Disitamab Vedotin is China’s first original antibody drug conjugate (ADC) developed by RemeGen. It is the first Chinese ADC drug to be dually recognized as a breakthrough therapy by the FDA of US and NMPA of China. Its gastric cancer and urothelial cancer indications were approved for marketing by NMPA of China in June 2021, and December 2021, respectively, and entered into the National Reimbursement Drug List in January 2022 and January 2023 respectively. In August, 2021, Seagen, the internationally renowned biopharmaceutical company has obtained an exclusive global (excluding Asia Pacific) licensing agreement for the drug, with an upfront payment and milestone payments of up to 2.6 billion US dollars as well as sales royalties ranging from high single digit to more than 15%. Its transaction volume set a new record for overseas licensing of a single product by a Chinese pharmaceutical company.
RC88 is an ADC independently developed by the company targeting mesothelin (MSLN).
It uses the company’s independently developed innovative bridging technology to connect antibodies and drugs. Its structure includes MSLN-targeting antibodies, cleavable linkers, and small molecule cytotxins (MMAE). By targeting and binding to MSLN-positive tumor cells, it mediates the endocytosis of the antibody, thereby effectively delivering better tumor killing effects.
RC98 is a new type of PD-L1 monoclonal antibody independently developed by the company. Based on preclinical research data, RC98 has equivalent or potential better target affinity and anti-tumor effect than other PD-L1 antibodies. RC98 monotherapy for gastric cancer has significant efficacy.
Treating patients with c-MET-positive solid tumors, RC108 is an antibody-drug conjugate (ADC) independently developed by the company that targets cellular-mesenchymal epithelial transition factor (c-MET). RC108 consists of c-MET targeting antibodies, linkers and small molecule cytotoxins. Its mechanism of action is similar to that of RC48. It can target and bind to c-MET-positive tumor cells, and mediate the endocytosis of the antibody, thereby effectively delivering cytotoxins to cancer cells, achieving better tumor killing effects.
RC118 is an innovative antibody drug conjugate (ADC) independently developed by the company. It is used to treat patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression. It is composed of recombinant humanized anti-Claudin 18.2 monoclonal antibody, Tubulin inhibitor Monomethyl Auristatin E (MMAE) conjugated to each other through a linker that can be cleaved by cathepsins with optimized drug-antibody ratio.
RC148 is a new bispecific antibody independently developed by the company and is the first bispecific antibody product approved for clinical use. In July 2023, its phase 1 clinical trial study of single-agent treatment of advanced malignant solid tumors was officially approved by CDE.
Telitacicept is the world’s first and first-in-class recombinant B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) dual-target novel fusion protein product for injection independently developed by RemeGen. A total of eight of its indications in the field of autoimmune diseases are in commercialization or late-stage clinical trials. Among them, the indication for systemic lupus erythematosus (SLE) was approved for domestic sale in March 2021, and entered into the National Reimbursement Drug List (NRDL) at the end of the same year. Due to the characteristics of new target, new structure, and new mechanism, the invention patent of the drug has been authorized by China, the US, Europe, etc. The drug has received major scientific and technological support from the country’s “Significant New Drugs Creation” during the “Eleventh Five-Year Plan”, “Twelfth Five-Year Plan” and “Thirteenth Five-Year Plan.”
RC28 is a potential first-in-class VEGF/FGF dual-target fusion protein for the treatment of eye diseases. There are a total of 3 indications in the field of ophthalmology in Phase2/3 clinical trials. RC28 has demonstrated the potential to more effectively inhibit abnormal blood vessel proliferation related to various eye diseases than single-target VEGF inhibitors, due to its dual channels of VEGF and FGF, which may allow for better dosing regimens.
We have state-of-the-art production facilities that comply with global GMP standards. They meet the production needs of the company’s product pipelines in the clinical and commercial stages. There are also advanced disposable bag bioreactors. We already have the competitive strength to produce a variety of innovative biopharmaceutical products on a large scale, and at the same time, 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.