Innovent and ASK Pharm to market limertinib for lung cancer

Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have entered into a strategic partnership to commercialize limertinib, a therapeutic option for lung cancer patients. Limertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) taken orally. Under this collaboration, Innovent will have exclusive commercial rights to limertinib within mainland China. In return, Innovent will receive a service fee based on the net sales of the drug. ASK Pharm will act as the marketing authorization holder, responsible for the product's manufacturing and commercial distribution. Additionally, ASK Pharm is set to receive upfront payments and milestone-related payments upon achieving specific regulatory and sales targets.

At present, two new drug applications for limertinib are under review by China's National Medical Products Administration. One application seeks approval for the treatment of adults with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), particularly in those whose disease has progressed following EGFR TKI therapy. The other application requests approval for the first-line treatment of NSCLC in adults with EGFR exon 19 deletions or exon 21 L858R mutations.

The efficacy and safety of limertinib were assessed in a randomized, multicentre, double-blind, controlled Phase III clinical trial. This trial compared limertinib to gefitinib for the first-line treatment of patients with advanced or metastatic NSCLC with EGFR mutations. The study achieved its primary endpoint, suggesting that limertinib could be a promising new treatment option for patients battling this form of lung cancer.

Dr. Michael Yu, the founder, chairman, and CEO of Innovent, expressed his enthusiasm about the partnership with ASK Pharm. He highlighted that ASK Pharm is one of the leading biopharmaceutical companies in China, and this collaboration will further bolster Innovent's leadership in oncology. Dr. Yu emphasized that Innovent, in collaboration with its partners, has successfully developed several high-quality innovative treatments for lung cancer. These treatments include TYVYT (sintilimab Injection), BYVASDA (bevacizumab Injection), Retsevmo (selpercatinib), Dupert (fulzerasib), and Taletrectinib (ROS1 Inhibitor). The addition of limertinib is expected to provide a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.

In August 2024, Innovent's Kristen rat sarcoma G12C inhibitor, Dupert (fulzerasib), received approval from China’s National Medical Products Administration (NMPA) for the treatment of advanced non-small cell lung cancer (NSCLC) in adults. This approval marks a significant milestone for Innovent and underscores their continued commitment to providing advanced treatment options for cancer patients.