CMAB Biopharma (Suzhou), a pure-play biologics CDMO, and BJ Bioscience have signed an agreement for the development and manufacturing of a bi-functional antibody called BJ-005 as the first initiative in an exclusive collaboration.

As per the terms of the agreement, CMAB will offer a complete range of CMC research and manufacturing services that address the IND application requirements of China and also the US.

The cooperation between the parties will support the clinical development of BJ-005 across the world by BJ Bioscience.

BJ-005 will be developed based on CMAB’s CMC process development and manufacturing platform. CMAB will further support the drug with an experienced R&D team in IND applications in China and the US along with a product quality system.

Dr. Yongzhong Wang – CMAB CEO said: “CMAB fully understands the most critical needs of innovative drug R&D startups such as BJ. Our objective is to support BJ in attaining another milestone through the quality of IND applications in both China and the United States at the highest speed possible.

“CMAB will achieve this through our excellent core team, which has practical experience in IND applications in both regions, a mature technology integration capability, pure CDMO services, equipment and facilities of international mainstream brands, and a first-class international GMP quality system (as demonstrated by recent success in an external European QP audit).”

CMAB Biopharma is a full-service CDMO that offers customized development and manufacturing services of antibodies and biologics in China and across the world.

Dr. Haizhou Zhang – Co-founder and CEO of BJ Bioscience said: “CMAB boasts a competent CMC research and manufacturing team covering the entire chain of CMC. Secondly, BJ Bioscience does not develop ME TOO products.

“We strive to make breakthroughs and innovations. BJ Bioscience is strong in discovery and development of innovative biologics and, therefore, we need a strong CMC partner with a strong expertise and experience in compliance like CMAB.”

  BJ Bioscience, China, CMAB Biopharma, Dr. Haizhou Zhang, Dr. Yongzhong Wang