Taiwan has developed a mature biomedical industry and a high-quality healthcare system, including 19 medical centers and 124 clinical trial hospitals, of which 28 are engaged in the joint development of reagents, including those for rapid screening and nuclear acid tests for COVID-19. Moreover, Taiwan's pharmaceutical industry is of excellent quality and fully complies with international PIC/S GMP requirements. At present, two Taiwanese companies are capable of synthesizing remdesivir and three have invested into developing vaccines to combat COVID-19.

1. RT-PCR (reverse transcription polymerase chain reaction) kit
Taiwan’s R&D facilities and manufacturers have sufficient capacity to develop rapid test reagents. Most of these facilities and manufacturers involved in producing PCR nucleic acid tests have obtained the EU CE marking. Among them, General Biologicals Corporation (GBC) has obtained a number of international certification (including the European CE marking, Taiwan FDA, Indian CDSCO and Australian ARTG) for its PCR kits, which can accurately identify 2 to 3 genes. Currently it has a monthly production capacity of 800,000 kits, and exports its competitively-priced products to Southeast Asia (India, Indonesia and Malaysia), the Middle East (Saudi Arabia and Iraq), Africa, Europe, the US, Mexico and other countries. GBC also announced on July 1 that it received authorization from Academia Sinica for the technology transfer of a rapid immune-based test.

Kim Forest Enterprise Co., Ltd., (KF) worked with US-based PacGenomics Laboratory to use Kim Forest’s PCR kits for experimental verification, which obtained the emergency use authorization (EUA) notification from the US Food and Drug Administration (FDA). The KF test kits are currently sold in the United States at a competitive price. Having gained both CE marking and FDA certificate, Medigen Biotechnology Corp. (MBC), one of the few Taiwanese firms whose PCR kits and rapid screening tests have both received double certification from CE and FDA. MBC has a complete line of test products, including reagents and instruments with high-standard sensitivity and accuracy. Medigen Vaccine Biologics Corp. (MVC), a subsidiary of the MBC group, has joined hands with the US National Institutes of Health (NIH) to develop vaccines. It also has developed high quality PCR kits that can detect double genes with high accuracy.

2. Rapid screening tests
In terms of rapid screening test kits, United BioPharma (UBP) developed an antibody rapid test kit (ELISA) with 100% accuracy as early as February. The kit has been certified under the US EUA and can effectively detect the antibodies of patients who have been infected for about 10 days. With a production capacity of 500,000 sets over 2 weeks, UBP has sold the ELISA test kit to Colorado, New York, New Jersey, and California. BluSense Diagnostics (BSD) has performed multiple clinical verifications and collected more than 122 specimens in Denmark and Italy. The clinical verification data have been consistent with the ELISA test and have consistency of over 90% with PCR tests, indicating its high level of accuracy. The test requires only a drop of blood sample (10 ul), and the test result is obtained in 12 minutes. BSD has obtained CE marking and has shipped the kits to Italy, Denmark and Saudi Arabia.

3. Rapid tests – technology transfers with research facilities
In addition to manufacturers, our R&D facilities in Taiwan have also been actively developing rapid screening test and instruments. This March, Academia Sinica synthesized and developed antibody materials for the rapid test in just 19 days! It has since transferred the antigen rapid test technology to Infung, TaiDoc, Panion & BF Biotech, Formosa Biomedical, Tonyar Biotech, and GBC for mass production and the antibody rapid test technology to Agnitio Science and Technology, Formosa Biomedical, and GBC. In addition to domestic collaboration, Academia Sinica has also partnered foreign countries. The European Economic and Trade Office announced on March 18 that the EU and Academia Sinica will jointly develop a rapid screening test and vaccine. Additionally, the antigen rapid screening test jointly developed by the National Health Research Institutes (NHRI) and the National Defense Medical Center has been transferred to Taiwan Advance Bio-Pharmaceutical Incorporation, Taiwan Carbon Nano Technology Corporation, Enimmune Corporation, Trison Tech Corp., and Cold Spring Biotech.

4. PCR Instruments
The Industrial Technology Research Institute (ITRI) has developed a “portable intelligent rapid molecular diagnostic system”, the size of a drink can. Weighing only 600 grams, this handheld detector is only one-57th of the weight of an ordinary nucleic acid instrument, which is around 32 kg. Its portable size and short test time, of one hour compared to the usual 4 hours, won award at the 15th National Innovation Award.
Additionally, TCI GENE Inc.’s automated coronavirus detector operates around the clock to detect close to 900 specimens per day. Meanwhile, GeneReach Biotechnology Corp. is not only capable of producing up to one million PCR kits in the third quarter this year, it has also invented an instrument that can extract and test the nucleic acid at the same time, all within 85 minutes. The instrument makes a breakthrough in overcoming the need for two instruments to process the specimen in succession. Both the reagents and instruments of GeneReach areUS EUA notified, and are approved by the European CE-IVD and the Taiwan FDA. As overseas demand for such devices increases, their automated detectors will be highly competitive globally.

5. Drugs and vaccines
Research facilities in Taiwan have long built up capabilities in new drug development. The NHRI and Academia Sinica completed the synthesis of 100-mg high-purity remdesivir in February 2020, while the Development Center for Biotechnology synthesized Favipiravir in March 2020. In terms of manufacturers, both Formosa Laboratories, Inc. (FLI) and Chunghwa Chemical Synthesis & Biotech Co., Ltd. are capable of synthesizing 100-mg remdesivir. Among them, FLI synthesized 168 grams in April 2020, and is ready for further development and production pending demands and licensing from the patent owner, US-based Gilead Sciences.
In terms of vaccines, MVC, a subsidiary of the MBC group, has joined hands with the US’ National Institute of Health (NIH) to develop vaccines, which has currently entered the animal and toxicology testing stage. Meanwhile, Adimmune Corporation, a company that does early stage vaccine R&D and mass production has also made special progress. Its subsidiary, Enimmune Corporation, announced on July 1 that the DNA vaccine it developed with NHRI has completed animal testing which showed that the vaccine can induce specific antibodies to neutralize the virus and help with the immune response.