Innovent and ASK Pharm Announce NMPA Approval of Limertinib for Lung Cancer

SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 -- Innovent Biologics, Inc. ("Innovent") and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) have announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib. This drug is intended for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by the EGFR T790M mutation.

Limertinib is the latest addition to Innovent's portfolio and strengthens its suite of tyrosine kinase inhibitors (TKI). It provides a novel precision therapy option for lung cancer patients. Clinical trials, including a significant Phase 2b study with 301 participants, highlighted limertinib's effectiveness. The study revealed an overall response rate of 68.8% and a disease control rate of 92.4%. Additionally, the median progression-free survival was recorded at 11.0 months, with a median duration of response of 11.1 months. Importantly, for patients with central nervous system lesions, the CNS best overall response rate was 65.9%, with a median progression-free survival of 10.6 months. The safety profile of limertinib was consistent with other drugs targeting EGFR.

Limertinib's performance was further validated in a Phase 3 clinical trial, where it was compared to gefitinib for the initial treatment of NSCLC with EGFR mutations. A separate application for the first-line treatment of NSCLC with specific EGFR mutations is currently pending with the NMPA.

Professor Shi Yuankai from the Chinese Academy of Medical Sciences, the principal investigator of the clinical studies, emphasized the drug's efficacy in treating NSCLC patients with the EGFR T790M mutation. Limertinib has shown promise in reducing the risk of CNS progression or death, offering a new treatment avenue for advanced EGFR-mutated NSCLC.

Dr. Hui Zhou, a Senior Vice President at Innovent, highlighted the approval of limertinib as a landmark achievement. The drug offers new treatment possibilities for patients with T790 mutation-positive lung cancer who have seen progression following previous EGFR-TKI treatments. Innovent is hopeful that the first-line treatment indication will soon benefit more patients. As Innovent's 14th commercial product, limertinib marks a significant step forward in precision medicine for lung cancer.

Jingfei Ma, CEO of ASK Pharm, noted that limertinib, in addition to its recent approval, is also undergoing regulatory review for first-line treatment of NSCLC with EGFR 19DEL+ or L858R+ mutations in China. Furthermore, ASK Pharm is developing ASKC202, a selective c-Met inhibitor, for use in combination with limertinib to combat resistance to third-generation EGFR-TKI treatments. This first approval of limertinib signifies a notable advancement in ASK Pharm's journey towards innovative drug development.

Lung cancer, particularly NSCLC, remains a major global health challenge, with EGFR mutations often prevalent among Asian patients. EGFR-TKIs are typically the recommended first-line treatment, and third-generation EGFR inhibitors like limertinib are increasingly important.

Limertinib, a third-generation EGFR TKI, has been approved for treating T790M-mutated NSCLC and is awaiting further approval for treating other EGFR mutations. The drug has proven successful in trials, demonstrating its potential as a groundbreaking treatment option.

Innovent is a prominent biopharmaceutical company committed to affordable and high-quality medicines. Founded in 2011, Innovent has developed numerous products and has several drugs under regulatory review. It collaborates with various global healthcare entities to enhance the availability of effective pharmaceutical treatments.

ASK Pharm, established in 2003, is a research-oriented pharmaceutical company focusing on developing innovative drugs for oncology and chronic diseases. With a robust research pipeline, ASK Pharm has consistently been recognized for its contributions to pharmaceutical innovation in China.