Hansoh Pharma's Core Product Almonertinib Receives New Indication Approval, Deepening Its Lung Cancer Portfolio

　　【Pharmaceutical Network Enterprise NewsRecently, the Center for Drug Evaluation of the National Medical Products Administration announced that the marketing application of Hansoh Pharma's Osimertinib Mesylate Tablets has been accepted. This application is reportedly for the approval of a new indication for the product, which is expected to further expand clinical treatment options and provide more treatment possibilities for NSCLC patients with EGFR mutations at different stages and treatment phases.
 

This drug is a third-generation EGFR-TKI independently developed by Hansoh Pharma. Since its approval in March 2020, it has been approved for five indications in China, including: the indication approved in 2020 for patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are positive for the T790M mutation.
 

In 2021, it was approved as a first-line treatment for adult patients with locally advanced or metastatic NSCLC who are positive for EGFR exon 19 deletion or exon 21(L858R) substitution mutations.
 

Approved in 2025 for the treatment of patients with unresectable locally advanced NSCLC with EGFR exon 19 deletion or exon 21(L858R) substitution mutations who did not experience disease progression after platinum-based radical chemoradiotherapy.
 

Approved in 2025 for the treatment of adult patients with Stage II-IIIB NSCLC harboring EGFR exon 19 deletions or exon 21(L858R) substitution mutations, who have previously undergone surgical resection and may or may not receive adjuvant chemotherapy as determined by their physician.
 

Approved in 2026 for first-line treatment in adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21(L858R) substitution mutations, in combination with pemetrexed and platinum-based chemotherapy.
 

Among them, four indications have been included in the National Medical Insurance Catalogue, including adjuvant treatment after surgery for EGFR-mutated NSCLC patients, maintenance therapy after radiotherapy and chemotherapy for unresectable locally advanced NSCLC, as well as first-line and second-line treatments for advanced NSCLC.
 

Notably, last month, this drug was successfully approved for marketing in the EU for the treatment of advanced non-small cell lung cancer with specific mutations. The industry anticipates that this new indication application will not only offer more treatment possibilities for EGFR-mutated NSCLC patients at different stages but also has the potential to further reduce patients' medication costs through future national reimbursement negotiations.
 

According to reports, lung cancer is the malignant tumor with the highest incidence and mortality rate in China, and approximately one-third of patients have EGFR mutations. After Hansoh Pharma's Aumolertinib Mesylate Tablets were approved for marketing, their sales at retail pharmacies in Chinese cities continued to rise from 2021 to 2023, exceeding 1.1 billion yuan in 2023, with a 61.22% increase in Q1 2024.
 

Overall, the continuous approval of Ameitinib's indications demonstrates that its clinical value and product quality have gained recognition from international regulatory agencies and the market. It also proves that in the globally competitive field of anti-tumor treatments, China's innovative drugs can achieve breakthrough innovations and offer a better "Chinese solution" for patients worldwide. This will further boost confidence in local innovation, attract more resources, and accelerate China's transformation from a pharmaceutical powerhouse to an even stronger leader in the industry.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.