Yuanbo Pharma Secures Clinical Trial Approval for Feline GnRH-Based Immunocontraceptive Vaccine, Advancing into Pet Healthcare Market
Recently, Guangzhou Yuanbo Medical Technology Co., Ltd. (hereinafter referred to as “Yuanbo Pharma”) independently developed itsFeline Recombinant GnRH-Leukotoxin Fusion Protein (E. coli-derived) Receives Clinical Trial Approval, preparing to enter comprehensive clinical research.
Yuanbo Medical, established in February 2017, is a developer of biological products for human and veterinary use. Leveraging its baculovirus-insect cell antigen expression technology platform and structure-based immunoadjuvant vaccine design technology platform, the company conducts R&D focused on pet biological products, includingPet-related vaccines, therapeutic biologics, and pathogen detectionand other aspects.
As China’s economic level rises, the elderly population expands, and the number of young single individuals increases, all contributing to the continued growth of the “loneliness economy.” Shifts in attitudes toward pet ownership, coupled with consumption upgrades, are driving the steady growth of China’s pet industry, making the pet economy a new hotspot.
According to the 2021 China Pet Industry White Paper, the number of pet dogs and cats in urban households in China exceeded 100 million in 2021. The pet healthcare industry has become the second-largest essential market after pet food, with a market size reaching RMB 60 billion, accounting for approximately 22% of the entire pet industry, and this proportion continues to rise year by year.
Currently, the number of pet dogs and cats in China is on par with that of the United States, the world’s largest pet market. However, there remains a significant gap in the markets for pet vaccines and biological products. The market size for pet-specific pharmaceuticals in China is still less than RMB 8 billion, accounting for less than 1/50th of that in the United States, while the penetration rate of pet vaccines is below 50%.
Dr. Wang Yi, Founder of Yuanbo MedicalDuring my stay in Canada, I observed that pet ownership is prevalent among households abroad, with deep emotional bonds between owners and their pets, often amounting to lifelong companionship. Pets can be infected with various viruses, parasites, and even certain zoonotic diseases; therefore,Pet vaccines and diagnostic products are essential.. As pets age, they become susceptible to various diseases such as diabetes, reproductive disorders, and tumors, necessitating the use of therapeutic biologics. Recognizing the significant market opportunities in veterinary medicine, Dr. Wang Yi began to conduct in-depth research in this field.
According to Dr. Wang Yi, in the early stages of development of China’s pet healthcare industry, factors such as a shortage of biological products and relatively lax regulation led to a fragmented, dispersed, and disordered market landscape. As the number of registered pets has continued to rise, pet owners’ knowledge levels have improved, and market demand has surged, these trends have further exacerbated issues such as irregular medication practices and limited treatment options due to drug shortages.
First,Domestic Pet Vaccine Market Dominated by Imported Brands, making it vulnerable to being choked off. Secondly, decades of use of foreign vaccine strains have led to mutations in the virus strains prevalent in China, thereby resulting inImported vaccines exhibit poor neutralizing efficacy against domestic strains, with a significant decline in effectiveness.Furthermore,Vaccines for Multiple Viruses Remain Unresolved, these are all issues faced by pet vaccines.
Currently, foreign biological products have not been registered for marketing in China and can only enter the country through irregular channels, thereby facing policy risks.Most domestic biopharmaceutical products are still in their early stages and face challenges related to product quality and regulatory compliance.. In addition, there is virtually a blank slate in China for biological products in the fields of oncology, diabetes, and other diseases.
In recent years, with the influx of capital, veterinary hospitals have begun to evolve toward a development pattern characterized by group-based operations, standardization, and high-quality services.Promote the development of the pharmaceutical market toward standardization, legalization, high quality, and high technological content.This will also enable companies with technological development and innovation capabilities to stand out, rapidly enter the pet healthcare market, and secure a leading position by offering products with significant efficacy and consistent quality.
Against this backdrop, Dr. Wang Yi founded Yuanbo Medical. The core team members possess robust technical expertise in viral immunology, engineered cell line development, large-scale animal cell culture and column chromatography purification, peptide antigen epitope design, tumor vaccine development, and pharmacodynamics and pharmacokinetics studies, with strong technological complementarity among them. All core team members have many years of experience in the research, development, and production of vaccines, new drugs, and diagnostic reagents.
The company is equipped with standardized pilot-scale production workshops, cell culture rooms, virus cultivation rooms, and conventional molecular biology laboratories. It has established a recombinant baculovirus expression system technology platform, a computer-aided design and screening platform based on immune structural bioinformatics methods, and multiple core technologies and development platforms for pet vaccine R&D, including pilot-scale purification of genetically engineered vaccines and adjuvant formulation.
Leveraging its technological platform, Yuanbo Medical has strategically positioned and developed a portfolio that includesPet Anti-Estrus Protein Vaccine, Pet Preventive Vaccine, BiopharmaceuticalsandDiagnostic Productsproducts in four areas, including feline contraceptive vaccines, canine contraceptive vaccines, feline combination multivalent vaccines, interferons for cats and dogs, and cytokines, to fill the market gap for domestic pet biologicals and diagnostic products.
In recent years, there has been growing concern for pet health. Sterilization can prevent overbreeding, extend pets’ lifespan, and avoid the occurrence of gonadal diseases. Traditional sterilization methods involve surgical procedures to render pets infertile,GnRH Fusion Protein Vaccine Sterilization: An Emerging Novel Method for Pet Sterilization
According to Dr. Wang Yi, common methods of castration in animals are classified into surgical castration, chemical castration, and immunocastration.
Surgical castration is the earliest and most commonly used method for animal castration, involving the surgical removal of the testes and epididymis in male animals or the ovaries and uterus in female animals. Orchiectomy in male animals is technically simple but prone to postoperative infection, while ovari hysterectomy in female animals is more complex and may have long-term effects on the female urogenital system. Furthermore, surgery causes significant pain to animals, raising animal welfare concerns.
Chemical castration, also known as pharmacological castration, achieves castration without harming the organism by injecting certain acids, alkalis, salts, mercury preparations, and metal oxides into the testicular parenchyma to destroy testicular tissue, causing degeneration, necrosis, and atrophy. Traditional chemical castration methods impose strict requirements on injection volume and technique; insufficient dosage may lead to castration failure, while injection into areas outside the testicular parenchyma can cause tissue degeneration and necrosis. Additionally, hormonal contraceptives can disrupt endogenous hormone levels, leading to metabolic abnormalities.
Immunocastration is a method that suppresses the development of sexual organs to achieve castration through immunological means. It primarily works by inducing sufficiently high levels of antibodies against antigens that play crucial roles in the reproductive process. These antibodies block the regulatory pathways of reproductive hormones via antigen-antibody reactions, thereby achieving the goal of fertility control.Immunocastration offers advantages such as safety and convenience, mild efficacy, minimal animal stress, and reversibility., offering significant advantages over surgical and chemical castration. However, the primary issue isHow to Select Suitable Antigens with Sufficient Immunogenicity, to obtain contraceptive products.
Currently, the primary antigens used in immunization include zona pellucida (ZP) antigens, which play a crucial role during fertilization by surrounding the oocyte; gonadotropin-releasing hormone (GnRH) antigens; luteinizing hormone/choriogonadotropin receptor (LH) antigens; and follicle-stimulating hormone (FSH) antigens. These antigens can all induce high antibody titers, thereby achieving a castration effect.
However, ZP can only be used in female animals, and its sterilization efficacy in cats remains uncertain. The duration of immunity against LH and FSH is relatively short. Among the various antigens studied, GnRH has been the most comprehensively investigated. GonaCon, a GnRH-based vaccine marketed in the United States, has a labeled duration of efficacy of one year; nevertheless, its sterilization rates remain at 73%, 53%, and 40% in the second, third, and fourth years post-vaccination, respectively.
The anti-estrus protein vaccine approved for clinical trials by Yuanbo Medical, as the first domestic pet anti-estrus protein product, is preciselyUsing GnRH as an antigen, preliminary studies have shown that vaccination in cats achieves castration levels exceeding 90% within two years, demonstrating strong potential for market application.
Dr. Wang Yi stated that, in addition to the Yiqing protein vaccine recently approved for clinical trials, several other products independently developed by the company, such as canine and feline interferons, have also sequentially entered the clinical registration phase. In 2021, the company completed the construction of production lines for pet vaccines and nucleic acid reagents, and submitted clinical registration applications for several reagent products.
Currently, Yuanbo Medical is in a phase of rapid growth. The companyAbout to complete a new round of financing for the construction of GMP vaccine production lines, to meet the market launch requirements for product varieties.
In the future, regulatory oversight of veterinary healthcare policies will intensify, leading to a more standardized industry. Companies will adopt refined management practices, and the sector’s substantial growth potential will undoubtedly create more opportunities for veterinary healthcare professionals. Looking ahead, Guangzhou Yuanbo Medical Technology Co., Ltd. is committed to innovating the development of veterinary vaccines and biological products, safeguarding the health of pets.