CONBA(SH:600572) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-12-30 08:08Core Viewpoint - Zhejiang Kang En Bei Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for two specifications of the drug "Bromhexine Hydrochloride Inhalation Solution," indicating a significant step in expanding its product portfolio and potential market presence [1][2]. Drug Basic Information - The drug is named Bromhexine Hydrochloride Inhalation Solution, available in two specifications: (1) 0.3ml:30μg and (2) 0.5ml:50μg [1]. - It is classified as a Class 3 chemical drug, with the registration numbers H20256396 and H20256397 [1]. - The approval confirms that the drug meets the registration requirements under the Drug Administration Law of the People's Republic of China [1]. Market Context - Bromhexine Hydrochloride was first launched in Japan in 2002 under the brand name "Meptin," and it has not been marketed in the US, UK, or EU [2]. - The drug is primarily used to relieve symptoms of bronchial asthma, chronic bronchitis, and emphysema [2]. - In 2024, the total sales amount for Bromhexine Hydrochloride Inhalation Solution in domestic retail and medical terminals is projected to be 130 million yuan [4]. R&D Investment - The company has invested approximately 6.85 million yuan in the research and development of Bromhexine Hydrochloride Inhalation Solution [3]. Competitive Landscape - As of the announcement date, there are 16 domestic manufacturers, including Kang En Bei, that have received approval for the Class 3 chemical drug registration of Bromhexine Hydrochloride [4]. - The drug is listed as a Class B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 edition) [4].