Innovent Enters into Collaboration with ASK Pharm for Limertinib, and Lung Cancer Treatment
Tuesday, October 08, 2024
Innovent Biologics has partnered with Jiangsu Aosaikang Pharmaceutical to work on limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) designed for lung cancer treatment.
Lung cancer remains the leading cause of cancer-related deaths globally, with non-small cell lung cancer (NSCLC) making up about 80% to 85% of cases. In China, NSCLC has the highest incidence and mortality rates among ancers, affecting a significant number of patients who are not eligible for surgery.
Approximately 30% to 50% of Asian NSCLC patients have EGFR mutations, making EGFR-TKIs the recommended first-line treatment for this group, particularly third-generation inhibitors.
Limertinib represents a promising addition to the treatment options available for EGFR-mutated lung cancer, enhancing Innovent's existing portfolio of innovative medicines, including TYVYT® (sintilimab Injection) and BYVASDA® (bevacizumab Injection).
This collaboration aims to improve access to effective treatments for patients in China, ensuring that more individuals benefit from advanced therapies.
Under this agreement, Innovent will hold exclusive rights to commercialise limertinib in mainland China. They will receive a service fee based on the product’s net sales in the region. ASK Pharm, as the marketing authorisation holder (MAH), will manage the production and supply of limertinib and will be entitled to receive upfront, regulatory, and sales milestone payments.
Limertinib is a novel orally administered third-generation EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib are currently under review by China's National Drug Administration (NMPA).
One application is for treating adults with locally advanced or metastatic NSCLC who test positive for the EGFR T790M mutation and whose disease has progressed after previous EGFR TKI therapy.
The other is for the first-line treatment of adults with locally advanced or metastatic NSCLC featuring EGFR exon 19 deletions or exon 21 L858R mutations.
In a Phase 3 clinical trial, limertinib's safety and efficacy were compared with gefitinib for patients with EGFR mutations. The trial met its primary endpoint, with results expected to be shared at future academic conferences or published in journals.
Previous results from a Phase 2b study were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
Source: innoventbio.com
