Home Qilu Pharmaceutical Secures Approval for Carfilzomib for Injection, a Global $1.5 Billion Blockbuster Drug

Qilu Pharmaceutical Secures Approval for Carfilzomib for Injection, a Global $1.5 Billion Blockbuster Drug

Oct 13, 2025 20:30 CST Updated 20:30
Qilu Pharmaceutical

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On October 11, according to the latest announcement on the official website of the National Medical Products Administration (NMPA),Qilu Pharmaceutical (Hainan)According to the Chemical Drug Registration ClassificationCategory 4DeclaredCarfilzomib for InjectionApproved for marketing and deemed to have passed the evaluation. In the past three years, this product has performed remarkably in the global market, with annual sales exceeding 1 billion US dollars, demonstrating significant market potential.

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Screenshot source: NMPA


CarfilzomibByProteolixThe company was the first to develop the drug, which then underwent two rounds of acquisitions: Onyx acquired it in 2009, and Amgen acquired Onyx in August 2013. In July 2012, the drug was first approved for marketing in the United States for patients who have received at leastBortezomibPatients with multiple myeloma treated with two regimens of immunomodulators, becoming the successorBortezomibThe second proteasome inhibitor to receive FDA approval. Currently,CarfilzomibIt has been launched in many countries around the world, with sales continuing to rise. Global sales broke through 1 billion US dollars in 2020, and according to the Maxia Medicine database, sales exceeded 1.5 billion US dollars in 2024.

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Screenshot source: Mosan Pharma Global Drug R&D Database


In the Chinese market, this drug was approved for marketing in China in 2021 and was subsequently successfully included in the National Reimbursement Drug List (NRDL). After being incorporated into the NRDL, its market demonstrated rapid growth. In 2024, carfilzomib’s sales revenue in the all-terminal hospital market strongly exceeded 200 million yuan, with a year-on-year growth rate of 90.45%. Entering 2025, its growth momentum remains robust, with sales reaching 152 million yuan in just the first half of the year, representing a year-on-year increase of 39.13%, indicating significant market potential.

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Screenshot source: Mosentropy Medicine All-Terminal Hospital Sales Database


InCarfilzomibIn terms of domestic generic drug development, as of now,Sichuan Huiyu Pharmaceutical, Yangtze River Pharmaceutical, Chongqing Yaoyou Pharmaceutical, Zhengda Tianqing PharmaceuticalA total of 13 pharmaceutical companies, including [names], have submitted Class 4 generic drug marketing applications, and all these applications are currently in the review and approval stage.

In terms of domestic approvals, apart from the original research company, only Jiangsu Hengrui Medicine has successfully obtained approval.Injectable CarfilzomibThe production approval, securing the first domestic generic. This time, Qilu Pharmaceutical has been approved for marketing, becoming the...2 CompaniesThe approval of this drug variety has led to a competition landscape of 1 original research drug + 2 domestically produced drugs.

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Screenshot source: Mosentropy Medicine Approved Drugs Summary Database


It is worth mentioning that the original research drug has registered and disclosed two patents on the registration platform, involving compound and composition patents, with the expiration date of protection being August 7, 2025. Now that the patent has expired, Qilu Pharmaceutical's approval for marketing at this time can be said to have taken full advantage of favorable timing.

Qilu Pharmaceutical's strength in the pharmaceutical field is evident to all. Since the beginning of this year, 24 varieties have been approved and passed the evaluation, among which...Ixazomib Citrate CapsulesIbrutinib TabletsEtoposide InjectionAmisulpride InjectionOlanzapine for Injection5 products are the first batch in China to pass the evaluation. This timeCarfilzomib for InjectionThe approval and market launch undoubtedly adds another powerful product to its lineup, further demonstrating Qilu Pharmaceutical's strong capabilities in pharmaceutical research, development, and innovation.

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