Junshi Biosciences Announces sNDA Approval for Toripalimab in 1st-Line Advanced TNBC Treatment

SHANGHAI, June 25, 2024 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a prominent innovation-driven biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab (product code: JS001) in combination with paclitaxel for injection (albumin-bound) as a first-line treatment for recurrent or metastatic triple-negative breast cancer (TNBC).

Breast cancer has become the most prevalent cancer globally, with 2.31 million new cases and 0.67 million deaths reported in 2020, as per GLOBOCAN statistics. In China, breast cancer accounted for 0.36 million new cases and 0.07 million deaths, representing 15.5% and 11.2% of global cases, respectively. TNBC, a particularly aggressive form of breast cancer, constitutes about 10% to 15% of all breast cancer cases. TNBC is known for its high recurrence rate and poor prognosis, and advanced stages do not respond well to targeted or endocrine therapies, leaving chemotherapy as the standard treatment in China. However, chemotherapy alone or in combination has shown limited efficacy, with a median survival period of 9 to 12 months and a 5-year survival rate below 30%.

The sNDA approval is underpinned by the TORCHLIGHT study (NCT04085276), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial conducted across 56 centers in China. Professor Zefei JIANG, Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO), and from the Department of Oncology of the Chinese People’s Liberation Army General Hospital, served as the principal investigator.

In February 2023, the Independent Data Monitoring Committee (IDMC) concluded in an interim analysis that the primary endpoint of the TORCHLIGHT study had met the pre-defined efficacy boundary. The study is notably the first registered domestic Phase III trial to achieve positive results in the field of advanced TNBC immunotherapy.

The interim results of the TORCHLIGHT study, published in Nature Medicine in January 2024, showed that toripalimab combined with paclitaxel significantly extended progression-free survival (PFS) in PD-L1-positive patients diagnosed with stage IV or recurrent metastatic TNBC, compared to paclitaxel alone. Additionally, overall survival (OS) exhibited a positive trend, marking a significant advancement in TNBC immunotherapy in China. The median PFS in the toripalimab group reached 8.4 months, and the risk of disease progression or death was reduced by 35%. The median OS was extended by 13.3 months, with the risk of death decreasing by 38%. The safety profile of toripalimab was consistent with previous data, with no new safety concerns identified.

Professor Zefei JIANG emphasized the critical role of immunotherapy in TNBC treatment, noting that the TORCHLIGHT study successfully incorporated immune checkpoint inhibitors with traditional chemotherapy, significantly enhancing PFS and OS. This positions toripalimab as a new standard for first-line treatment of TNBC in China.

Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, highlighted the lack of effective treatments for advanced TNBC and expressed optimism that this new approval offers renewed hope for Chinese patients. As of now, toripalimab has received 10 approved indications in China. Moving forward, the company remains devoted to patient care and collaborative efforts with Chinese experts to meet the long-standing unmet clinical needs of many patients.

Toripalimab, an anti-PD-1 monoclonal antibody, is designed to block PD-1 interactions with its ligands, enhancing the immune system's ability to target and destroy tumor cells. Junshi Biosciences has conducted over 40 company-sponsored clinical studies globally, evaluating toripalimab across various tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

Junshi Biosciences, founded in December 2012, is committed to the discovery, development, and commercialization of innovative drugs. With a diversified R&D pipeline of over 50 drug candidates, the company has achieved significant milestones, including the approval of toripalimab in China and the US, and numerous ongoing clinical developments.

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