Biopharmaceutical company Innovent Biologics has announced that China’s National Medical Products Administration (NMPA) has approved Dupert (fulzerasib) for advanced non-small cell lung cancer (NSCLC).
The therapeutic agent was approved to treat adult advanced NSCLC patients harbouring KRAS G12C mutation. The patients must have received at least one systemic therapy to become eligible for Dupert treatment.
Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor. It is designed to target the GTP/GDP exchange by changing the cysteine residue of KRAS G12C protein.
This prevents the downstream signal pathway to induce tumour cells’ apoptosis and cell cycle arrest.
Innovent entered into an exclusive licence agreement with GenFleet Therapeutics in September 2021 for the development and commercialisation of fulzerasib in China including Hong Kong, Macau and Taiwan.
Fulzerasib received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of NMPA in January 2023.
The latest approval is based on the results from a single-arm registrational Phase 2 clinical study of fulzerasib. The trial tested the efficacy and safety of fulzerasib monotherapy who not intolerant to standard treatment in the country.
Among 116 NSCLC subjects, Fulzerasib was generally well-tolerated, the company said.
Innovent senior vice president Dr Hui Zhou said: “Patients with advanced NSCLC harbouring KRAS G12C mutations have limited treatment options, with traditional chemotherapy offering minimal benefits.
“We are excited that Dupert has become the first KRAS G12C inhibitor approved in China, marking the beginning of a new era in targeted therapy for KRAS mutations.
“As Innovent’s eleventh drug, Dupert further strengthens our robust oncology portfolio. Innovent will continue to leverage its leadership and expertise in oncology to drive innovation in cancer treatment and serve more patients in need.”
Last month, Innovent Biologics entered into a partnership with WeComput to advance its artificial intelligence (AI) driven drug discovery and development platform.
