Drugs / HS-20093

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed bone osteosarcoma 1 milestone
Filed China (NMPA) — bone osteosarcoma 2026-09-24

“用于治疗≥12周岁经既往至少二线治疗失败的骨肉瘤患者的上市许可申请获中国国家药品监督管理局(NMPA)受理” hansoh.cn ↗

Filed small cell lung carcinoma 1 milestone
Filed China (NMPA) — small cell lung carcinoma 2026-09-02

“HS-20093(risvutatug rezetecan, or Ris-Rez)for injection was been accepted by the National Medical Products Administration (the “NMPA”) of China on September 2, 2026” hspharm.com ↗

“HS-20093(Risvutatug Rezetecan)用于治疗既往含铂治疗失败的小细胞肺癌(SCLC)成人患者的上市许可申请获中国国家药品监督管理局(NMPA)受理” hansoh.cn ↗

Trials 24

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT07462923 Jan → Dec 2026 expected adenocarcinoma Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1 NCT07186452 Sep 2025 → Jul 2026 overdue cancer Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1 NCT07115446 Aug 2025 → Dec 2027 expected prostate cancer Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1 NCT07063407 Jul 2025 → Apr 2026 overdue small cell lung carcinoma Shanghai Hansoh Biomedical Co., Ltd Not yet recruiting No outcome recorded
Phase 1 NCT06963502 May 2025 → Dec 2028 expected colorectal cancer, non-small cell lung carcinoma Jiangsu Hansoh Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT06769425 May 2025 → May 2026 overdue female breast carcinoma, gastric cancer, ovarian cancer, prostate cancer +1 Jiangsu Hansoh Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT06699576 Dec 2024 → Dec 2026 expected osteosarcoma, soft tissue sarcoma Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 1 NCT06621563 Dec 2024 → Mar 2026 overdue colorectal cancer, non-small cell lung carcinoma Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1 NCT06825624 Oct 2024 → Oct 2026 expected colorectal cancer Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1 NCT06332170 Apr 2024 → May 2026 overdue neoplastic disease or syndrome Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT07736612 Aug 2026 → Aug 2028 expected malignant pancreatic neoplasm Zhejiang University Not yet recruiting No outcome recorded
Phase 27 trials
Phase 2 NCT07824882 Sep 2026 → Mar 2028 expected non-small cell lung carcinoma Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 2 NCT07230106 Dec 2025 → Dec 2028 expected prostate cancer Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06052423 Nov 2024 → Jun 2025 small cell lung carcinoma Hansoh BioMedical R&D Company Withdrawn No outcome recorded Stop: Business
Phase 2 NCT06112704 Feb 2024 → Jul 2026 overdue neoplasm Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 2 NCT06001255 Jan → Dec 2024 overdue castration-resistant prostate carcinoma Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 2 NCT06007729 Dec 2023 → Dec 2025 overdue head and neck squamous cell carcinoma Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 2 NCT05830123 Jun 2023 → Dec 2025 overdue osteosarcoma Hansoh BioMedical R&D Company Recruiting No outcome recorded
Phase 35 trials · 1 met primary
Phase 3 NCT07621601 Jul 2026 → Dec 2030 expected esophageal squamous cell carcinoma Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 3 NCT07464327 Mar 2026 → Dec 2028 expected non-small cell lung carcinoma Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 3 NCT06935409 Apr 2025 → Aug 2026 overdue osteosarcoma Hansoh BioMedical R&D Company Active not recruiting Met primary
Phase 3 NCT06526624 Sep 2024 → Nov 2027 expected small cell lung carcinoma Hansoh BioMedical R&D Company Not yet recruiting No outcome recorded
Phase 3 NCT06498479 Jul 2024 → Sep 2026 overdue small cell lung carcinoma Hansoh BioMedical R&D Company Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 41

DateIssuerRelease
2026-09-24 Hansoh BioMedical R&D Company Regulatory 翰森制药 | 瑞康立伏妥塔单抗治疗骨肉瘤上市许可申请获国家药品监督管理局受理 hansoh.cn ↗
2026年9月24日,翰森制药集团有限公司(翰森制药,03692. HK)宣布,公司自主研发的注射用瑞康立伏妥塔单抗(HS-20093)用于治疗≥12周岁经既往至少二线治疗失败的骨肉瘤患者的上市许可申请获中国国家药品监督管理局(NMPA)受理,受理号为CXSS2600155,该适应症此前已于2026年9月14日被NMPA纳入优先审评审批程序.
2026-09-13 Jiangsu Hansoh Pharmaceutical Co., Ltd. Results 2026 WCLC | HANSOH PHARMA ANNOUNCES INTERIM RESULTS FROM PHASE 3 ARTEMIS-008 STUDY OF RISVUTATUG REZETECAN (HS-20093) IN PATIENTS WITH RELAPSED SMALL CELL LUNG CANCER hspharm.com ↗
At the prespecified interim analysis, the study met its primary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement in survival.
2026-09-13 Hansoh BioMedical R&D Company Results WCLC 2026 | 翰森制药公布瑞康立伏妥塔单抗(HS-20093)用于复发性小细胞肺癌患者Ⅲ期ARTEMIS-008研究期中数据 hansoh.cn ↗
此次WCLC 2026披露的ARTEMIS-008研究期中分析结果显示:瑞康立伏妥塔单抗在复发性小细胞肺癌患者中展现出具有统计学意义和临床意义的OS改善.
2026-09-13 GlaxoSmithKline Results Ris-Rez reduced risk of death by 54% versus topotecan in patients with relapsed small cell lung cancer in China gsk.com ↗
Patients receiving Ris-Rez lived a median of 18.5 months (n=230) compared with 10.3 months for those receiving topotecan (n=231).
2026-09-07 Jiangsu Hansoh Pharmaceutical Co., Ltd. Regulatory BIOLOGICS LICENSE APPLICATION OF RISVUTATUG REZETCAN (HS-20093) FOR INJECTION FOR SMALL CELL LUNG CANCER ACCEPTED BY THE NMPA hspharm.com ↗
2026-09-02 Hansoh BioMedical R&D Company Regulatory 翰森制药注射用HS-20093治疗小细胞肺癌的上市许可申请获国家药品监督管理局正式受理 hansoh.cn ↗
2026年9月2日,翰森制药集团有限公司(翰森制药,03692. HK)宣布,公司自主研发的注射用HS-20093(Risvutatug Rezetecan)用于治疗既往含铂治疗失败的小细胞肺癌(SCLC)成人患者的上市许可申请获中国国家药品监督管理局(NMPA)受理,受理号为CXSS2600134.
2026-07-28 Jiangsu Hansoh Pharmaceutical Co., Ltd. Results HANSOH PHARMA ANNOUNCES ARTEMIS-011 PHASE 3 TRIAL OF RISVUTATUG REZETECAN (HS-20093) MET PRIMARY ENDPOINT OF IRC-ASSESSED PFS IN OSTEOSARCOMA hspharm.com ↗
Compared with chemotherapy, Ris-Rez demonstrated a statistically significant and clinically meaningful improvement in IRC-assessed PFS.
2026-07-28 Hansoh BioMedical R&D Company Results 翰森制药 | B7-H3 ADC Risvutatug Rezetecan(HS-20093)骨肉瘤III期临床ARTEMIS-011达到IRC-PFS主要终点 hansoh.cn ↗
与化疗相比,Risvutatug Rezetecan 在 IRC 评估的 PFS 方面显示出具有统计学显著性和临床意义的改善.
2026-07-10 Jiangsu Hansoh Pharmaceutical Co., Ltd. Results HANSOH PHARMA ANNOUNCES ARTEMIS-008 TRIAL OF RISVUTATUG REZETECAN (HS-20093) MET ITS PRIMARY ENDPOINT OF OVERALL SURVIVAL IN SMALL CELL LUNG CANCER hspharm.com ↗
At a pre-specified interim analysis, Ris-Rez provided statistically significant and clinically meaningful OS improvements compared with topotecan.
2026-07-10 Hansoh BioMedical R&D Company Results 翰森制药 | HS-20093(B7-H3 ADC)小细胞肺癌Ⅲ期临床研究ARTEMIS-008达到OS主要终点 hansoh.cn ↗
在预设的期中分析中,与托泊替康相比,Risvutatug Rezetecan在OS方面显示出具有统计学意义和临床意义的改善.
2026-07-10 GlaxoSmithKline Results GSK’s licensor Hansoh Pharma announces positive phase III results for Ris-Rez in China patient population gsk.com ↗
In the trial, conducted in patients in China, Ris-Rez demonstrated statistically significant and clinically meaningful improvements in OS compared with the standard of care, topotecan.
2026-06-18 Jiangsu Hansoh Pharmaceutical Co., Ltd. Results ESMO TAT ASIA 2026 | HANSOH PHARMA PRESENTS PHASE 2 DATA OF RISVUTATUG REZETECAN (RIS-REZ) IN RELAPSED OR REFRACTORY SARCOMAS hspharm.com ↗
At ESMO TAT Asia 2026, long-term follow-up results were presented for adult and adolescent (12-<18 years) patients with osteosarcoma, as well as for adult patients with soft tissue sarcoma (STS) from this study.

All press releases naming this drug 44 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 24 sources stand behind the page.

FieldValueCited text
Known as HS-20093 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06052423 ↗
23

NCT06112704 ↗

NCT07063407 ↗

NCT07464327 ↗

NCT06498479 ↗

NCT06526624 ↗

NCT06963502 ↗

NCT07462923 ↗

NCT06935409 ↗

NCT06007729 ↗

NCT07824882 ↗

Show 13 more sources

Modality Other / unclassified “fully humanized IgG1 antibody-drug conjugate (ADC)” NCT05830123 ↗
Route Intravenous “Intravenous (IV) administration of HS-20093 Q3W” NCT05276609 ↗