Qilu Pharmaceutical Breaks Through with Two Major Injectables: China's First Romiplostim and Cetrorelix Acetate Targeting Multi-Billion-Yuan Markets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Recently, Qilu Pharmaceutical has been reporting frequent successes. According to the official website of NMPA,Qilu PharmaceuticalClass 3.4 BiologicsRomiplostim for InjectionApproved for Marketing(Application No.: CXSS2200029), the speculated indication is primary immune thrombocytopenia. At the same time, a Category 4 generic drugCetrorelix Acetate for InjectionAlsoApproved for marketing and deemed to have passed the evaluation.
Screenshot source:NMPA
First Chinese-Approved Product, Qilu’s New Launch Targets Billion-Dollar Market
RomiplostimByAmgenAs the original research and a second-generation TPO-R agonist drug, after being first launched in the United States in August 2008 and undergoing strict approval by institutions such as the EMA, it quickly gained application worldwide.N01 Romiplostim for InjectionAs the first long-acting platelet-increasing drug produced in China, its clinical advantages are particularly prominent. It not only acts quickly with a high early response rate but also requires extremely low dosing frequency—just once a week—greatly reducing the medication burden for patients. According to data from PharmaYun, the sales peak of drugs for blood and hematopoietic system in China's hospital market exceeded 100 billion yuan, with sales reaching 113.53 billion yuan in 2022.
Screenshot source: Pharma Intelligence China Hospital Sales Database
In China, Kyowa Kirin's romiplostim injection was approved for marketing in January 2022 for the treatment of primary immune thrombocytopenia.（ITP）. This approval marks the first domestically produced product in China.
Screenshot source:PharmCube China Drug Evaluation Database
Qilu Pharmaceutical has obtained 7 approvals this year, including 5 new products.Eltrombopag Ethanolamine TabletsIt is the first hemostatic drug approved by the company.N01 Romiplostim for InjectionIt is a significant new addition to Qilu Pharmaceutical's hemostatic drug market, and this product is also the first biologic approved for Qilu Pharmaceutical this year.
Screenshot source:PharmCube China Drug Approval Database
Over 200 Million Injectable Large Varieties, Qilu Pharmaceutical Co., Ltd. Latest Achievement!
Cetrorelix Acetate for InjectionOriginal Research fromMerck SeronoCompany. It is a third-generation gonadotropin-releasing hormone antagonist.（GnRH-A）The drug is suitable for preventing premature ovulation in women under controlled ovarian stimulation, facilitating subsequent oocyte retrieval and assisted reproductive technology treatments. According to the data from Pharma Intelligence Cloud,Cetrorelix Acetate for InjectionExceeding 200 million yuan in sales revenue in the Chinese hospital market in 2022.
Screenshot source: PharmaCloud China Hospital Sales Database
Currently, except for the original research manufacturerMerck，Cetrorelix Acetate for InjectionIn the Chinese market, Ferring Pharmaceuticals, Livzon Group, GenSci Pharma, Hainan Tiansheng Baohe, and Hainan Zhonghe Pharmaceutical are five pharmaceutical companies that have received approval for marketing. This time, Qilu Pharmaceutical has become the sixth domestically produced product in China.
Screenshot source:PharmCube China Drug Approval Database
In terms of generic drug layout, seven pharmaceutical companies in China, including Nanjing Kangzhou Pharmaceutical Science, Changzhou Qianhong Biochemical Pharmaceutical, Kaifeng Mingren Pharmaceutical, and Yangtze River Pharmaceutical Group, have submittedCetrorelix Acetate for InjectionThe generic applications of the product are all under review and approval.
Screenshot source:PharmCube Approved Drugs Summary Database
From 2024 to present, Qilu Pharmaceutical Co., Ltd. hasFluorouracil Injection, Cefaclor Capsules, Cefpodoxime Proxetil for Suspension, Cetrorelix Acetate for Injection, Azacitidine for Injection, Mirabegron Sustained-Release Tablets, Eltrombopag Ethanolamine TabletsSeven varieties passed the evaluation.
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