Qilu Pharmaceuticals Files for Market Launch as Second Domestic Manufacturer of Polymyxin B Sulfate for Injection, a 1.5-Billion-Yuan Anti-Infective

Sep 20, 2024 17:05 CST Updated 17:05

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Note: This article does not constitute any investment opinions or recommendations; please refer to official/company announcements for accuracy. This article only provides an introduction to drugs related to medical health, not a recommendation of treatment plans (if involved), and does not represent the platform's position. Authorization is required for the reprint of any article.

On September 19, according to the CDE official website,Qilu Pharmaceutical (Hainan)Submitted Generic Drug Category 3Polymyxin B Sulfate for InjectionListedApplication Accepted.According to the PharmaCloud database, the sales revenue of this variety in China's hospital market in 2023 was nearly 1.5 billion yuan.

Screenshot source: CDE

Polymyxin B Sulfate for InjectionBelongs to Class B medical insurance anti-infective drugs, mainly used clinically in public hospitals. It is a group of antimicrobial peptides isolated from Bacillus polymyxa, used against acute infections primarily caused by Gram-negative bacteria, especially Pseudomonas aeruginosa. Polymyxin B causes bacterial death by altering the permeability of the bacterial cell membrane. According to the Pharma Intelligence Cloud database, in 2023Polymyxin B Sulfate for InjectionSales in the Chinese hospital market reached nearly 1.5 billion yuan.

Screenshot source: Pharma Intelligence China Hospital Sales Database

Currently in China,Injectable Polymyxin B SulfateThe only pharmaceutical company producing it is Shanghai Pharmaceutical First Biochemical. In terms of generic drug development, 13 pharmaceutical companies including Qilu Pharmaceutical (Hainan), Hainan Better Pharmaceutical, and Sichuan Huiyu Pharmaceutical have submittedInjectable Polymyxin B SulfateThe race to secure the Class 3 generic registration is on; who will be the first to gain approval and become the second domestically-produced option in China? We'll have to wait and see.

Screenshot source:PharmCube China Drug Evaluation Database

From 2024 to present, Qilu Pharmaceutical(Including Subsidiaries)Submitted generic applications for 22 varieties including Relugolix Tablets, Injectable Polymyxin B Sulfate, Vitamin K1 Injection, and Letermovir Tablets. Since the beginning of this year, Qilu Pharmaceutical(Including Subsidiaries)Thirty-six varieties have passed the evaluation, includingCarvedilol Tablets, Metformin Empagliflozin Tablets (Ⅵ)Eight varieties, including [specific names], were the first to pass the evaluation.

END

This article is original. Please leave a message to obtain authorization for reprint.

Recent Popular Resource Acquisition

Reply to the keyword "Report", access dozens of exclusive reports produced by PharmaCloud
Reply to the keyword "First Generic in 2023", Obtain the List of First Generic Drugs Approved in 2023
Reply in the background"GLP-1 In-depth Report", to obtain the complete "GLP-1 Industry Status and Future Development" PDF version.
Reply in the background"China Class I New Drug", get complete"China Class I New Drug Targets" PDF Version.
Background Reply“NAFLD/NASH”, to obtain the complete "NAFLD/NASH Report" PDF version.
Background reply"AI + Pharmaceutical", get complete"White Paper on China's AI Pharmaceutical Companies"PDF Version.
Background reply“XXG”, get complete"Analysis Report on Cardiovascular System Drugs in China"PDF Version.
Background Reply“FZZJ”, get completeAnalysis of Complex Injectable Formulations Based on Dosage Form OptimizationPDF Version.
Background Reply"Pharmaceuticals Import and Export", get completeWhite Paper on China's Pharmaceutical Imports and ExportsIn-depth Report - PDF Version.

Contact us to experience more professional services from PharmaCloud.

MeetingDiscussion

CombinedMade

GardenDistrict

TakeWu

Database

Consultation

Customization

Service

Media

Cooperation

ClickReadRead the Original Text, learn more about the brand upgrade details!