Introduced 15 months of Simcere Pharmaceuticals and submitted a new drug listing application for CDK 4/6 inhibitors

ArticleMedicine Guanlan

On November 29, Simcere announced that its new drug marketing application (NDA) for injection of trilaciclib, an innovative drug for bone marrow protection, submitted to the National Medical Products Administration (NMPA), has been accepted

Although many targeted therapies and immunotherapies have shown good curative effects in the treatment of various cancers, for many patients, chemotherapy is still one of the main means to control the development of tumors

Trirazilide is a short-acting CDK 4/6 inhibitor.

According to Simcere’s press release, the first indication applied for Trirazil in China is: preventive use in patients with extensive-stage small cell lung cancer receiving platinum-containing drugs combined with etoposide regimen to reduce chemotherapy-induced The incidence of bone marrow suppression

In the United States, Trirazil has been granted breakthrough therapy designation and priority review by the FDA, and has been approved by the FDA for marketing in February 2021.

The effectiveness of trirazilide is supported by 3 randomized, double-blind, placebo-controlled studies in patients with extensive-stage small cell lung cancer

The FDA once pointed out in a press release that for patients with extensive-stage small cell lung cancer, protecting bone marrow function can help make their chemotherapy safer and allow them to complete the course of treatment as planned

In addition to small cell lung cancer, G1 and Simcere Pharmaceuticals have also initiated phase 3 clinical trials of Trirazil for colorectal cancer and triple-negative breast cancer.

Reference materials:

[1] Simcere Pharmaceuticals announced that the world’s first comprehensive bone marrow-protecting drug trerazil had been accepted for marketing authorization.

[2] Simcere and G1 Therapeutics announced the signing of an exclusive license agreement for Trilaciclib products in the Greater China region.