抗感染药物
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奥赛康:子公司注射用德拉沙星葡甲胺获药品注册证书
Xin Lang Cai Jing· 2025-12-22 11:02
奥赛康公告称,其全资子公司江苏奥赛康近日收到药监局核准签发的注射用德拉沙星葡甲胺《药品注册 证书》。该药品为国内独家获批上市,用于急性细菌性皮肤及皮肤结构感染和社区获得性细菌性肺炎治 疗,填补国内市场空白。德拉沙星抗菌活性强、不易耐药、安全性好。2024年喹诺酮类抗菌药销售额约 49亿元,市场潜力大。此次获批将丰富公司抗感染产品组群,对经营产生积极影响,但产品销售情况有 不确定性。 ...
黑龙江珍宝岛药业股份有限公司关于全资子公司获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-12-02 19:19
Core Viewpoint - Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd. has received a drug registration certificate for Moxifloxacin Hydrochloride Tablets, indicating an expansion in its product portfolio and enhancing its competitive position in the anti-infection market [1][4]. Drug Basic Information - The drug is Moxifloxacin Hydrochloride Tablets, with a specification of 0.4g and classified as a prescription drug [1]. - The drug registration certificate number is 2025S03558, and it is valid for 36 months, expiring on November 24, 2030 [1]. - The drug is approved for various infections, including acute bacterial sinusitis and community-acquired pneumonia [2]. Market and Financial Impact - Moxifloxacin Hydrochloride Tablets have been included in the National Basic Medical Insurance Directory for 2024, with a projected market size of 530 million RMB in China [3]. - The company has invested 13.64 million RMB in the research and development of this drug [3]. - There are currently 24 approved manufacturers for Moxifloxacin Hydrochloride Tablets in China [3]. Company Impact - The approval of Moxifloxacin Hydrochloride Tablets enhances the company's core product offerings in the anti-infection sector, thereby improving its market competitiveness [4]. - The company aims to broaden its business scope and strengthen its product matrix with this new addition [4].
珍宝岛(603567.SH):全资子公司获得药品注册证书
Ge Long Hui A P P· 2025-12-02 10:50
Core Viewpoint - The company has received approval for the production and sale of Moxifloxacin Hydrochloride Tablets, enhancing its product portfolio in the anti-infection sector [1][2]. Group 1: Product Approval - The company's wholly-owned subsidiary, Harbin Zhenbao Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Moxifloxacin Hydrochloride Tablets from the National Medical Products Administration [1]. - Moxifloxacin is a broad-spectrum antibacterial agent effective against various bacteria, including Gram-positive, Gram-negative, anaerobic, and atypical microorganisms [1]. Group 2: Market Impact - The approval allows the company to expand its core product offerings in the anti-infection field, thereby increasing its competitiveness in the systemic anti-infection market [2]. - The introduction of Moxifloxacin Hydrochloride Tablets will not have a significant impact on the company's current operating performance [2].
富祥药业股价下跌5.55% 半年报显示亏损收窄
Jin Rong Jie· 2025-08-27 20:24
Group 1 - The stock price of Fuxiang Pharmaceutical on August 27 was 10.05 yuan, down 0.59 yuan or 5.55% from the previous trading day [1] - The company primarily engages in the research, production, and sales of active pharmaceutical ingredients and intermediates for anti-infection drugs, while also expanding into lithium battery electrolyte additives and synthetic biology microbial protein [1] - Fuxiang Pharmaceutical is the largest supplier of sulbactam globally and the only domestic supplier in the sulbactam field certified by international standards [1] Group 2 - According to the company's 2025 semi-annual report, it achieved operating revenue of 515 million yuan in the first half of the year, a year-on-year decrease of 24.6%, with a net profit attributable to the parent company of -6.91 million yuan, an improvement from a loss of 22.46 million yuan in the same period last year [1] - In the lithium battery electrolyte additive business, the company has established an annual production capacity of 8,000 tons for VC products and 3,700 tons for FEC products [1] - The company has a production capacity of 1,200 tons per year in the microbial protein sector and is constructing a project with an annual capacity of 20,000 tons [1] Group 3 - On August 27, the net inflow of main funds into Fuxiang Pharmaceutical was 17.78 million yuan, accounting for 0.39% of the circulating market value; over the past five days, the cumulative net inflow was 20.96 million yuan, representing 0.46% of the circulating market value [2]
山东新华制药股份子公司获得克拉霉素干混悬剂《药品注册证书》
Zhi Tong Cai Jing· 2025-08-26 09:41
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Clarithromycin suspension, which is expected to enhance the company's product offerings in the anti-infection drug category and improve its overall competitiveness [1][2]. Group 1: Product Approval - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin suspension by the National Medical Products Administration [1]. - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and was accepted, with the registration certificate obtained in August 2025 [1]. Group 2: Indications and Market Potential - Clarithromycin is indicated for treating infections caused by pathogens sensitive to it, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [2]. - The estimated sales revenue for Clarithromycin in public medical institutions in China is approximately RMB 1.123 billion in 2024 [2]. - The approval of Clarithromycin suspension will enrich the company's anti-infection drug portfolio [2].