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Two new medical device products—the Hanlin Bio Cardiac Troponin I (cTnI) Test Kit (Fluorescent Immunochromatographic Assay) and the Medical Recombinant Humanized Collagen Wound Dressing—have been approved.

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Honors Announcement

发布时间：2024-09-14

【概要描述】 Recently, the Class II medical device product—cardiac troponin I (cTnI) test kit (fluorescent immuno-chromatographic assay) and medical-grade recombinant humanized collagen wound dressing—submitted by Hebei Hanlin Biotechnology Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, has been approved for registration. Since the beginning of this year, Hanlin Biotechnology has secured approval for a total of six new products.

Two new medical device products—the Hanlin Bio Cardiac Troponin I (cTnI) Test Kit (Fluorescent Immunochromatographic Assay) and the Medical Recombinant Humanized Collagen Wound Dressing—have been approved.

Recently, the Class II medical device—cardiac troponin I (cTnI) test kit (fluorescent immuno-chromatographic assay) and a medical-grade recombinant humanized collagen wound dressing—submitted by Hebei Hanlin Biotechnology Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, have been approved for registration. Since the beginning of this year, Hanlin Biotechnology has secured approval for a total of six new products.

According to available information, the cardiac troponin I (cTnI) assay kit (fluorescent immuno-chromatographic assay) is the Group’s first approved in vitro diagnostic reagent. It is primarily used for the quantitative in vitro detection of cardiac troponin I (cTnI) levels in human whole blood, serum, or plasma samples and is clinically indicated as an adjunctive diagnostic tool for myocardial infarction. The medical recombinant humanized collagen wound dressings are available in Type A and Type B formulations and are mainly intended for the care of non-chronic superficial wounds, such as those resulting from laser, photon, glycolic acid peeling, or minimally invasive cosmetic procedures.

In recent years, Hanlin Biotechnology of Shijiazhuang Sihua Pharmaceutical Group has aligned its strategic focus with national development priorities and cutting-edge market needs, leveraging innovation as the driving force to strategically position itself in the fields of biopharmaceuticals, life sciences, and biotechnology. The company has vigorously promoted synergistic development among its biotechnology, pharmaceutical, and research centers, continuously expanded its product portfolio, and enhanced the quality and efficiency of its operations in medical devices and in vitro diagnostic reagents.

Currently, the Group’s Hanlin Biotechnology has more than 20 Class II and Class III products in development, and has registered and launched for sale two Class I in vitro diagnostic reagents for nucleic acid collection and detection—namely, nucleic acid extraction or purification reagents and single-use viral sampling tubes. In addition, seven Class II medical device products have been approved, including disinfectant medical ultrasonic coupling agents, medical radiation protection sprays, medical liquid spray dressings, medical gynecological gels, sterile medical ultrasonic coupling agents, sterile saline nasal sprays, and medical recombinant humanized collagen wound dressings; furthermore, one Class II in vitro diagnostic reagent—the cardiac troponin I (cTnI) test kit (fluorescent immuno-chromatographic assay)—has also been approved. As a result, the Group’s portfolio of medical devices and biological products is becoming increasingly diverse and comprehensive.

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