Innovent and Ask Pharm Announce Collaboration on Third-Generation EGFR TKI for Lung Cancer

Innovent Biologics, Inc. (Innovent) and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) have announced a strategic collaboration for the commercialization of limertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI) designed for treating lung cancer. As part of the agreement, Innovent will have 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, responsible for the production and commercial supply of limertinib, will be entitled to upfront, regulatory, and sales milestone payments.

Limertinib is an oral, third-generation EGFR TKI with proprietary rights. China’s National Drug Administration (NMPA) is currently reviewing two New Drug Applications (NDAs) for limertinib: one for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed after EGFR TKI therapy, and another for first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.

A Phase 3 clinical trial evaluated the efficacy and safety of limertinib compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. This trial met its primary endpoint, and the detailed results will be presented at future academic conferences or published in academic journals. Previously, results of a Phase 2b clinical study for limertinib were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

Dr. Michael Yu, Founder, Chairman, and CEO of Innovent, expressed enthusiasm about the collaboration, noting that it will bolster Innovent's leadership in oncology and expand their portfolio of high-quality innovative medicines for lung cancer treatments. Dr. Yu highlighted the importance of collaborations and innovation in enhancing the accessibility and affordability of advanced therapies in China to benefit more patients.

Mr. Jingfei Ma, Director and General Manager of ASK Pharm, echoed this sentiment, emphasizing that oncology is a core focus area for ASK Pharm. He highlighted that limertinib, ASK Pharm’s first innovative drug, targets lung cancer, the most common and deadly cancer in China. Mr. Ma expressed confidence that the partnership with Innovent, which has a strong product pipeline in lung cancer, will help maximize limertinib's clinical value and benefit more patients.

NSCLC accounts for approximately 80% to 85% of all lung cancers, and around 70% of NSCLC patients are diagnosed with advanced or metastatic disease that is ineligible for surgical resection. EGFR mutations are frequent drivers of NSCLC, occurring in 30% to 50% of Asian patients. EGFR TKIs are the recommended first-line treatment, with third-generation inhibitors offering the broadest applicability.

Innovent, founded in 2011, is a biopharmaceutical company focused on creating high-quality, affordable medicines for intractable diseases. The company has launched 11 products and has multiple new drug applications and clinical trials underway. Innovent collaborates with over 30 global healthcare companies to advance the biopharmaceutical industry.

ASK Pharm, established in 2003, integrates innovative research, development, manufacture, and sales of pharmaceuticals. The company specializes in oncology, digestive disease, multidrug-resistant infections, and chronic diseases. ASK Pharm is committed to developing small-molecule targeted and immuno-oncology biologic drugs and has received numerous accolades for its contributions to pharmaceutical R&D in China.