Core Viewpoint - Jiangsu Wuzhong Pharmaceutical Development Co., Ltd. announced that its subsidiary has received approval for the consistency evaluation of Lincomycin Hydrochloride Injection, enhancing its market competitiveness and sales potential [1][3]. Drug Basic Information - Drug Name: Lincomycin Hydrochloride Injection - Dosage Form: Injection - Specification: 2ml: 0.6g (calculated as C18H34N2O6S) - Approval Number: National Drug Approval No. H32021365 - Registration Category: Chemical Drug - Holder of Marketing Authorization: Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. Suzhou Pharmaceutical Factory [1]. Market and Financial Impact - The total sales of Lincomycin Hydrochloride Injection in hospitals nationwide for 2024 are approximately 22.1165 million yuan [3]. - The drug is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024) as a Class A variety [3]. - As of August 2025, the company has invested approximately 3.1324 million yuan in the research and development of Lincomycin Hydrochloride Injection [3]. Regulatory and Clinical Use - The drug is indicated for severe infections caused by sensitive strains of Streptococcus, Pneumococcus, and Staphylococcus, specifically for patients allergic to penicillin or deemed unsuitable for penicillin use [2]. - Lincomycin Hydrochloride Injection was first approved by the FDA on December 29, 1964, and has since been approved in various countries, including Japan and European nations [2]. Competitive Advantage - The approval of the drug through the consistency evaluation is expected to positively impact its market sales and competitiveness, as healthcare institutions are encouraged to prioritize the procurement of drugs that have passed this evaluation [3].
江苏吴中医药发展股份有限公司关于盐酸林可霉素注射液通过仿制药一致性评价的公告