BeiGene: Bizean new indication marketing authorization application accepted

BeiGene announced December 30 that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted a new indication authorization application (sBLA) for the treatment of first-line patients with unresectable or metastatic hepatocellular carcinoma (HCC) by BioGene ®.

HCC is the most common type of primary liver cancer worldwide and has an extremely poor prognosis^[i]. China accounts for about half of the global number of new cases and deaths from HCC, with a 5-year survival rate of only 14% ^[ii].

"Although the incidence of HCC in China continues to rise, the current treatment status has not progressed accordingly, the survival benefit of newer treatment regimens is relatively limited, and the tolerability of multi-kinase inhibitors is only suboptimal," said Dr. Wang Lai, BeiGene's head of global research and development. BeiGene's global clinical development program for the use of HCC at a high standard is evident in the evidence strongly supporting the ® efficacy and well-tolerability of BioGene ®. We will continue to communicate closely with NMPA on this application to bring new treatment options for HCC patients in China."

The sBLA submitted is based on clinical trial data from RATIONALE 301 (NCT03412773). The results of the clinical trial, which enrolled a total of 674 patients from research centers in Asia, Europe and the United States, were presented as an oral presentation of the latest breakthrough at the 2022 European Society of Medical Oncology (ESMO) Congress in Paris, France.

Bazean ® has been approved by the NMPA for the treatment of 9 indications, including conditionally approved for the treatment of hepatocellular carcinoma (HCC) that has undergone at least one systemic therapy. In addition, the following new indication marketing authorization applications are ® under review by CDE: combination chemotherapy for first-line treatment of patients with PD-L1-expressing advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and combination chemotherapy for first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). At present, Bazean ® has not been approved in countries or regions other than China.