Liferiver Bio-Tech

Shanghai ZJ Bio-Tech Co., Ltd. (688317.OC), established in 2005, is a high-tech enterprise specializing in the research, development, production, and sales of molecular diagnostic reagents and instrument equipment for the biopharmaceutical industry. It is the only company to have received WHO certification and been listed in its official procurement directory during the last three global public health emergencies (Ebola, Zika, and COVID-19). The company's rapid real-time fluorescent PCR diagnostic test kits are mainly used in clinical medicine, public health emergencies, entry-exit inspection and quarantine, food testing, animal husbandry, and aquaculture. The company has built two 100,000-grade and two 10,000-grade production workshops, passed the ISO 13485 system certification, and also passed the SFDA quality management assessment for in vitro diagnostic reagents, qualifying it for medical device production and operation licenses. Currently, the company offers over 400 diagnostic products covering all legally defined infectious diseases in China. It has obtained more than 100 domestic medical device registration certificates/filing credentials, including 36 Class III registration certificates, and 244 products have received EU CE certification. The company holds 58 patents, including 23 invention patents. Additionally, to better serve customers' needs for operational convenience and safety, the company has launched several instruments such as the Autrax series, EX series automatic nucleic acid extraction instruments, and the AutraMic mini series fully automated nucleic acid testing platform. Continuous independent innovation capabilities and abundant achievements have laid a solid foundation for the company’s rapid growth. In response to the sudden outbreak of the novel coronavirus, the company quickly responded by leveraging its accumulated experience and technology, taking immediate action and leading the team in scientific research efforts, playing a significant role in advancing scientific prevention and treatment. On January 26, 2020, the company became one of the first in China to receive certification for its SARS-CoV-2 nucleic acid test kit. On February 26, its COVID-19 test kit was among the earliest in China to obtain EU CE certification, with subsequent approvals from international certifications including Australia (TGA), South Africa (SAHPRA), Philippines (PFDA), India (CDSCO), Malaysia (MDA), and Singapore (HSA). On May 22, the company's COVID-19 test kit received certification from the World Health Organization (WHO) and was included in the Emergency Use Listing (EUL). After receiving an urgent notice from the Shanghai Municipal Party Committee and Government to support epidemic areas, the company demonstrated corporate responsibility by providing 10 sets of its Autrax fully automated nucleic acid testing equipment to Wuhan municipal hospitals and disease control centers within 24 hours. It rapidly dispatched an 11-person technical support team to assist with installation and debugging, trained frontline medical staff on operating procedures, and provided a complete solution from sample collection to sample processing to obtaining test results, effectively enhancing Wuhan’s ability to conduct large-scale SARS-CoV-2 testing and making a significant contribution to the timely completion of Wuhan’s "test all who should be tested" mission.