本次药品GMP符合性检查中，盐酸米诺环素原料药是上市前的首次药品GMP符合性检查，对应生产线 是新建生产线后首次通过GMP符合性检查，截至目前，上述车间相关固定资产累计投入约9,916万元， 其中已完成投入约8,630万元(未经审计)。 智通财经APP讯，海正药业(600267.SH)发布公告，近日，公司全资子公司海正药业南通有限公司(简 称"海正南通公司")收到江苏省药品监督管理局下发的《药品GMP符合性检查告知书》(苏药监药生告知 〔2025〕438号)。 ...

Core Viewpoint - Zhejiang Hai Zheng Pharmaceutical Co., Ltd. has received approval for the production of Minocycline Hydrochloride API, which is expected to enhance the company's product line and market competitiveness [1][3]. Group 1: Drug Approval Details - The Minocycline Hydrochloride API has been granted a registration number Y20240000032 and a notification number 2025YS00742 by the National Medical Products Administration [1]. - The product is packaged in 5kg bags and is approved for domestic production [1]. Group 2: Indications and Market Data - Minocycline Hydrochloride is indicated for various infections caused by sensitive pathogens, including but not limited to urinary tract infections, superficial pyogenic infections, and bacterial pneumonia [2][3]. - Global sales of Minocycline Hydrochloride API are projected to be approximately 35,648.65 kg in 2024, with domestic sales around 7,914.50 kg [3]. Group 3: Company Investment and Development - The company has invested approximately 19.21 million RMB in the research and development of this drug [3]. - The approval signifies that the product meets national technical standards for drug approval, allowing for production and sales [3].

Core Viewpoint - Haizheng Pharmaceutical's subsidiary has received approval for the marketing of Minocycline Hydrochloride raw material from the National Medical Products Administration, indicating a significant advancement in the company's product portfolio and potential revenue growth [1] Group 1: Regulatory Approval - Haizheng Pharmaceutical's wholly-owned subsidiary, Haizheng Pharmaceutical Nantong Co., Ltd., has been granted the marketing approval for Minocycline Hydrochloride raw material by the National Medical Products Administration [1] Group 2: Sales Projections - The global sales volume for Minocycline Hydrochloride is projected to be approximately 35,648.65 kilograms in 2024, with domestic sales expected to reach around 7,914.5 kilograms [1] - For the first quarter of 2025, the global sales volume is estimated at about 8,572.46 kilograms, while domestic sales are anticipated to be approximately 2,092.66 kilograms [1] Group 3: Investment in Development - The company has invested approximately 19.21 million RMB in the development project for this pharmaceutical product [1]