Simcere's 2 new anti-tumor drugs SIM1811-03 and paxalisib were approved for clinical use

ArticleMedicine Guanlan

On December 7, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that two Class 1 new drugs of Simcere Pharmaceuticals have obtained the implicit approval for clinical trials.

This is another important development in Simcere's innovative drug R&D pipeline recently

Screenshot source: CDE official website

Public information shows that SIM1811-03 (SIM0235) is an innovative anti-tumor drug independently developed by Simcere Pharmaceuticals.

Preclinical studies have shown that SIM1811-03 has high binding specificity, can effectively block the activation of NF-κB signaling pathway induced by the combination of tumor necrosis factor α (TNFα) and TNFR2, effectively inhibit the proliferation and function of Treg cells, and regulate immunity Microenvironment

In the in vivo pharmacodynamic model, SIM1811-03 has a significant anti-tumor effect in a variety of models, and has a significant combined effect with anti-PD-L1 antibody

It is reported that SIM1811-03 approved this time is a multi-center, open phase 1 clinical study for the treatment of advanced solid tumors and cutaneous T-cell lymphoma, which will evaluate the safety, pharmacokinetics, and efficacy of SIM1811-03 Academic characteristics and anti-tumor efficacy

Another approved clinical product, paxalisib (ie SIM0395), is a small molecule PI3K/mTOR pathway inhibitor introduced by Simcere from Kazia Therapeutics for more than US$290 million.

Glioblastoma is a common and very aggressive primary brain tumor

According to the information disclosed earlier by Simcere, the paxalisib clinical trial application was approved, and it will join the key international multi-center phase 2/3 platform clinical trial GBM AGILE being carried out globally in China

In recent years, Simcere has gradually shifted from being mainly engaged in generic drug business to being dominated by innovative drug business

Reference materials:

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

[3]Kazia Licenses Rights to Paxalisib in Greater China to Simcere, a Leading Chinese Pharmaceutical Company.

[4] One Article Reading | Simcere Pharmaceuticals Announces 2021 Interim Results: R&D investment continues to increase, and the progress of research projects exceeds expectations.