Drugs / Tenofovir Amibufenamide
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07295873 | Dec 2025 → Jun 2026 overdue | fibrotic liver disease | Beijing Continent Pharmaceutical Co, Ltd. | Not yet recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05382351 | May 2022 → Apr 2024 | chronic hepatitis B virus infection | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06743438 | Mar 2022 → Jun 2024 overdue | chronic hepatitis B virus infection | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase not applicable2 trials · 1 met primary | ||||||
| — | NCT05797714 | Jun 2022 → Apr 2024 overdue | chronic hepatitis B virus infection | Ruijin Hospital | Active not recruiting | Met primary |
| — | NCT05398393 | Jan 2022 → Jun 2023 | chronic hepatitis B virus infection, lip disorder | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 0 | NCT07553767 Background | Mar 2026 → Dec 2034 expected | chronic hepatitis B virus infection, hepatocellular carcinoma | Ningbo No.2 Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07797231 Background | Sep 2026 → Sep 2028 expected | chronic hepatitis B virus infection | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| — | NCT06323681 Comparator | Feb 2024 → Feb 2027 expected | chronic hepatitis B virus infection | Qing XIe | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-06 | Hansoh BioMedical R&D Company | Results APASL 2026 │ 翰森制药恒沐®8项真实世界研究发布，2项成果获口头报告展示 hansoh.cn ↗
研究表明，先使用NUC治疗，再联合恒沐®与聚乙二醇干扰素α-2b，相较于直接联合治疗，能显著提高HBsAg清除率. |
| 2026-02-02 | Hansoh BioMedical R&D Company | Results 翰森制药 | 恒沐®5年循证集萃 14部指南共识共荐 hansoh.cn ↗
治疗144周时，维持TMF治疗组患者HBV DNA <20 IU/mL比例达86. 2%[7]；而240周（约5年）时，这一比例进一步提升至95%，其中高达92%的患者实现了HBV DNA<10 IU/mL的更高治疗标准[8]. |
| 2025-11-11 | Hansoh BioMedical R&D Company | Results AASLD│翰森制药恒沐®6项成果发布，肝硬化研究获评“杰出壁报” hansoh.cn ↗ |
| 2025-08-05 | Hansoh BioMedical R&D Company | Results WJG│翰森制药恒沐®144周研究结果发表，证实其长期治疗血脂稳定且肾脏安全 hansoh.cn ↗ |
| 2025-07-04 | Hansoh BioMedical R&D Company | Results JCTH I 全球首个针对ALT正常慢乙肝人群RCT，恒沐®PROMOTE 48周结果发表 hansoh.cn ↗ |
| 2025-05-09 | Hansoh BioMedical R&D Company | Results EASL 2025丨翰森制药恒沐3项研究成果亮相，乙肝肝硬化/肝衰竭治疗及免疫学机制再添力证 hansoh.cn ↗
翰森制药自主研发的中国首个原研口服抗乙型肝炎病毒药物恒沐®（艾米替诺福韦片，TMF）3项学术研究成果在大会上发布，分别涵盖恒沐®在乙肝病毒（HBV）相关肝硬化及肝衰竭患者中的应用，以及恒沐®抗病毒治疗的免疫学机制. |
| 2025-04-09 | Hansoh BioMedical R&D Company | Results APASL 2025丨翰森制药恒沐®20余项成果亮相，5年随访Ⅳ期研究及免疫学机制研究获口头报告 hansoh.cn ↗ |
| 2024-11-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results AASLD 2024 | HANSOH PHARMA RELEASES FOUR RESEARCH FINDINGS ON TENOFOVIR AMIBUFENAMIDE hspharm.com ↗
Among them, the first prospective, multi-center RCT study targeting individuals with normal ALT levels suffering from HBV confirmed that TMF provides significant benefits for this population. |
| 2024-11-15 | Hansoh BioMedical R&D Company | Results AASLD 2024 | 翰森制药艾米替诺福韦4项研究成果发布 hansoh.cn ↗
PROMOTE研究显示了TMF在ALT正常的慢性乙型肝炎患者中的显著临床益处，其显著提高了HBV DNA<20 IU/mL、HBV DNA下降、HBsAg下降的患者比例，并且具有良好的肾脏和血脂安全性. |
| 2024-04-19 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results APASL 2024丨HANSOH PHARMA RELEASED FOUR KEY RESEARCH RESULTS ON TENOFOVIR AMIBUFENAMIDE TABLETS hspharm.com ↗
Four research results on the new generation of tenofovir —Tenofovir Amibufenamide Tablets (TMF, trade name: Hengmu), were released. |
| 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 ↗
Another innovative drug of the Company, Tenofovir Amibufenamide Tablets (brand name: Hengmu 恒沐), also succeeded in renewal. |
| 2022-11-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results NOTEWORTHY ADVANCEMENT | 96-WEEK DATA FROM LARGE-SCALE PHASE III CLINICAL TRIAL OF HANSOH PHARMA'S HENGMU PUBLISHED IN JCTH hspharm.com ↗
Compared with the existing first-line standard-of-care drug TDF, TMF demonstrated a comparable virologic suppression rate and a higher ALT normalization rate. |
| 2022-07-25 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results JOINT RELEASE IN SIX CITIES | ANNIVERSARY CELEBRATION FOR LAUNCH OF HANSOH PHARMA'S HENGMU SUCCESSFULLY HELD hspharm.com ↗
the decrease in bone mineral density from baseline was significantly superior to that in TDF group |
| 2021-06-23 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory GOOD NEWS FOR HEPATITIS B PATIENTS! HANSOH PHARMA'S NEW CLASS 1 DRUG HENGMU (TENOFOVIR AMIBUFENAMIDE TABLETS) BECOMES AVAILABLE ON THE MARKET hspharm.com ↗ |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tenofovir amibufenamide | “First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally,...” NCT06323681 ↗7“Tenofovir amibufenamide” NCT07553767 ↗ |
| Known as | HS-10234 | “Tenofovir amibufenamide (TMF; codename: HS-10234), another formulation of tenofovir, shared the same ProTide technology as tenofovir alafenamide, which can provide more...” NCT05797714 ↗ |
| Known as | TMF | “First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally,...” NCT06323681 ↗5“Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB).” NCT06743438 ↗ “Tenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.” NCT07797231 ↗ “new drug Tenofovir Amibufenamide(TMF)” NCT05398393 ↗ “Drug: Tenofovir Amibufenamide（TMF）” NCT05797714 ↗ “Tenofovir Amibufenamide(TMF)” NCT07295873 ↗ |
| Action | Inhibit | “Tenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.” NCT07797231 ↗ |
| Route | Oral | “enofovir amibufenamide orally 25mg once a day with meals” NCT05382351 ↗ |