Technology Platform

Since its establishment, Baike Biotech has been primarily dedicated to the research, development, manufacturing, and commercialization of innovative biopharmaceuticals for the prevention and control of infectious diseases. The company has continuously deepened its expertise in five core technology platforms: the “Viral Large-Scale Cultivation Platform,” the “Formulation and Adjuvant Technology Platform,” the “Genetic Engineering Technology Platform,” the “Bacterial Vaccine Technology Platform,” and the “mRNA Vaccine Technology Platform.” These platforms complement one another, creating strong synergies that facilitate breakthroughs in industrial-scale technologies and critical manufacturing processes. As a result, the company is able to develop vaccine products more cost-effectively and efficiently, build a diversified vaccine portfolio, and establish a well-structured product pipeline.

(1) Viral Large-Scale Cultivation Technology Platform

The viral large-scale cultivation technology platform employs appropriate culture systems to achieve large-scale virus production. Key applications include the use of cell factories or bioreactors for cell culture to produce viral vaccines.
The company has established a large-scale viral cultivation technology platform based on human diploid cell and Vero cell culture technologies. By increasing the cell culture surface area per unit volume, virus yield is enhanced; moreover, through extensive research, optimal cell and virus cultivation conditions have been identified. Leveraging this technology platform, varicella vaccine and herpes zoster vaccine have been launched and have become the company’s primary revenue drivers.

(2) Formulation and Adjuvant Technology Platform
A dosage form refers to a pharmaceutical preparation manufactured in accordance with specific formulation requirements to meet therapeutic or prophylactic needs, and which is ultimately intended for administration to the patient. For vaccine products, the primary dosage forms include lyophilized formulations and liquid formulations. Given that vaccines are biologically active products, the selection of an appropriate dosage form can optimize therapeutic efficacy and maintain vaccine stability.

Adjuvants are specific immune enhancers that, when administered concurrently with or prior to an antigen, can augment the host’s immune response to the antigen or alter the nature of that response. Commonly used adjuvants today include aluminum adjuvants and MF59. Through years of continuous research and development—covering the design and characterization of novel vaccine adjuvant systems, optimization of formulation and manufacturing processes, evaluation of compatibility between specific candidate antigens and adjuvant systems, optimization of antigen–adjuvant combinations, as well as assessment of immunization strategies and protective efficacy—the company has, after nearly three years of exploration, developed a nano-aluminum adjuvant and incorporated it into a DTP (three-component) vaccine project, which is currently undergoing Phase III clinical trials. In addition, the company has developed the BK-01 and BK-02 adjuvants, which have now been applied in the development of adjuvanted influenza vaccines and recombinant shingles vaccines, respectively. Clinical trial applications for an influenza split-virus vaccine formulated with the BK-01 adjuvant, a trivalent influenza split-virus vaccine also using the BK-01 adjuvant, a DTP vaccine for adolescents and adults, and a recombinant shingles vaccine have all been approved.

Thanks to research on vaccine stabilizers, the company has successfully developed the world’s first varicella vaccine with a 36-month shelf life. With regard to the intranasal influenza vaccine, to enhance its ease of use, a liquid formulation for intranasal administration has obtained manufacturing approval, and expanded-age-group clinical trials have been initiated. The formulations for these stabilizers have also been granted patents in multiple countries. The establishment of a formulation and adjuvant technology platform has laid the foundation for the future commercialization of related vaccines.

(3) Genetic Engineering Technology Platform

Genetic engineering is grounded in molecular genetics and employs modern techniques from molecular biology and microbiology to construct recombinant DNA molecules in vitro by combining genes from different sources, which are then introduced into living cells or bacteria to produce recombinant biological products.

This technology platform primarily encompasses nucleic acid vaccine preparation technologies, Escherichia coli–based virus-like particle expression systems, CHO cell–based expression of fully human monoclonal antibodies, and baculovirus–insect cell expression systems, among others. By leveraging this genetic engineering technology platform, optimized antigen genes are selected and combined with suitable vectors to establish a key technological development and application platform for constructing genetically engineered vaccine candidates. This platform supports the design, evaluation, and development of novel therapeutic and prophylactic vaccine candidates, including genetic engineering vaccines, DNA vaccines, and viral vector–based vaccines, while also exploring and advancing the research and development of preventive products targeting major diseases such as Alzheimer’s disease, tuberculosis, and pneumonia.

Leveraging this technology platform, the company is developing therapeutic vaccines for Alzheimer’s disease, as well as preventive and therapeutic monoclonal antibodies against RSV, rabies, and tetanus. Specifically, the rabies monoclonal antibody has completed Phase II clinical site activities and is now in the final stages; the tetanus monoclonal antibody has completed Phase Ia clinical trials and is currently conducting Phase Ib and Phase II trials; and the clinical trial application for the recombinant shingles vaccine has been approved.

(4) Bacterial Vaccine Technology Platform

Bacterial vaccine technology enables the large-scale cultivation of bacteria through fermentation processes and facilitates the research, development, and scalable production of vaccines by extracting bacterial polysaccharides, toxins, and other immunogenic components. The technological platform also encompasses polysaccharide conjugation technology, which involves covalently linking bacterial polysaccharides to carrier proteins to form polysaccharide–protein conjugates, thereby enhancing the immunogenicity of the antigen.

Purification protocols can be designed based on recombinant approaches or the inherent multivalency of genes, employing techniques such as salting out, anti-coagulation, alcohol precipitation, and chromatography to purify the target antigen. Toxoids are obtained by detoxifying toxins using inactivating agents. Large-scale bacterial fermentation, along with polysaccharide and protein purification technologies, constitute the core, universally applicable technologies for both bacterial vaccines and genetically engineered vaccines that use bacteria as a production platform. The DTP vaccine (three-component formulation) is currently undergoing Phase III clinical trials; applications for clinical trials of the Hib vaccine, the DTP-Hib combination vaccine, and the adolescent and adult DTP vaccine have already been approved.

(5) mRNA Vaccine Technology Platform

As a cutting-edge biotechnology and a platform technology, mRNA technology can be applied to the prevention of infectious diseases, cancer treatment, and protein replacement therapy. It offers advantages such as rapid R&D, high safety, robust immune protection, and ease of manufacturing, making it a major technological trend in the vaccine and biopharmaceutical sectors. In recent years, mRNA technology has achieved breakthroughs in the development of vaccines against infectious diseases, thereby creating substantial market potential and growth prospects for mRNA vaccines in both prevention and treatment. The company’s investigational HSV-2 mRNA vaccine has now initiated Phase I clinical trials.