SHANGHAI, China, Dec. 29, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, is pleased to announce that toripalimab has been included in the updated National Reimbursement Drug List (NRDL) (2020 Edition) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA). The primary drug format specification is the 80mg(2ml)/vial. Toripalimab is the only anti-PD-1 monoclonal antibody for the treatment of melanoma that has been included in the NRDL.
Melanoma is an aggressive form of solid tumor with a rapid systemic dissemination. Toripalimab received a conditional approval by the NMPA for the 2nd line treatment of patients with unresectable or metastatic melanoma in December 2018 as the first approved domestically produced PD-1 monoclonal antibody.
“Toripalimab is the first independently developed anti-PD-1 monoclonal antibody in China as well as the first domestic drug to make major breakthroughs in the field of melanoma. Its efficacy and safety are comparable to those of internationally imported drugs,” commented Jun Guo, Professor and Chief Physician, Vice President of Beijing Cancer Hospital, Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO), and Board Member of the CSCO Melanoma and Renal Cancer Expert Committee. “Currently, anti-PD-1 monoclonal antibodies have become the standard treatment for melanoma patients. Combination therapies including anti-PD-1 monoclonal antibodies have shown promising efficacy in the field of melanoma, especially in acral and mucosal melanoma, two melanoma subtypes commonly found in Asia. Therefore, the addition of toripalimab to the NRDL will greatly reduce the financial burden for melanoma patients and significantly increase chances of survival.”
“We are very grateful for the approval given by the National Healthcare Security Administration. As a leading domestic innovation-driven pharmaceutical company, it is our responsibility to improve the accessibility and affordability of China’s anti-cancer drugs. Now that toripalimab is in the NRDL list, we can further increase the accessibility of cancer immunotherapy and improve the usage efficiency of public funding supported by NRDL for melanoma. As for the future, Junshi Biosciences will strive to develop novel therapeutics, and save lives in China and all over the world with innovations,” said Dr. Ning Li, Chief Executive Officer of Junshi Biosciences.
Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain a 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 December 17, 2018, Toripalimab obtained a conditional approval from the NMPA, for the 2nd line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the 3rd line treatment of recurrent/metastatic nasopharyngeal carcinoma and 2nd line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020 respectively. Both supplemental NDAs received priority review designations by the NMPA in July 2020. In addition, toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the US Food and Drug Administration in September 2020. In December 2020, toripalimab was included in the NRDL for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 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 26 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurologic, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company to obtain marketing approval for PD-1 monoclonal antibody in China and clinical trial application approval for PCSK9 monoclonal antibody from the NMPA. The world’s first-in-human, first-in-class BTLA blocking antibody for solid tumors is currently in phase I clinical trials in the US and China. In early 2020, Junshi Biosciences joined forces with Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has about 2,000 full time employees in the United States and China, including research and development centers in San Francisco, Maryland, Shanghai, Suzhou, Beijing and Guangzhou. For more information, please visit: http://junshipharma.com.
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