Disitamab Vedotin (RC48) is the first Chinese ADC drug created and developed by RemeGen to receive breakthrough designations in both the United States and China, the treatment of gastric cancer had been granted approval by NMPA in 2021 and also been included in the National Reimbursement Drug List (NRDL), the indication of urothelial carcinoma had been granted approval by NMPA in the same year.
Telitacicept (RC18) is a first-in-class TACI-Fc fusion protein for injection developed by RemeGen which targets two important cell-signaling molecules, B-cell lymphocyte stimulator (BLyS) and A proliferation inducing ligand (APRIL). Seven indications of Telitacicept are in commercial or clinical trials stage in autoimmune diseases area and the treatment of systemic lupus erythematosus(SLE) has been granted approval by NMPA and also been included in the National Reimbursement Drug List (NRDL).
RC28 is a potential first-in-class VEGF/FGF dual-targeting fusion protein for the treatment of eye diseases. Compared to single-target VEGF inhibitors, RC28 has the potential to more effectively inhibit the abnormal blood vessel growth implicated in various eye diseases through both VEGF and FGF pathways, potentially allowing for a better dosing profile. RC28 has completed a Phase I dose escalation study in patients with wet age-related macular degeneration (wet AMD) in China.
We have leading manufacturing facilities with global GMP standards to meet the clinical and commercial production requirements of our pipeline, our manufacturing facility currently houses six 2000L disposable bioreactors and we have the competitive strength of scale production of a variety of innovative biological pharmaceutical products. Meanwhile, we are building new production facilities.
RemeGen has integrated production capacities to produce monoclonal antibodies, fusion proteins, antibody-drug conjugates, bifunctional antibodies and other complex molecules. Its factory buildings and the ancillary facilities have reached world leading. We have built a professional quality assurance team led by medical professionals with decades of biopharmaceutical development experience in Europe or the United States. We have been focused on building a quality management system that meets the international standards to expand our global outreach. RemeGen have established the quality policy of Making Medicines With Integrity, Scientific Management,Continuous Improvement and Pursuit of Excellence. We shall build a quality management system that meets the GMP requirements of FDA, EMA and NMPA.