Innovent and ASK Pharm's Limertinib: A New Hope for Lung Cancer Patients

Innovent Biologics, Inc. (HKEX: 01801) and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ) have jointly announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). This approval marks a significant milestone for both companies and offers new hope for lung cancer patients in China.

Limertinib is an orally administered, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with proprietary rights. It is designed to target tumors with mutations in the gene encoding for the EGFR protein, specifically those with the T790M mutation, which is a common cause of resistance to first- and second-generation EGFR TKIs. The approval of limertinib is based on robust clinical trial data, which demonstrated its superior efficacy and safety compared to existing treatments.

In a Phase 2b pivotal study, limertinib showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4% in patients with locally advanced or metastatic EGFR T790M-mutated NSCLC. The median progression-free survival (PFS) was 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions, the CNS best-ORR was 65.9% with a median PFS of 10.6 months. These impressive results highlight the potential of limertinib as a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.



In addition to its strong clinical performance, limertinib has a favorable safety profile. In the Phase 2b study, 96.0% of patients experienced at least one treatment-related adverse event (TRAE), with the most common being diarrhea (81.7%), anemia (32.6%), rash (29.9%), and appetite decrease (28.2%). Grade ≥3 TRAEs occurred in 34.6% of patients, with the most common including diarrhea (13.0%), hypokalemia (4.3%), anemia (4.0%), and rash (3.3%). TRAEs leading to dose interruption and dose discontinuation occurred in 24.6% and 2% of patients, respectively. No TRAE led to death.



The approval of limertinib is a testament to the collaborative efforts of Innovent and ASK Pharm. Innovent will hold exclusive rights to commercialize limertinib in mainland China and will receive a commercialization 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. This strategic collaboration aims to improve access to effective treatments for patients in China, ensuring that more individuals benefit from advanced therapies.

In conclusion, the approval of limertinib by the NMPA is a significant milestone for Innovent and ASK Pharm, offering a new hope for lung cancer patients in China. With its robust efficacy, favorable safety profile, and strong clinical trial data, limertinib has the potential to become a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. The collaborative efforts of Innovent and ASK Pharm will ensure that more patients have access to this innovative therapy, further enhancing the accessibility and affordability of innovative therapies in China.