On the 29th, TaiMed Biologics announced that it has been selected by a U.S. client to provide production and manufacturing services for an antibody drug used in clinical trials. This marks the company’s first international contract since launching its CDMO (Contract Development and Manufacturing Organization) business, which is expected to contribute to future operational growth.

TaiMed noted that under a close collaboration agreement with the client, a formal contract is expected to be signed soon, after which the company will initiate technology transfer, analytical testing, and related manufacturing activities. This contract from an international client represents a significant milestone for TaiMed, showcasing the recognition of its CDMO capabilities on a global scale.

TaiMed highlighted that its protein antibody drug facility in Zhubei is equipped with multiple bioreactors ranging from 50 to 2,000 liters, capable of meeting the production needs for both clinical and commercial drugs. Since the establishment of the facility, multiple successful batches of antibody drugs have been produced. The facility has also passed inspections by the U.S. FDA in 2022 and 2023 without any deficiency reports, demonstrating its advanced equipment and ample production capacity.

In addition to CDMO contracts, TaiMed’s new drug development for HIV treatment is also progressing. The most notable candidates, the long-acting TMB-365 and TMB-380, designed for bi-monthly HIV treatment, have completed Phase 2a clinical trials, with the final participant finishing all treatment regimens. Preliminary data analysis is expected by late 2024 to early 2025.

Resource (mandarin): 中裕首獲美國CDMO訂單 進補