Innovent and Ask Pharm join forces to commercialize third-generation lung cancer therapy

Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (Ask Pharm) have announced a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) intended for the treatment of lung cancer.

Under the terms of the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China and will receive a fee based on the product’s net sales in the region. Ask Pharm will be responsible for production and commercial supply of limertinib and will receive upfront, regulatory and sales milestone payments.

“Limertinib, Ask Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China,” said Jingfei Ma, director and general manager of Ask Pharm. “Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it."

Limertinib is an oral, third-generation EGFR TKI, a type of treatment that targets tumors with mutations in the gene encoding for the EGFR protein. These treatments have completely changed the way non-small cell lung cancer (NSCLC) is treated, allowing doctors and patients to steer away from chemotherapy and rely instead on targeted and personalized therapies.

Since the approval of the first EGFR TKI, gefitinib, more than 20 years ago now, multiple EGFR TKI drugs have been approved for the treatment of lung cancer. The most advanced drugs in this category are third-generation EGFR TKIs, which target the T790M mutation in the EGFR gene. Cancer patients can acquire this mutation after being treated with first- or second- generation EGFR TKIs, which pushed the development of a third generation that could address this common mutation in addition to the mutations targeted by the first two generations.

In a phase 3 clinical trial, limertinib showed superior efficacy and safety compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. Based on these results, Ask Pharm has filed two new drug applications (NDAs) for limertinib, which are currently under review by China’s National Drug Administration.