Congratulations to TaiGen for their anti-influenza drug TG-1000 and capsule (CXHL2000100、CXHL2000099) has obtained IND approval from the CDE (Center For Drug Evaluation), NMPA for clinical trials. The potential indications for TG-1000 are adult influenza A and B treatment.
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.
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.
Sundia once again demonstrates our one-stop service platform is been able to shorten the timeline and reduce the cost for the development of customers’ preclinical new drug programs. Sundia strive to provide a fully integrated CRO services and quality project management service for more and more partners, reducing cost and increase efficiency for the drug research and development. We are looking forward to the success of TaiGen on bringing more innovative and quality drug to Chinese patients.
About TaiGen Biotechnology
Founded in 2001, TaiGen Biotechnology Co., Ltd. is a research-based and market-driven pharmaceutical company engaging in the development of novel therapeutics for infectious diseases, cancer and diabetes-related complications. TaiGen has a wholly-owned Beijing subsidiary with proven capacities to conduct clinical trials and related registrations. TaiGen Biotechnology became a publicly listed company in Taipei Exchange (Ticker 4157.TWO) in January 2014.
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.