Ameile (aumolertinib) / Jiangsu Hansoh Pharma, Abdul Latif Jameel Health - LARVOL DELTA

Progression of drug resistance or multiple primary lung cancer: a case report and literature review of a patient with mesenchymal-epithelial transition factor exon 14 skipping alterations lung adenocarcinoma. (PubMed, Anticancer Drugs) - "The patient opted against surgical intervention and local treatments, choosing instead a combination therapy regimen that included almonertinib and crizotinib. This treatment approach led to a significant reduction in the size of the right upper lung lesion. The patient's condition has remained stable without any signs of progression, resulting in an overall survival duration exceeding 53 months."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A multicenter, open-label, single-arm phase I/II study to assess the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ advanced non-small cell lung cancer (NSCLC) in China (NCT06631989). (ASCO 2025) - P1, P1/2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT06631989 Background: Although 3rd-generation EGFR TKIs, such as Osimertinib, Almonertinib, Furmonertinib, Befotertinib etc. are highly effective in front-line metastatic EGFR-mutated (EGFRm) NSCLC, treatment resistance ultimately occurs, including the emergence of the on-target C797S mutation for which there are no approved TKIs. Enrollment in this study for dose expansion cohorts is ongoing and 15 sites are open across China. Clinical trial information: NCT06631989."

Clinical • Metastases • P1/2 data • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Benefit of switching to firmonertinib following almonertinib-induced interstitial pneumonitis in a patient with advanced non-small-cell lung cancer: a case report. (PubMed, Anticancer Drugs) - "Closely monitoring ILD in clinical practice and promptly switching to similar drugs may avoid chemotherapy intervention and optimize treatment strategies. This case marks the first report of clinical experience achieving sustained remission by switching to a similar drug, firmonertinib, in patients with ILD related to almonertinib."

Journal • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Phase II Study of BL-B01D1 and Almonertinib for EGFR+ Stage II-IIIB NSCLC (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Survival of induction aumolertinib followed by aumolertinib and concurrent radiotherapy (RT) in unresectable EGFR-mutated stage III NSCLC: Final analysis of the phase III ADVANCE trial and real-world data. (ASCO 2025) - P=N/A, P3 | "The ADVANCE trial and RWD demonstrate that induction EGRF TKI followed by TKIs and RT delays progression and improves survival in unresectable stage III EGFR-mutated NSCLC."

Clinical • P3 data • Real-world • Real-world evidence • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

VOLUNTARY ANNOUNCEMENT THE FOURTH NEW DRUG APPLICATION OF AMEILE (AUMOLERTINIB MESILATE TABLETS) WAS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews) - "The board of directors (the 'Board') of Hansoh Pharmaceutical Group Company Limited (the 'Company' and together with its subsidiaries, the 'Group') is pleased to announce that the fourth New Drug Application ('NDA') of Ameile (Amele) (Aumolertinib Mesilate Tablets), an innovative drug developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ((Jiangsu Hansoh Pharmaceutical Group group co., ltd.), a subsidiary of the Company, has been accepted by the National Medical Products Administration of the People’s Republic of China ('NMPA') for the treatment in patients with locally advanced, unresectable, epidermal growth factor receptor ('EGFR') exon 19 deletions or exon 21(L858R) mutations, non-small cell lung cancer ('NSCLC') without progression following definitive platinum-based chemoradiotherapy."

China filing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

APEAK: A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (clinicaltrials.gov) - P1/2 | N=71 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor • KRAS

HS-10375, a selective EGFR C797S tyrosine kinase inhibitor, in advanced non-small cell lung cancer. (PubMed, J Transl Med) - P1/2 | "HS-10375 demonstrated potent and mutant-selective activity against the EGFR C797S mutation in preclinical results, and showed an acceptable safety profile and objective response in a first-in-human phase 1 trial. Trial registration This trial is registered on China Drug Trials (CTR20220045), and ClinicalTrials.gov (NCT05435248)."

IO biomarker • Journal • Anorexia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (APEAK) (ChiCTR) - P1/2 | N=72 | Not yet recruiting | Sponsor: Sun Yat sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Colorectal Cancer • Lung Cancer • Solid Tumor • KRAS

A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy with BL-B01D1 in Combination with Almonertinib Followed by Adjuvant Almonertinib in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=40 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

MHRA approves aumolertinib to treat non-small cell lung cancer (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 3 June 2025, approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer (NSCLC). Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor (EGFR) and who have not yet received treatment for their cancer which has spread to other parts of the body (metastatic cancer)....In a Phase 3 clinical trial, aumolertinib was found to reduce the risk of disease progression or death by 54% in patients with advanced or metastatic NSCLC who had specific EGFR mutations, when compared to an already-approved cancer treatment called gefitinib."

Evidence highlight • MHRA approval • Non Small Cell Lung Cancer • Oncology • EGFR

Tumor Cavitation with Anlotinib Treatment in Lung Adenocarcinoma. (PubMed, Diagnostics (Basel)) - "This case describes a 52-year-old Chinese female with advanced EGFR-mutated lung adenocarcinoma (Exon 19 deletion), which was metastatic to bilateral lungs, brain, and right adrenal gland, who exhibited a radiographic response to combination therapy with the third-generation EGFR tyrosine kinase inhibitor (TKI) aumolertinib and the anti-angiogenic agent anlotinib. This case underscores the potential efficacy of EGFR TKIs and anti-angiogenic agents in inducing unique tumor microenvironment modifications, while highlighting the transient nature of such responses and the critical need to address resistance mechanisms. Tumor cavitation may serve as a radiographic marker of anti-angiogenic activity but does not preclude metastatic spread, necessitating vigilant monitoring even in the setting of favorable imaging changes."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

High-dose third-generation EGFR-TKIs combined with intrathecal pemetrexed in advanced EGFR-mutant NSCLC with leptomeningeal metastases following EGFR-TKI therapy. (PubMed, BMC Cancer) - "High-dose third-generation EGFR-TKIs combined with pemetrexed intrathecal chemotherapy demonstrated a high rate of intracranial symptom relief and manageable safety in patients with EGFRm NSCLC who developed leptomeningeal metastases after previous EGFR-TKI therapy."

Journal • Infectious Disease • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor

Synergistic and mechanistic effects of neogambogic acid in enhancing almonertinib sensitivity in non-small cell lung cancer. (PubMed, Int Immunopharmacol) - "Meanwhile, it inhibited the EGFR/PI3K/AKT pathway and enhanced the sensitivity of NSCLC to Almonertinib, exerting synergistic anti-tumor effects. Our findings suggest a promising strategy for integrating active TCM components with targeted therapy in NSCLC management."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP3A4

Aumolertinib Plus Bevacizumab for Untreated Advanced NSCLC with EGFR Sensitive Mutation (Front Oncol) - P2 | N=21 | "Between September 16, 2020, and November 11, 2021, a total of 21 patients were enrolled in the study. The median follow-up was 36.8 months (ranging from 33.2 to 40.4 months), and all 21 patients were included in the evaluation. The PFS% at 12-month was 81% (95% confidence interval (CI): 64.1-97.9%), the median PFS was 26 months (95% CI: 16.5-35.5) and the ORR reached 85.7%, with an average reduction of the target lesions of 48.2%. Among patients with CNS metastasis, the ORR was 92.9% (13/14), and for TP53 co-mutation patients, the ORR was 86.6% (12/14)."

P2 data • Non Small Cell Lung Cancer

Hansoh Pharma | Ameile’s fourth indication approved for marketing, targeting post-operative adjuvant therapy for EGFR mutation-positive non-small cell lung cancer (Hansoh Pharma Press Release) - "On May 9, 2025, Hansoh Pharmaceutical Group Co., Ltd...announced that a new indication for Ameile (almonertinib mesylate tablets) has been approved for marketing. The new indication is for the adjuvant treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) mutations, and who have undergone tumor resection. Ameile now has four approved indications in China, maintaining its leading position among domestically developed third-generation EGFR-TKIs. This approval is primarily based on the ARTS study (HS-10296-302), a randomized, double-blind, controlled, multicenter Phase III clinical trial."

China approval • Evidence highlight • Non Small Cell Lung Cancer • EGFR

Effective neoadjuvant aumolertinib therapy facilitates transformation of unresectable to resectable advanced non‑small cell lung: A case report. (PubMed, Oncol Lett) - "The patient received icotinib followed by neoadjuvant aumolertinib, resulting in significant tumor shrinkage and downstaging to meet resectability criteria. The present findings provide novel insights into potential treatment choices for patients with inoperable stage IIIC NSCLC, emphasizing the possibility of achieving PR and undergoing surgery despite drug resistance. However, individual variations in such cases necessitate further research and validation before this approach can be widely implemented."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR

Influences of Magnesium Isoglycyrrhizinate on the Pharmacokinetics of Almonertinib in Rats and Its Potential Mechanisms. (PubMed, Biopharm Drug Dispos) - "There is a drug-drug interaction (DDI) between MgIG and almonertinib, which leads to an increase of systemic exposure for almonertinib. Meanwhile, CYP3A1 and P-gp in the liver may be the primary targets of mediating the DDI, but further clinical trials are needed to confirm these results."

Journal • PK/PD data • Preclinical • Hepatology • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP3A4 • EGFR

AACR 2025 Oral Report | Hansoh Pharmaceuticals' Phase III data on postoperative adjuvant therapy for non-small cell lung cancer is released globally for the first time, with a 2-year disease-free survival rate of 90.2% [Google translation] (Hansoh Pharma Press Release) - P3 | N=192 | ARTS (NCT04687241) | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | "A total of 214 Chinese patients completed randomization (107 in the aumolertinib group and 107 in the placebo group)....The median follow-up time evaluated by BICR was 27.6 months. The median DFS in the aumolertinib group was not reached (95%CI: 29.1-NA), and that in the placebo group was 19.4 months (95%CI:11.2-26.2), with a hazard ratio (HR) of 0.17 (95%CI: 0.09-0.29), P <0.0001. The DFS results assessed by the investigators were consistent with the BICR assessment , with a 2-year DFS rate of 90.2% in the aumolertinib group, significantly better than the 44.4% in the placebo group. OS data are not yet mature (OS event rates in the aumolertinib group/placebo group: 2.8%/3.8%)."

P3 data • Non Small Cell Lung Cancer

Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (EVOLUTION): protocol for a single-arm, phase II clinical trial. (PubMed, BMJ Open) - P2 | "The results of the study will be disseminated through peer-reviewed journals and presentations at academic conferences. NCT06463171."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem) - "This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

APEAK: A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (clinicaltrials.gov) - P1/2 | N=71 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P1/2 trial • Solid Tumor • KRAS

Aumolertinib as adjuvant therapy in patients with stage II-IIIB EGFR-mutated NSCLC after complete tumor resection: A randomized, double-blind, placebo-controlled, phase 3 trial (ARTS) (AACR 2025) - P3 | "Adjuvant aumolertinib demonstrates a statistically significant and clinically meaningful improvement in DFS in patients with stage II-IIIB EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy, when indicated. This DFS benefit underscores the promise of aumolertinib in fulfilling an unmet need for effective adjuvant EGFR-targeted therapy in early-stage NSCLC."

Clinical • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Aumolertinib with or without chemotherapy as first line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations (AENEAS2) (AACR 2025) - P3 | "AENEAS2 (NCT04923906) is a randomized, open-label, multicenter, phase 3 study assessing the efficacy and safety of aumolertinib plus chemotherapy versus aumolertinib alone as first-line treatment in locally advanced or metastatic NSCLC with sensitizing EGFR mutations. Patients who were naïve to treatment with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R mutation) were randomly assigned in a 1:1 ratio to receive aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5), versus to receive aumolertinib 110 mg QD monotherapy. Aumolertinib plus chemotherapy as a first-line treatment in advanced EGFR-mutant NSCLC demonstrated a statistically significant and clinically meaningful PFS improvement over aumoletinib monotherapy, with a manageable safety profile."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Bayesian network meta-analysis of EGFR-tyrosine kinase inhibitor treatments in patients with EGFR mutation-positive non-small cell lung cancer. (PubMed, Cancer Pathog Ther) - "We conducted a network meta-analysis of randomized controlled trials comparing osimertinib, lazertinib, aumolertinib, befotertinib, furmonertinib, dacomitinib, afatinib, erlotinib, gefitinib, icotinib, and chemotherapy. Osimertinib is the first choice of treatment with considerable efficacy and safety for EGFR mutation-positive NSCLC. The treatments associated with the best PFS in patients with exon 19 deletions and Leu858Arg mutations were furmonertinib and lazertinib, respectively."

Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR