Hansoh Pharma Submits NDA for HS-10365, a Novel Class 1 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）, due to RET fusion and RET point mutations, abnormal activation 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 Dose Escalation Trial Research Data。

The results showed that HS-10365 demonstrated efficacy in RET fusion-positive advanced NSCLC patients with no standard treatment options available, or unable to access or tolerate standard treatments.Good safety, tolerability and pharmacokinetic characteristics, and displaySuperior 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.

Insight database shows that currently in China, there are alreadyTwo RET inhibitors approved for marketing,Pralsetinib（Blueprint Medicines/CStone PharmaceuticalsAnd Selpercatinib(Eli Lilly). In addition, RET inhibitors produced in China have begun to enter the harvest period, with several3 Products Submitted for Marketing Approval, except forIn addition to HS-10365, there are also Kelun Botai's Lunbotinib and Shouyao Holdings' Suotinib.

Hansoh Pharma's innovative drugs currently generating sales revenue in ChinaA total of 7 productsIn the first half of this year, the sales revenue of Hansoh Pharma's innovative drugs and collaborative products amounted to approximately RMB 6.145 billion, representing a year-on-year increase of 22.1% and accounting for 82.7% of total revenue.HS-10365 is expected to bring new performance growth for Hansoh Pharma in the future.

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