INNOVENT BIO (01801): The third generation EGFR TKI lung cancer targeted drug Optini (Erlotinib tablets) has been approved by the National Medical Products Administration for listing.

INNOVENT BIO (01801) announced that its third-generation epidermal growth factor receptor tyrosine kinase inhibitor targeting drug, Ocni (Er-Ocimantine), has received approval from the China National Medical Products Administration for market authorization. It is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received EGFR-TKI treatment or have disease progression after treatment and have been confirmed to have positive EGFR T790M mutation. In a Phase IIB clinical study of Er-Ocimantine in the treatment of EGFR T790M mutation-positive NSCLC, a total of 301 patients who had disease progression after previous EGFR-TKI treatment were included. The objective response rate assessed by an independent review committee was 68.8%, the disease control rate (DCR) was 92.4%, the median duration of response (DoR) was 11.1 months, and the median progression-free survival (PFS) was 11.0 months. In patients with measurable lesions in the brain, the best ORR assessed by IRC was 65.9% with a median PFS of 10.6 months, indicating good efficacy of Er-Ocimantine in patients with central nervous system (CNS) involvement. The main adverse reactions of Er-Ocimantine were consistent with those reported for other EGFR-targeted inhibitors, and the drug was well tolerated. Furthermore, a Phase III clinical trial comparing Er-Ocimantine with gefitinib as first-line treatment for locally advanced or metastatic NSCLC patients with EGFR mutations has reached its primary endpoint. The second NDA for Er-Ocimantine was accepted and is under review by the NMPA in August 2024, for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletion (19DEL) or exon 21 substitution mutations (L858R). Ocni (Er-Ocimantine) is the company's 14th commercialized product, which will further strengthen the company's brand and product portfolio in the field of precision treatment of lung cancer, and bring new treatment hope to patients with advanced NSCLC with EGFR mutations. The company is committed to consolidating its leadership position in the field of oncology treatment and driving innovative treatment solutions through innovation and collaboration.