Pipelines & Products

Ricefidase (KJ103) is a novel IgG-cleaving enzyme derived from the non-human pathogen S. equi ssp. equi. It rapidly breaks down pathogenic “bad antibodies” through a unique and efficient mechanism, effectively alleviating symptoms of related diseases. With broad therapeutic potential, it is being developed for the treatment of acute and severe autoimmune diseases, as well as the elimination of neutralizing antibodies in gene therapy.

This enzyme efficiently cleaves IgG into F(ab’)₂ and Fc fragments, with its pharmacological effects manifesting within one hour of administration. Independently developed by Bao Pharma, it is protected by a global patent portfolio. It has completed Phase I clinical trials with positive results in both New Zealand and China and is currently in Phase II/III trials.

Additionally, Ricefidase has received FDA approval for clinical trials targeting a wide range of autoimmune diseases caused by pathogenic IgG. Extensive clinical data demonstrate that it is safe and well-tolerated, with rapid and complete IgG degradation achievable as the dosage increases.

A subcutaneously administered anti-CD20 antibody resistant to degradation by IgG degrading enzymes, with the potential for combination therapy with KJ103 in treating moderate to severe autoimmune diseases.

A subcutaneously administered anti-CD154 antibody resistant to degradation by IgG-degrading enzymes, developed specifically for solid organ transplantation, xenotransplantation, and autoimmune diseases such as lupus nephritis and multiple sclerosis.

Hyaluronic acid (HA), or Hyaluronan, is an acidic glycosaminoglycan that is widely present in the extracellular matrix of human tissues, such as the vitreous humor of the eye, synovial fluid of joints, and other connective tissues. As a gel-like substance, it restricts the diffusion of water and other extracellular materials, thereby limiting the mobility of subcutaneous fluids. Hyaluronoglucosaminidase (hyaluronidase) (EC 3.2.1.35), abbreviated as HAase, is an endoglycosidase that can break down hyaluronic acid. It hydrolyzes the β-1,4 glycosidic bonds within HA polymer molecules, producing small molecular HA or oligosaccharides, thereby increasing tissue permeability and fluid infiltration. In clinical field, hyaluronidase can be used as a drug permeation enhancer, anesthetic adjuvant, or postoperative edema-relieving agent. It promotes the diffusion of locally accumulated drug solutions, exudates, or blood, accelerates drug absorption, reduces local tissue tension and pain, and aids in the absorption and dissipation of edema and inflammatory exudates.

KJ015 is a bispecific anti-HER2 antibody independently designed by Bao Pharma, derived from common light chain technology. Due to its ability to maintain high affinity for two epitopes simultaneously, KJ015 clusters with the antigen on the cell membrane surface, demonstrating characteristics significantly superior to combination monoclonal antibodies in HER2-positive tumors. The lead indication validated in preclinical studies is gastroesophageal adenocarcinoma, and it also shows promise in treating other cancers such as cholangiocarcinoma, gallbladder cancer, parotid gland cancer, endometrial cancer, ovarian cancer, and colorectal cancer. This makes KJ015 particularly promising for clinical outcomes in HER2 high-expression and moderate-expression malignant tumors. Moreover, even in HER2-positive breast cancer, KJ015 exhibits pharmacodynamic properties that give it a competitive edge.

The symmetrical molecular design of KJ015 ensures high stability, high expression levels, and a simple, cost-effective production process. When combined with the company’s independently developed hyaluronidase, KJ015 further leverages the clinical advantages of safe and convenient subcutaneous administration, making it highly competitive in the market.

A subcutaneous formulation of ceftriaxone sodium for the treatment of bacterial infections. It is indicated for a wide range of infections caused by susceptible bacteria, including lower respiratory tract infections, urinary tract infections, biliary tract infections, gonorrhoea, intra-abdominal infections, pelvic inflammatory disease, skin and soft-tissue infections, bone and joint infections, bacterial septicaemia, meningitis, and for perioperative prophylactic use.

An innovative subcutaneous formulation of cefoperazone sodium–sulbactam sodium. This combination product is widely used to treat bacterial infections, including respiratory tract infections, urinary tract infections, intra-abdominal infections, gynaecological infections, skin and soft-tissue infections, bone and joint infections, bacterial septicaemia, meningitis, endocarditis, as well as for perioperative prophylactic use.

An innovative subcutaneous formulation of cefazolin sodium (a first-generation cephalosporin antibiotic), which acts by inhibiting bacterial cell-wall synthesis and ultimately causing cell lysis. Similar to the intravenous formulation of cefazolin sodium, BJ009 has the potential to treat a wide range of bacterial infections, including those of the skin, bones, joints, reproductive organs, blood, heart valves, respiratory tract, biliary tract, and urinary tract.

Chymotrypsin is a protease that rapidly breaks down proteins, liquefies pus, and necrotic tissue. It has been in clinical use for over 50 years and is widely applied in nearly 20 medical departments, including respiratory medicine, surgery, otorhinolaryngology, gynecology and obstetrics, pediatrics, dentistry, ophthalmology, dermatology, gastroenterology, and proctology.
Currently available domestic drugs are extracted from bovine or porcine pancreas, leading to widespread concerns about the biosafety risks associated with animal-derived drugs. Bao Pharma has pioneered the use of a yeast expression system to produce medicinal recombinant chymotrypsin as a replacement for animal-derived products. This method yields high-purity proteins, which are non-allergenic, and offers a wide range of raw material sources at low cost, with enhanced safety and reliability. The production of non-animal and plasma-free biologics to replace products extracted from animal tissues represents the future trend in upgrading biochemical extraction drugs.

Recombinant ulinastatin, a serine protease inhibitor with broad anti-inflammatory properties. Clinically, it is used to manage acute pancreatitis, sepsis, and postoperative systemic inflammatory responses by inhibiting proteolytic enzymes such as trypsin, elastase, and kallikrein.
Traditionally, ulinastatin has been extracted from human biological fluids through biochemical methods. However, this approach faces limited yield, high production costs, and potential contamination risks. Bao Pharma has overcome these limitations by producing recombinant ulinastatin using mammalian cell expression. This innovation represents an important step towards safer and more effective anti-inflammatory therapies.

Follicle-stimulating hormone (FSH) is a glycoprotein gonadotropin synthesized and secreted by the basophilic cells of the anterior pituitary. In males, it promotes the development of seminiferous epithelium, stimulates spermatogenesis, and aids in sperm maturation. In females, it stimulates follicular development and maturation, and in coordination with luteinizing hormone (LH), it promotes the secretion of estrogen and ovulation from mature follicles, playing a key role in regulating the menstrual cycle. For patients undergoing superovulation or assisted reproductive technologies, FSH can stimulate the development of multiple follicles.

SJ02 (FSH-CTP) is a long-acting follicle-stimulating hormone with modified glycosylation sites. It does not alter the binding of FSH to its receptor or its biological activity but extends its half-life in the body by 2 to 3 times compared to regular FSH. Unlike traditional short-acting FSH, which requires daily injections for 10 to 14 consecutive days, SJ02 requires only a single injection to replace 7 days of traditional short-acting therapy. This improves the patient treatment experience while ensuring therapeutic efficacy and safety, and also reduces the workload of healthcare institutions and lowers medical costs.

The production process of SJ02 is complex, with high technical barriers in both expression and purification, making it a breakthrough in an area of unmet need in China. Bao Pharma has independently developed the first recombinant FSH-CTP product in China, successfully breaking the monopoly of foreign products, enhancing the international competitiveness of China’s biopharmaceutical industry, and reducing the cost and physical and psychological burden on patients.

Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the placenta that stimulates gonadal activity. In females, hCG promotes the maturation of ovarian follicles and induces ovulation, transforming the ruptured follicle into the corpus luteum and stimulating it to secrete progesterone. In males, hCG enhances the function of the seminiferous tubules and Leydig cells in the testes, increasing androgen production, promoting testicular descent, and stimulating spermatogenesis.
hCG is commonly used in assisted reproduction to accelerate follicle maturation and trigger ovulation. During ovulation induction, large doses of hCG are injected to mimic the pre-ovulatory luteinizing hormone (LH) surge, thereby promoting final follicular maturation and inducing ovulation. Beyond its use in fertility treatments, hCG is also employed in the treatment of prepubertal cryptorchidism, male hypogonadism, female luteal phase insufficiency, and functional uterine bleeding.