Drugs / Pegmolesatide
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 42 trials | ||||||
| Phase 4 | NCT07045155 | Aug 2025 → Dec 2027 expected | anemia due to chronic disorder, end stage renal failure | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06946394 | May 2025 → Dec 2026 expected | — | The First Affiliated Hospital of Dalian Medical University | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07136792 | Sep 2025 → Dec 2026 expected | anemia due to chronic disorder | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-06-05 | Hansoh BioMedical R&D Company | Results ERA 2026 | 翰森制药圣罗莱®两项研究成果亮相，聚焦联合治疗与优化给药 hansoh.cn ↗ |
| 2026-05-28 | Hansoh BioMedical R&D Company | Results Front Pharmacol│翰森制药圣罗莱®改善尿毒症性心肌病双重机制研究发表 hansoh.cn ↗
体外实验发现，培莫沙肽对CKD血清诱导的心肌细胞肥大和促纤维化反应具有直接抑制作用. |
| 2026-03-31 | Hansoh BioMedical R&D Company | Results 翰森制药 | 圣罗莱®两项研究成果亮相2026世界肾脏病大会 hansoh.cn ↗
结果发现，在肾切除模型中，联合治疗组在治疗第13天显示出较强的疗效协同作用，Hb提升幅度超过培莫沙肽或HIF-PHI单药治疗组13-29g/L. |
| 2025-11-05 | Hansoh BioMedical R&D Company | Results 圣罗莱®最新机制研究于《国际免疫药理学》发布，证实具有潜在心血管保护作用 hansoh.cn ↗
整体而言，该研究证明了圣罗莱®能够通过抑制CD131表达、阻断EPOR-CD131异二聚体的形成，进而阻断JAK2/STAT3通路的激活，从而有效缓解硫酸吲哚酚诱导的心肌细胞肥大，揭示了一种新的心脏保护机制. |
| 2025-11-05 | Hansoh BioMedical R&D Company | Results 翰森制药 | 圣罗莱®两项研究成果亮相ASN 2025，心血管安全性优势再添力证 hansoh.cn ↗
无论在透析还是非透析人群中，培莫沙肽均能使绝大多数（≥87%）的患者实现Hb≥10g/dL，达标率均高于短效促红素对照组，且主要心血管不良事件(5P-MACE：包括心血管死亡、心肌梗死、卒中、不稳定性心绞痛及需住院的心力衰竭)和扩展心血管事件的发生率均一致更低. |
| 2025-02-27 | Hansoh BioMedical R&D Company | Results J Transl Med｜翰森制药圣罗莱®长效促红细胞生成机制研究发表 hansoh.cn ↗
结果表明，培莫沙肽在透析和非透析CKD贫血患者中，均能有效地提高并维持血红蛋白（HGB）水平. |
| 2025-02-07 | Hansoh BioMedical R&D Company | Results WCN2025 | 翰森制药培莫沙肽治疗非透析CKD贫血患者的III期临床研究事后分析发布 hansoh.cn ↗ |
| 2024-12-25 | Hansoh BioMedical R&D Company | Results 翰森制药圣罗莱®治疗非透析CKD贫血患者Ⅲ期临床研究在国际期刊Kidney International Reports发布 hansoh.cn ↗
结果显示，在全分析集（FAS）中，培莫沙肽组疗效评估期Hb自基线平均升高19. 2 g/L，阿法依泊汀组则平均升高15. 4g/L，两组差异为3. 8 g/L（95% CI，0. 7-6. 9，P= 0. 02），达到预设的非劣标准. |
| 2024-10-31 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ASN 2024 | HANSOH PHARMA RELEASES POST-HOC ANALYTICAL RESULTS OF PHASE III STUDY ON PEGMOLESATIDE hspharm.com ↗
The post-hoc analysis results, released at the 2024 ASN annual meeting, confirmed that pegmolesatide injection is capable of achieving the goals of maintaining hemoglobin level more effectively than short-acting erythropoietins (EPOs), and is superior in terms of safety. |
| 2024-10-24 | Hansoh BioMedical R&D Company | Results ASN 2024 | 翰森制药培莫沙肽Ⅲ期研究事后分析结果发布 hansoh.cn ↗ |
| 2023-12-22 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S SAINT LUOLAI IS ADDED TO THE NATIONAL REIMBURSEMENT DRUG LIST, OPENING A NEW CHAPTER IN THE LONG-TERM TREATMENT FOR CKD RENAL ANEMIA IN CHINA hspharm.com ↗
Pegmolesatide Injection (brand name: Saint Luolai 圣罗莱), Hansoh Pharma's Category 1 innovative drug researched and developed by the Group, is first included in the updated NRDL |
| 2023-11-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results WIDELY ACCLAIMED | STUDY RESULTS ON SAINT LUOLAI FROM HANSOH PHARMA PUBLISHED IN ECLINICALMEDICINE FROM WORLD-LEADING LANCET JOURNALS hspharm.com ↗
Pegmolesatide was not inferior to epotin alfa in terms of its primary efficacy endpoint (the mean change in hemoglobin level from the baseline level to the level during the efficacy evaluation period), and even exhibited superior efficacy. |
| 2023-08-07 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results HANSOH PHARMA RELEASES KEY DATA FOR SAINT LUOLAI®, INTRODUCING A SAFE AND LONG-LASTING INNOVATIVE DRUG TO CKD PATIENTS WITH RENAL ANEMIA hspharm.com ↗
At the special session, Professor Wang Rong from Shandong Provincial Hospital released and provided a detailed interpretation of the data regarding the studies on the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Non-Dialysis Patients" and the "Efficacy and Safety of Pegmolesatide for the Treatment of Anemia in CKD Dialysis Patients". |
| 2023-07-05 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA’S SAINT LUOLAI, THE GLOBAL UNIQUE ONCE-MONTHLY PEPTIDE-BASED HIGHLY SPECIFIC EPO RECEPTOR ACTIVATOR, GRANTED APPROVAL FOR MARKETING hspharm.com ↗
On June 30, Hansoh Pharma's Saint Luolai(Pegmolesatide Injection) ,the global unique once-monthly p eptide-based highly specific E PO r eceptor a ctivator 【PERA】 ,was granted approval by the National Medical Products Administration (NMPA) for marketing. |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegmolesatide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07045155 ↗ |
| Action | Activate | “Pegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist” PMID 37954906 ↗ Oct 2023 |
| Modality | Peptide | “Pegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist” PMID 37954906 ↗ Oct 2023 |
| Route | Subcutaneous | “once every 4 weeks by subcutaneous injection.” NCT06946394 ↗ |