This BTD for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC patients that received IBI351 monotherapy. Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed. The study results will be published at the upcoming American Society Of Clinical Oncology (ASCO) Annual Meeting 2023.

IBI351 is the first KRAS^G12C inhibitor that received NMPA BTD for advanced CRC.  In January 2023, IBI351 has received NMPA BTD for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS^G12C mutation who have received at least one systemic therapy.

"We are glad to see the NMPA grants another Breakthrough Therapy Designation based on the preliminary results of IBI351 monotherapy in advanced colorectal carcinoma," said Dr. Hui Zhou, Senior Vice President of Innovent. "The prognosis of advanced colorectal carcinoma patients with KRAS^G12C mutation is worse than KRAS wild type patients with limited therapeutic options. Currently, there are no approved drugs targeting KRAS^G12C available on the market in China. The preliminary data of IBI351 monotherapy has shown outstanding efficacy and favorable safety in previously treated advanced colorectal carcinoma. We look forward to obtaining more data from the ongoing clinical trials, and further validating the clinical benefits of IBI351 as monotherapy or combination therapy in patients with advanced colorectal carcinoma."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace.