Drugs / Almonertinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | China (NMPA) | Ameile | non-small cell lung carcinoma | 2024-11-27 | “New Drug Application (“NDA”) of the Group’s innovative drug Ameile (阿美乐 ® ) (Aumolertinib Mesylate Tablets) has been accepted” hspharm.com ↗ |
| Filed | China (NMPA) | Ameile | non-small cell lung carcinoma | 2024-07-19 | “New Drug Application (NDA) for Ameile (almonertinib mesylate tablets), an independently-developed class 1 new drug, was accepted by the National Medical Products Administration (NMPA)” hspharm.com ↗ “the new drug application ("NDA") for a new indication of Ameile (Aumolertinib Mesylate Tablets) has been accepted by the National Medical Products Administration ("NMPA")” hspharm.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Aumseqa | — | 2026-02-12 | europa.eu ↗ |
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News releases announcing trial results or a regulatory action · 49
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Hansoh BioMedical R&D Company | Results 翰森制药 | 阿美乐® ADVANCE 研究重磅发表于国际顶级期刊 Nature 子刊 STTT hansoh.cn ↗
较同步放化疗可显著延长无进展生存期（中位 PFS 34. 0个月 vs. 7. 4个月，HR 0. 15，P < 0. 001），降低疾病进展风险 85%，且安全性更优[1]. |
| 2026-07-24 | Hansoh BioMedical R&D Company | Results 翰森制药 | 阿美乐® ACTIVE 研究在线发表于国际期刊 JTO hansoh.cn ↗
对奥希替尼不耐受后接受阿美替尼治疗的患者，3个月转换成功率为70. 6% ，中位无进展生存期11. 6个月，疾病控制率86. 5%[1]. |
| 2026-06-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results PIVOTAL TRIAL OF AMEILE® PLUS CHEMOTHERAPY (AENEAS2) PUBLISHED IN THE LANCET ONCOLOGY hspharm.com ↗
Data showed that aumolertinib combined with platinum-based doublet chemotherapy significantly improved progression-free survival (PFS) in advanced EGFR mutation-positive NSCLC patients, with overall manageable safety. |
| 2026-06-01 | Hansoh BioMedical R&D Company | Results ASCO 2026 | 翰森制药阿美乐®NEOVADE研究入选，探索序贯化学-免疫新辅助治疗疗效与安全性 hansoh.cn ↗
阿美替尼序贯化免显示了突破性疗效：主要病理缓解率（MPR）达40. 6%，病理完全缓解率（pCR）15. 6%；在化疗联合免疫治疗阶段后，客观缓解率（ORR）得到进一步提升. |
| 2026-04-01 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 ELCC︱恒瑞医药4款创新药共7项肺癌研究亮相国际舞台 hengrui.com ↗
SHR-A2009联合阿美替尼用于一线和二线及以上 EGFR 突变阳性 NSCLC治疗展现出可控的安全性与具有前景的抗肿瘤活性。 |
| 2026-03-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ELCC 2026 | HANSOH PHARMA PRESENTED RESULTS OF DALMELITINIB (HS-10241, A HIGHLY SELECTIVE MET-TKI) COMBINED WITH AUMOLERTINIB FROM A PHASE IB STUDY IN PATIENTS WITH MET-AMPLIFIED ADVANCED NSCLC POST EGFR TKI hspharm.com ↗
In 115 efficacy-evaluable NSCLC patients with MET-amplification post EGFR TKI treatment, median PFS was 7.4 months and median OS was 25.4 months. |
| 2026-03-13 | Hansoh BioMedical R&D Company | Results ACROSS 2研究荣登全球顶刊CA！阿美替尼联合化疗破解EGFR共突变非小细胞肺癌治疗难题 hansoh.cn ↗ |
| 2026-02-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES THE NEW DRUG APPLICATION OF DALMELITINIB MESYLATE TABLETS WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION hspharm.com ↗ |
| 2026-02-20 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory AUMOLERTINIB MESYLATE TABLETS WAS APPROVED IN THE EU AS MONOTHERAPY hspharm.com ↗
The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). |
| 2026-01-12 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA | AMEILE’S FIFTH INDICATION FOR “TARGETED THERAPY PLUS CHEMOTHERAPY” APPROVED, MARKING FULL-COURSE COVERAGE OF CHINA’S ORIGINAL THIRD-GENERATION EGFR-TKI hspharm.com ↗
On January 6, 2026, Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma," 03692.HK) announced that a new indication of Ameile (Aumolertinib Mesylate Tablets) has been approved for marketing. |
| 2025-09-15 | Hansoh BioMedical R&D Company | Results 2025 CSCO | 翰森制药阿美乐®携多项研究成果亮相 hansoh.cn ↗
此外，阿美替尼在治疗早期NSCLC的ARTS研究中展现出优异疗效：阿美替尼组的2年DFS率达90. 2%，降低疾病复发风险83%，同时安全性更佳，可作为EGFR突变NSCLC术后辅助治疗优选. |
| 2025-09-10 | Hansoh BioMedical R&D Company | Results 2025 WCLC | 翰森制药阿美乐®18项创新研究亮相国际学术大会 hansoh.cn ↗
经研究者评估，联合治疗组与单药组的中位无进展生存期（PFS）分别为19. 78个月和16. 53个月（风险比HR=0. 55，95% CI: 0. 339–0. 910；P=0. 0205）. |
| 2025-06-05 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA | AUMOLERTINIB: APPROVED BY UK’S MHRA FOR THE TREATMENT OF NSCLC — MARKING THE FIRST OVERSEAS LAUNCH OF CHINA-DEVELOPED EGFR-TKI hspharm.com ↗
With this approval, Almonertinib has become the first innovative drug from Hansoh Pharma to be approved for the overseas market, and also the first China-developed EGFR-TKI to be launched overseas. |
| 2025-05-26 | Hansoh BioMedical R&D Company | Results ASCO 2025 | 翰森制药阿美乐®ADVANCE研究最终分析揭晓，PFS延长至34个月 hansoh.cn ↗
中位随访时间为25. 5m，试验组PFS显著延长(34. 0m vs 7. 8m; HR为0. 15, 95% CI: 0. 06-0. 24). |
| 2025-05-09 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA | AMEILE'S FOURTH INDICATION APPROVED FOR MARKETING, TARGETING POST-OPERATIVE ADJUVANT THERAPY FOR EGFR MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER hspharm.com ↗
On May 9, 2025, Hansoh Pharmaceutical Group Co., Ltd (hereinafter referred to as "Hansoh Pharma”, 03692.HK) announced that a new indication for Ameile (almonertinib mesylate tablets) has been approved for marketing. |
| 2025-05-09 | Hansoh BioMedical R&D Company | Regulatory 翰森制药 | 阿美乐®第四项适应症：用于EGFR突变阳性NSCLC术后辅助治疗获批上市 hansoh.cn ↗
此 次 获 批，使 得 阿 美 乐®在 国 内 获 批 的 适 应 症 数 量 达 到 四 项，持 续 领 跑 中 国 原 研 三 代EGFR-TKI. |
| 2025-04-29 | Hansoh BioMedical R&D Company | Results AACR 2025 口头报告 | 翰森制药阿美乐®联合化疗一线治疗晚期非小细胞肺癌Ⅲ期数据发布，中位PFS延长至28.9个月 hansoh.cn ↗
中位无进展生存时间（mPFS）延长至28. 9个月，客观缓解率（ORR）高至93. 2%，未发现新的安全性风险. |
| 2025-04-29 | Hansoh BioMedical R&D Company | Results AACR 2025 口头报告 | 翰森制药阿美乐®非小细胞肺癌术后辅助治疗Ⅲ期数据全球首发，患者2年无病生存率达90.2% hansoh.cn ↗ |
| 2025-03-28 | Hansoh BioMedical R&D Company | Results ELCC 2025 | 翰森制药阿美乐®6项创新研究入选，持续探索非小细胞肺癌领域治疗方案 hansoh.cn ↗
总人群4年DFS率为74. 1%，Ⅰ期患者4年DFS率为82. 7%. |
| 2025-03-10 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S AMEILE MARKETING APPLICATION APPROVED FOR THIRD INDICATION hspharm.com ↗
This is the third indication approved for Ameile since its commercial launch five years ago. |
| 2025-03-10 | Hansoh BioMedical R&D Company | Regulatory 翰森制药 | 阿美乐®第三项适应症获批上市，用于Ⅲ期不可切NSCLC患者放化疗后的维持治疗 hansoh.cn ↗
此为阿美乐®上市5年来获批的第三项适应症. |
| 2024-11-28 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory FOUR INNOVATIVE DRUGS OF HANSOH PHARMACEUTICAL GROUP HAVE BEEN RENEWED IN THE NATIONAL REIMBURSEMENT DRUG LIST (2024 VERSION) hspharm.com ↗ |
| 2024-11-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S AMEILE MARKETING APPLICATION FOR THE FIFTH INDICATION ACCEPTED hspharm.com ↗
Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced the fifth New Drug Application (“NDA”) of the Group’s innovative drug Ameile (阿美乐 ® ) (Aumolertinib Mesylate Tablets) has been accepted by the National Medical Products Administration of China (“NMPA”). |
| 2024-10-22 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results HANSOH PHARMA ANNOUNCES POSITIVE RESULTS FOR PHASE III REGISTRATIONIAL TRIAL EVALUATING 阿美乐 ® (AMEILE, AUMOLERTINIB) IN COMBINATION WITH CHEMOTHERAPY FOR EGFR-MUTATED ADVANCED LUNG CANCER hspharm.com ↗
Based on blinded independent central review, data from AENEAS2 phase III demonstrate a statistically significant risk reduction over 50% in disease progression or death in patients with the combination of AMEILE and chemotherapy in comparison to AMEILE monotherapy. |
| 2024-09-29 | Hansoh BioMedical R&D Company | Results 2024 CSCO | 翰森制药阿美乐®科研成果高频亮相创新药物数据专场 hansoh.cn ↗
12个月时，所有患者存活且无疾病复发，1年DFS为100%. |
| 2024-08-19 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S AMEILE MARKETING APPLICATION FOR THE FOURTH INDICATION ACCEPTED hspharm.com ↗
the new drug application ("NDA") for a new indication of Ameile (Aumolertinib Mesylate Tablets) has been accepted by the National Medical Products Administration ("NMPA") |
| 2024-07-19 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S AMEILE MARKETING APPLICATION FOR ADJUVANT TREATMENT OF LUNG CANCER RECEIVED hspharm.com ↗ |
| 2024-06-07 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2024 ASCO ANNUAL MEETING | FIVE INNOVATIVE STUDIES SPONSORED BY HANSOH PHARMA PRESENTED AT GRAND ACADEMIC EVENT hspharm.com ↗
Conclusions: Almonertinib exhibited promising efficacy and maintained tolerable safety as a first-line therapy in EGFR-mutated NSCLC with CNS metastases. |
| 2023-11-29 | Hansoh BioMedical R&D Company | Results 2023 ESMO ASIA | 翰森制药阿美替尼5篇创新成果入选国际学术盛会 hansoh.cn ↗
截至2023年8月，所有患者均存活，无肿瘤复发. |
| 2023-03-23 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2023 ELCC | MULTIPLE STUDIES OF HANSOH PHARMA'S AUMOLERTINIB TO BE PRESENTED ONCE MORE AT AUTHORITATIVE INTERNATIONAL ACADEMIC CONFERENCE hspharm.com ↗
2-year DFS was 99%. |
| 2023-03-23 | Hansoh BioMedical R&D Company | Results 2023 ELCC | 翰森制药阿美替尼多项研究再次亮相国际权威学术年会 hansoh.cn ↗ |
| 2023-01-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory THE FIRST-LINE TREATMENT INDICATION OF AMEILE, CHINA'S FIRST ORIGINAL THIRD-GENERATION EGFR-TKI, WAS ADDED TO THE NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
In January 2023, the first-line treatment indication was included in the National Reimbursement Drug List, which will greatly reduce the drug burden of NSCLC patients and improve drug accessibility. |
| 2023-01-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S SEVERAL INNOVATIVE DRUGS AND NEW INDICATIONS WERE ADDED TO THE 2022 NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
The first-line indication of Ameile (Aumolertinib Mesylate Tablets) and the rare disease drug Xinyue (Inebilizumab Injection) were successfully added to the National Reimbursement Drug List, and two other innovative were successfully renewed. |
| 2022-12-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory MAA FOR HANSOH PHARMA'S AUMOLERTINIB ACCEPTED BY EMA hspharm.com ↗ |
| 2022-12-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory EQRX’S MARKETING AUTHORIZATION APPLICATION FOR AUMOLERTINIB IN EGFR-MUTATED NON-SMALL CELL LUNG CANCER ACCEPTED BY THE EUROPEAN MEDICINES AGENCY (EMA) hspharm.com ↗ |
| 2022-09-09 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2022 ESMO | HANSOH PHARMA'S CLINICAL RESEARCH RESULTS OF AUMOLERTINIB RECEIVE FURTHER RECOGNITION hspharm.com ↗
For PFS, the primary efficacy endpoint, the Bucher HR for aumolertinib vs osimertinib was 1.00 (95% CI: 0.72 - 1.39), and the STC HR was 0.98 (95% CI: 0.68 - 1.42), suggesting no statistical difference. |
| 2022-09-09 | Hansoh BioMedical R&D Company | Results 2022 ESMO丨翰森制药阿美替尼临床研究成果再传捷报 hansoh.cn ↗
对于主要研究终点PFS，阿美替尼对比奥希替尼的Bucher HR为1. 00（95% CI:0. 72-1. 39），STC HR为0. 98（95% CI:0. 68-1. 42），均提示无统计学差异. |
| 2022-08-04 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2022 WCLC | 21 ABSTRACTS ON HANSOH PHARMA'S AUMOLERTINIB TO BE RELEASED hspharm.com ↗
The confirmed partial response (PR) were 6 (54.5%) patients and stable disease (SD) were 3 (27.3%) patients, the ORR was 54.5% (6/11) and the DCR was 81.8 % (9/11). |
| 2022-08-04 | Hansoh BioMedical R&D Company | Results 2022 WCLC | 翰森制药阿美替尼21篇摘要闪耀登顶 原研之光展现中国创新力量 hansoh.cn ↗
11例患者均达到PR，总体ORR为100%(11/11)；7例脑转移患者接受颅内靶病灶评估，其中5例达到PR，2名SD，iORR为71. 4%(5/7)，iDCR为100%(7/7). |
| 2022-07-20 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory MARKETING AUTHORIZATION APPLICATION FOR HANSOH PHARMA'S AUMOLERTINIB ACCEPTED BY UK'S MHRA hspharm.com ↗
On June 15, Hansoh Pharmaceutical Group Company Limited (3692.HK, "Hansoh Pharma" or the "Company") announced that the UK's Medicines and Healthcare products Regulatory Agency ("MHRA") had formally accepted the Marketing Authorization Application ("MAA") from the Company's partner, EQRx, INC. ("EQRx"), for aumolertinib, a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor ("EGFR-TKI") for the first-line treatment of locally advanced or metastatic non-small cell lung cancer ("NSCLC") with sensitizing EGFR mutations and for the treatment of locally advanced or metastatic T790M mutation-positive NSCLC that has progressed on prior EGFR-TKI therapy. |
| 2021-09-16 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results LONGEST TO DATE - MEDIAN OVERALL SURVIVAL OF 30.2 MONTHS! HANSOH PHARMA'S AMEILE ESTABLISHES NEW STANDARD FOR SECOND-LINE TREATMENT OF EGFR-T790M MUTATION-POSITIVE NSCLC hspharm.com ↗ |
| 2021-06-05 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2021 ASCO丨HANSOH PHARMA'S STUDY DATA ON AMEILE FOR FIRST-LINE TREATMENT OF NSCLC IN CHINESE POPULATION RELEASED: A MPFS OF 19.3 MONTHS hspharm.com ↗
With a median progression-free survival (mPFS) of 19.3 months, the amazing data demonstrate the Company's innovation capability, bring a major breakthrough in first-line lung cancer treatment, and provide new options and survival benefits to more patients with advanced lung cancer. |
| 2021-05-20 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 19.3-MONTH MPFS! FIRST-LINE CLINICAL STUDY RESULTS OF HANSOH PHARMA'S AMEILE TO BE RELEASED AT ASCO hspharm.com ↗
Patients treated with Ameile as first-line therapy had significantly longer progression-free survival (PFS) (median PFS: 19.3 months vs 9.9 months) and significantly longer duration of remission (DoR) (median DoR: 18.1 months vs 8.3 months). |
| 2021-05-13 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory PRIORITY REVIEW! HANSOH PHARMA APPLIES FOR MARKETING APPROVAL OF FIRST-LINE TREATMENT INDICATION FOR AMEILE hspharm.com ↗ |
| 2021-04-17 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory EXPAND FIRST-LINE TREATMENT WITH COMBINED CHEMOTHERAPY – ANOTHER REGISTERED CLINICAL STUDY OF ALMONERTINIB WAS APPROVED hspharm.com ↗ |
| 2021-03-30 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results ANOTHER MAJOR BREAKTHROUGH | AMEILE OF HANSOH PHARMA, TAPPING MAXIMUM POTENTIAL FOR PATIENTS' HEALTH hspharm.com ↗
The conference announced that the phase III study of the third-generation EGFR-TKI Ameile for first-line treatment of EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) achieved positive results, reaching the preset main study endpoint. |
| 2020-12-28 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory PROMISING PROSPECTS: HANSOH PHARMA'S CLASS 1 INNOVATIVE DRUGS, AMEILE, HANSOH XINFU AND FULAIMEI, INCLUDED IN CHINA’S NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
Hansoh Pharma's Ameile (Almonertinib Mesylate Tablets), Hansoh Xinfu (Flumatinib Mesylate Tablets) and Fulaimei (Polyethylene Glycol Loxenatide Injection) are included. |
| 2020-04-27 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Results 2020 AACR ANNUAL MEETING | THE LATEST CLINICAL RESEARCH RESULTS ON HANSOH PHARMA'S AMEILE (ALMONERTINIB) ANNOUNCED hspharm.com ↗
At the AACR Annual Meeting, Prof. Lu Shun released the efficacy and safety data of Almonertinib from Phase II clinical trials followed up to August 1, 2019, and for the first time, the efficacy data of patients with brain metastasis. |
| 2020-03-19 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA’S AMEILE (ALMONERTINIB) RECEIVES MARKETING AUTHORIZATION IN CHINA FOR SECOND-LINE TREATMENT FOR PATIENTS WITH EGFR T790M-MUTATION NON-SMALL CELL LUNG CANCER hspharm.com ↗
AMEILE is the second 3 rd generation EGFR TKI to be approved for metastatic NSCLC patients with EGFR T790M. |
All press releases naming this drug 57 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 75 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | almonertinib | “Almonertinib (HS-10296) is a novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI) that targets both EGFR-sensitizing and T790M resistance mutations.” PMID 32916310 ↗ Sep 202053“Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 2022 “Gentuximab: 8mg/kg or 12mg/kg intravenous (IV) infusion administered on Day 1 and 15 of each cycle; Almonertinib: 110 mg orally once daily.” NCT05223595 ↗ “Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.” NCT04401059 ↗ “Dose escalation: HS-10241 and Almonertinib will be administered in combination.” NCT05430386 ↗ “Intervention: Oral almonertinib (110 mg/day) for three months” NCT06924398 ↗ “2. Almonertinib: 110mg, orally once a day” NCT04978753 ↗ “almonertinib 220mg once daily” NCT07398599 ↗ |
| Known as | Almonertinib Mesilate | “Almonertinib Mesilate Tablets.” NCT06474455 ↗ |
| Known as | aumolertinib | “Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 202219“All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib).” NCT07637448 ↗ “INTERVENTIONS: Patients received aumolertinib, 165 mg, orally once daily until disease progression or unacceptable toxic effects.” PMID 40569623 ↗ Aug 2025 |
| Known as | aumolertinib mesylate | “Aumolertinib mesylate tablets are administered 110 mg orally once a day” NCT06102928 ↗ |
| Known as | HS-10296 | “This is a phase II, single-arm, open-label study to evaluate the efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) Almonertinib (HS-10296) as...” NCT04685070 ↗3“Almonertinib (HS-10296) is a novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI) that targets both EGFR-sensitizing and T790M resistance mutations.” PMID 32916310 ↗ Sep 2020 “Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation epidermal growth factor receptor tyrosine kinase inhibitor approved in China.” PMID 35580297 ↗ May 2022 |
| Action | Inhibit | “tyrosine kinase inhibitor (EGFR TKI)” PMID 32916310 ↗ Sep 2020 |
| Modality | Small molecule | “novel, third-generation EGFR tyrosine kinase inhibitor (EGFR TKI)” PMID 32916310 ↗ Sep 2020 |
| Route | Oral | “Eligible patients were enrolled and randomly assigned in a 1:1 ratio to orally receive either aumolertinib or gefitinib in a double-blinded fashion.” PMID 39016053 ↗ Jul 2024 |
| Target | EGFR | “targets both EGFR-sensitizing and T790M resistance mutations” PMID 32916310 ↗ Sep 2020 |