Hengrui PD-1 5th adaptive listing application is to be included in the priority review: first-line nasopharyngeal cancer.

On September 2, Hengrui Pharmaceutical PD-1 Karelli Pearl Single Resistance submitted an application for the listing of a new adaptation and, in accordance with the scope of priority review (v) the drug that meets the conditions for approval, is to be included in the priority review and approval procedure.
according to an announcement issued by Hengrui Pharmaceuticals on August 13th, this new adaptation should be a partial recurrence or distant metastatic nasopharyngeal cancer treated by Karelliju monoantigen and Gissythabhamin.
Previously, Hengrui Pharmaceuticals announced the injection of Karelli pearl monoantigen (Erika) in a joint cisplatin and Gisithamin first-line treatment of randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies (hereinafter referred to as "CAPTAIN-1st" studies), conducted by the Independent Data Monitoring Board (ID) MC) determined that the in-period analysis results of the main study endpoint reached the optimal standard of the program preset, and the results showed that the injection of kariliju monoantigenated cisplatin and Gissithamin first-line treatment of local recurrence or distant metastatic nasopharyngeal cancer patients, compared with the standard first-line treatment of cisplatin gigysithambin, can significantly extend the patient's progress-free survival.
study (CAPTAIN-1st study) is an evaluation of the first-line treatment of local recurrence or metastatic nasopharyngeal cancer in injections with kariliju monoantigen and Gissythabine contrast placebo combined with cistin and gissythabin. Randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies (CTR20181864, NCT03707509), led by Professor Zhang Zhang of Sun Yat-sen University-affiliated Oncology Hospital.
research endpoint of the study was progress-free survival (PFS) assessed by the Independent Review Board (IRC) on the basis of reCIST v1.1.
secondary study endpoints include PFS assessed by researchers, objective efficiency (ORR), total lifetime (OS), and safety.
The study included 250 subjects who were randomly assigned to a group of 1:1, who received a combined 4-6 cycles of injection with carellidot monoantigen or placebo combined cisplatin and gissythabhamin, followed by an injection of carellidate monoantigen or placebo to maintain treatment until the disease progressed, toxicity was not acceptable, or other conditions required termination of treatment.
Recently, the study by the Independent Data Monitoring Committee (IDMC) determined that the main study end of the period analysis results reached the program preset of the best efficiency standards, the results show that the injection of karili-pearl monoantigen anti-combined cisplatin and gisithamid first-line treatment of local recurrence or distant metastatic nasopharyngeal cancer patients, compared to the standard first-line treatment of cisplatin gigsithambin, can significantly extend the patient's non-progress survival.
announced that so far, the cumulative investment in research and development costs of the injection karili pearl monoantigen has been about 111,797 million yuan.
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