Limertinib is intended for the treatment of patients with lung cancer. Credit: New Africa/Shutterstock.

Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have signed a strategic partnership agreement for the commercialisation of limertinib to treat lung cancer.

Limertinib is an orally administrated third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

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This collaboration will grant Innovent exclusive rights to commercialise the asset within mainland China, and entitles the company to a service fee based on net sales.

ASK Pharm will serve as the marketing authorisation holder and will oversee the manufacturing and commercial distribution of the product.

ASK Pharm is entitled to upfront payments and milestone payments contingent on meeting regulatory and sales goals.

Two new drug applications for limertinib are currently under review by China’s National Medical Products Administration.

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One application is for an indication to treat adults with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), post-EGFR TKI therapy progression.

The other is for the first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations in adults.

The efficacy and safety of limertinib were evaluated in a randomised, multicentre, double-blind, controlled Phase III clinical trial comparing it to gefitinib for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations.

The trial successfully met its primary endpoint, indicating a potential new option for patients with this form of lung cancer.

Innovent founder, chairman and CEO Dr Michael Yu stated: “We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent’s leadership in oncology.

“Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT (sintilimab Injection), BYVASDA (bevacizumab Injection), Retsevmo (selpercatinib), Dupert (fulzerasib) and Taletrectinib (ROS1 Inhibitor).

“The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.”

In August 2024, the company’s Kristen rat sarcoma G12C inhibitor, Dupert (fulzerasib), received China’s National Medical Products Administration (NMPA) approval to treat advanced non-small cell lung cancer (NSCLC) in adults.