Hansoh Pharma Announces Phase 2 Clinical Results of Risenitinib, a Novel Small-Molecule RET Inhibitor, for RET Fusion-Positive Non-Small Cell Lung Cancer

On December 18, Hansoh Pharma announced that its self-developedHighly Selective RET (Rearranged During Transfection) Inhibitor Resnitinib (HS-10365 Receptor Tyrosine Kinase Capsules), used forRETGene Fusion-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)The results of the treatment study were presented as a poster at the ESMO ASIA 2025, the annual meeting of the European Society for Medical Oncology in Asia.

HS-10365-101 Study (NCT05207787) is a multicenter, open-label phase 1/2 clinical trial with a "basket design," aimed at evaluating the safety, tolerability, PK profile, and efficacy of oral administration of Ruisentini. Preliminary data from the phase 1 study were disclosed at the 2023 American Association for Cancer Research (AACR) Annual Meeting.This ESMO ASIA disclosed the Phase 2 study results with a larger sample size and longer follow-up period., further validating the drug's efficacy inRETClinical Value in Patients with Locally Advanced or Metastatic NSCLC with Fusion Positivity.

The research results show:

• Efficacy: As of January 18, 2025, a total of 326 patients with advanced solid tumors received Ruisentini 160mg orally twice daily (BID) during the Phase 2 research stage, including Cohort 1 [patients who progressed after receiving platinum-based chemotherapy combined with or sequentially followed by PD-(L)1 treatment].RETFusion-positive locally advanced or metastatic NSCLC] with 75 cases, Cohort 2 (treatment-naïveRETThere were 60 cases of locally advanced or metastatic NSCLC with fusion positivity. The efficacy results assessed by the IRC for Cohort 1 and Cohort 2 are as follows:The confirmed objective response rates were 80.0% and 83.3%, respectively; the disease control rates were 96.0% and 93.3%, respectively; and the 12-month progression-free survival rates were 81.1% and 79.3%, respectively.

• Well Tolerated: During the study, the most common treatment-emergent adverse events with Ruisentini monotherapy were elevated alanine aminotransferase (64.7%), elevated aspartate aminotransferase (64.1%), and decreased white blood cell count (45.4%). The vast majority of adverse events were controllable and manageable, with only 4.9% of patients discontinuing treatment due to adverse events. No new safety signals were identified, further validating the drug's safety in clinical application.

In summary, the research results show that Ruisentini inRETIn both treatment-naïve and previously treated patients with locally advanced or metastatic NSCLC who are fusion-positive, significant and durable anti-tumor efficacy has been demonstrated, along with a well-manageable safety profile, offering a promising new treatment option for this patient population.

Ruisenitinib is a small molecule, highly selective RET receptor tyrosine kinase inhibitor that directly targets intracellular protein tyrosine kinases, competitively binding with ATP to inhibit tyrosine kinase phosphorylation, thereby effectively controlling tumor growth. In October 2025, the product's New Drug Application (NDA) was accepted by the National Medical Products Administration (NMPA) of China for the treatment ofRETAdult patients with locally advanced or metastatic non-small cell lung cancer positive for gene fusion.

References:
[1]ESMO ASIA | Hansoh Pharma's Ruisentini (HS-10365 Capsule) Research Results Released for the Treatment of RET Fusion-Positive Locally Advanced or Metastatic NSCLC. From https://mp.weixin.qq.com/s/7b_pQ2XFH0VdOz6kelriqw

Disclaimer: This article is for information exchange purposes only. The views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes the views mentioned. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.