Hisun Pharmaceutical(600267) announced on the evening of July 23 that the company recently received the approval notice for the marketing application of bedaquiline fumarate raw material issued by the State Food and Drug Administration.
It is reported that bedaquiline fumarate is a diarylquinoline antimycobacterial drug, which is used as a combination therapyIt is a part of the FDA's FDA-approved drug, which is suitable for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adults and adolescents (12 years old to 30 kg). The original manufacturer is Xi'an Janssen Pharmaceuticals. Currently, major domestic manufacturers include Hisun Pharmaceuticals and Simcere Pharmaceuticals Co., Ltd.
The IQVIA database shows that the global sales volume of this raw material in 2024 will be approximately 1,482.57 kilograms, of which approximately 151.08 kilograms will be sold domestically; the global sales volume in January-March 2025 will be approximately 167.39 kilograms, of which approximately 37.43 kilograms will be sold domestically.
Looking back at the application process of the API, the National Medical Products Administration accepted the API registration application submitted by the company on January 5, 2024. On July 22, 2025, the API passed the technical review of the Drug Evaluation Center of the National Medical Products Administration, and its status on the API registration information platform was "A". So far, the company has invested approximately RMB 14.422 million in the drug research and development project.
The company said that the approval proves that the raw material meets the relevant national technical standards for drug approval and can be produced and sold, which will help enrich the product line and enhance market competitiveness.

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