Since our inception, RemeGen has been dedicated to the research and development of biologics with novel targets, innovative design and breakthrough potential with the mission of fulfilling global unmet clinical needs for patients worldwide. We have established fully integrated, end-to-end R&D platforms covering all key functions of biologics development including discovery, pre-clinical pharmacology, process and quality development, clinical development, and manufacturing in compliance with global good manufacturing practices (GMP).
RemeGen’s robust pipeline of innovative biologics was made possible by our world-class proprietary research and development engine consisting of three specialized platforms: antibody and fusion protein platform, antibody-drug conjugate (ADC) platform and bifunctional antibody (HiBody) platform. Our technology platforms enable the discovery, screening and development of new molecules and proprietary technologies, and the efficient optimization of manufacturing processes in order to ensure end-to-end integration of drugs in the pipeline from R&D to commercialization.
The discovery and development capabilities of our antibody and fusion proteins are driven by innovative technologies and our expertise in bioinformatics assisted protein design and protein engineering. Our antibody and fusion proteins include the following key functions:
· antibody/fusion protein screening and protein engineering;
· cell line/process development;
· drug (DS)/ drug product (DP) GMP manufacturing.
Through this platform, we have researched and developed the first class of innovative biologic drugs with dual targeting mechanisms in China, such as our BLyS/APRIL targeting fusion protein, telitacicept (RC18) and our VEGF/FGF targeting fusion protein, RC28.
RemeGen is uniquely positioned in China with an in-house fully integrated end-to-end ADC platform. Our in-house capabilities cover the comprehensive process of ADC development and manufacturing. Our ADC platform comprise of the following main functions:
· Screening platform for ADC linker and payload optimization
· Proprietary Thiel-bridge conjugation technology
· Process development for linker, payload and conjugation
· GMP syntheses of linker, payload and link-payload
· GMP manufacturing of ADC DS and DP.
Our in-house platforms were utilized to research and develop more than 5 ADC candidate drugs, two of which have reached late stage clinical development in China and five of which are in IND-enabling stage. Our lead drug candidate, disitamab vedotin (RC48) is a novel antibody-drug conjugate discovered and developed in-house for the treatment of various HER2 expressing solid tumors. It is the first antibody drug conjugate approved for clinical development in China and has been proven to have good efficacy and safety in clinical trials.
Remegen’s latest proprietary Hibody platform features cutting-edge design and engineering capabilities to create next-generation bifunctional antibodies. The bifunctional antibody (HiBody) technology is based on novel molecular format and can be widely used to generate a variety of bispecific antibodies, including our internally developed three IND-enabling HiBody compounds (RC138, RC148 and RC158). The main functions of our HiBody platform include:
· R&D on proprietary bifunctional antibodies (HiBody) for multiple products
· R&D on next generation immune oncology therapeutics
· High manufacturability and product quality
With the potential to increase the efficacy and specificity of antibody-based therapies, our HiBody technology will enable us to explore the new frontier of therapeutic R&D strategies.
RemeGen is led by a visionary management team with decades of drug R&D experience in China and United States. Our team has proven track records in the fields of innovative drug R&D, clinical development and commercialization.
Dr. Jianmin Fang possesses over 20 years of R&D experience in the biopharmaceuticals industry and is the key inventor of biologic drug candidates in our pipeline.Led by our CEO and CSO, Dr. Fang, RemeGen has over 280 employees in our research and development team, with a majority having master's or doctorate degrees in life science fields, covering all major functions involved in the development of biologic drugs.
Under the leadership of Dr. Ruyi He, our Chief Medical Officer, RemeGen has built a 200 person clinical development team responsible for executing our global clinical development plan while adhering to rigorous trial design and trial operational excellence. In the spirit of following where the data leads, our clinical development team often discovers and explores unanticipated clinical opportunities, which in turn spur the organic growth and expansion of our clinical program and pipeline.