A BLA submission has been initiated with the FDA for the PD-1 monoclonal antibody pianprinumab (AK105), which was co-developed by Canfang Biologics and China Biopharma.

On July 23, 2021, a media outlet found on Clinicaltrials.gov that Kangfang Bio had conducted a new phase III study in the first-line treatment of metastatic recurrent nasopharyngeal carcinoma.

However, as early as May 24, 2021, Canfang Bio announced that Canfang Bio has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of its PD-1 monoclonal antibody, paiamprimab (AK105), co-developed with China Biopharma, for the third-line treatment of metastatic nasopharyngeal carcinoma. Canfang Biologics will undergo marketing review under the RTOR program (the fastest approval pathway) and expects to receive approval in the third quarter.

While domestic approval is still pending, the overseas development of Canfang Biologics' paiamprimab is progressing more smoothly. in October 2020, the paiamprimab Phase II clinical trial for the registration of third-line treatment of metastatic nasopharyngeal carcinoma met its primary endpoint and was granted Fast Track status by the FDA.

Also on July 23, Incyte announced that the FDA denied approval of the company's biologics license application (BLA) for retifanlimab.

Retifanlimab is an intravenous PD-1 inhibitor with a BLA indication for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease has progressed or is intolerant to platinum-based chemotherapy. 94 subjects were recruited. The primary endpoint of the study was the objective remission rate (ORR) as assessed by the Independent Committee on Evaluation (ICR) according to RECIST v1.1 criteria. Secondary endpoints included DoR, DCR, PFS, OS, safety and pharmacokinetics.

The industry believes that Retifanlimab was denied single-arm Phase II launch necessitating completion of a Phase III clinical study because of the poor ORR data. the objective remission rate (ORR) for Retifanlimab monotherapy was 14% and the disease control rate (DCR) was 49%. Remission was observed regardless of PD-L1 status, presence of liver metastases, age, and HIV+ status, and was durable, with a median duration of remission (DOR) of 9.5 months. Median progression-free survival (PFS) was 2.3 months and median overall survival (OS) was 10.1 months.