Congratulations to TaiGen Biotechnology Company, Limited (“TaiGen”) for the new influenza antiviral drug TG-1000 receiving the US Food and Drug Administration (FDA) approval for clinical trial application (IND). TG-1000 is a cap-dependent endonuclease inhibitor, novel treatment for influenza A and B.
Sundia assists TaiGen TG-1000 API CMC part and accelerated the new drug development process. Sundia contributes to complete the toxicology batch, process optimization, process scale-up, process verification, GMP API production, and other production services. Analytical services such as the development and validation of analytical methods for APIs, impurities. Regulatory services include preclinical IND document preparation, and packaging integration services. We are looking forward to the success of TaiGen on bringing more innovative and quality drug to global patients.
Kuo-Lung Huang, the Chairman and CEO of TaiGen notes thatinfluenza is a life threatening disease with significant unmet medical needs and high medical burden. The safety advantages of TG-1000 can provide much safer and more effective treatment options for influenza patients worldwide. “With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. in the near future.”
According to Global Data, the global market for influenza antivirals reached 2.34 billion USD in 2019 and is estimated to reach 5.03 billion USD by 2026 at a CAGR of 11.5%. Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. With the recent introduction of baloxavir into the market, institutional investment analysts expect the market share of endonuclease inhibitors to increase at the expense of neuraminidase inhibitors. TaiGen’s TG-1000 is poised to take full advantage of this development.
TG-1000 is a Cap-dependent endonuclease inhibitor, which acts as a cap grabbing mechanism necessary for the virus replication process, and can effectively block the replication and spread of the virus. The results of pre-clinical experiments show that TG-1000 can effectively fight against influenza A, B and avian influenza, and it is not limited by the golden period of medication within 48 hours. The medication is still effective after 72 hours of symptoms and is not vulnerable to influenza Resistance caused by mutation.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to TG-1000, TaiGen has three other in-house discovered NCEs: Taigexyn®, a novel non-fluorinated quinolone available in both oral and intravenous formulations, TG-3000, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. Taigexyn® is already on the market in the mainland China and Taiwan, TG-3000 has completed Phase 2 clinical studies, and Furaprevir is currently in Phase 3 clinical development.
As a leading, fully-integrated ‘one-stop-shop’ service provider, Sundia provides a variety of CRO services in drug discovery and development which includes Library Design, Parallel Synthesis, Custom Synthesis, Medicinal Chemistry, in vitro & in vivo Biology, DMPK, Process Development, Analytical Chemistry, Formulation Development, and Preclinical testing to meet clients’ specific project needs. Leveraging our rich project management and IND submission expertise, Sundia can efficiently integrate all the studies that are required for NMPA/FDA IND submissions and are compliant with global GMP standards.