On May 2, 2022 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", "Junshi", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that the U.S. Food and Drug Administration ("FDA", "the Agency") has issued a complete response letter ("CRL") for the Biologics License Application ("BLA") for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma ("NPC") and for toripalimab monotherapy in the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy (Press release, Coherus Biosciences, MAY 2, 2022, View Source [SID1234613306]).

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The CRL requests a quality process change that Coherus and Junshi Biosciences believe is readily addressable. Coherus and Junshi Biosciences plan to meet with the FDA directly and expect to resubmit the BLA by mid-summer 2022. The Agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required onsite inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China.

"We will continue to work closely with our partner, Junshi Biosciences, to facilitate the completion of the FDA’s review of the toripalimab BLA. In late April, we responded quickly to an FDA request for a quality process change and implemented required actions," said Denny Lanfear, CEO of Coherus. "We plan to first meet with the FDA and directly thereafter to resubmit the BLA. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions. We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data."

"Junshi Biosciences is dedicated to the discovery, development and commercialization of innovative new drugs on a global scale," said Dr. Ning Li, CEO of Junshi Biosciences. "Toripalimab, our PD-1 inhibitor, has demonstrated a compelling clinical profile in studies across multiple tumor types and is currently approved in China for four indications. We fully support our partner, Coherus, in its efforts to seek toripalimab approval in the United States for advanced nasopharyngeal carcinoma, as well as in the subsequent commercial launch, if approved. Our respective teams are working diligently together in a well coordinated effort to achieve these goals as partners."

About Nasopharyngeal Carcinoma (NPC)

NPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In the United States, there are presently no immunotherapies approved for the treatment of NPC.

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 thirty 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 European countries. 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 China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are four approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, two supplemental New Drug Applications ("NDAs") for toripalimab are currently under review by the National Medical Products Administration ("NMPA") in China:

in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic ESCC.
in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.
In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Coherus and Junshi Biosciences plan to resubmit a BLA for toripalimab for advanced NPC by mid-summer 2022. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next several years for multiple other cancer types.