On March 3, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. ("Coherus", Nasdaq: CHRS) reported the initiation of the rolling submission of the Biologics License Application ("BLA") for toripalimab to the U.S. Food and Drug Administration ("FDA") for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("NPC") (Press release, Coherus Biosciences, MAR 3, 2021, View Source [SID1234576011]). A rolling submission allows Junshi Biosciences to submit sections of the BLA to the FDA as they are completed.

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Toripalimab has been granted Breakthrough Therapy Designation by the FDA for the treatment of recurrent or metastatic nasopharyngeal carcinoma based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. Toripalimab is the first anti-PD-1 monoclonal antibody developed in China with a BLA submission to the FDA in process.

In February 2021, Junshi Biosciences and Coherus entered into a collaboration for the development and commercialization of toripalimab in the United States and Canada. Coherus will be responsible for all commercial activities in the licensed territory. Closing of the collaboration agreement is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act, which is expected later this month.

"There has been limited development of treatment approaches for patients with advanced NPC in the U.S.," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "We are determined to advance effective treatments in the U.S. by leveraging the successful experience with toripalimab, a safe and effective treatment for previously treated NPC that is now approved for marketing in China. We appreciate the FDA’s recognition of this potentially important new treatment through its Breakthrough Therapy Designation, which enables the acceleration of the review process. We will work closely with the FDA to facilitate the review of the U.S. marketing application in order to make toripalimab available for patients in the U.S. as soon as possible."

"Toripalimab could address a significant unmet medical need as a new treatment for advanced NPC, and we are encouraged by the initiation of the BLA submission," said Denny Lanfear, CEO of Coherus. "With an extensive clinical development program across a range of tumor types, a broad therapeutic profile is developing for toripalimab. We look forward to working with Junshi Biosciences to bring this new anti-PD-1 antibody to patients in the U.S. and Canada."

Following potential approval of toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma, and assuming successful closing of their collaboration agreement, Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare cancers as well as highly prevalent cancers, including non-small cell lung cancer ("NSCLC").

About Toripalimab

Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. 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 National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designation from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.