Group 1 - The core point of the announcement is that Harbin Pharmaceutical Group Co., Ltd. has received approval for its Norfloxacin capsules to pass the consistency evaluation of generic drug quality and efficacy by the National Medical Products Administration [1][2] - The drug Norfloxacin capsules are indicated for urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid, and other salmonella infections [1] - The company has invested approximately 7.5972 million RMB in the research and development of the drug for the consistency evaluation [2] Group 2 - As of the announcement date, there are 586 production licenses for Norfloxacin capsules in China, with 15 manufacturers having passed the consistency evaluation [2] - The retail market sales for Norfloxacin capsules in 2023 were 530 million RMB, while the projected sales for 2024 are 441 million RMB [2] - The approval is expected to enhance the market share and competitiveness of the drug, providing valuable experience for the company in future evaluations of other products [2]
哈药股份: 哈药集团股份有限公司关于所属企业药品通过仿制药一致性评价的公告