WuXi XDC Congratulates EDDC on FDA Clearance of IND Application for First Made-in-Singapore Antibody-Drug Conjugate

Rhea-AI Summary

WuXi XDC, a global leader in CRDMO services, has announced that the Experimental Drug Development Centre (EDDC) in Singapore has received U.S. FDA clearance for EBC-129 to begin its first-in-human trial for solid tumors. This marks EBC-129 as Singapore's first antibody-drug conjugate (ADC). WuXi XDC facilitated the Investigational New Drug (IND) application with its advanced integrated technology platforms, ensuring high-quality results. CEO Jimmy Li praised the collaboration, emphasizing the role of CRDMOs in advancing clinical trials. WuXi XDC aims to streamline ADC development, achieving IND filings in under 15 months.

Positive

• FDA clearance for EBC-129 enhances WuXi XDC's credibility and market position.
• Successful partnership with EDDC showcases WuXi XDC's technology capabilities.
• EBC-129 is Singapore's first ADC, highlighting the company's innovative contributions.

Negative

• None.

SHANGHAI,  March 8, 2023 /PRNewswire/ -- WuXi XDC ("XDC"), a leading global CRDMO company dedicated to end-to-end bioconjugate services, congratulates its partner, the Experimental Drug Development Centre (EDDC), Singapore's national drug discovery and development platform hosted by the Agency for Science, Technology and Research (A*STAR), and its collaborators on clearance by the U.S. FDA for EBC-129 to begin its first-in-human trial in patients with solid tumors. EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC).

With the employment of WuXi XDC's proprietary integrated technology platforms, all of the CMC studies for EBC-129's Investigational New Drug (IND) application were completed effectively and at the highest level of quality. The partnership between EDDC and WuXi XDC demonstrates how collaborative science can translate research into promising therapeutic candidates when enabled by CRDMOs.

Dr. Jimmy Li, CEO of WuXi XDC, commented, "Congratulations to EDDC and its collaborators on reaching this exciting milestone. We are honored to enable innovative partners such as EDDC in advancing ADCs from research to clinical trials through WuXi XDC's integrated and open-access bioconjugate technology platform. We wish the program great success for the future benefit of patients worldwide."

About WuXi XDC

WuXi XDC, a joint venture between WuXi Biologics and WuXi STA, provides end-to-end contract research, development and manufacturing services for bioconjugates, including antibody drug conjugates (ADCs). The company's services cover antibodies and other biologics, chemical payloads and linkers, as well as bioconjugated drug substance and drug product. WuXi XDC has been successful in bringing multiple ADC projects to the Investigational New Drug (IND) filing stage in 15 months or less, nearly cutting in half the traditional development timeline. For more information about WuXi XDC, please visit: https://www.wuxibiologics.com/services-solutions/#XDC.

Contacts

Media

PR@wuxibiologics.com

Investor

IR@wuxibiologics.com

 

View original content:https://www.prnewswire.com/news-releases/wuxi-xdc-congratulates-eddc-on-fda-clearance-of-ind-application-for-first-made-in-singapore-antibody-drug-conjugate-301765858.html

SOURCE WuXi Biologics

FAQ

What is the significance of WuXi XDC's FDA clearance for EBC-129?

The FDA clearance allows WuXi XDC and EDDC to commence first-in-human trials for EBC-129, marking a significant milestone in ADC development in Singapore.

How does WuXi XDC support drug development for EBC-129?

WuXi XDC provided integrated technology platforms to complete all CMC studies for EBC-129's Investigational New Drug application effectively.

What impact does EBC-129's trial have on WuXi XDC's stock, WXXWY?

FDA clearance and the initiation of clinical trials for EBC-129 potentially boost investor confidence, positively impacting WuXi XDC's stock performance.

When did WuXi XDC receive FDA clearance for EBC-129?

WuXi XDC announced the FDA clearance for EBC-129 on March 8, 2023.