On January 18, the National Healthcare Security Administration announced the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022) ("National Reimbursement Drug List"). The first-line treatment indication of Hansoh Pharma's Ameile (Aumolertinib Mesilate Tablets), China's first original third-generation EGFR-TKI, was newly added to the National Reimbursement Drug List for the first-line treatment of adult patients having locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or positive exon 21 (L858R) substitution mutation.

Improved drug accessibility for NSCLC patients

The inclusion of the first-line treatment indication of Ameile in the National Reimbursement Drug List has brought a Chinese first-line treatment option to the market of medically insured third-generation EGFR-TKI-targeted drugs, which will provide greater access to medication for NSCLC patients.

On March 17,2020, aumolertinib was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic NSCLC who have progressed on prior EGFR tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive.

In December 2020, it entered the National Reimbursement Drug List nine months after launch, greatly relieving the financial pressure of NSCLC patients.

In December 2021, the first-line treatment indication was approved, opening a new era of first-line treatment with China's original EGFR-TKI.

In January 2023, the first-line treatment indication was included in the National Reimbursement Drug List, which will greatly reduce the drug burden of NSCLC patients and improve drug accessibility.

China's first original targeted drug for first-line treatment of EFGR mutated NSCLC

Lung cancer is a malignant tumor with the highest morbidity and mortality in the world. It is estimated that nearly one-third of NSCLC patients worldwide (approximately 85% of lung cancer patients) have EGFR mutations. Ameile is China's first original third-generation EGFR-TKI approved for first-line indication. It can irreversibly and highly selectively inhibit EGFR-sensitive mutations and T790M resistant mutations, showing good efficacy and safety. The AENEAS study, a registered study of Ameile, showed excellent mPFS benefit in the treatment of patients with brain metastasis, exon 19 deletion, and positive exon 21 (L858R) substitution mutation, with the lowest risk of disease progression in patients receiving first-line treatment with Ameile.

Effective inhibition of tumor growth

Through the introduction of an innovative cyclopropyl structure, aumolertinib has stronger anti-tumor activity and stronger inhibition of EGFR-sensitive mutations and T790M-resistant mutations.

Effective control of brain metastasis

The lipophilicity of cyclopropyl increases the blood-brain barrier permeability of aumolertinib, enabling effective control of brain metastasis.

Significantly reduced incidence of toxic and side effects

The metabolite is single and stable, and no toxic metabolites with inhibitory effect on wild-type EGFR are produced.

Exploration of more treatment options

Since its approval for marketing, Ameile has been widely used in clinical practice and has won unanimous praise from doctors and patients for its excellent efficacy and safety. To explore the therapeutic potential of Ameile in the lung cancer segment, Hansoh Pharma is also conducting multiple registered clinical studies, including multiple clinical studies of Ameile in combination with platinum-containing dual-agent chemotherapy for the first-line treatment of NSCLC with sensitive mutations and the adjuvant treatment of NSCLC, which will provide more NSCLC patients with a full range of multidimensional dosing options from early to late stage, from perioperative adjuvant treatment, first-line and second-line treatment to posterior-line treatment and bring more hope to lung cancer patients.