Qilu Pharmaceutical Surges with Launch of First Liposomal Drug and Next-Gen Antibiotic, Targeting a Billion-Dollar Market
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On May 27, according to the official website of NMPA,Qilu PharmaceuticalTwo Generic Chemical Drugs SubmittedDoxorubicin Hydrochloride Liposome Injection(Cybele®)AndTedizolid Phosphate TabletsApproved for listing on the same day and deemed to have passed the evaluation. According to statistics from PharmaCloud, Qilu Pharmaceutical has had 13 varieties pass the evaluation this year.
Qilu Pharmaceutical Secures First Liposome Drug, Hospital Market Sales Exceed 2.5 Billion Yuan
Doxorubicin HydrochlorideAs a broad-spectrum antineoplastic drug, it exerts its tumor-treating effects by inhibiting DNA, RNA, and protein synthesis. It is commonly used in the chemotherapy of multiple myeloma, lymphoma, ovarian cancer, and breast cancer.Doxorubicin Hydrochloride Liposome InjectionThis can enhance drug efficacy, reduce toxicity, achieve targeted accumulation, and enable precise treatment. According to statistics from the Pharma Intelligence Cloud,Liposomal Doxorubicin Hydrochloride InjectionExceeded 2.5 billion yuan in sales revenue in the Chinese hospital market in 2022.
According to the PharmaOcean database, there were previously 15 approvals for liposome injectables in use in China. These correspond to six active ingredients, among which...Liposomal Doxorubicin HydrochlorideThe largest number of approvals, totaling eight, were granted to five pharmaceutical companies: Zhejiang Hisun Pharmaceutical, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Zhejiang Zhida Pharmaceutical, Changzhou Jinyuan Pharmaceutical, and CSPC Ouyi Pharmaceutical.
According to the PharmaOcean database, as of 2022, there are four active substances with relevant sales information: doxorubicin hydrochloride, mitoxantrone hydrochloride, amphotericin B, and paclitaxel. Between 2015 and 2020, China's liposome market maintained rapid growth, with an annual compound growth rate of 18%; after 2020, sales decreased year by year. The market is currently dominated by doxorubicin hydrochloride and paclitaxel, both of which are anti-tumor drugs. In recent years, CSPC Pharmaceutical Group has rapidly increased its share in China’s liposome market, accounting for approximately half of the market share by 2022.（In-depth Analysis and Reading on Liposomes:Improved New Drug Market Worth Billions! Liposomes See Strong Growth, CSPC Group Dominates Half of the Market...）
Liposome drug formulations belong to high-tech barriers and require large R&D investment as advanced complex formulations. They have long transformation cycles and low clinical success rates, and there are very few enterprises both in and outside China that are capable of successfully developing them. According to Qilu Pharmaceutical GroupThe message shows that this time,Saibez®As the first liposomal drug formulation of Qilu Pharmaceutical, this marks another significant breakthrough in a key technology platform for Qilu, following its achievements in albumin nanoparticles, submicron emulsions, microspheres, and microcrystals, showcasing Qilu Pharmaceutical's strong capabilities in the field of high-end complex formulations.
Add Another Super Antibiotic, Targeting a Billion-Dollar Market
Tedizolid PhosphateAs a derivative of linezolid, it is a second-generation oxazolidinone antibiotic.Tedizolid PhosphateInitially by South KoreaDong-A PharmaceuticalResearch and development, followed byMerckAndBayerCommercially developed, it was first approved for marketing by the FDA in June 2014 and received EU approval in June 2015. The original researchTedizolid Phosphate TabletsAndTedizolid Phosphate for InjectionApproved to enter the Chinese market in 2019.
Linezolid, as the "predecessor" of tedizolid phosphate, has consistently demonstrated strong market performance. In 2019, its in-hospital sales reached a peak of 1.75 billion yuan. Meanwhile, the sales peak of systemic anti-infective drugs in China's in-hospital market exceeded 130 billion yuan, with...Tedizolid Phosphate TabletsWith the gradual promotion and application in the Chinese market, the development of this super antibiotic in the cityWillWorth looking forward to.
As of now, Qilu Pharmaceutical has had 163 varieties pass or be considered to have passed the consistency evaluation.Of which 56 are the first in China; there are57 Systems Use Anti-Infective Drugs Approved and Passed Consistency Evaluation. From 2024 to present(As of May 28)Qilu PharmaceuticalCarvedilol Tablets, Doxorubicin Hydrochloride Liposome Injection, Cefpodoxime Proxetil for Suspension, Cetrorelix Acetate for InjectionThirteen varieties, including [drug name], have passed the evaluation.
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