Qilu Pharmaceutical's Capmatinib Tablet NDA Accepted by CDE, Poised to Secure First-to-File Generic Status for MET-Targeted Lung Cancer Therapy

(Source: MosaMed Big Data)

On September 4, the CDE official website showed,Qilu Pharmaceutical Co., Ltd.The marketing application for Capmatinib Hydrochloride Tablets, registered as a Class 4 chemical drug, has been accepted. As a milestone drug for the precise treatment of MET-driven lung cancer, this medicine is currently only available in China as an original research product.Qilu PharmaceuticalSmoothly approved, or may become the first generic drug in China.

Capmatinib is the world's first approved orally bioavailable, highly selective MET receptor tyrosine kinase inhibitor. The development of this drug beganIncyteCompany,NovartisIt obtained its R&D and promotion license in 2009.

From May 2020 to present, capmatinib has been successively approved for marketing in the United States, Japan, the European Union, Switzerland, and other countries and regions. It is also prioritized in international lung cancer guidelines as a recommended treatment for METex14 exon-skipping non-small cell lung cancer (NSCLC) across all treatment lines.

According toMoxie Medical DatabaseThe global sales of the drug have been increasing year by year: $90 million in 2021, a year-on-year increase of 157.14%; breaking through to $133 million in 2022, a year-on-year increase of 47.78%; and reaching a new high of $154 million in 2023, with the market size steadily expanding.

In China, capmatinib was included in the second batch of the directory for urgently needed imported drugs and medical devices from Hong Kong and Macao in the Greater Bay Area in 2022. It was approved for use at Guangzhou Modern Hospital to meet the urgent clinical treatment needs of patients.

On June 12, 2024, capmatinib hydrochloride tablets (Toreada®) were approved for marketing by the NMPA. Its approval was based on strong data support from the global multicenter clinical study GeoMETry mono-1 and the clinical study GeoMETry-C conducted in the Chinese population.

The study showed that, in the first-line treatment of METex14 skipping mutation advanced non-small cell lung cancer patients, the ORR evaluated by the Blinded Independent Review Committee (BIRC) for capmatinib was 61.5%, while the Investigator (INV)-assessed ORR reached 69.2%. Both BICR and INV assessments showed a DCR of 100%, consistent with global research data, demonstrating excellent therapeutic efficacy.

According to data from Mose Pharm, the field of anti-tumor drugs – protein kinase inhibitors, to which this drug belongs, is experiencing strong growth momentum. The market size continues to expand year by year, with hospital sales reaching 33.879 billion yuan in 2024, marking an 8.52% year-on-year increase compared to the previous year. The industry's growth drivers remain prominently evident.

From the market data, the performance of Capmatinib Hydrochloride Tablets is remarkable. Its cumulative sales in all-terminal hospitals (including all provinces) reached 3.5935 million yuan, with a year-on-year increase of 344.15% in the first quarter of 2025, fully demonstrating strong market potential.

As of now, onlyQilu PharmaceuticalA generic listing application for capmatinib hydrochloride tablets has been submitted, and no other pharmaceutical companies have made a generic application for this variety yet. The field currently shows a "single-application" situation.

Qilu PharmaceuticalThis submission is based on two completed BE trials: the fed-state human bioequivalence study of Camatimib Hydrochloride Tablets (CTR20252206) and the fasting-state human bioequivalence study of Camatimib Hydrochloride Tablets (CTR20251951), fully covering equivalence validation under different medication conditions, providing substantial data support for the submission.

This declaration, which is bothQilu PharmaceuticalThe validation of its own R&D capabilities, while precisely seizing the market opportunity where domestic original research is exclusive and generic drug competition has not yet heated up. If it successfully gains approval to secure the first generic drug, it will establish itself in the niche market first, which is expected to contribute to solving the problem of drug accessibility for patients in China. The subsequent review progress and market prospects of this drug may attract dual attention from the industry and patients.