Congratulations to Longwood Biopharmaceuticals Co., Ltd for theirLW402 and tablet (CXHL2000303, CXHL2000304, CXHL2000305) have been accepted by the CDE (Center for Drug Evaluation), NMPA for clinical trials. The potential indications of LW402 are mainly for the treatment of Rheumatoid Arthritis.
Sundia assists Longwood Biopharmaceuticals to complete the API production research of LW402 tablets, including the preparation and release testing of non-GMP batches and GMP batches, API stability research and packaging material selection, as well as the CTD document preparation, which accelerated the development of Longwood’s new drug. LW402 is the firstIND approved project among Longwood’s pipelines.
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 Longwood Biopharmaceuticals on bringing more innovative and quality drug to global patients.
About Longwood Biopharmaceuticals
Longwood Biopharmaceuticals Co., Ltd is the brainchild of a group of scientists who wanted to build a platform to provide the innovative life-saving products that will pass quality and affordability requirements physicians desire.
A research and development-focused biotechnology company, Longwood uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral diseases and cancer. Longwood’s current research and development focuse are placed on hepatitis B virus, NASH, immuno oncology targeted small molecule compounds and drugs for auto-immume diseases.
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