Ark Biosciences taps WuXI STA for CMC development

By Maggie Lynch

- Last updated on GMT

(Image: Getty/otawa)
(Image: Getty/otawa)

Related tags CMC RSV Wuxi apptec WuXi STA marketing authorization

WuXi AppTec subsidiary, STA Pharmaceutical partners with Ark Biosciences for CMC development of RSV therapy.

Ark Biosciences will use China’s Marketing Authorization Holder (MAH) system to accelerate its drug development.

Through the partnership with WuXi STA, Ark Biosciences will be able to optimize manufacturing processes, reduce commercial production costs, mitigate business risk, and improve operational efficiency.

The contract development and manufacturing organization (CDMO), WuXi STA, will provide its integrated process R&D manufacturing solution for the chemistry, manufacturing and controls (CMC) development for Ark’s drug candidate and current pipeline.

Ark Bioscience has a pipeline of active discovery programs and in-licensed drug assets for clinical development, including its drug candidate, Ziresovir (AK0529), an F-protein inhibitor for the treatment of respiratory syncytial virus (RSV). The therapy has completed three Phase I clinical trials and is currently in a global phase II clinical trial.

WuXi STA has been in collaboration with companies to enable domestic innovative drug development.

Related news

Show more

Related products

show more

Drug Solubility and the Need for Speed

Drug Solubility and the Need for Speed

Lonza Small Molecules | 28-Mar-2023 | Technical / White Paper

A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways...

Are You Prepared to Meet the New FDA Guidelines?

Are You Prepared to Meet the New FDA Guidelines?

Elligo Health Research® | 23-Mar-2023 | Insight Guide

On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Formedix | 10-Mar-2023 | Technical / White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Elligo Health Research® | 10-Mar-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

Related suppliers

Follow us


View more