Hansoh Pharma Submits NDA for Class 1 New Anticancer Drug HS-10365, a Highly Selective RET Inhibitor, for RET Fusion-Positive NSCLC

On October 23, the CDE official website showedIndicates that Hansoh Pharma has independently developedRET InhibitorHS-10365Capsule Market Application Accepted, Insight Database Speculates Indication asRET Fusion-Positive Non-Small Cell Lung Cancer（NSCLC）. This is the third domestically produced RET inhibitor to be submitted for marketing approval in China.

HS-10365 is aHighly efficient and highly selective tyrosine kinase inhibitor。The RET gene is a relatively rare oncogene that encodes the RET protein.(Tyrosine Kinase Receptor）, Abnormal activation due to RET fusion and RET point mutations can promote the development and progression of various solid tumors through downstream signal transducer and activator of transcription as well as phospholipase Cγ pathways.

Previously, Hansoh Pharma announced HS-10365 at the 2023 AACR Conference.InRET Gene Fusion-Positive AdvancedNSCLC Single Drug in the PopulationI Data from the dose escalation study。

The results showed that HS-10365 demonstrated efficacy in RET fusion-positive advanced NSCLC patients without standard treatment options or unable to access or tolerate standard treatments.Good safety, tolerability and pharmacokinetic characteristics, and showedSuperior Antitumor Activity。

HS-10365 The ORR for treatment-naïve NSCLC patients was 83.3%, and the ORR for previously treated NSCLC patients was 66.7%, with complete response of target lesions observed in 2 subjects., with the longest remission time exceeding 48 weeks, demonstrating remarkable and durable anti-tumor activity.