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默沙东九价HPV疫苗在华获批男性适应证; 双成药业可能被实施退市风险警示
Policy Developments - The National Medical Products Administration (NMPA) approved the registration of 308 medical device products as of March 2025, including 248 domestic Class III medical devices, 34 imported Class III medical devices, 19 imported Class II medical devices, and 7 medical devices from Hong Kong, Macau, and Taiwan [1] Drug Approvals - Chengdu Saijing Bio's ursodeoxycholic acid oral suspension has been approved as the first domestic generic Class 3.1 new drug for treating cystic fibrosis-associated liver disease (CFALD), filling a gap in the market for this indication [2] - Kowa Company's pemafibrate tablets have been approved in China for the treatment of dyslipidemia [3] - Merck Sharp & Dohme (MSD) announced that its nine-valent HPV vaccine has received approval for male use in China, targeting males aged 16-26, enhancing public awareness of HPV infections in men [5] Capital Market - Zhongjie Chaorun completed a Pre-A round financing of several million yuan, primarily for clinical trials of its artificial meniscus implant and commercialization of its innovative meniscus suturing device [4] Financial Reports - Aoyang Health reported a 2024 revenue of 2.01 billion yuan, a year-on-year decrease of 7.54%, with a net profit of 40.56 million yuan, down 18.36% [6] - Novogene announced a total revenue of 2.111 billion yuan for 2024, a year-on-year increase of 5.45%, with a net profit of 197 million yuan, up 10.52% [7] - Tianyi Medical reported a revenue of 419 million yuan for 2024, a year-on-year increase of 9.98%, but a net loss of 744,000 yuan [8] - Luoxin Pharmaceutical disclosed a net loss of 962 million yuan for 2024, despite a revenue increase of 11.99% to 2.647 billion yuan [9] - Dongxing Medical reported a revenue of approximately 435 million yuan for 2024, a slight increase of 0.4%, with a net profit of about 97.42 million yuan, up 0.21% [10] Public Sentiment - Xinbang Pharmaceutical announced the resignation of independent director Zhou Jun, with the company reporting a revenue of 6.032 billion yuan for 2024, down 6.63%, and a net profit of 101 million yuan, down 64.70% [11] - Shuangcheng Pharmaceutical warned of potential delisting risk due to expected negative net profit and revenue below 300 million yuan for 2024 [12]