In the past 15 years, the drug discovery and development CRO sector in China has undergone rapid development and expansion towards a highly sophisticated industry. Companies such as Wuxi Biologics, Mabplex, Tigermed, have grown to be global standard CROs capable of offering highly specialized and integrated R&D services.
I-Mab's R&D model is to rely on its own in-house core discovery and development capabilities, which are complemented strategically and effectively by CROs of global standards. The management team has accumulated extensive experiences in effectively practicing this R&D model to deliver R&D results with the quality, speed and cost-effectiveness.
I-Mab's R&D partnership takes place at three R&D stages. At the discovery stage, the Company works with academic institutions, such as institutes of the Chinese Academic of Sciences, and specialized CROs or biotech companies to deliver novel molecules, i.e. monoclonal antibody, Ig-cytokine fusion or bi-specific antibody (see Technology Platforms). Currently, I-Mab has discovery partnerships with Genexine, ABL-Bio, GCT and other entities. At the CMC and pre-clinical development stage, I-Mab forms strategic partnerships with Wuxi Biologics (news link), Mabplex and Covance. The partnership with these CROs takes global development into consideration. That is, CMC, GLP-tox and antibody manufacturing must meet the global regulatory and development standards, satisfying parallel regulatory and development requirements in China and US. At the clinical development stage, I-Mab embarks on clinical development path through strategic partnerships with the world-class clinical CRO, such as Covance and TigerMed for regional and China development and Pharmaron and RRD for clinical development in US.
I-Mab's pipeline focus on two ways. The first is "In China for Globe", there are seven on-going monoclonal antibodies and fusion proteins based on China develop innovative drugs for globe those are about to IND filling in China and US parallelly. Second one is "In China for China", with respect to Chinese patient pool and demand, there are five products with indications at type II diabetes, oncology, autoimmune diseases.
The next-wave pipeline for I-MAB's innovative biologics will be focused on "Bi-functional molecules" which is composed of two molecular formats, i.e. Ig-cytokine fusion and bi-specific antibody. The strategy is to attach a cytokine or another antibody Fab to the antibody of interest through antibody engineering platform to create a synergistic effect for efficacy improvement.
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