講師
Date:24 July
Time:13:00– 13:15 (GMT+8)
Chief Commercial Officer
Bora Biologics
At the BioAsia conference I will address the view of Bora Biologics on the CDMO trends for Biologics in Asia and USA. Bora Biologics have a presence in both Taiwan and the USA. At BIO in Boston and by GlobalData the trends for a mAbs and ADC remain strong. The USA maintains a leading role in scientific innovation, VC funding, and first-in-class asset development. The FDA remains the gold standard, and being FDA-registered is a major commercial asset, especially for supporting global clients seeking U.S. approvals. Asia is now 31% of all new pipeline assets (vs. 35% for the U.S.), indicating rapid catch-up. For a CDMO based in Asia with U.S. capabilities, this is an advantage: you offer Asian cost-efficiency with U.S.-grade compliance. Total pipeline size continues to expand: 23,875 drugs in development in 2025, up 4.6% YoY. 39% of new assets are anticancer, a key area for mAbs and ADCs. Emerging biotechs are driving pipeline growth and now account for 55% of clinical programs. 84% of all programs are still in early clinical stages, highlighting a continued need for clinical-phase manufacturing support. ADCs, while a niche, are part of the broader oncology focus, which remains the top therapy area in terms of pipeline assets and deal value. Large pharma companies maintain a 50:50 split between internal and externally sourced innovation, reinforcing sustained demand for CDMO partnerships. FDA-approved facilities with 2,000L single-use bioreactors are well-positioned, especially for commercial supply of niche biologics. While economic relationships get reformatted thru new trade relationships by the US Administration a.o., the above trends remain strong. Bora Biologics offers an excellent proposition of first in human service out of its facilities in Zhubei with a seamless technical transfer capacity to the FDA licensed facility in San Diego provides a secured access to US patients. In 2026 Bora Biologics will open new 2000 L SUB capacity in San Diego. Our parent Bora offers Fill and Finish services from its facilities in Baltimore which are part of our integrated offering.