By Fineline Cube Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that they have not received an action letter from the US FDA regarding the Biologics License Application (BLA) for the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The ongoing delay is attributed to the failure to inspect the manufacturing site. The BLA, which covers Tuoyi’s use in combination with chemotherapy as a treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC), was previously set a Prescription Drug User Fee Action (PDUFA) date of December 23, 2022.
FDA Inspection and Review Status
The FDA had earlier indicated that an onsite inspection of Junshi’s manufacturing facility for toripalimab is required before the agency can approve the application. However, the FDA was unable to conduct the inspection during the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and its US partner Coherus BioSciences, Inc. (NASDAQ: CHRS) are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.
Toripalimab’s Regulatory Milestones and Market Presence
Toripalimab was China’s first domestic PD-1 inhibitor to be approved (in December 2018) as a second-line treatment for melanoma. Further indication nods were granted in February 2021 as a second-line treatment of nasopharyngeal carcinoma (NPC), in April 2021 for locally advanced or metastatic urothelial cancer (UC) in previously treated patients, in November 2021 as a first-line treatment for NPC, and in May 2022 as a first-line treatment of esophageal squamous cell carcinoma (ESCC). The molecule was included on the National Reimbursement Drug List (NRDL) for the three indications last year, the only PD-1 inhibitor to treat melanoma and NPC to make the list.
Global Regulatory Filings and Future Prospects
Recurrent or metastatic NPC is an aggressive form of head and neck tumor which has no FDA-approved treatment options. The FDA has said that it is open to regulatory flexibility for the indication as a relatively rare tumor type, including being open to accepting clinical data from a single country source. Junshi has completed the online part of the on-site manufacturing inspection. The FDA requested that the company carry out a change to the product’s quality control processes in May this year, which Junshi completed before re-filing two months later, when the PDUFA date of December 23 was set.
Market approval filings for the drug in NPC and ESCC have also been made with the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and the European Medicines Agency (EMA). This global regulatory strategy underscores Junshi Biosciences’ commitment to bringing Tuoyi to patients worldwide, addressing significant unmet medical needs in oncology.-Fineline Info & Tech