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Bioperfectus Technologies Secures Chinese Approval for Hepatitis C and Chikungunya Test Kits

ENTHMSVIIDZHZH-TWJAKOHI
Sep 24, 20261 min read
Bioperfectus Technologies Secures Chinese Approval for Hepatitis C and Chikungunya Test Kits

Summary

Jiangsu Bioperfectus Technologies (688399.SH) has received registration certificates from China's National Medical Products Administration for two new nucleic acid detection kits, expanding its portfolio in the in-vitro diagnostics sector.

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Background

Jiangsu Bioperfectus Technologies Co., Ltd. (688399.SH) has received regulatory approval for two new in-vitro diagnostic (IVD) test kits from China's National Medical Products Administration (NMPA). The approvals expand the company's portfolio of molecular diagnostic products for infectious diseases.

New Product Registrations

According to a company announcement cited by Zhitong Finance APP, Bioperfectus has secured medical device registration certificates for the following products:

  • Hepatitis C Virus (HCV) Nucleic Acid Detection Kit (Fluorescence PCR method)
  • Chikungunya Virus Nucleic Acid Detection Kit (Fluorescence PCR method)

These certificates permit the sale and use of the diagnostic kits within the Chinese market, a key step for commercialization.

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Strategic Impact

The company stated that the successful registration of these two test kits enriches its product line and strengthens its strategic position in the domestic IVD market. Bioperfectus emphasized that the new products will help meet diverse clinical demands.

From an investor perspective, the expansion of its approved product pipeline is expected to enhance the company's overall competitiveness and support its market expansion capabilities. These approvals are crucial for driving future revenue growth in its core diagnostics segment.

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