Qilu Pharma Targets First Generic of Novartis' Blockbuster MET Inhibitor to Tap into a RMB 30 Billion Market
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On September 4, the CDE official website showed,Qilu Pharmaceutical Co., Ltd.According to the registration and declaration of Class 4 chemical drugsCapmatinib Hydrochloride TabletsThe listing application has been accepted. As a milestone drug for MET-driven lung cancer precision treatment, this medicine is currently only available as an original research product in China.Qilu PharmaceuticalSuccessfully approved, and may become the first generic drug in China.
Screenshot source: CDE official website
Capmatinib（Capmatinib）It is the world's first approved orally bioavailable, highly selective MET receptor tyrosine kinase inhibitor. The drug's development beganIncyteCompany,Novartis（Novartis）It obtained its R&D and promotion license in 2009.
Source of screenshot: Mosan Medical Global Drug Research and Development Database
From May 2020 to present,CapmatinibIt has been successively approved for marketing in multiple countries and regions, including the United States, Japan, the European Union, and Switzerland, and is prioritized as an international guideline recommendation for non-small cell lung cancer with METex14 exon skipping mutations.（NSCLC）Full-line treatment.
According to the database of Mose Pharm, the global sales of this drug have been increasing year by year: reaching 90 million US dollars in 2021, a year-on-year increase of 157.14%; breaking through to 133 million US dollars in 2022, a year-on-year increase of 47.78%; and reaching a new high of 154 million US dollars in 2023, with the market size steadily expanding.
Source of screenshot: Mosentropy Global Drug R&D Database
In China,CapmatinibIn 2022, it 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's mainland China. It was approved for use at Guangzhou Modern Hospital to meet the urgent clinical treatment needs of patients.
June 12, 2024Capmatinib Hydrochloride Tablets(Tourette®)Approved for marketing by the NMPA. Its approval is based on strong data support from the global multicenter clinical study GeoMETry mono-1 and the clinical study GeoMETry-C targeting the Chinese population.
Screenshot source: Mose Pharm China Drug Approval Database
Studies have shown,CapmatinibBlinded Independent Review Committee for First-Line Treatment of METex14 Skipping Mutation in Advanced Non-Small Cell Lung Cancer Patients（BIRC）The ORR was assessed at 61.5% by the investigators.（INV）The ORR assessed was 69.2%, and the DCR evaluated by BICR and INV reached 100%, consistent with global research data, demonstrating excellent therapeutic efficacy.
Efficacy Evaluation of GEOMETRY mono-1 and GeoMETry-C Studies
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 in-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 continue to be prominent.
Screenshot source: Mosentropy Medicine National Hospital (All-Terminal) Sales Database
From the market data,Capmatinib Hydrochloride TabletsThe performance is commendable, especially in hospitals across all terminals in China.(Including all provinces)Total sales 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.
Screenshot source: Mosentropy Medicine All-Terminal Hospital Sales (Including Provinces) Database
As of now, onlyQilu PharmaceuticalForCapmatinib Hydrochloride TabletsSubmitted a generic drug marketing application, and no other pharmaceutical companies have filed for the generic version of this product yet, making the field currently exhibit a "single applicant" situation.
Screenshot source: Mosentropy China Drug Evaluation Database
Qilu PharmaceuticalThis application is based on the two completed BE trials:Capmatinib Hydrochloride TabletsPostprandial Human Bioequivalence Study（CTR20252206）、Capmatinib Hydrochloride TabletsFasting Human Bioequivalence Study（CTR20251951）, fully covering the equivalence verification under different medication statuses, providing sufficient data support for the submission.
Screenshot source: Mosentropy Medicine China Clinical Trial Database
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 intensified. If it successfully gains approval to secure the first generic drug, it will establish itself in the niche market ahead of others, potentially contributing to solving the issue of drug accessibility for patients in China. The subsequent review progress and market prospects of this drug may attract dual attention from both the industry and patients.
END
This article is original. Please leave a message to obtain authorization for reprint.
More RecentlyMoxie ConsultingPopular Report, Scan the QR Code Below to Claim
Contact us to experience more professional services from Mosen Pharma. | ||||
MeetingDiscussion ConformityMade | GardenDistrict TakeWu | Database Consultation | Customization Service | Media Cooperation |
ClickImage Above, you can start the Mosan Chemical Data Query
