SL PHARM(SZ:002038) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-04-08 23:09Core Viewpoint - Beijing Shuanglu Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its nitroglycerin spray (brand name: Lishengle), marking a significant milestone as the first domestic approval for this new dosage form [1][2]. Group 1: Drug Information - The nitroglycerin spray is classified as a chemical drug of category 4, with each bottle containing 200 sprays, and each spray delivering 0.4 mg of nitroglycerin [1][2]. - The drug acts quickly, with clinical studies showing that 23.5% of patients experience immediate effects, 62% within one minute, and up to 85.75% within two minutes [2]. - The spray is designed for emergency situations, particularly for acute angina attacks, and is noted for its safety and efficacy compared to aerosol forms, as it does not contain propellants and avoids cooling effects [2][3]. Group 2: Market Context - There are approximately 330 million cardiovascular disease patients in China, with around 11 million suffering from coronary heart disease, indicating a significant market for emergency medications like nitroglycerin [3]. - The overall market size for nitroglycerin formulations (including tablets and aerosols) is estimated to be between 1 billion to 2 billion yuan in 2023, with an expected annual growth rate of 8% to 12% due to the aging population and rising cardiovascular diseases [3]. - The newly approved nitroglycerin spray has been included in the national medical insurance category B, enhancing its market accessibility [3]. Group 3: Company Impact - The approval of the nitroglycerin spray will enrich the company's product portfolio in the cardiovascular medication sector, positioning it as the sole domestic provider of this new dosage form [3].