Hansoh Pharma (03692): The third indication of ILEAD (Apatinib mesylate tablets) obtained the drug registration certificate issued by the National Medical Products Administration.

HANSOH PHARMA (03692) announced that the group's innovative drug Amelec (amitinib mesylate tablets) has obtained a drug registration certificate issued by the China National Medical Products Administration (NMPA), approving the addition of the indication for "treatment of unresectable locally advanced late-stage non-small cell lung cancer (NSCLC) patients with exon 19 deletion or exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) who have not experienced disease progression after platinum-based definitive concurrent chemoradiotherapy". This is the third indication approved for Amelec. Amelec (amitinib mesylate tablets) is China's first innovative third-generation EGFR-TKI drug. Previously, it has been approved in China for two indications: in March 2020, it was approved for locally advanced or metastatic NSCLC patients who have progressed after previous EGFR-TKI treatment with positive T790M mutation; in December 2021, it was approved for first-line treatment of locally advanced or metastatic NSCLC adult patients with positive EGFR exon 19 deletion or exon 21 (L858R) substitution mutations. Both indications have been renewed and included in the 2024 National Medical Insurance Directory in November 2024. Amelec has two other New Drug Application (NDA) approvals accepted by the NMPA, for: adjuvant treatment after tumor resection in adult NSCLC patients with positive EGFR exon 19 deletion or exon 21 (L858R) substitution mutations; and first-line treatment in combination with pemtumomab and platinum-based chemotherapy drugs for locally advanced or metastatic NSCLC adult patients with positive EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.