resencatinib (HS-10365) / Jiangsu Hansoh Pharma - LARVOL DELTA

Hansoh Pharmaceutical Group Co., Ltd… announced that the encouraging results of resencatinib，a highly selective RET receptor tyrosine kinase inhibitor, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring RET gene fusions were presented in a poster session at the ESMO ASIA Congress 2025 (December 05-07, Singapore). (Hansoh Pharma Press Release) - "Efficacy results for Cohort 1 and Cohort 2 as assessed by the Independent Review Committee (IRC) are as follows: confirmed Objective Response Rate (ORR) was 80.0% and 83.3%, respectively; Disease Control Rate (DCR) was 96.0% and 93.3%, respectively; and 12-month Progression-Free Survival (PFS) rate was 81.1% and 79.3%, respectively."

P1/2 data • Non Small Cell Lung Cancer

Resencatinib (HS-10365) in RET-fusion locally advanced or metastatic NSCLC: Updated results (ESMO Asia 2025) - P1/2 | "These results demonstrate resencatinib's potential as a line-agnostic targeted therapy in pts with RET-fusion locally advanced/metastatic NSCLC."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • RET

…Hansoh Pharmaceutical Group Company Limited…is pleased to announce that, on October 23, 2025, the New Drug Application (NDA) of the Group’s innovative drug HS-10365 capsules…has been accepted by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) (HKEXnews)

China filing • Non Small Cell Lung Cancer

Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=62 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase Ⅰ/Ⅱ Study of the HS-10365 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=48 ➔ 306 | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Apr 2024

Enrollment change • Metastases • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • PD-L1 • RET

HS-10365, a highly potent and selective RET tyrosine kinase inhibitor, demonstrates robust activity in RET fusion positive NSCLC patients (AACR 2023) - P1 | "Background: Activating RET alterations drive oncogenic signaling in lung, thyroid, and other solid tumors.Until recently, only two RET tyrosine kinase inhibitor (TKI), BLU-667 and LOXO-292, had received approval for advanced NSCLC by FDA and NMPA. HS-10365 showed a manageable safety profile and favorable PK properties. The promising antitumor activity with expectable response time was observed in RET fusion+ NSCLC pts, no matter with or without previous treatments."

Clinical • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • CCDC6 • KIF5B • RET