Betta Pharmaceuticals submits a marketing application for a new generation of multi-targeted kinase inhibitors

TextPharmaceutical Guanlan

On January 11, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China announced that Betta Pharmaceuticals submitted a marketing application for a class 1 new drug, voronib tablets, and was accepted

Screenshot source: CDE official website

According to the public information of Betta Pharmaceuticals, voronib has anti-angiogenic efficacy against multiple targets such as VEGFR, PDGFR, c-Kit, Flt-3, CSF1R, etc.

Currently, the product is undergoing clinical trials in patients with end-stage renal disease and chronic age-related macular degeneration

▲Voronibu research and development progress (screenshot source: Betta Pharmaceuticals official website)

At the 2021 American Society of Clinical Oncology (ASCO) annual meeting, Betta Pharmaceuticals announced the results of the CONCEPT study

The results of the study showed that the progression-free survival (PFS) of the voronib + everolimus combination therapy group was longer than that of the everolimus single-agent group (median PFS, 10.

In terms of safety, there were 132, 127 and 131 treatment-related adverse events (TRAEs) in the three groups of patients, respectively

▲CONCEPT research results (Image source: Reference [2])

Betta Pharmaceuticals stated in a press release that the CONCEPT study is the first Phase 3 study of mTOR and VEGF-targeted drugs in second-line therapy

This time Betta Pharmaceuticals has submitted a new drug listing application for voronib in China, which means that the product has entered the stage of listing application

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China.