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.

AMEILE is the second 3^rd 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.

Lung cancer remains the leading cause of cancer-related deaths worldwide and in China. EGFR mutation is the most common mutation and accounts for about 40% of NSCLC patients in China. Approximately 50% of NSCLC patients will develop drug-resistant T790M mutation following treatment with first or second generation EGFR TKI. In its registrational study, APOLLO (n=244), patients taking AMEILE has shown a median progression-free-survival (mPFS) of greater than a year, the longest in its class as a monotherapy in second line therapy. AMEILE provides a new option with favorable safety profile and high efficacy for NSCLC patients in China, and is another illustration of Hansoh Pharma's steadfast commitment in developing life-changing medicines to help patients and families in need around the world.

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. ^[1,2]

"AMEILE has demonstrated a compelling efficacy and tolerability in NSCLC patients with EGFR mutations," said Professor Shun Lu, the Principal Investigator of APOLLO trial and Professor of Shanghai Chest Hospital, Affiliated Hospital of Shanghai Jiao Tong University. "AMEILE provides a new targeted-therapy option for NSCLC patients with EGFR-mutations, especially for patients with brain metastasis."

"Almonertinib serves as a promising option for NSCLC patients, which is supported by the efficacy and safety data from APOLLO as well as other studies," said Professor James Chih-Hsin Yang of Graduate institute of Oncology at National Taiwan, China University College of Medicine.

About Non-Small Cell Lung Cancer

Lung cancer is the leading cause of cancer deaths among both men and women globally and in China. In 2018, there were approximately 867,500 new diagnoses of lung cancer in China, of which 737,400, or approximately 85%, were recorded as NSCLC in 2018, with a five-year survival rate of only 19.3%. About 40% of these are EGFR mutation-positive and approximately 50% of patients treated with first- or second-generation EGFR TKI therapy will acquire resistance related to the T790M mutation. ^[3]

About Almonertinib

Almonertinib 110mg once-daily tablet is a medicine indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an NMPA-approved test, who have progressed on or after prior EGFR TKI therapy. Almonertinib has high, nanomolar inhibitory activity against common EGFR mutations as well as drug-resistant T790M mutations in preclinical studies.

About Hansoh Pharma

Hansoh Pharma (3692:HK) is a leading biopharmaceutical company in China committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders, together with its 9,000 dedicated employees in China and United States.

Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting a leadership position in oncology, central nervous system (CNS), anti-infectives, gastrointestinal disorders, diabetes, and autoimmune diseases, among others. With approximately 1,400 professionals across R&D, Hansoh ranks top 2 in innovation among all biotech and pharmaceutical companies in China based on new molecular entity investigational new drug (IND) applications submitted for clinical development since 2011. Internally discovered and NMPA approved innovative products include morinidazole, a third-generation nitroimidazole antibiotic; PEG-loxenatide, the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; flumatinib, a second-generation BCR-ABL inhibitor for the treatment of chronic myeloid leukemia (CML); and almonertinib, a third-generation EGFR inhibitor for the treatment of NSCLC.  

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