Drugs / SHR-4849
last change Dec 2025 re-read 9 days ago

SHR-4849

Developed for
cancer
Investigated by
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shanghai Hengrui Pharmaceutical Co., Ltd.

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06443489 Jun 2024 → Dec 2026 expected cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT07268040 Dec 2025 → Dec 2028 expected cancer Shanghai Hengrui Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT07028281 Jul 2025 → Dec 2028 expected cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-09-16 Jiangsu HengRui Medicine Co., Ltd. Results 2025 WCLC口头报告|恒瑞创新药SHR-4849在复发性小细胞肺癌患者中的首次人体Ⅰ期研究结果披露 hengrui.com ↗
结果显示 [1] ,SHR-4849在复发性小细胞肺癌患者中展现出可耐受且可控的安全性特征。
2025-09-07 IDEAYA Biosciences Results IDEAYA Biosciences and Hengrui Pharma Present Positive Phase 1 Data for IDE849 (SHR-4849), a Potential First-in-Class DLL3 TOP1 ADC, in Small Cell Lung Cancer at the IASLC 2025 World Conference on Lung Cancer ideayabio.com ↗
80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR in 2L SCLC; a 73.7% (14/19) ORR and 57.9% (11/19) confirmed ORR (1 pending confirmation) were observed across all lines of SCLC at the 2.4 mg/kg expansion dose of IDE849
2025-05-06 IDEAYA Biosciences Regulatory IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors ideayabio.com ↗

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as SHR-4849 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06443489 ↗
2

NCT07028281 ↗

NCT07268040 ↗