新药1拟用于敏感细菌所引起的下列轻、中、重度感染：(1)医院获得性肺炎;(2)社区获得性肺炎;(3)急性细菌性鼻窦炎;(4)慢性支气管炎的急性细菌性发作;(5)复杂性皮肤及皮肤结构感染;(6)非复杂性皮肤及皮肤软组织感染;(7)慢性细菌性前列腺炎;(8)复杂性尿路感染;(9)急性肾盂肾炎;(10)单纯性尿路感染;(11)吸入性炭疽(暴露后)。Fosun Pharma (02196) announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as the "Company"...
Zhitong Finance and Economics APP News, Fosun Pharma (02196) announced that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as the "Company")'s holding subsidiary Chongqing Yaoyou Pharmaceutical Co., Ltd. applied for the registration of Levofloxacin Injection (referred to as "New Drug 1") and the holding subsidiary Gisme (Wuhan) Pharmaceutical Co., Ltd. applied for the registration of Arabinoside Cytidine Injection (referred to as "New Drug 2"), which were accepted by the National Medical Products Administration.
Both New Drug 1 and New Drug 2 are chemical drugs independently developed by the Group (i.e., the Company and its holding subsidiaries/units).
New Drug 1 is intended for the following mild, moderate, and severe infections caused by sensitive bacteria: (1) hospital-acquired pneumonia; (2) community-acquired pneumonia; (3) acute bacterial sinusitis; (4) acute bacterial exacerbations of chronic bronchitis; (5) complicated skin and skin structure infections; (6) uncomplicated skin and skin tissue infections; (7) chronic bacterial prostatitis; (8) complicated urinary tract infections; (9) acute pyelonephritis; (10) uncomplicated urinary tract infections; (11) inhalation anthrax (post-exposure).
New Drug 2 is intended for: (1) induction and maintenance of remission in acute myeloid leukemia in adults and children in combination with other cell suppressants; (2) treatment of acute lymphocytic leukemia, lymphoblastic proliferation crisis, and polycythemia in chronic myeloid leukemia; (3) in combination with other cytotoxic drugs for pediatric non-Hodgkin's lymphoma, can be used alone or in combination with other cell suppressants; (4) high-dose treatment of acute leukemia; (5) alone or in combination with hydroxypropyl sodium succinate and methotrexate for intrathecal prevention and treatment of meningitis.
As of September 2024, the Group's cumulative research and development investment for New Drug 1 and New Drug 2 amounted to approximately RMB 1.33 million and RMB 2.57 million respectively (unaudited).
According to the latest data from IQVIACHPA, in 2023, the sales of Levofloxacin Injection (approved for marketing within China excluding Hong Kong, Macao, and Taiwan) amounted to approximately RMB 2.47 billion, and the sales of Arabinoside Cytidine Injection amounted to approximately RMB 0.265 billion.
