Junshi Biosciences Announces Acceptance of the Supplemental NDA for Toripalimab in Combination with Chemotherapy for Advanced Triple-negative Breast Cancer

SHANGHAI, China, May 23, 2023 (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 National Medical Products Administration (“NMPA”) has accepted the supplemental new drug application ("sNDA”) for the company’s anti-PD-1 monoclonal antibody, toripalimab, used in combination with albumin-bound paclitaxel for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer (“TNBC”).

According to GLOBOCAN 2020, breast cancer exhibited the highest incidence rates worldwide, with 2.26 million new cases and 0.68 million deaths in 2020. In China, 0.42 million new cases and 0.12 million deaths due to breast cancer were reported in 2020, accounting for 18.4% and 17.1% of global cases, respectively. Amongst these breast cancer cases, approximately 10% to 15% were classified as TNBC. TNBC is a more aggressive type of cancer with a higher risk of recurrence and a poor prognosis. Unfortunately, advanced TNBC does not respond well to targeted therapy and endocrine therapy, and there are currently no specific treatment methods available.

In recent years, clinical studies have shown that immunotherapy in combination with chemotherapy for the treatment of advanced TNBC can achieve better efficacy and tolerability. To this day, however, no immunotherapy drugs have been approved for advanced TNBC in China, and chemotherapy remains the primary treatment option. Alternative drugs include anthracyclines, taxanes, platinum-based drugs, etc. Both mono-chemotherapy and combination chemotherapy have poor efficacy, with a median survival time of about 9 to 12 months and a 5-year survival rate of less than 30%.

The supplemental new drug application is based on the TORCHLIGHT study (NCT04085276), which is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study jointly conducted across 56 centers nationwide, with Professor Zefei JIANG from the Department of Oncology of the Chinese People’s Liberation Army General Hospital and Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO), serving as the principal investigator. The study was designed to compare the efficacy and safety of toripalimab combined with albumin-bound paclitaxel versus placebo combined with albumin-bound paclitaxel in patients with an initial diagnosis of stage IV or recurrent metastatic TNBC. In February 2023, the Independent Data Monitoring Committee (IDMC) determined in an interim analysis that the primary endpoint of the TORCHLIGHT study had met its pre-defined efficacy boundary.