Baiyunshan (00874) Branch obtained supplementary application approval for chemical raw materials

Zhitong Finance App News, Baiyunshan (00874) issued an announcement. Recently, the company's branch Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. Baiyunshan Chemical Pharmaceutical Factory (hereinafter referred to as “Baiyunshan Chemical Pharmaceutical Factory”) received the “Notice of Approval of Supplementary Application for Chemical Ingredients” issued by the China Drug Administration (hereinafter referred to as the “State Drug Administration”).

Baiyunshan Chemical Pharmaceutical Factory obtained a new drug certificate and production approval for the chemical ingredient cefuroxime sodium in December 2005 (Sinopharm Standard [H20059870], Registration Number [Y20190005522]). This product is cefuroxime sodium, a chemical raw material prepared by Baiyunshan Chemical Pharmaceutical Factory using a new production process. After completing relevant research and improving quality standards, it was changed and accepted by the State Drug Administration in February 2023.

Cefuroxime is used for the following infections caused by sensitive bacteria: respiratory infections, otolaryngological infections, urinary tract infections, skin and soft tissue infections, sepsis, meningitis, gonorrhea, bone and joint infections, etc.

According to inquiries, manufacturers of the chemical ingredient cefuroxime sodium currently on the market in China also include Shandong Xinlitai Pharmaceutical Co., Ltd., Zhejiang Prodebon Pharmaceutical Co., Ltd., and Qilu Anti Pharmaceutical Co., Ltd. According to data from the Mi Intranet, the sales volume of injectable cefuroxime sodium in Chinese public hospitals in 2023 was RMB 2.37 billion. The company was unable to obtain production or sales data from other manufacturers of the chemical ingredient cefuroxime sodium from public channels.

Baiyunshan Chemical Pharmaceutical Factory has now obtained an approval notice for the chemical ingredient cefuroxime sodium supplementation, which has optimized the production process of the active ingredient cefuroxime sodium, which is conducive to enhancing the market competitiveness of this product. The approval notice for this drug supplement application was obtained, which had no significant impact on the company's current performance.