Innovent Announces NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharma, for the First-line Treatment of Lung Cancer
Innovent Biologics (HKEX: 01801) announces NMPA approval of limertinib for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. The approval is based on a Phase 3 trial of 337 patients comparing limertinib to gefitinib.
Key trial results show limertinib significantly improved median progression-free survival (PFS) to 20.7 months vs 9.7 months for gefitinib, representing a 56% risk reduction. In patients with CNS lesions, median CNS PFS was 20.7 months vs 7.1 months, showing a 72% risk reduction.
The drug demonstrated a well-tolerated safety profile with predominantly mild to moderate adverse events. This approval follows Innovent's commercial collaboration with ASK Pharm in 2024 for limertinib in Mainland China.
Innovent Biologics (HKEX: 01801) annuncia l'approvazione da parte della NMPA di limertinib per il trattamento di prima linea del carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato o metastatico con specifiche mutazioni EGFR. L'approvazione si basa su uno studio di Fase 3 condotto su 337 pazienti che ha confrontato limertinib con gefitinib.
I risultati chiave dello studio mostrano che limertinib ha migliorato significativamente la sopravvivenza libera da progressione mediana (PFS), raggiungendo 20,7 mesi contro 9,7 mesi per gefitinib, con una riduzione del rischio del 56%. Nei pazienti con lesioni del sistema nervoso centrale (SNC), la PFS mediana nel SNC è stata di 20,7 mesi contro 7,1 mesi, con una riduzione del rischio del 72%.
Il farmaco ha mostrato un profilo di sicurezza ben tollerato, con eventi avversi prevalentemente lievi o moderati. Questa approvazione segue la collaborazione commerciale di Innovent con ASK Pharm nel 2024 per limertinib nella Cina continentale.
Innovent Biologics (HKEX: 01801) anuncia la aprobación por parte de la NMPA de limertinib para el tratamiento de primera línea del cáncer de pulmón no microcítico (NSCLC) localmente avanzado o metastásico con mutaciones específicas en EGFR. La aprobación se basa en un ensayo de Fase 3 con 337 pacientes que comparó limertinib con gefitinib.
Los resultados clave del ensayo muestran que limertinib mejoró significativamente la supervivencia libre de progresión (PFS) mediana a 20,7 meses frente a 9,7 meses con gefitinib, lo que representa una reducción del riesgo del 56%. En pacientes con lesiones en el sistema nervioso central (SNC), la PFS mediana en SNC fue de 20,7 meses frente a 7,1 meses, mostrando una reducción del riesgo del 72%.
El medicamento mostró un perfil de seguridad bien tolerado, con eventos adversos mayormente leves a moderados. Esta aprobación sigue a la colaboración comercial de Innovent con ASK Pharm en 2024 para limertinib en China continental.
Innovent Biologics (HKEX: 01801)는 특정 EGFR 돌연변이를 가진 국소 진행성 또는 전이성 비소세포폐암(NSCLC) 1차 치료제로 리머티닙(limertinib)의 NMPA 승인을 발표했습니다. 이번 승인은 337명의 환자를 대상으로 리머티닙과 게피티닙을 비교한 3상 임상시험 결과에 근거합니다.
주요 임상 결과에 따르면 리머티닙은 무진행생존기간(PFS) 중앙값을 20.7개월 대 9.7개월로 유의미하게 개선하여 56%의 위험 감소를 나타냈습니다. 중추신경계(CNS) 병변 환자에서는 CNS 무진행생존기간 중앙값이 20.7개월 대 7.1개월로 72%의 위험 감소를 보였습니다.
이 약물은 주로 경증에서 중등도의 부작용을 보이며 내약성이 우수한 안전성 프로파일을 입증했습니다. 이번 승인은 2024년 Innovent가 ASK Pharm과 중국 본토에서 리머티닙에 대해 체결한 상업적 협력에 따른 것입니다.
Innovent Biologics (HKEX : 01801) annonce l'approbation par la NMPA de limertinib pour le traitement de première ligne du cancer du poumon non à petites cellules (NSCLC) localement avancé ou métastatique présentant des mutations spécifiques de l'EGFR. Cette approbation repose sur un essai de phase 3 incluant 337 patients comparant limertinib au gefitinib.
Les résultats clés de l'essai montrent que limertinib a significativement amélioré la survie sans progression médiane (PFS), atteignant 20,7 mois contre 9,7 mois pour le gefitinib, soit une réduction du risque de 56 %. Chez les patients présentant des lésions du système nerveux central (SNC), la PFS médiane au niveau du SNC était de 20,7 mois contre 7,1 mois, témoignant d'une réduction du risque de 72 %.
Le médicament a démontré un profil de sécurité bien toléré, avec des événements indésirables principalement légers à modérés. Cette approbation fait suite à la collaboration commerciale d'Innovent avec ASK Pharm en 2024 pour limertinib en Chine continentale.
Innovent Biologics (HKEX: 01801) gibt die Zulassung der NMPA für Limertinib zur Erstlinienbehandlung von lokal fortgeschrittenem oder metastasiertem nicht-kleinzelligem Lungenkrebs (NSCLC) mit spezifischen EGFR-Mutationen bekannt. Die Zulassung basiert auf einer Phase-3-Studie mit 337 Patienten, die Limertinib mit Gefitinib verglich.
Wesentliche Studienergebnisse zeigen, dass Limertinib das mediane progressionsfreie Überleben (PFS) signifikant auf 20,7 Monate gegenüber 9,7 Monaten bei Gefitinib verbesserte, was einer Risikoreduzierung von 56 % entspricht. Bei Patienten mit ZNS-Läsionen betrug das mediane ZNS-PFS 20,7 Monate gegenüber 7,1 Monaten, was einer Risikoreduzierung von 72 % entspricht.
Das Medikament zeigte ein gut verträgliches Sicherheitsprofil mit überwiegend milden bis moderaten Nebenwirkungen. Diese Zulassung folgt der kommerziellen Zusammenarbeit von Innovent mit ASK Pharm im Jahr 2024 für Limertinib in Festlandchina.
- Significant PFS improvement: 20.7 months vs 9.7 months compared to gefitinib
- Superior CNS efficacy with 72% risk reduction in brain metastasis patients
- Well-tolerated safety profile with mild to moderate adverse events
- Expanded market potential with both first-line and second-line treatment approvals
- None.
The approval of this new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomized 1:1 to receive either limertinib or gefitinib. The primary endpoint was progression-free survival (PFS), as assed by an independent review committee (IRC).
The data showed that limertinib significantly prolonged median PFS compared to gefitinib (20.7 months vs. 9.7 months), representing a
The safety profile of limertinib was consistent with that of known EGFR-targeted therapies. Adverse events were predominantly mild to moderate and well-tolerated, with no new safety signals identified during the clinical trial. Full data and analysis from this pivotal Phase 3 study will be published in academic journals.
"Limertinib has demonstrated exceptional efficacy and safety as first-line therapy in patients with EGFR-muted locally advanced or metastatic NSCLC, including notable efficacy in those with brain metastases. The approval of this first-line indication introduces a new treatment option for Chinese patients, addressing a critical clinical need in this population." said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 3 Clinical Study.
Dr. Hui Zhou, Senior Vice President of Innovent, stated："We are delighted that both the first-line and second-line indications for limertinib have been successively approved. As a next-generation EGFR TKI, limertinib is poised to significantly improve survival outcomes for mutation-positive patients. Innovent has built a rich portfolio of precision therapies for lung cancer—including limertinib, Retsevmo®(selpercatinib), Dupert®(fulzerasib) and DOVBLERON® (taletrectinib)—with ongoing efforts to enhance their synergistic value. We will continue to work closely with Ask Pharm to ensure that limertinib brings a new hope to the broad population of patients with EGFR-mutated NSCLC."
Mr. Jingfei Ma, CEO of ASK Pharm, stated: "Within a few months, limertinib has obtained approvals for both second-line and first-line indications. The approval of the first-line indication further expands its clinical applicability. Meanwhile, ASK Pharm is advancing a clinical trial of limertinib in combination with the cMET inhibitor ASKC202 for patients with NSCLC resistant to third-generation EGFR-TKIs. We look forward to working with our partner Innovent to accelerate the accessibility of limertinib for more patients in need."
About EGFR mutation-positive non-small-cell lung cancer (NSCLC)
Lung cancer remains one of the deadliest and most common cancers globally[1], with NSCLC accounting for approximately
About Limertinib
Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights. It has been approved by the
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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.
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, 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
For more information, visit www.ask-pharm.com.
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
[1] 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.
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