Baopharma 宝济药业

Overview

We have developed a proprietary technology platform capable of rapidly degrading immunoglobulin G (IgG). This platform employs a globally leading low-pre-existing antibody IgG-degrading enzyme, which, when administered intravenously, can completely eliminate total IgG from plasma and tissues.

IgG is the main component of immunoglobulins in human serum, accounting for about 10-20% of total serum protein. Under normal conditions, IgG protects the body from foreign pathogens. However, in certain disease states, such as IgG-type multiple myeloma or autoimmune diseases caused by pathogenic IgG (e.g., Goodpasture syndrome, Guillain-Barré syndrome, myasthenia gravis), IgG becomes a pathogenic factor.

Even normal IgG can impede life-saving acute treatments for some patients. In allogeneic or xenogeneic organ transplants, IgG in the body recognizes non-self antigens in donor tissue, activating the immune system and leading to rejection. In gene therapy based on viral vectors, IgG can neutralize the vectors, rendering them ineffective.

For such large quantities of pathogenic or treatment-interfering IgG, conventional medical management methods are slow and costly. Ricefidase is a globally leading next-generation IgG-degrading enzyme, derived from an enzyme of Streptococcus pyogenes, which does not infect humans. It was independently developed and modified through our proprietary design. Ricefidase specifically degrades the lower hinge region of IgG, rendering it inactive.

Phase I clinical trials conducted in New Zealand and China have demonstrated that within 1 to 2 hours of Ricefidase administration, nearly all IgG in serum and tissues of the subjects was cleaved by the enzyme. The cleaved fragments are unable to mediate Fc-dependent pathological mechanisms, thereby preventing and inhibiting adverse immune reactions such as IgG-induced complement activation, cell killing, and cell activation.

Compared to Imlifidase, which has a high pre-existing antibody rate of over 85% and is approved for use in Europe, Ricefidase has a lower pre-existing antibody rate of less than 20% and exhibits low immunogenicity. Therefore, it can be used in combination with immunosuppressants like methotrexate (MTX). Ricefidase also expands the treatment window and holds broader therapeutic potential for conditions such as autoimmune diseases requiring repeated administration, maintenance therapy post-sensitizing organ transplantation, gene therapy, and the treatment of IgG-type multiple myeloma.

Clinical Progress

March 2022: Ricefidase received approval from New Zealand's Medsafe to initiate Phase I clinical trials.

May 2022: Ricefidase obtained clinical trial approval from FDA for the treatment of a range of autoimmune diseases caused by pathogenic IgG.

August 2022: Ricefidase was granted NMPA clinical trial authorization for desensitization therapy in highly sensitized kidney transplant patients.

April 2023: Ricefidase completed Phase I clinical trials in China and New Zealand (CTR20222595/NCT05274659).

August 2024: Ricefidase received NMPA clinical trial authorization for the treatment of anti-GBM disease and initiated Phase II clinical trials in China (NCT06607016).

September 2024: Ricefidase achieved positive topline data in Phase II clinical trials for desensitization therapy in highly sensitized kidney transplant patients (CTR20234137).

Production

Our production process complies with current GMP requirements, and the production scale during clinical phases meets future commercialization needs.

Therapeutic Areas

Autoimmune Diseases

Autoantibodies are antibodies that target the body’s own tissues, organs, cells, and their components. In healthy individuals, autoantibody levels are generally low and do not cause harm. However, abnormal levels of autoantibodies can attack healthy tissues, leading to severe autoimmune diseases. The autoimmune category encompasses hundreds of diseases, most of which are rare and have low incidence rates, making diagnosis and treatment especially difficult. Acute-onset autoimmune diseases, in particular, have high rates of mortality and disability. The rapid action of Ricefidase enables it to race against time, saving the lives of critically ill patients.

Cancer

In cancer treatment, therapeutic antibodies based on IgG molecules have become one of the mainstream and affordable options. While certain cancers express the targets for antibody drugs, some patients experience abnormally elevated IgG levels, which can interfere with the antibody drug through malignant competition, leading to its premature depletion and reduced efficacy. In these cases, patients cannot benefit fully from the intended treatment. For example, in multiple myeloma—the most common subtype being the IgG type, accounting for about 50% of cases—effective and affordable treatment options remain limited. Ricefidase can safely and efficiently clear excess IgG in advance, creating a favorable environment for patients to receive antibody-based therapies effectively.

Gene Therapy

Gene therapy, known for its single-dose, long-lasting efficacy, has become a prominent field of emerging treatments. Adeno-associated virus (AAV) is the preferred vector in gene therapy, with several AAV-based therapies already approved. However, a high percentage of the population has pre-existing anti-AAV antibodies that can neutralize the viral vector, hindering its delivery, leading to treatment failure or requiring higher doses that increase the risk of adverse effects. This limits the broad application of gene therapy. Expanding the eligible patient population and enhancing safety are crucial challenges in this field. Pre-treatment with Ricefidase to clear pre-existing anti-AAV antibodies opens a safe and effective gene therapy window for such patients.

Transplantation

Highly sensitized patients, who have widespread and high levels of anti-HLA antibodies, face significant challenges in finding suitable donors for transplantation. These patients typically have panel reactive antibody (PRA) levels ≥80%, and even after desensitization and transplantation, they remain at high risk for hyperacute rejection and antibody-mediated rejection. High levels of anti-HLA antibodies limit the success rate of kidney transplants and reduce long-term graft survival. The clinical application of Ricefidase offers transplantation opportunities for previously ineligible patients and helps prevent post-transplant hyperacute rejection.

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