dalmelitinib (HS-10241) / Jiangsu Hansoh Pharma - LARVOL DELTA

ELCC 2026 | Hansoh Pharma Presented Results of Dalmelitinib (HS-10241, a Highly Selective MET-TKI) Combined with Aumolertinib from a Phase Ib Study in Patients with MET-Amplified Advanced NSCLC Post EGFR TKI (Hansoh Pharma Press Release) - "(i) Encouraging Efficacy：In 115 efficacy-evaluable NSCLC patients with MET-amplification post EGFR TKI treatment, median PFS was 7.4 months and median OS was 25.4 months; (ii) Manageable safety profile: Overall, the combination of Dalmelitinib with Aumolertinib in 132 patients showed a manageable safety profile. Most TEAEs were grade 1-2, and were generally reversible."

P1 data • Non Small Cell Lung Cancer

HS-10241 combined with aumolertinib in EGFR-TKIs pretreated EGFR-mutant and MET-amplified advanced NSCLC: A phase Ib study (ELCC 2026) - P1 | "The treatment related adverse events (TRAEs) leading to discontinuation were reported in 5.3% of pts. The grade ≥3 TRAEs occurring in ≥15% of pts were gamma-glutamyltransferase increased (15.9%), alanine aminotransferase increased (15.9%) and, aspartate aminotransferase increased (15.2%); the incidence of grade ≥3 oedema peripheral was only 3.0%.Conclusions The combination of HS-10241 and aumolertinib showed a favorable safety profile and promising efficacy in pts with NSCLC harboring EGFR mutation and METamp.Editorial acknowledgement Medical writing support was provided by Liangjie Zhong, an employee of Shanghai Hansoh BioMedical Co., Ltd."

Metastases • P1 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Hansoh secured NMPA acceptance for its new Dalmelitinib lung cancer drug combination. (TipRanks)

China filing • Non Small Cell Lung Cancer

…New Drug Application (NDA) of the Group’s innovative drug Dalmelitinib Mesylate Tablets in combination with Aumolertinib Mesylate Tablets (Ameile), has been accepted by the…NMPA of China for the treatment of patients with locally advanced or metastatic…EGFR mutation-positive…NSCLC whose tumors have...MET amplification after prior EGFR tyrosine kinase inhibitor (TKI) therapy (HKEXnews)

China filing • Non Small Cell Lung Cancer

Pharmacokinetic Study of HS-10241 Tablets 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-10241 Combined With Almonertinib Versus Platinum-based Chemotherapy in Treatment of Advanced NSCLC With MET Amplification After Failure of EGFR-TKI Therapy (clinicaltrials.gov) - P3 | N=314 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Metastases • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Lung Adenocarcinoma Patient with Co-mutations of MET Exon 14 Skipping and EGFR exon21 L858R responded to Aumolertinib (IASLC-WCLC 2023) - P1 | "The prevalence rate of coexisting MET exon 14 mutations and EGFR sensitive mutations (L858R, exon 19 deletions) in Chinese population was reported to be 0.2%,and the management of these subtype is not identified.This patient has received significant clinical benefits from antivascular drugs combined with chemotherapy sequential third generation EGFR-TKI Aumolertinib therapy, especially the sustained remission of intracranial lesions, which provides a reference for our clinical treatment of such patients. Case presentation. In November 2021,a 47-year-old male patient developed head discomfort with left lower limb weakness for 1 week.Brain MRI showed multiple intracranial lesions, which were considered to be brain metastases.In order to identify the primary lesion,CT showed a soft tissue mass in upper lobe of the right lung and mediastinal lymphadenopathy.To determine the pathological type,In December 2021,he underwent a lung biopsy, whose path report showed lung..."

Clinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • MET • ROS1

Phase 1b study of HS-10241 combined with almonertinib in pre-treated advanced non-small cell lung cancer (NSCLC) harboring EGFR mutation. (ASCO 2023) - P1 | "HS-10241 in combination with almonertinib was well tolerated, and showed encouraging antitumor activity in treatment of advanced NSCLC with EGFR mutation and MET amplification following prior EGFR-TKI, whether MET GCN ≥10 or MET GCN ≥5 but < 10. Clinical trial information: NCT05430386."

Metastases • P1 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • EGFR • MET

Phase 1 Study of the Selective c-MET Inhibitor, HS-10241, in Patients With Advanced Solid Tumors. (PubMed, JTO Clin Res Rep) - "The selective c-MET inhibitor HS-10241 was well tolerated and had clinical activity in advanced NSCLC, especially in patients with positive MET. Furthermore, this study expounds on the therapeutic potential of HS-10241 in patients with cancer."

Journal • Metastases • P1 data • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase I Study of the Selective c-Met Inhibitor, HS-10241, in Patients with Advanced Solid Tumours (J Thorac Oncol) - P1 | N=27 | "A total of 27 patients with advanced non-small cell lung cancer (NSCLC) received HS-10241, and DLT was observed in three patients after 600 mg qd HS-10241 treatment. For qd dosing, MTD was 400 mg, and for bid dosing, the maximal safe escalated dose was 300 mg and MTD was not reached....At 400 mg qd, Css,max was 5076 ng/mL and steady-state area under the curve was 39998 h·ng/mL. Patients (n = 5) with positive MET (MET exon 14-skipping, MET amplified and MET immunohistochemistry 3+) had confirmed partial responses (n = 1) or stable disease (n = 3), with a disease control rate of 80.0%....The selective c-MET inhibitor HS-10241 was well-tolerated and showed clinical activity in advanced NSCLC, especially in patients with positive MET."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of HS-10241 in Combination With Almonertinib in Patients With Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=174 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Combination therapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

PhaseⅠStudy of the HS-10241 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Oncology • Solid Tumor