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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Hanlin Technology of Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Its First In-Vitro Diagnostic Reagent in 2025
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发布时间：2025-01-23
【概要描述】
As the Spring Festival approaches, good news keeps pouring in: the Myoglobin (MYO) Test Kit (Fluorescent Immunochromatographic Assay) developed by Hebei Hanlin Biotechnology Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, has successfully obtained registration approval. This marks Hanlin Technology’s first in vitro diagnostic reagent to receive approval so far this year.
With the Spring Festival approaching, good news keeps pouring in: the Myoglobin (MYO) Test Kit (Fluorescent Immunoassay Lateral Flow Assay) developed by Hebei Hanlin Biotechnology Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, has successfully obtained registration approval. This marks Hanlin Technology’s first in vitro diagnostic reagent to receive approval so far this year.
According to available information, the myoglobin (MYO) test kit (fluorescent immunoassay lateral flow assay) is used for the in vitro quantitative determination of myoglobin (MYO) levels in whole blood, serum, or plasma samples, and is clinically primarily employed as an adjunctive diagnostic tool for myocardial infarction.
To date, Hanlin Technology has received approval for three Class II in vitro diagnostic reagent products, all of which are cardiac biomarker assays: Creatine Kinase-MB Isoenzyme (CK-MB) Assay Kit (Fluorescent Immunochromatographic Assay), Cardiac Troponin I (cTnI) Assay Kit (Fluorescent Immunochromatographic Assay), and Myoglobin (MYO) Assay Kit (Fluorescent Immunochromatographic Assay).
Over the past two years, Hanlin Technology has grounded its technological innovation in clinical needs, strategically positioning itself in the “biopharmaceutical, life sciences, and biotechnology sectors.” By integrating the full lifecycle of medical device products, the company has vigorously promoted synergistic development among its biotechnology, pharmaceutical, and research centers. This approach has enabled a diversified product portfolio—ranging from single-use items to medical devices, in vitro diagnostic reagents, and disinfectants—resulting in an increasingly robust product mix and continuous expansion of market opportunities.
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