Guangzhou Baiyunshan Pharmaceutical Holdings (00874): Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Factory has received the "Drug Registration Certificate" issued by the National Medical Products Administration for Cefclox Slow-release Tablets (II).
Baiyunshan (00874) announced that recently, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. (hereinafter referred to as "the Company")'s subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Pharmaceutical Factory (hereinafter referred to as "Baiyunshan Pharmaceutical Factory"), received the "Drug Registration Certificate" issued by the National Medical Products Administration for Ceftolozane Sulfate Sustained-Release Tablets (II).
Guangzhou Baiyunshan Pharmaceutical Holdings (00874) announced that its subsidiary, Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Group Co., Ltd. (referred to as "the Company"), received the Drug Registration Certificate for Cefaclor Sustained-Release Tablets (II) issued by the National Medical Products Administration.
Cefaclor Sustained-Release Tablets is a second-generation cephalosporin antibiotic, clinically used for infections caused by sensitive pathogens, including acute and chronic exacerbations of bronchitis, pharyngitis, tonsillitis, pneumonia, sinusitis, uncomplicated urinary tract infections, and skin and soft tissue infections. The original manufacturer of Cefaclor Sustained-Release Tablets is Lederle Laboratories in the United States, which was approved for sale in the U.S. in June 1996. In 2002, it was approved for sale in China.
On October 25, 2024, Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Factory submitted a drug marketing registration application to the National Medical Products Administration, which was accepted on December 27, 2024. Currently, the domestic manufacturers for Cefaclor Sustained-Release Tablets (II) include Yiteng Medicine (Suzhou) Co., Ltd. and Yangtze River Pharmaceutical Group Co., Ltd. According to data from Minet, the sales of Cefaclor Sustained-Release Tablets (II) in domestic cities, county-level public hospitals, urban areas, and online pharmacies in 2025 amounted to 425 million RMB.
Up to now, Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Factory has invested approximately 14.6254 million RMB (unaudited) in research and development for the Cefaclor Sustained-Release Tablets (II) project.
Obtaining the Drug Registration Certificate for Cefaclor Sustained-Release Tablets (II) enriches the variety of anti-infection products of Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Factory and enhances the competitiveness of the Company in the anti-infection market. Guangzhou Baiyunshan Pharmaceutical Holdings Pharmaceutical Factory will carry out production in accordance with relevant requirements and market demand.
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