Jixi Branch of Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd. (hereinafter referred to as "Jixi Branch") has received the Approval Notice for Chemical Active Pharmaceutical Ingredient (API) Marketing Application for moxifloxacin hydrochloride. This indicates that the said API complies with the relevant national technical standards for API evaluation. Upon satisfying the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals, the API may be manufactured and marketed in the domestic market. This approval will further enrich the product portfolio of Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company") and help expand the Company's business scope.
The production and sale of pharmaceuticals are subject to the impact of factors such as national policies and changes in market conditions, and thus carry considerable uncertainties. Investors are kindly requested to guard against investment risks.
Recently, Jixi Branch has received the Approval Notice for Chemical Active Pharmaceutical Ingredient (API) Marketing Application issued by the National Medical Products Administration (NMPA). The relevant details are hereby announced as follows:
I. Basic Information of the Pharmaceutical Product
Chemical API Name: Moxifloxacin HydrochlorideNotice No.: 2024YS00189Registration No.: Y20220000100Chemical API Registration Standard No.: YBY62122024Packaging Specification: 15kg/packageValidity Period: 24 monthsManufacturer: Jixi Branch of Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd.Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, upon review, this product meets the relevant requirements for drug registration and is approved for registration. The production process, quality standards and labels shall be implemented in accordance with the attached documents. Validity Period of the Notice: Until March 10, 2029
II. Other Information of the Pharmaceutical Product
Moxifloxacin hydrochloride is a fourth-generation antibiotic, mainly indicated for patients with acute exacerbation of chronic bronchitis, chronic obstructive pulmonary disease (COPD), community-acquired pneumonia (CAP), acute bacterial sinusitis, etc. Clinically, it is commonly used for patients with poor response to conventional antibiotics or those with conventional antibiotic resistance. It features broad-spectrum antibacterial activity, low resistance rate, long half-life and few adverse reactions.
Data from Minenet shows that, in China's public hospital terminals and retail pharmacies in key cities, the total sales volume of moxifloxacin hydrochloride tablets reached approximately RMB 300 million in 2022 and about RMB 170 million in the first half of 2023; the total sales volume of moxifloxacin hydrochloride and sodium chloride injection hit around RMB 1.45 billion in 2022 and roughly RMB 980 million in the first half of 2023. Data from Yaowang.com indicates that the consumption volume of moxifloxacin hydrochloride API stood at 64.88 tons in 2022. Up to now, there are 43 domestic manufacturers with an "A" registration status for this API.
