Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma

3rd Orphan Drug designation for Toripalimab

SHANGHAI, China, Sept. 17, 2020 (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 U.S. Food and Drug Administration (FDA) has recently granted Orphan Drug designation to Toripalimab for the treatment of soft tissue sarcoma. This is the third such designation granted to Toripalimab. The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

About Soft Tissue Sarcoma
Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types and obvious tumor heterogeneity. The current clinical treatment of soft tissue sarcoma mainly uses cytotoxic anti-tumor drugs, which have significant adverse reactions and poor tolerance. Alternative efficacious treatment with less side effects is urgently needed.

About Orphan Drug Designation
Orphan drugs refer to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. at the time of designation. The orphan-drug designation granted by the FDA is beneficial for the continuous development of Toripalimab and the enjoyment of certain policy support in terms of registration and commercialization in the United States, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent. The designation will reduce the R&D investment on the new drug to a certain extent and accelerate the progress of clinical trials and market registration.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed by Junshi Biosciences.  Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019. So far, more than 30 clinical studies covering more than ten indications have been carried out in China, the United States and other countries.

In April 2020, the supplemental New Drug Application (“NDA”) of Toripalimab Injection for the treatment of new indications of recurrent/metastatic nasopharyngeal carcinoma after failure of second-line and above systemic treatment has been accepted by the NMPA. The supplemental NDA is the world’s first NDA of anti-PD-1 monoclonal antibody for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In addition, JUPITER-02 study (NCT03581786), a Phase III clinical study of Toripalimab Injection combined with chemotherapy as a first-line treatment in patients with recurrent or metastatic nasopharyngeal carcinoma has completed the enrollment. In May 2020, the supplemental NDA of Toripalimab Injection for the treatment of new indications of locally advanced or metastatic urothelial carcinoma after systemic treatment has been accepted by the NMPA. The two supplemental NDAs were included in the process of priority review by the NMPA in July 2020. Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA in September 2020.

In March 2020, Toripalimab in combination with axitinib in the treatment of mucosal melanoma was granted the orphan-drug designation by the FDA. In May 2020, Toripalimab was granted the orphan-drug designation by the FDA in the treatment of nasopharyngeal carcinoma.

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 that obtained marketing approval for PD-1 monoclonal antibody in China and clinical trial application approval for anti PCSK9 monoclonal antibody from NMPA. The world’s first in human anti-BTLA antibody for solid tumors was officially approved for clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences pooled its efforts with Chinese science institutions to co-develop JS016, China’s first neutralizing human monoclonal antibodies against SARS-Cov-2, that has entered clinical trial, part of our continuous innovation for disease control and prevention in China and beyond. We have about 2,000 employees in San Francisco and across Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou, China. For more information, please visit: http://junshipharma.com.

Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646.389.6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800