Hansoh Pharma's Ameile® (Almonertinib) Receives NMPA Acceptance for Fourth Indication NDA
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
On August 19, 2024, Hansoh Pharma's self-developed Class 1 new drug, Amelotin®(New Indication NDA for Aumolertinib Mesylate Tablets Accepted by NMPA) The new indication marketing application (NDA) for Aumolertinib Mesylate Tablets has been accepted by the National Medical Products Administration (NMPA) for the treatment of patients with unresectable locally advanced epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation non-small cell lung cancer (NSCLC) who have not experienced disease progression after platinum-based radical chemoradiotherapy. This is Ameile.®The fourth indication for marketing application submitted in China. It is worth mentioning that, for this indication, Amelie®Included in the list of breakthrough therapies after being公示by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on August 9, 2024.
This marketing application for the indication is based on the clinical trial data from the HS-10296-304 study. This is a randomized, controlled, double-blind Phase III clinical study designed to evaluate the efficacy and safety of Aumolertinib Mesylate compared with placebo in treating patients with unresectable locally advanced epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation non-small cell lung cancer (NSCLC) who have not experienced disease progression after platinum-based radical chemoradiotherapy. The primary endpoint is progression-free survival (PFS) assessed by an independent review committee; secondary endpoints include overall survival (OS), time to central nervous system (CNS) progression, time to death or distant metastasis (TTDM), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and safety, all evaluated by the independent review committee.
As the first China-developed third-generation EGFR-TKI, Almonertinib®It was approved in China in 2020 and 2021, respectively, for second-line treatment of patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI therapy and are T790M mutation-positive, and for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Both indications have been included in the National Reimbursement Drug List (NRDL). In addition, Amelio...®The third indication for marketing authorization application was recently accepted by the National Medical Products Administration (NMPA) for adjuvant treatment in adult patients with non-small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, following tumor resection.
Lung cancer is the cancer type with the highest number of new cases and deaths in China. Statistics released by the National Cancer Center show that in 2022, there were 1.0606 million new lung cancer patients in China, and the number of deaths reached 733,300, indicating a significant unmet clinical need. Hansoh Pharma has long been committed to addressing the treatment conditions of lung cancer patients and continuously exploring more effective lung cancer treatment solutions. The company is actively working on expanding Almonertinib (Ameile).®While expanding the range of indications to benefit more lung cancer patients, Hansoh Pharma is also actively advancing its pipeline research and development to explore new treatment options for lung cancer patients in China and globally.
Editor: Mu Mian
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