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.”

Disitamab Vedotin

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.

Product Pipeline

Currently, the company’s product pipeline has dozens of innovative drugs in the R&D and commercialization stages. In addition to two world-class new drugs, Telitacicept and Disitamab Vedotin, another dual-target VEGF/FGF innovative fusion protein product, RC28, with the potential to be the First-in-class has entered Phase 3 clinical study in the field of ophthalmic treatments. Four drugs are in Phase 1/2 clinical studies, and many drugs are in the IND preparation stage.
  • Oncology
  • Autoimmune Diseases
  • Ophthalmology

Production and Manufacturing

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.

Quality Assurance

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.