We have developed a proprietary technology platform that rapidly degrades immunoglobulin G (IgG). This platform utilizes the world's leading low-immunogenic IgG-degrading enzyme, which, when administered intravenously, can completely clear pathogenic IgG in the plasma and tissues within just one hour.
IgG is the one of the primary components in human serum, accounting for about 10-20% of the total protein. Normally, IgG protects the body from foreign pathogens. However, in certain pathological states, such as IgG-type multiple myeloma or autoimmune diseases including glomerulonephritis, Guillain-Barré syndrome, myasthenia gravis, etc., IgG is the cause of the disease.
Normal IgG can also hinder the life-saving treatment in acute medical needs. In allogeneic or xenogeneic organ transplants, IgG recognizes foreign histocompatibility antigens in the donor tissue, activating the immune system and leading to rejection. In gene therapy based on viral vectors, IgG may neutralize the vectors, rendering them ineffective.
For such a level of pathogenic or interfering IgG, conventional medical management is slow and expensive. Ricefidase is the next generation IgG-degrading enzyme in the world, derived from a non-human pathogenic Streptococcus equi subspecies, and obtained through our independently designed modification. Ricefidase can specifically degrade the IgG lower hinge region, making it inactive.
Phase I clinical trials have been conducted in New Zealand and China. It has already proven that almost all the IgG in the serum and tissues of the subjects was cleared within 1 to 2 hours after administration of Ricefidase. The enzymatically cleaved fragments cannot mediate pathological effects dependent on Fc, thus preventing and inhibiting adverse immune reactions such as complement activation, cell killing, and immune cell over-activation.
Compared to Imlifidase, which has a high level of pre-existing antibodies above 85% and is approved for marketing in Europe, Ricefidase has a lower percentage (<20%) of pre-existing antibodies in the body and is less immunogenic. It can be used in combination with immunosuppressants like MTX. Ricefidase can also be used to enlarge the treatment window, with broader potential indications, such as the treatment of autoimmune diseases requiring repeated administration, maintenance therapy after allergenic organ transplantation, gene therapy, and the treatment of IgG-type multiple myeloma.
Mar 2022, Ricefidase received IND approval from the New Zealand Medicines Regulatory Agency (Medsafe) to launch Phase I clinical trial.
May 2022, Ricefidase received IND approval from FDA for the treatment of diseases caused by pathological IgG.
Aug 2022, Ricefidase received IND approval from NMPA for desensitisation of highly sensitised kidney transplant patients.
Apr 2023, Ricefidase completed Phase I clinical trials in China and New Zealand (CTR20222595/NCT05274659).
Aug 2024, Ricefidase received IND approval from NMPA for the treatment of anti-GBM disease, and launch Phase II clinical trial in China (NCT06607016).
Sep 2024, Positive topline results from Phase II of Ricefidase for desensitisation therapy in highly sensitised kidney transplant patients (CTR20234137).
Our production management complies with current GMP standards.