Baopharma 宝济药业

Overview

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.

Clinical progress

Ricefidase has been approved in the US for acute severe autoimmunediseases mediated by pathogenic immunoglobulin G (lgG) autoantibodies.

Ricefidase has completed Phase I clinical trials in New Zealand and China.

Ricefidase has entered Phase II in China, with the indication for desensitization therapy in highly sensitized adult renal transplant patients. These patients are unable to undergo conventional renal transplantation due to positive cross-matching with existing donors.

Manufacture

Our manufacturing process adheres to current GMP standards, and the production scale during clinical trials meets the requirements for future commercialization.

Therapeutic areas

autoimmune disease

In healthy individuals, autoreactive antibodies are present at low, non-disease-causing levels. Elevated levels, however, can damage healthy tissue and cause autoimmune diseases. Autoimmune diseases include hundreds of conditions, many rare and with low incidence. Diagnosing and treating these, especially acute forms, is difficult due to their high mortality and disability rates. Ricefidase's rapid clearance of autoreactive antibodies can be life-saving for patients with severe onset.

Cancer

In cancer treatment, IgG-based therapeutic antibodies are accessible and affordable options for the public. However, some cancers with corresponding antigens also exhibit abnormal high IgG levels, which can interfere therapeutic antibodies by competition, reducing their efficacy. For instance, in multiple myeloma, an IgG-related subtype comprises about 50% of cases, and current therapies are often ineffective or costly. Ricefidase can safely eliminate excess IgG, allowing patients to benefit from antibody drugs as intended.

gene therapy

Gene therapy, a one-time treatment with enduring effects, is gaining popularity. Adeno-associated virus (AAV) is the preferred vector for approved gene therapies. However, the high prevalence of pre-existing antibodies against AAV in the population can neutralize the virus, impeding delivery and potentially causing treatment failure or increased side effects, limiting the use of gene therapy. Therefore, expanding the accessibility and enhancing safety are critical issues in the field. Pre-treatment with Ricefidase to clear AAV pre-existing antibodies can create a safe and effective window for gene therapy in these patients.

transplantation

Patients highly sensitized with extensive and high levels of anti-HLA antibodies face challenges in finding compatible donors for transplantation. With panel reactive antibody (PRA) levels at ≥80%, they are at significant risk of hyperacute and antibody-mediated rejection, even after desensitization. This high antibody load restricts the success of organ transplants and the longevity of the graft. Ricefidase offers a clinical solution, enabling transplantation for patients who would otherwise be ineligible and reducing the risk of post-operative hyperacute rejection.

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