Hansoh Pharma's Class 1 Innovative Drug Aumolertinib (Almonertinib) Granted New Indication for First-Line Treatment of NSCLC

On December 16, 2021, Hansoh Pharmaceutical Group Company Limited (Stock Code: HK.03692) ("Hansoh Pharma" or the "Company") announced that Almonertinib Mesylate Tablets (brand name: Almele®), a Class 1 innovative drug independently developed by its subsidiary Hansoh Pharma, had received the Drug Registration Certificate from the National Medical Products Administration (NMPA) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have positive epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This marks the second approved indication for Almele®, further enriching and enhancing the Company's oncology product portfolio. Data shows that Almele® demonstrates significant safety and efficacy advantages in first-line treatment of EGFR mutation-positive locally advanced or metastatic NSCLC adult patients, officially ushering in a new era of first-line treatment with China-developed third-generation EGFR-TKI.

Ameile® is a Class 1 innovative drug independently developed by Hansoh Pharma and also the first China-originated third-generation EGFR-TKI. It has demonstrated significant efficacy in treating adult patients with locally advanced or metastatic NSCLC who have tested positive for the EGFR T790M mutation and experienced disease progression during or after prior treatment with EGFR-TKIs. It received expedited approval from the NMPA through the priority review designation and was supported by the national "Major New Drug Development" science and technology project. In March 2020, Ameile® obtained marketing approval for its first indication, filling the gap for third-generation EGFR-TKIs in China. Just nine months later, Ameile® was successfully included in the National Reimbursement Drug List (NRDL). In June 2021, Ameile® was recognized as one of the representatives of "new and effective drugs with high clinical value" in the "2020 Annual Drug Evaluation Report" released by the National Medical Products Administration due to its excellent efficacy and safety, offering more clinical options and bringing greater hope to lung cancer patients. This time, Ameile® has been approved for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, officially ushering in a new era of first-line treatment with China-originated third-generation EGFR-TKIs, benefiting even more lung cancer patients.

To explore the treatment potential of Almonertinib Mesylate Tablets (阿美乐®) in细分领域 of lung cancer, Hansoh Pharma will continue to carry out multiple registrational clinical studies. These include first-line treatment of Almonertinib Mesylate Tablets combined with platinum-based doublet chemotherapy for NSCLC patients with sensitive mutations, adjuvant therapy for NSCLC, and other indications. Multiple clinical studies will provide comprehensive and multi-dimensional medication solutions for more NSCLC patients, ranging from early to advanced stages, including perioperative adjuvant therapy, second-line and subsequent treatments, as well as first-line treatment.

Editor: Liuli

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