Drugs / HS-20094
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | obesity disorder | 2026-06-03 | “2026年6月3日，中国国家药品监督管理局（NMPA）受理了翰森制药HS-20094的上市许可申请（NDA），适用于肥胖或超重成人的长期体重管理.” hansoh.cn ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07057674 | Apr 2025 → Feb 2026 overdue | obesity disorder | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05116410 | Nov 2021 → Oct 2022 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06901648 | Feb 2024 → Mar 2025 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT06118021 | Oct 2023 → Aug 2024 | — | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT06118008 | May 2023 → Jan 2024 | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07156500 | Sep 2025 → Mar 2027 expected | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07156539 | Sep 2025 → Mar 2027 expected | type 2 diabetes mellitus | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06839664 | Nov 2024 → Jan 2026 | obesity disorder | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Hansoh BioMedical R&D Company | Results EASD 2026 | 48周减重19.3%，胃肠道耐受性优异！双偏向型GLP-1/GIP受体激动剂奥莱泊肽Ⅲ期（LIGHTEN）研究数据以突破性摘要口头报告公布 hansoh.cn ↗ |
| 2026-06-16 | Hansoh BioMedical R&D Company | Results ENDO 2026丨翰森制药发布新型双偏向性GLP-1/GIP受体激动剂奥莱泊肽体外药理学研究报告 hansoh.cn ↗
HS-20094显著减弱GLP-1R内化（Emax=65%，EC₅₀=87nM；天然GLP-1为99%，6. 6nM）和GIPR内化（Emax=26%，EC₅₀=23 nM；天然GIP为98%，6. 3nM），有利于延长受体在细胞表面的驻留时间，维持持续的cAMP信号传导. |
| 2026-06-04 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory NEW DRUG APPLICATION FOR OLATOREPATIDE INJECTION ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION hspharm.com ↗ |
| 2026-06-04 | Hansoh BioMedical R&D Company | Regulatory 翰森制药丨GLP-1/GIP双靶点减重创新药奥莱泊肽注射液上市许可申请获国家药品监督管理局受理 hansoh.cn ↗
2026年6月4日，翰森制药集团有限公司（以下简称“翰森制药”，03692. HK）宣布，公司创新药奥莱泊肽注射液上市许可申请（NDA）获中国国家药品监督管理局(NMPA)受理，适用于肥胖或超重成人的长期体重管理. |
| 2026-03-09 | Regeneron Pharmaceuticals | Results Olatorepatide Obesity Treatment Licensed by Regeneron Demonstrates Positive Phase 3 Results in Chinese Patients regeneron.com ↗
The trial met its co-primary endpoints, demonstrating that olatorepatide compared to placebo led to a statistically significant reduction in body weight from baseline, and also a statistically significant greater proportion of participants who achieved at least 5% weight loss at 48 weeks. |
| 2026-03-07 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results OLATOREPATIDE (HS-20094) ACHIEVES UP TO 19.3% WEIGHT LOSS AT WEEK 48 IN PHASE 3 STUDY WITH FAVORABLE GASTROINTESTINAL TOLERABILITY hspharm.com ↗
The study met its co-primary endpoints, demonstrating a statistically significant reduction in body weight from baseline at Week 48 and a statistically significantly greater proportion of participants achieving at least 5% weight loss at Week 48 with olatorepatide versus placebo. |
| 2026-03-07 | Hansoh BioMedical R&D Company | Results 翰森制药｜奥莱泊肽（HS-20094）在 III 期研究中实现48周平均体重降幅最高达 19.3%，且胃肠道耐受性显著改善 hansoh.cn ↗
奥莱泊肽在第 48 周实现平均体重降幅最高达 19. 3%，且达到具有临床意义减重阈值的受试者比例高. |
| 2024-09-13 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results EASD2024 | HANSOH PHARMA RELEASED THE PHASE II CLINICAL STUDY DATA OF THE NOVEL DUAL GIP AND GLP-1 RECEPTOR AGONIST hspharm.com ↗
The recently published Phase II study results of HS-20094 demonstrate that in patients with T2DM, HS-20094 was generally safe and showed meaningful HbA 1c , fasting blood glucose and body weight reductions. |
| 2024-09-13 | Hansoh BioMedical R&D Company | Results EASD 2024 | 翰森制药GLP-1R/GIPR双靶点激动剂Ⅱ期临床研究数据发布 hansoh.cn ↗
本次在EASD年会发表的HS-20094的Ⅱ期临床研究结果显示，在2型糖尿病（T2DM）患者中，HS-20094总体安全性良好，并且在降低糖化血红蛋白(HbA1c）、空腹血糖和体重方面表现出显著效果. |
| 2024-07-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2024 ADA | HANSOH PHARMA RELEASED THE PHASE II CLINICAL STUDY DATA OF THE NOVEL DUAL GIP AND GLP-1 RECEPTOR AGONIST hspharm.com ↗
Hansoh Pharma's HS-20094 (a novel Dual GIP and GLP-1 Receptor Agonist) Phase II clinical Study Data were presented in the form of a poster + e-poster live Q&A at the conference. |
| 2024-06-21 | Hansoh BioMedical R&D Company | Results 2024 ADA | 翰森制药GLP-1R/GIPR双靶点激动剂Ⅱ期临床研究数据发布 hansoh.cn ↗
本次在ADA年会发表的HS-20094的Ⅱ期研究结果显示，HS-20094在2型糖尿病受试者中具有良好的安全性、耐受性特征，并展现出优秀的降糖减重疗效. |
| 2023-12-11 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2023 IDF | HANSOH PHARMA RELEASE THE PHASE 1 STUDY DATA OF THE NOVEL DUAL GIP AND GLP-1 RECEPTOR AGONIST hspharm.com ↗
This study shows that HS-20094 exhibites good safety, well tolerance, and a good effect in reducing glucose and body weight in healthy adults. |
| 2021-06-04 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S CLINICAL TRIAL APPLICATION FOR INNOVATIVE DRUG HS-20094 ACCEPTED hspharm.com ↗
Recently, the clinical trial application of Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or the "Company") for HS-20094, an independently developed innovative drug, was accepted by the National Medical Products Administration (NMPA). |
All press releases naming this drug 14 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HS-20094 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06118021 ↗ |
| Action | Activate | “a Novel Dual GIP and GLP-1 Receptor Agonist” NCT06901648 ↗ |
| Route | Subcutaneous | “Administrated SC” NCT05116410 ↗ |