Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

SHANGHAI, China, July 30, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is the fifth NDA submitted for toripalimab in China.

The supplemental NDA is based on the JUPITER-06 study (Clinicaltrials.gov identifier: NCT03829969), which is a randomized, double-blind, placebo-controlled Phase III clinical study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. A total of 514 patients were enrolled. The co-primary endpoints were progression-free survival (PFS) as assessed by the Blinded Independent Review Committee (BICR) and overall survival (OS). Secondary endpoints included the PFS assessed by investigator, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety. Based on the results of the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the co-primary endpoints of PFS and OS have crossed the prespecified efficacy boundaries and that toripalimab combined with standard chemotherapy as the first-line treatment significantly prolonged the PFS and OS of patients with advanced or metastatic ESCC, compared with placebo combined with standard chemotherapy. Data from the JUPITER-06 study will soon be presented at the 2021 ESMO Annual Meeting.

“As an innovation-driven biopharma company who follows the ‘In China, For Global’ strategy, Junshi Biosciences focuses on tumor types that are 1) highly prevalent in China; 2) responsive to immunotherapy; and 3) where there is urgent unmet need for better and safer treatments. China is one of the countries with the highest incidence and mortality of esophageal cancer in the world, and there is a clear and substantial unmet clinical need.” Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences, said, “The results of JUPITER-06 study showed that compared with chemotherapy, toripalimab in combination with chemotherapy significantly improved both progression-free survival (PFS) and overall survival (OS) for patients with advanced or metastatic ESCC, regardless of their PD-L1 expression status. We will continue to work closely with the NMPA to make this exciting new treatment option available for patients with advanced or metastatic ESCC as soon as possible.”

About Esophageal Cancer

Esophageal cancer is a primary malignant tumor of the esophageal mucosa epithelium, which is one of the most common cancers in the world. According to data released by GLOBOCAN 2020, esophageal cancer was the seventh most common malignant tumor in the world and the sixth leading cause of cancer death in 2020. Approximately 320,000 new esophageal cancer cases and approximately 300,000 deaths due to esophageal cancer occurred in China, with the incidence and death rates ranking fifth and fourth among all malignant tumors, respectively. Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer. Esophageal squamous cell carcinoma is the main subtype in China, accounting for 90% of all esophageal cancer. For patients with advanced or metastatic esophageal squamous cell carcinoma, the current standard first-line treatment is platinum-based chemotherapy, but the 5-year overall survival rate is less than 20%.

About Toripalimab

Toripalimab is the first domestic anti-PD-1 monoclonal antibody obtaining marketing approval in China. So far, more than thirty company sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On 17 December 2018, toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of patients with unresectable or metastatic melanoma. In December 2020, toripalimab injection was successfully included in the updated National Reimbursement Drug List. In February 2021, the sNDA for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy has been granted a conditional approval by the NMPA. In the same month, the sNDA for toripalimab combined with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma was accepted for review by the NMPA. In March 2021, toripalimab received Breakthrough Therapy Designation for the first-line treatment of advanced mucosal melanoma by the NMPA. In April 2021, the sNDA for toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy has been granted a conditional approval by the NMPA. Toripalimab has also been included in the Guidelines of the Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma, the Guidelines of CSCO for the Diagnosis and Treatment of Head and Neck Tumors, the Guidelines of CSCO for the Diagnosis and Treatment of Urothelial Carcinoma and other indications.

In March 2021, Junshi Biosciences started a rolling submission of a Biologics License Application for toripalimab for the second-line treatment of recurrent or metastatic nasopharyngeal carcinoma to the US Food and Drug Administration (“FDA”). Currently, toripalimab has been granted 1 Breakthrough Therapy, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences 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 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: .

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