Qilu Pharmaceutical Launches Five Class 1 New Drugs Targeting Two Billion-Dollar Markets
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On September 3, according to the official website of the CDE,Qilu PharmaceuticalClass 1 New Drug ApplicationMeropenem and Plazbactam for InjectionReceived implied permission for clinical trials, intended for the treatment of complicated intra-abdominal infections. According to the PharmaOcean database, from 2024 to date, Qilu Pharmaceutical has received clinical approval for 8 Class 1 new drugs.
Meropenem and Plazbactam for InjectionOn June 13, 2024, the clinical application was accepted by the CDE.Meropenem-Plebactam for InjectionYesAn antibacterial drug, which is produced byMeropenem（Meropenem）AndPulabatan（Vaborbactam）Composite preparation composed of multiple components.According to the PharmaOcean database, systemic anti-infective drugs(Chemical drug or biologic)Total sales in hospitals across China exceed 100 billion yuan.
In recent years, Qilu Pharmaceutical has continuously advanced its innovation strategy, increasing R&D investment to support pharmaceutical innovation. To date, Qilu Pharmaceutical has over 30 Class 1 new drugs in the approved clinical and higher stages.(Excluding already marketed new drugs and new indications under development), mainly focusing on anti-tumor drugs. According to the PharmaOcean database, Qilu Pharmaceutical Co., Ltd. hasMeropenem-Plebactam for Injection, QLS4131 for Injection, QLC1101 Capsules, QLF31907 for InjectionEight Class 1 new drugs, including one systemic anti-infective drug, four anti-tumor and immunomodulatory drugs, have been approved for clinical trials. The sales revenue of anti-infective drugs, anti-tumor drugs, and immunomodulatory drugs in these two major fields exceeds tens of billions of yuan in the Chinese hospital market.
In the field of anti-infectives, Qilu Pharmaceutical has several new drugs under development, among whichFL058 for Injection, QL-007 TabletsBoth have completed Phase II clinical trials and are respectively used for the treatment of complicated urinary tract infections.(Including acute pyelonephritis), Chronic Hepatitis B.In addition, the company is actively promoting the approval process for the production of Pertuzumab Injection, a Class 3.3 new drug. Meanwhile, several biosimilars, such as Bevacizumab Injection and Denosumab Injection, have been successfully approved for marketing.
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