Jicang Bio Files IPO Prospectus: Offering End-to-End Vaccine CXO Services Powered by Five Core Technology Platforms

Since the onset of the COVID-19 pandemic in 2019, vaccines have rapidly become a focal point for both primary and secondary markets, owing to their swift efficacy in preventing and controlling infectious diseases. In recent years, the vaccine industry has entered a period of rapid growth, driven by the promulgation of relevant vaccine policies and regulations, the emergence of novel technologies such as mRNA platforms, and heightened consumer awareness and demand for vaccination.

Despite the vaccine R&D sector being characterized by the “five highs”—high risk, high investment, long development cycles, high barriers to entry, and high gross margins—along with significant uncertainty and competition, innovative vaccine companies continue to emerge in large numbers. Alongside the booming vaccine industry, the vaccine CXO (Contract Research/Manufacturing Organization) sector has also gained substantial traction.

Chengdu Jicang Biotechnology Co., Ltd. (hereinafter referred to as “Jicang Biotech”) is a start-up CXO company dedicated to providing global vaccine R&D enterprises with integrated, one-stop CXO services covering the entire process of preventive biologics research and development, clinical trials, and manufacturing through technical cooperation, technical consulting, and joint development.

Leveraging a team with extensive experience in R&D, manufacturing, and commercial operations, Jicang Biology has entered the vaccine CXO sector with high-barrier technologies and product offerings. In less than two years, the company has established three core business segments: technical services, adjuvants, and vaccine bulk drug substances. Most importantly, Jicang Biology has built five core technology platforms that enable it to provide four major solutions to enterprises.

In April 2022, four like-minded entrepreneurs co-founded Jicang Biotechnology in Chengdu.

Among them, Dr. Yan Song is the founder of Jicang Biotechnology and an entrepreneur with nearly 20 years of extensive experience in the biopharmaceutical industry. He holds a Master’s degree in Biochemistry and Molecular Biology from Southwest Jiaotong University and a Doctorate in Management from the University of Arizona in the United States.

Prior to joining Jicang Bio, he founded several innovative high-tech enterprises, including Purun Medical and Zhongling Intelligent Medical, where he held key positions such as Chairman and General Manager. He managed a team of nearly 100 employees and led these companies to achieve a combined annual revenue exceeding RMB 100 million, accumulating extensive experience in team management and corporate operations.

Furthermore, the other three members of the team also possess nearly 20 years of experience in vaccine research and development, manufacturing, and sales. During their careers, they observed that despite the leapfrog development of China’s vaccine industry over the past two decades—transitioning from a shortage of routine vaccine supplies to fully meeting immunization needs—companies in the sector still face challenges such as lagging innovative technologies, weak foundational research on upstream raw materials, and reliance on imported raw materials.

Therefore, to break through R&D barriers and the monopoly landscape, four members formed a team, established a company, and boldly entered the vaccine CXO sector. After more than a year of effort, the team completed its technical reserves and product line layout, giving rise to Jicang Bio at the opportune moment.

Furthermore, Jicang Biology has built a core technical team with extensive experience in the research and development, production, and testing of biological products. Notably, all three members of its advisory board are alumni of the School of Life Sciences and Engineering at Southwest Jiaotong University.

Adjuvants are essential raw materials in vaccine development. They are non-specific immunopotentiators that lack intrinsic immunogenicity. When co-administered with antigens, adjuvants can enhance the body’s immune response to the antigen or modulate the type of immune response elicited. An ideal adjuvant not only augments the immune response but also enables the host to achieve optimal protective immunity.

Adjuvants are particularly critical in recombinant protein vaccines. As a type of subunit vaccine, recombinant protein vaccines contain only immunogenic proteins. Compared with live-attenuated or inactivated vaccines, they offer higher antigen purity and reduced side effects; however, the lower molecular weight of protein antigens results in diminished immunogenicity and a shorter duration of immune response. Therefore, the addition of adjuvants is one of the strategies to enhance their immunogenicity.

Currently, only six novel adjuvants have received FDA approval for market launch, all of which are produced by overseas vaccine manufacturers. The majority of domestic vaccine companies rely on adjuvants supplied by firms such as GSK and Novartis, leaving them vulnerable to supply chain bottlenecks.

“Accelerating the market launch of innovative products and breaking through R&D barriers” is one of the founding missions of Jicang Bio. The company’s core team aims to deliver high-quality adjuvant products and provide one-stop CXO services—including drug research, development, and manufacturing—through an efficient R&D system and cost-effective production capabilities, thereby shortening clinical development cycles for enterprises and accelerating industrialization.

The company boasts a team with extensive experience in recombinant protein expression systems, along with an automated protein purification system featuring intelligent optimization of experimental conditions and advanced bacterial culture process development technologies. Furthermore, the company has established a P2 biosafety laboratory spanning over 1,500 square meters, including more than 600 square meters of cleanroom space. The facility comprises over ten specialized laboratories, such as biochemistry labs, physicochemical analysis labs, fermentation suites, purification rooms, and comprehensive testing labs, each fully equipped with professional instrumentation and equipment.

Building on this foundation, Jicang Bio has established a comprehensive biotechnology platform encompassing the entire production chain, including adjuvant raw material preparation, high-efficiency antigen design, and process development and scale-up. The company currently operates five core platforms: the Bacterial Vaccine Technology Platform, the Viral Vaccine Technology Platform, the Conjugate Vaccine Technology Platform, the Recombinant Protein Technology Platform, and the Novel Vaccine Adjuvant Technology Platform.

Supported by its core platform, the company adheres to the principles of “quality first, priority on excellence, and continuous improvement,” complies with GLP and GMP standards, and provides high-quality custom development services for recombinant proteins as well as manufacturing services for preclinical samples and Phase I/II clinical trial materials of fully controlled inactivated vaccines, live attenuated vaccines, subunit vaccines (protein-based and polysaccharide-based vaccines), combination multivalent vaccines, genetically engineered vaccines, and adjuvants, all tailored to customer requirements. These offerings can be summarized into four major solutions:

Currently, the development of vaccine adjuvants in China is progressing slowly due to limitations in technology and raw materials. Taking the RSV vaccine as an example, the AS01 adjuvant is a critical component for enhancing the immunogenicity of its antigen. AS01 is a combination adjuvant composed of MPL and QS-21. MPL activates the innate immune system via the TLR4 receptor, while QS-21 activates macrophages; their synergistic action on the innate immune system stimulates a robust immune response in the body. However, there are currently few domestic enterprises capable of independently producing the raw materials for the AS01 adjuvant, with most supplies being imported.

Jicang Bio can produce QS-21 in accordance with GMP standards, achieving sample purity of over 95% and excellent batch-to-batch consistency. This makes it an ideal raw material for novel adjuvants, reducing the reliance of domestic enterprises on imported materials. Furthermore, the company manufactures adjuvant products designed to facilitate vaccine delivery. Among these, aluminum hydroxide and aluminum phosphate adjuvants can effectively adsorb protein antigens to form precipitates and can be combined with other adjuvant types (such as MPL) to promote a balanced Th1/Th2 immune response.

Human diploid cells are currently the primary cell substrate for inactivated viral vaccines both domestically and internationally. However, their subcultivation ratio and passage number are relatively limited, which is unfavorable for large-scale cell culture. Furthermore, the prolonged culture cycle results in a lengthy development timeline, low yield, and poor stability for this class of vaccines.

Unlike traditional human diploid cell culture methods, Jicang Bio employs large-scale microcarrier culture technology in bioreactors and provides a complete set of production technologies, which can shorten the average R&D cycle for human diploid cell-based virus cultivation by three years. Taking a 100-L bioreactor as an example, the cell concentration per gram of microcarriers can reach 10×10⁸units, with each batch capable of stably producing the human diploid cell substrate required for over 100,000 doses of rabies vaccine.

Diphtheria toxin non-toxic mutant protein (CRM197) and tetanus toxoid (TT) are commonly used carrier proteins in currently approved vaccines. Compared with TT, CRM197 is non-toxic, does not require chemical detoxification agents such as formaldehyde, and can be directly purified from culture supernatants with a purity of up to 90%, making it an ideal alternative polysaccharide conjugate protein to TT.

Jicang Bio offers CRM197 protein with favorable safety and stable carrier effects. Serum bactericidal assays conducted by the company demonstrated that the seroconversion rates for all serogroups in mice immunized with its developed quadrivalent meningococcal polysaccharide conjugate vaccine (serogroups A, C, Y, and W-135; CRM197 carrier) exceeded 80%, meeting all relevant pharmacopoeial requirements. The immunogenicity of serum antibodies against serogroups A and C showed no statistically significant difference compared to existing bivalent meningococcal polysaccharide conjugate vaccines (serogroups A and C; tetanus toxoid [TT] carrier). Furthermore, no differences were observed in seroconversion rates across all serogroups when compared with other CRM197-based carriers.

Jicang Bio provides pharmaceutical companies with a comprehensive, one-stop CXO service package that includes specialized tool products for vaccine R&D, pilot-scale process optimization, sample testing, and standardized regulatory submission services. Additionally, the company offers related services such as biologics facility design, establishment of quality management systems for biologics, and GMP self-inspections.

In addition, Jicang Bio possesses service capabilities for vaccine development. Leveraging its existing core technology platforms and team strengths, the company is simultaneously expanding into the field of vaccine R&D. Dr. Yan Song, the founder, stated, “Our team does not merely provide adjuvant raw materials and clinical trial application services; rather, we aim to overcome challenges in vaccine development through our core platforms, thereby further empowering our clients with advanced technology and R&D support.”

Therefore, by leveraging its independently developed novel raw materials such as MPL, QS-21, and CRM97, Jicang Biologics is able to advance its pipeline R&D autonomously, providing clients with investigational vaccine products currently in Phase I and Phase II clinical trials.

Based on an analysis of novel, original vaccine products worldwide, the company has strategically differentiated its portfolio with seven pipeline candidates. Phase I candidates include a recombinant zoster vaccine, an ACYW135 meningococcal polysaccharide conjugate vaccine, and an RSV vaccine. Phase II candidates include a recombinant serogroup B meningococcal vaccine, a 20-valent pneumococcal conjugate vaccine, an adult tuberculosis vaccine, and an ABCWY meningococcal vaccine.

Furthermore, in line with the Company’s development trajectory, the team will flexibly adjust its product portfolio and, in due course, independently develop vaccine products and advance them through to regulatory approval and market launch.

Currently, Jicang Bio has completed the preclinical studies of its recombinant zoster vaccine and ACYW135 meningococcal polysaccharide conjugate vaccine, and is preparing to submit Investigational New Drug (IND) applications, with approval expected in 2024.

Currently, Jicang Biotech has completed an angel financing round worth tens of millions of RMB and is accelerating the research and development of adjuvant products and its pipeline. In the future, Jicang Biotech will further expand into overseas markets on the basis of advancing its domestic CXO business, promoting the global outreach of its technical services.

In the process, Jicang Biotech has been continuously building its patent moat. Currently, the company has six invention patents pending.

“Amidst the vast sea, a time will come to ride the wind and cleave the waves; I’ll set my cloud-white sail to cross the blue ocean.” Moving forward, Jicang Bio will “ride the wind and brave the mighty waves,” continuing to build a biotechnology platform with differentiated advantages. Meanwhile, it will rapidly advance its pipeline candidates, including the recombinant zoster vaccine and the ACYW135 meningococcal polysaccharide conjugate vaccine, into clinical trials, thereby further providing high-quality CXO services to global pharmaceutical companies.