Zhejiang Hai Zheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" or "Haizheng Pharmaceuticals") has received a Notice of Approval of Supplementary Application for Cycloserine Capsule from the State Drug Administration (hereinafter referred to as the "State Drug Administration"), and the Company's drug Cycloserine Capsule has passed the generic drug consistency evaluation. (hereinafter referred to as "the State Drug Administration") issued the "Drug Supplement Application Approval Notice" for Cycloserine Capsule, and the Company's drug Cycloserine Capsule has passed the consistency evaluation of the quality and efficacy of generic drugs.

Cycloserine Capsule is suitable for the treatment of active pulmonary tuberculosis and extrapulmonary tuberculosis (including renal tuberculosis) caused by tuberculosis bacteria that are sensitive to the drug and have been poorly treated with first-line anti-tuberculosis drugs (e.g., streptomycin, isoniazid, rifampicin and ethanol). Cycloserine capsules were developed by Eli Lilly and Company in the United States, and were launched in the United States in 1982. At present, the only domestic manufacturer of cycloserine capsules is Hai Zheng Pharmaceutical.

According to statistics, the global sales of Cycloserine Capsules in 2022 is about USD 38,960.00 million, of which the domestic sales is about USD 30,015.10 million; the global sales in January-September 2023 is about USD 33,099.7 million, of which the domestic sales is about USD 25,179.9 million (data from IQVIA database). The company is the first domestic company to pass the consistency evaluation of this product. The Company's sales of Cycloserine Capsules in 2022 amounted to approximately RMB 113,441,600,000, and sales from January to September 2023 amounted to approximately 83,175,200,000 RMB.

On January 6, 2023, the State Drug Administration accepted the application for consistency evaluation of cycloserine capsules submitted by the Company. Up to now, the Company has invested approximately RMB11.05 million for the consistency evaluation of the quality and efficacy of the generic version of the drug.

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