Qilu Pharmaceutical Secures First-to-File Generic Approval for Ixazomib Citrate Capsules and Cyclosporine Soft Capsules, Two Blockbuster Products Worth Over RMB 4 Billion and RMB 8 Billion Respectively
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On February 7, according to the latest information on the NMPA official website,Qilu PharmaceuticalTwo submitted Category 4 generic drugsIxazomib Citrate CapsulesAndCyclosporine Soft CapsulesApproved on the same day and deemed to have passed the consistency evaluation, among whichIxazomib Citrate CapsulesApart from the original research, no pharmaceutical companies in China have been approved yet. This time, Qilu Pharmaceutical Co., Ltd. has been successfully approved, becoming the first generic drug manufacturer of this variety in China.
Screenshot source: NMPA
Over 400 Million Capsule Varieties: Qilu Pharmaceutical Secures First Generic
Citrate Ixazomib（Ixazomib Citrate）ByTakedaQilu Pharmaceutical's Millennium Pharmaceuticals developed an orally administered, highly selective proteasome inhibitor, which received approval from the U.S. Food and Drug Administration on November 20, 2015.（FDA）The market approval was granted by the European Medicines Agency on November 21, 2016. After this product's market launch, the sales revenue in the hospital market significantly increased, according to the Mosun Pharmaceutical Database.Ixazomib Citrate CapsulesIn 2024(Q1~Q3 Quarter)Sales in the Chinese hospital market exceeded 400 million yuan, with a year-on-year increase of 18.62%.
Screenshot source:MoxEntropy PharmaceuticalsNational Hospital Sales Database
In ChinaIxsalo Citrate CapsulesApart from the original research, no pharmaceutical companies in China have been approved yet. In terms of generic drug development, Qilu Pharmaceutical is also the first company in China to apply for generic market entry, with no other pharmaceutical companies currently involved. This time, Qilu Pharmaceutical has been successfully approved, becoming the first generic drug manufacturer of this variety in China, breaking the monopoly of the original research drug.
Screenshot source:Summary Database of Drugs Approved by Moxie Pharmaceuticals
Over 800 Million Heavyweight Variety, Qilu Pharmaceutical Adds Another Member
Cyclosporine Soft CapsulesByNovartisDeveloped and launched in Germany in 1994, it received FDA approval in the United States in July 1995. It is an immunosuppressant mainly used to prevent organ transplant rejection and GVHD in bone marrow transplants, and is also suitable for endogenous uveitis, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome. According to the Mosun Pharma database,Cyclosporine Soft CapsulesIn 2024(Q1~Q3 Quarter)Sales in the Chinese hospital market exceeded 800 million yuan, with a year-on-year increase of 21.99%.Among them, Grand Pharmaceutical tops the list with a market share of 58.57%, Novartis ranks second with a market share of 21.27%, and North China Pharmaceutical ranks third with a market share of 12.60%.
Screenshot source:Mox Entropy PharmaceuticalsNational Hospital Sales Database
In the Chinese market,Cyclosporine Soft CapsulesThe competition is relatively fierce. More than 10 pharmaceutical companies in China have obtained production approval for this drug, and so far, five companies have passed the evaluation: Qilu Pharmaceutical, North China Pharmaceutical, Jiangsu Xinfu Pharmaceutical, Livzon Group Livzon Pharmaceutical Factory, and Hangzhou Zhongmei Huadong Pharmaceutical. However, Qilu Pharmaceutical's recent approval for marketing makes it the fifth company to pass the evaluation for this drug. This will undoubtedly further consolidate Qilu Pharmaceutical's market position in the field of immunosuppressants.
Screenshot source:MoxEntropy Pharmaceutical Approved Drugs Summary Database
Since the beginning of 2025, Qilu Pharmaceutical has continued to make efforts in the field of generic drugs, with 7 varieties already.(Including subsidiaries)Approved and deemed to have passed the evaluation. Among them,Ixazomib Citrate CapsulesAndIbrutinib TabletsIt is the first domestically produced variety to pass the evaluation.
The simultaneous approval and market launch of these two significant capsule products once again demonstrates Qilu Pharmaceutical's strong capabilities in research, innovation, and market expansion. In the future, with the approval and launch of more varieties, Qilu Pharmaceutical is expected to occupy a more important position in the pharmaceutical market.
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