Jiangsu Huadong Medical Device Industrial, a subsidiary of Meihua International Medical Technologies (MHUA), has signed a cooperation agreement with Getein Biotech to jointly manufacture and market Covid-19 antigen test kits and other in vitro diagnostics (IVD) products in China.
Under the agreement, Jiangsu Huadong will act as an exclusive production, research and development centre for Getein Biotech in Northern Jiangsu Province.
Initially, Jiangsu Huadong will produce Covid-19 antigen test kits with the potential to produce other high-end IVD medical device products in the future.
Jiangsu Huadong recently finished construction of a brand-new workshop that is more than 8,000m2 in size and has an extra 15,000m2 of commercial warehouse space. The workshop was developed in compliance with good manufacturing practices (GMP).
The production base is said to have 52 new fully automated Covid-19 antigen test kit production lines. Over 400 new employees and 35 technical staff will be hired by Jiangsu Huadong to ensure the production of all the items.
The plant has secured Class III medical device production accreditation, as required by the Jiangsu Provincial Food and Drug Administration of China. It is prepared to start producing after 16 January 2023,
MHUA CEO Xin Wang said: “We expect that the newly adjusted production lines will soon obtain relevant credentials for Class III medical device production and once manufacturing commences, we estimate the production capacity will reach three million kits per day.
“Based on current market prices, we anticipate that the new facility to produce a maximum of RMB150 million (US$22 million) worth of products per month (if calculated at peak capacity).”
Getein Biotech, a manufacturer of POCT kits in China, is also one of the major manufacturers and distributors of Covid-19 antigen test kits.
The firm recently received approvals from the China National Medical Products Administration for the production, marketing, and sale of its products in China.