Drugs / HS-10504
last change 11 days ago re-read 9 days ago

HS-10504

targets EGFR via inhibition

Developed for
lung cancer · non-small cell lung carcinoma
Investigated by
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Trials 4

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07836504 Sep 2026 → Sep 2027 expected — Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT07685041 Jun → Nov 2026 expected non-small cell lung carcinoma Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT07414953 Mar 2026 → Apr 2027 expected lung cancer Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT06461156 Jun 2024 → Dec 2026 expected — Jiangsu Hansoh Pharmaceutical Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-05-21 Jiangsu Hansoh Pharmaceutical Co., Ltd. Regulatory THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR FOURTH-GENERATION EGFR-TKI HS-10504 TABLETS FOR NSCLC hspharm.com ↗
The NMPA's Breakthrough Therapy Designation for HS-10504 tablets marks a significant step towards its availability to patients, as Hansoh Pharma continues to focus on unmet medical needs, and prioritize developing differentiated, high-quality innovative therapies to benefit more patients worldwide.
2026-04-22 Jiangsu Hansoh Pharmaceutical Co., Ltd. Results AACR 2026 | HANSOH PHARMA PRESENTED RESULTS OF HS-10504 (A NOVEL, POTENT, HIGHLY SELECTIVE, FOURTH-GENERATION EGFR TKI) FROM A FIRST IN HUMAN PHASE 1 STUDY IN PATIENTS WITH ADVANCED NSCLC hspharm.com ↗
In 34 efficacy-evaluable advanced NSCLC patients harboring EGFR C797S with or without T790M resistance mutations who received 400 mg once daily (QD), Objective Response Rate (ORR) was 52.9% and median Progression-Free Survival (PFS) was 9.6 months.

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as HS-10504 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07836504 ↗
3

NCT07685041 ↗

NCT06461156 ↗

NCT07414953 ↗

Action Inhibit “tyrosine kinase inhibitor targeting EGFR C797S mutation” NCT06461156 ↗
Route Oral “administered orally once daily” NCT06461156 ↗
Target EGFR “targeting EGFR C797S mutation” NCT06461156 ↗