Drugs / Ris-Rez
Ris-Rez
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | small cell lung carcinoma | 2026-09-02 | “the biologics license application (BLA) of the Group’s innovative medicine HS-20093（risvutatug rezetecan, or Ris-Rez）for injection was been accepted by the National Medical...” hspharm.com ↗ “the biologics license application for Ris-Rez for the treatment of SCLC was accepted by the National Medical Products Administration (NMPA) of China” hspharm.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06551142 | Sep 2024 → Oct 2028 expected | neoplasm | GlaxoSmithKline | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 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 | 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 ↗ |
| 2026-07-28 | 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 | GlaxoSmithKline | Results GSK’s licensor Hansoh Pharma announces positive results from a second phase III trial for Ris-Rez in China gsk.com ↗
In the trial, conducted in patients in China, Ris-Rez, a B7-H3-targeted antibody-drug conjugate (ADC), demonstrated statistically significant and clinically meaningful improvements in PFS compared with chemotherapy. |
| 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 | 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. |
| 2026-06-18 | Hansoh BioMedical R&D Company | Results ESMO TAT ASIA 2026 | 翰森制药公布Risvutatug Rezetecan（B7-H3 ADC）用于复发或难治性肉瘤治疗的Ⅱ期研究数据 hansoh.cn ↗
中位随访时间为22. 1个月，经确认的ORR（cORR）为23. 1%，疾病控制率（DCR）为92. 3%，中位PFS为9. 4个月，中位OS为22. 6个月. |
| 2026-04-20 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results AACR 2026 | HANSOH PHARMA PRESENTED PHASE 1 RESULTS OF RISVUTATUG REZETECAN PLUS ADEBRELIMAB IN NON-SQUAMOUS NSCLC WITHOUT ACTIONABLE GENOMIC ALTERATIONS hspharm.com ↗
At AACR 2026, data from an expansion cohort of the phase 1 ARTEMIS-101 study evaluating risvutatug rezetecan plus adebrelimab in patients with previously treated nsq-NSCLC without AGAs were presented as an oral presentation. |
| 2026-04-20 | Hansoh BioMedical R&D Company | Results AACR 2026 | 翰森制药Risvutatug Rezetecan（B7-H3 ADC）联合阿得贝利单抗治疗驱动基因阴性的非鳞状NSCLC的Ⅰ期研究结果发布 hansoh.cn ↗
Risvutatug rezetecan联合阿得贝利单抗在既往经治的驱动基因阴性非鳞状非小细胞肺癌患者中确认的客观缓解率达47. 1%，中位无进展生存期为14. 0个月（32. 4%事件发生率），且安全性总体可控. |
| 2026-03-23 | GlaxoSmithKline | Regulatory GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan, granted Orphan Drug Designation for small-cell lung cancer in Japan gsk.com ↗ |
| 2026-03-06 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results CANCER CELL PUBLISHES PHASE 1 LUNG CANCER RESULTS OF RISVUTATUG REZETECAN hspharm.com ↗
In ES-SCLC (N=65), the cORR was 52.3% in a population in which approximately 60% had received ≥2 prior lines of therapy; median duration of response (DoR) was 7.1 months, median progression-free survival (PFS) was 6.2 months and median overall survival (OS) was 13.0 months. |
| 2026-03-06 | Hansoh BioMedical R&D Company | Results 翰森制药丨Cancer Cell 发表B7-H3靶向ADC Risvutatug Rezetecan Ia/b期肺癌研究数据 hansoh.cn ↗
65例经治ES-SCLC患者中约60%既往接受过≥2线治疗，cORR为52. 3%，中位缓解持续时间（DoR）为7. 1个月，中位无进展生存期（PFS）为6. 2个月，中位总生存期（OS）为13. 0个月. |
| 2026-02-28 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ASCO GU 2026 | HANSOH PHARMA PRESENTED PHASE 2 DATA OF RISVUTATUG REZETECAN IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER hspharm.com ↗
Risvutatug rezetecan showed anti-tumor activity with a generally manageable safety profile in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after prior novel hormonal agents. |
| 2026-02-27 | Hansoh BioMedical R&D Company | Results ASCO GU 2026 | 翰森制药Risvutatug Rezetecan(B7-H3 ADC)治疗转移性去势抵抗性前列腺癌 (mCRPC)II期临床数据发布 hansoh.cn ↗
Risvutatug Rezetecan 在既往接受过紫杉烷类治疗和未接受过紫杉烷类治疗的转移性去势抵抗性前列腺癌患者中，均显示出令人鼓舞的抗肿瘤活性. |
| 2025-12-17 | Hansoh BioMedical R&D Company | Results ESMO ASIA | 翰森制药Risvutatug Rezetecan（ HS-20093）治疗NSCLC的Ⅰ期研究结果亮相 hansoh.cn ↗
该亚组中，8. 0 mg/kg 组经确认客观缓解率（cORR）达33. 3%，中位无进展生存期（mPFS）7. 0 个月，中位总生存期（mOS）尚未达到；10. 0 mg/kg 组 cORR 为 10. 7%，mPFS 4. 1 个月，mOS 17. 5 个月. |
| 2025-12-10 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ESMO ASIA | HANSOH PHARMA ANNOUNCES MINI ORAL PRESENTATION OF PHASE 1 STUDY OF RISVUTATUG REZETECAN (HS-20093, A B7-H3-TARGETED ADC) IN PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) hspharm.com ↗
Risvutatug rezetecan administered at 8.0 and 10.0 mg/kg every 3 weeks showed encouraging anti-tumour activity in patients with locally-advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), especially in patients with non-squamous NSCLC without actionable genomic alterations(AGAs). |
| 2025-12-10 | GlaxoSmithKline | Regulatory GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that its B7-H3-targeted antibody-drug conjugate GSK’227, now referred to by its International Nonproprietary Name, risvutatug rezetecan, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of small-cell lung cancer (SCLC). |
All press releases naming this drug 20 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ris-Rez | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06551142 ↗ |
| Known as | GSK5764227 | “The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227.” NCT06551142 ↗ |
| Known as | Risvutatug rezetecan | “The goal of this study is to assess the safety, tolerability, clinical activity and pharmacokinetics of Risvutatug rezetecan (Ris-Rez), also known as GSK5764227.” NCT06551142 ↗ |