FAB Has Successfully Helped Hansoh Pharma’s AMEILE (ALMONERTINIB) Receive Marketing Authorization in China!

Shanghai, China – March 19, 2020 – Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”), a leading biopharmaceutical company in China, announced that the National Medical Products Administration (NMPA) has granted marketing authorization for AMEILE (almonertinib, previously also known as HS-10296) once daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after other EGFR tyrosine kinase inhibitor (TKI) therapy. As a leader of local medical imaging CRO in China, FAB provided a full range of independent medical imaging services for the clinical trials of the drug.

AMEILE is the second 3rd generation EGFR TKI to be approved for metastatic NSCLC patients with EGFR T790M. The approval of AMEILE provides a highly efficacious treatment option with favorable safety profile for advanced NSCLC patients. 

The NMPA’s approval of AMEILE was supported by clinical results from APOLLO study, a multicenter, open-label, single-arm Phase 2 study conducted in patients with recurrent NSCLC harboring EGFR T790M mutations. In this study, a total of 244 patients were treated with 110mg of almonertinib. The primary endpoint was objective response rate (ORR) as determined by blinded independent central review (ICR). Key secondary endpoints include PFS assessed by ICR, disease control rate (DCR), duration of response (DoR), and overall survival (OS). In APOLLO trial, ORR was 68.9%, DCR was 93.4%, mPFS was 12.3 months, and ORR in patients with CNS metastasis was 61.5%.[1,2] Further, almonertinib was well tolerated, where most common AEs were grade 1 or 2, with less than three percent patients discontinued treatment with almonertinib due to drug-related AEs. There was no interstitial lung disease reported during this study while neither grade 3 rash nor QT prolongation was observed. The most commonly observed adverse events, regardless of attribution, were blood creatine phosphokinase increased, rash, pruritus, aspartate aminotransferase increased, and alanine aminotransferase increased.

As the leading and first established imaging CRO in China, FAB is honored to participate in the clinical trial project of AMEILE, and has carried out in-depth cooperation with Hansoh Pharma in central imaging.

During the project implementation process, FAB takes advantage of its professional advantages to meet the requirements of the project in terms of science, quality and time frame in all aspects with high standards, high efficiency and high quality, providing accurate and reliable independent evaluation results to speed up the progress of product launch declaration. FAB, as the central imaging IRC, always adheres to the principles of 'complete, high-quality imaging data, thorough interpretation of assessment criteria, full understanding of the imaging characteristics of the trial drug, combined with scientific design and assessment methods to make a true, correct, and reliable assessment of efficacy' to provide professional, accurate, and timely efficacy assessment for this product. The final IRC assessment results were highly consistent with clinical efficacy and successfully met the study endpoint. FAB strictly controls the quality of projects and has been awarded the titles of "Most Trustworthy Imaging CRO" and "Most Professional Imaging CRO" by the sponsors.