Innovent and ASK Pharm Jointly Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer

 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), jointly announce 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). Limertinib is the 14th product in Innovent's commercial portfolio and represents a cutting-edge addition to its strong TKI franchise, offering an innovative precision therapy option to lung cancer patients.

A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib's robust efficacy and safety profile. Independent review committee（IRC） assessment showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%. The median progression-free survival (PFS) reached 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions (N=99), the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile aligned with other EGFR-targeting agents in its class.

Additionally, limertinib met its primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.

"Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations. Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China," said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 2b and Phase 3 clinical studies.

Dr. Hui Zhou, Senior Vice President of Innovent, stated："The approval of limertinib's first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments. We anticipate the first-line treatment indication will benefit even more patients in the near future. As our 14th commercial product, limertinib represents an important advancement in precision medicine for lung cancer. We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC."

Mr. Jingfei Ma, CEO and Executive Director of ASK Pharm, stated: "Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in China. ASKC202, a new highly selective c-Met inhibitor, is currently undergoing clinical study in combination with limertinib to treat patients with third-generation EGFR-TKI resistance. Together with Innovent, we look forward to limertinib benefiting more Chinese lung cancer patients in the near future. The first approval of limertinib, a Class I innovative product, represents significant progress in the company's transformation toward innovative drug research and development. "

About EGFR mutation-positive non-small-cell lung cancer (NSCLC)

Lung cancer remains one of the deadliest and most common cancers globally[i], with NSCLC accounting for about 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic disease stages that cannot be surgically resected. EGFR mutations are particularly prevalent in Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability.

About Limertinib

Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, approved by the China's NMPA for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). A second NDA is under NMPA review for first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations.

The drug demonstrated success in a multi-center, randomized, double-blind, controlled Phase 3 clinical trial comparing its efficacy and safety of to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. With the primary endpoint met, results will be presented at upcoming academic conferences or published in academic journals.

In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 14 products in the market. It has 3 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. 

About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm)

Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas.

ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises".

Innovent's Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Reference

[i] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751.