Jiangsu Suzhong Pharma Group Co., Ltd, a leading pharmaceutical company based in China, has received a breakthrough therapy designation from the National Medical Products Administration (NMPA) for its drug candidate sutetinib, which is under development for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific non-resistant rare EGFR mutations, including L861Q, G719X, and/or S768I. This development is a significant milestone for the company, as it highlights the potential impact of sutetinib in addressing unmet medical needs for patients with these mutations.
Sutetinib, which is co-developed with Teligene Ltd, is a small molecule that targets EGFR and has demonstrated an impressive objective response rate (ORR) of 92.9% in a Phase IIa study involving patients with the aforementioned NSCLC who received a daily dose of 80mg sutetinib. The drug has shown promising results, suggesting its potential to become a new standard of care for patients with these mutations.
The company’s commitment to innovation in oncology is evident in its pipeline, which includes sutetinib as a key asset. The breakthrough therapy designation underscores the drug’s potential to offer a much-needed treatment option for patients with non-resistant rare EGFR mutations, who currently have limited therapeutic options available to them.- Flcube.com
