Biologics CDMO, HJB, has entered into a strategic partnership for CMC development and manufacturing with Ansun Biopharma, a clinical-stage biopharmaceutical company, on its therapeutic biologics pipeline.
The first programme is expecting to submit an Investigational New Drug (IND) application in 2021.
Under the agreement, Ansun will have the ability to leverage HJB's comprehensive expertise and capacities from cell line development, process and assay development to GMP manufacturing, IND-enabling full-service package and clinical and commercial supply in the global territory for the next three years. The agreement provides a strong support for Ansun's development goals and a potential significant acceleration of its portfolio to market.
"We are very excited about this strategic agreement with HJB, which we consider to be a key piece of foundation for advancing Ansun's strong biologics pipeline in the coming years," said, George Wang, Chief Technology Officer of Ansun. "As the company continues to expand its pipeline by advancing more early stage assets into clinical development, a partnership with a reliable and capable CDMO such as HJB will accelerate the successful transition of the promising sciences into clinical benefit for global patients."
Jerry Yang, General Manager of HJB, added: "A robust and top-notch supply chain is fundamental to biotech to achieve speed and success to market. The recent global disruption on drug development and manufacturing capacities due to a pandemic has made it even more pressing for companies to secure the much needed capacities while remaining focused and agile. We will continue creating value as a dedicated CDMO by empowering all our global and domestic partners to bring better treatments to the patients."
Capabilities
Since its Hangzhou facility's first GMP run in mid-2018, HJB has taken more than 20 CDMO projects, delivered 30 batches of GMP products and has been recognised by its global partners for quality, reliability and speed.
Currently, HJB's comprehensive capabilities include cell line and cell bank development, process and formulation development, technology transfer and optimisation as well as GMP manufacturing, with three DS production lines (500 - 2,000L), and a DP fill-and-finish line. HJB has served more than double amount of client programs during the first half of 2020 despite a minimal disruption of operation due to COVID-19. The performance demonstrated HJB's commitment to execution, delivery and quality system.
