Two innovative drugs are planned to be included in the priority review from Betta Pharmaceuticals and Cinda Bio

According to the latest announcement by the Center for Drug Evaluation (CDE) of the State Drug Administration of China, two innovative drugs were included in the proposed priority review on July 23, namely Betta Pharmaceuticals' ALK inhibitor Ensatinib and Xin Dabio's FGFR inhibitor pemigatinib tablets

Screenshot source: CDE official website

Betta Pharmaceuticals: Ensatinib

Mechanism of action: ALK inhibitor

Indications: First-line treatment of non-small cell lung cancer (NSCLC)

Ensatinib is a new, potent and highly selective next-generation anaplastic lymphoma kinase (ALK) inhibitor, jointly developed by Betta Pharmaceuticals and its holding subsidiary Xcovery

Screenshot source: CDE official website

This time, it is proposed to be included in the priority review application for a new indication for the first-line treatment of ALK-positive patients with locally advanced or metastatic NSCLC

The results of the study showed that as of December 8, 2020: In the intention-to-treat (ITT) population, the median progression-free survival (PFS) of patients in the Ensatinib group was 31.

Cinda Bio: pemigatinib tablets

Mechanism of action: FGFR inhibitor

Indications: patients with cholangiocarcinoma

Pemigatinib is a selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, jointly developed by Incyte and Innovent.

Screenshot source: CDE official website

According to the press release issued by Cinda Biologics, the drug's marketing application in mainland China is based on an open, single-arm, multi-center Phase 2 study, which aims to undergo at least first-line systemic treatment in the past To evaluate the efficacy and safety of pemigatinib in patients with locally advanced, recurrent or metastatic cholangiocarcinoma who have failed, unresectable surgery with FGFR2 fusion or rearrangement

In this study, 108 subjects with cholangiocarcinoma were enrolled