Xiamen Biotime Biotechnology Co., Ltd.

Company Description

Established in April of 2008, Xiamen Biotime Biotechnology Co., Ltd. is a hi-tech enterprise that specialized in R&D and production of POCT in vitro diagnostic devices and reagents. With the registered capital of 15 million RMB, Biotime has over 50000 ft2 workshop for manufacture and operation，in which over 10000 ft2 is certified as 100k class clean zone in purpose for assuring the quality of Xiamen Biotime Biotechnology Co., Ltd. products.. The production site is strictly planned according to national standard on medical instrument production and requirements of GMP specification. On April 3, 2013, we obtained the Medical Equipment Production License issued by Fujian Food and Drug Administration. By June of 2017, we have over 150 employees. We have established a long-term partnership with Xiamen University, Third Institute of Oceanography of State Oceanic Administration, Xiamen Medical College and other universities and research institutes for research-development-manufacturing. Several experts in R&D of in vitro diagnostic products are invited to our company as technical advisors. At present, we have 18 core independent intellectual property rights, including 3 national invention patents. Besides, there are 5 invention patents application are in process. We are pursuing continuous innovation and looking into achieving at least 2 national invention patents and 2 utility model patents every year. Year by year, Biotime is growing stronger with our efforts. In September of 2014, we are awarded the certification of “State High-Tech Enterprise” and won the honorary titles of “2015-2018 Xiamen Growing-Type Medium, Small and Micro-Sized Enterprise” and “2015-2018 Xiamen Specialized, Sophisticated, Distinctive and New Small and Micro-Sized Enterprise”. In August of 2015, we obtained the honor of “Xiamen Research and Development Institute”. In November of 2016, we are awarded the certification of “Xiamen Innovation-Based (Pilot) Enterprise”. In May of 2017, we are awarded the certification of “2017 Fujian Province (Xiamen) Little Giant of Science and Technology Enterprise” and became one of new-type R&D institutes of Fujian Province while Fujian government issued this title for the first time. Biotime has always been carrying the faith of “quality comes from professionalism and service makes the future”. Working under the spirit of “being unique from our competitors”, we have successfully established our mature medical marketing channels during the past years. Based on the thorough market research, we firmly seize the direction of in vitro diagnostic reagents and work closely with scientific researchers and institutes over the world for the R&D and industrialization of POCT technology. Among our R&D center, we count many of PhD scientists, master experts from highly respected international medical institutions, but most importantly we all share a common goal: to provide better solutions for heath care. With our professional experience and experts in the field of POCT and immunoassay lateral flow technology, we integrate advanced technological support from Xiamen University and quality overseas POCT instrument manufacturers. Based on our passionate team and leading technologies ,we successfully get our place in the IVD market with series of POCT products for healthcare. By January of 2017, we have successfully developed 42 CFDA-approved POCT kits/ instruments for the analysis of female hormones, antenatal screenings, diabetes, myocardium, kidney diseases, of which 9 products including diagnostic kits for TSH, progesterone and HCG quantitative assays based on the fluorescent lateral flow immunoassay platform are the first innovations worldwide. Our TSH and progesterone assay kits won the honor of “Specialized, Sophisticated, Distinctive and New” product (technology) of Xiamen small and micro-sized enterprises. Meanwhile, Biotime has more POCT products including gonadal hormones, thyroid function assays and tumor markers pending for CFDA approval. With our leading technologies, Biotime aims to develop superior IVD products which provide better solutions for heath care and benefit people all over the world.