lung cancer deaths in China amounted to 715,000, accounting for 23.8% of all cancer deaths in China. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases. Amongst these patients, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death. Radical surgery in combination with chemotherapy is a way to prevent recurrence, but chemotherapy alone, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefits and can only raise patients’ 5-year survival rate by approximately 5%.

The approval of the sNDA is primarily based on data from the NEOTORCH study (NCT04158440), a randomized, double-blind, placebo-controlled, multi-center phase III clinical study led by Professor Shun LU of Shanghai Chest Hospital of the Shanghai Jiao Tong University School of Medicine. Conducted across 56 centers nationwide, NEOTORCH is the world’s first phase III clinical study of anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive event-free survival (“EFS”) results.