- The new partnership will combine the research and development ingenuity of BJ Bioscience with the state-of-art biologics manufacturing set up of CMAB
- CMAB will provide full development and manufacturing services for BJ Bioscience’s BJ-005 bi-functional antibody
- BJ-005 is planned to enter clinical studies in China and the US following a dual IND filing
CMAB Biopharma (Suzhou) Inc. (“CMAB”), a pure-play biologics CDMO and BJ Bioscience Inc. (“BJ Bioscience”), an innovative biopharmaceutical enterprise, today announced a comprehensive strategic agreement for the development and manufacturing of a Bi-functional Antibody (BJ-005) as the first step in an exclusive collaboration.
Under this agreement, CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of both China and the United States. The strategic cooperation will support the clinical development of BJ-005 worldwide by BJ Bioscience and is based upon CMAB’s award-winning CMC process development and manufacturing platform, an experienced R&D team in IND applications in both China and the United States, and an impeccable product quality system.
“We had ambitious goals and aspirations at the beginning of setting up BJ Bioscience,” said Mr. Xiaoyong, JIN, Chairman of BJ Bioscience. “So far, China’s biopharmaceutical companies have very few innovative drugs on the market. We believe that BJ Bioscience will develop real innovative biologics in the foreseeable future. This is a high-risk, considerably complex systematic project. To achieve such objective, I have started systemic preparation for the entire innovation chain, from deep gene sequencing and data mining to large animal transgenic models for validation of function of new genes. Only through such wholistic efforts can we discover new targets and develop brand-new large and small molecular drugs as well as gene therapy products around these new targets. All the companies along the innovation chains are BJ Bioscience’s sister companies. The cluster of companies on this ecological chain will produce synergy. The primary goal for our cooperation with CMAB is that we may focus more on the innovative R&D fields that we are good at and leave the CMC part to CMAB because it is its expertise. We believe that our efforts in all respects will open up an era for stronger, win-win cooperation.”
“CMAB stood out in our strict screening of a number of CDMO companies for many reasons. First of all, BJ Bioscience and CMAB share the same view on talents. We both think that talent prevails over everything. In recent years, BJ Bioscience has attracted many outstanding returnees and talents with both academic and biopharmaceutical industry experience. We highly appreciate CMAB for that it has done exactly the same over the years. 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. Last but not least, CMAB, as a pure-play CDMO company, advocates absolute protection of the intellectual property rights of its customers. Therefore, we believe that our cooperation will accelerate the R&D process of BJ-005. We hope that such collaboration will speed up the development of the innovative therapies of BJ Bioscience to the patients worldwide,” said Dr. Haizhou ZHANG, Co-founder and CEO of BJ Bioscience.
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“We are extraordinarily delighted and honored to have the opportunity to provide CMC research and manufacturing services to cutting-edge biomedical R&D companies like BJ. 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 has won the trust of an increasing number of young innovative R&D institutions like BJ, which has enabled us to develop our dedication to doing every project well and serving every customer well,” said Dr. Yongzhong WANG, CMAB CEO.
Source: PR Newswire
