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

SHANGHAI, June 25, 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 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) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC).

According to the GLOBOCAN 2020 statistics, breast cancer became the most common cancer in the world, with 2.31 million new cases and 0.67 million deaths. In China, there were 0.36 million new cases and 0.07 million deaths due to breast cancer, accounting for 15.5% and 11.2% of global cases. Amongst these, TNBC accounts for about 10% to 15% of all breast cancer cases, making TNBC a more aggressive type of cancer with a higher risk of recurrence and poor prognosis. Advanced TNBC is not responsive to targeted or endocrine therapies and lacks specific treatment methods. Chemotherapy remains the standard treatment for advanced TNBC in China, but both mono-chemotherapy and combined 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 NDA approval is based on the TORCHLIGHT study (NCT04085276), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study jointly conducted in 56 centers across the country. 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) determined in an interim analysis that the primary endpoint of the TORCHLIGHT study had met the pre-defined efficacy boundary. TORCHLIGHT is the first registered domestic Phase III study to achieve positive results in the field of advanced TNBC immunotherapy.

In January 2024, Nature Medicine (Impact Factor: 58.7) published the interim results of the TORCHLIGHT study. The findings showed that, compared with paclitaxel alone, toripalimab in combination with paclitaxel in patients with an initial diagnosis of stage IV or recurrent metastatic TNBC can significantly prolong the progression-free survival (PFS) of PD-L1-positive patients. The overall survival (OS) also showed a positive trend, achieving a breakthrough in immunotherapy for advanced TNBC in China. The median PFS in the toripalimab group was 8.4 months, and the risk of disease progression or death was reduced by 35% (P=0.0102). The median OS in the toripalimab group was extended by 13.3 months (32.8 months vs 19.5 months), and the risk of death was reduced by 38% (P=0.0148). The safety profile of toripalimab remained consistent with the established safety profile, with no new safety signals identified.

“Immunotherapy has become the most important treatment for TNBC,” said Principal investigator Professor Zefei JIANG from the Department of Oncology of the Chinese People’s Liberation Army General Hospital. “The TORCHLIGHT study introduces immune checkpoint inhibitors in addition to traditional chemotherapy, which not only significantly prolongs the mPFS for patients with advanced TNBC, but also demonstrates notable benefits to overall survival, increasing the total survival time for TNBC patients to more than 30 months. As the very first approved immunotherapy for TNBC in China, toripalimab will set a new standard for the first-line treatment of TNBC.”

“For a long time, effective treatments for advanced TNBC have been lacking,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. “The approval of this new indication is another milestone success, and it offers new hope to Chinese patients with advanced TNBC. As of now, toripalimab has 10 approved indications in China. Moving forward, we will remain dedicated to patient care, collaborate with Chinese experts and scholars, and address the long-standing unmet clinical needs of many more patients.”

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). Currently, there are ten approved indications for toripalimab in the Chinese mainland:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
8. in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
9. in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
10. in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC).

The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

In the United States, the US FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.

In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (HSA) in January 2024. The HSA has also granted priority review designation for the NDA.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI^®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.

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