Hansoh Pharmaceutical's Ameile (Almonertinib) Approved as the World's Second Third-Generation EGFR-TKI Innovation Drug

　　【PharmNet | Industry Trends] On March 19, Hansoh Pharma announced that Ameile (almesitinib mesylate tablets), a Class 1 innovative drug independently developed by its subsidiary, Hansoh Pharmaceutical, had been approved for market launch. The availability of this drug may provide additional treatment options for patients with lung cancer.
 

It is reported that Almonertinib is China’s first third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and the world’s second innovative third-generation EGFR-TKI. It is also the first third-generation EGFR-TKI globally to achieve a median progression-free survival (PFS) of over one year in the second-line setting.
 

EGFR-TKIs are commonly used targeted therapies for patients with non-small cell lung cancer (NSCLC). The first third-generation EGFR-TKI launched globally was AstraZeneca’s Tagrisso. In January this year, AstraZeneca announced that Tagrisso (osimertinib mesylate tablets) had received approval in China and entered the Chinese market in mid-April.
 

In China, the incidence of lung cancer is very high, with a significant proportion of cases being non-small cell lung cancer (NSCLC) patients harboring EGFR gene mutations. According to statistical data, NSCLC patients account for approximately 80%–85% of all lung cancer cases in China. Patients with EGFR-sensitive mutations typically receive treatment with first- or second-generation EGFR tyrosine kinase inhibitors (EGFR-TKIs). Approximately two-thirds of these patients develop drug resistance due to the T790M mutation after about one year of treatment. Industry experts believe that the launch of Tagrisso has broken the dilemma of having no therapeutic options available after the development of resistance, bringing innovative treatment methods to lung cancer patients in China and marking the formal entry of lung cancer treatment in China into the era of comprehensive targeted therapy.
 

Almonertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression following prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and whose tumors are T790M mutation-positive, potentially offering greater survival benefits to patients with advanced lung cancer.
 

According to the evaluation by the Independent Review Committee, almonertinib monotherapy demonstrated superior efficacy and safety in registrational clinical studies, with effectiveness against brain metastases and significant clinical advantages.
 

In September 2019, at the 20th World Conference on Lung Cancer (WCLC), experts presented an oral report on new results from the Phase II clinical trial of almonertinib, a domestically produced third-generation EGFR-TKI. The report indicated that almonertinib not only demonstrated favorable efficacy but also exhibited a good safety profile. Common adverse events observed in the clinical study were tolerable and consisted mainly of Grade 1 or 2 events that were clinically manageable. The incidence rates of Grade 3 or higher adverse events, dose reductions, and treatment interruptions were low. No cases of interstitial pneumonia were reported in patients during the study period. The incidence and severity of drug-related rash, diarrhea, and QT interval prolongation were both low. Almonertinib mesylate tablets (brand name: Ameile) effectively overcome drug resistance, thereby providing additional therapeutic options for targeted therapy in lung cancer.
 

Industry experts believe that the launch of Aumolertinib reflects the enhanced innovation capabilities of domestic pharmaceutical companies in China. It provides physicians with more options for treatment regimens and offers patients greater choices.
 

Meanwhile, the market launch of domestically produced innovative drugs may lead to price reductions for imported originator drugs. For instance, after Beta Pharma’s Conmana (icotinib) was launched, AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (erlotinib) had to lower their prices to retain market share. In addition, following the inclusion of AstraZeneca’s Tagrisso (osimertinib) in the National Reimbursement Drug List (NRDL), patients’ monthly out-of-pocket expenses amount to approximately RMB 3,000–3,500. With the launch of Almonertinib (brand name: Ameile), industry experts anticipate that its pricing will be more competitive than that of imported alternatives. As Almonertinib is potentially included in the NRDL in the future, it is expected to benefit a larger patient population and significantly reduce their financial burden.
 

According to available information, Hansoh Pharma is a leading innovation-driven pharmaceutical company in China. After years of research and development, the company has built a robust pipeline and launched a series of innovative drugs. In addition to the recently approved Ameile, its portfolio includes Mailinda (morphonidazole and sodium chloride injection), a new-generation anti-anaerobic agent; FulaiMei (pegylated loxenatide injection), a glucose-lowering drug requiring only once-weekly injection; and Hansoh XinFu (flumatinib mesylate tablets), a “next-generation plus” therapy for chronic myeloid leukemia.