Led by an academician team, Shaanxi achieves "zero breakthrough" in self-developed vaccine production! How does Kunqin Biotech run with "new quality" in an "old track"?

Influenza Virus: A Persistent Global Health Challenge

However, the influenza vaccine coverage rate in China remains at a relatively low level. For instance, during the 2021-2022 season, the national vaccination rate was only 2.46%, far below the corresponding rate in the United States (approximately 50%). Behind this gap lie factors such as public health awareness and policy support, but it also reflects deeper issues within the vaccine supply system and industry distribution—over a long period, China's vaccine industry has exhibited an "east strong, west weak" pattern, with Beijing, Shanghai, Jiangsu, and Guangdong housing most of the country’s vaccine production capacity, while western regions have had a persistent void in the field of independent research and development of human vaccines.

In response to this structural gap, Shaanxi Kunqin Biotechnology Co., Ltd. (hereinafter referred to as "Kunqin Biotech") focuses on the mature vaccine track for engineering optimization and regional industrial repositioning.On January 31, 2026, the influenza virus split vaccine independently developed by Shaanxi Kunqin Biotechnology Co., Ltd. officially launched its Phase I clinical trial, marking a "zero breakthrough" in the field of independent research and development of human vaccines in Shaanxi Province.

Launch Ceremony Venue

KunQin Bio was established in 2021 as a technology transfer project facilitated by Academician Li Xiaofeng's team in collaboration with Weinan Industrial Investment and Shaanxi Science and Technology Control Investment Weinan Fund. Its core technology originates from Academician Li Xiaofeng of the Chinese Academy of Engineering, a national people's representative, Changjiang Scholar, and President of Wenzhou Medical University, along with his team.

In the field of recombinant protein drugs and vaccines, Academician Li Xiaokun's team has been deeply engaged for over 30 years, overcoming a series of technical challenges from basic theory to industrialization, and helping China become the world's first country to achieve the production of FGFs cell growth factors. This profound academic foundation provides a solid technical starting point for Kunqin Biotechnology in the development of human vaccines and recombinant protein drugs.

To achieve the robust transformation of scientific research results into clinical products, Kunqin Biotechnology has established a well-equipped pilot base in the modern agricultural industrial park of Weinan High-tech Zone. This base integrates process development, pilot production, testing and inspection, clinical evaluation, and preservation of bacterial and viral strains. It covers multiple fields, including fungal, viral, genetically recombinant vaccines, and cell growth factors, ensuring seamless transition from experimental research to pilot-scale production. This effectively fills the gap in the vaccine industry in Shaanxi and even Northwest China.

Relying on the scientific research platform of Wenzhou Medical University and the industrialization capability of Weinan Base, Kunqin Biotech has built a well-structured pipeline matrix. In addition to the recently entered clinical influenza vaccine, the company has also successively laid out recombinant shingles vaccine, influenza virus split vaccine (adjuvant), cell growth factor and other products. Among them, multiple products already have the conditions and capabilities from experiment to clinical trials, and are obtaining or have already obtained relevant batch number certificates.

Since its establishment, Kunqin Biotech has been focusing on the upgrading of traditional vaccines and the research and development of innovative vaccines.

The influenza virus split vaccine that has entered the clinical stage this time is an upgrade of the traditional vaccine. It adopts the mainstream second-generation split vaccine technology route both domestically and internationally, sharing the same technical origins as leading domestic companies such as Hualan Vaccine and Beijing Sinovac. It is a preventive biological product made by inoculating flu virus strains into embryonated eggs, followed by splitting, inactivation, and purification. It is suitable for preventing influenza caused by influenza virus strains.

Compared with whole-virus inactivated vaccines, the split-process can effectively remove viral nucleic acids and large molecular proteins, retaining core antigen components such as hemagglutinin (HA) and neuraminidase (NA), thereby significantly reducing adverse reactions like fever and local redness/swelling after vaccination.

Different processes require different lysis agents. KunQin Biotechnology explored various lysis agents, such as Triton X-100, Triton N-101, and Cetyltrimethylammonium Bromide (CTAB), eventually selecting the Triton X-100 lysis system. Systematic optimizations were carried out in lysis agent screening, purification procedures, and quality control. For instance, the company adopted a two-step purification process combining sucrose density gradient centrifugation with column chromatography to balance antigen purity, immunogenicity, and yield. The process is controllable, production costs are lower, vaccine safety is enhanced, and it is more suitable for large-scale vaccine manufacturing. This ensures both vaccine quality and effective population immunity.

Kunqin Biotech told VCBeat that, considering the trade-off of immunogenicity, vaccine efficacy does not solely depend on antigen purity. More crucially, it hinges on the breadth and strength of the immune response. Split vaccines contain various antigens such as HA, NA, NP, and M1, which can simultaneously induce humoral immunity and cellular immunity. Among these, the cellular immunity triggered by NP and M1 enhances cross-protection. Over-pursuing HA purity might weaken overall immunogenicity due to the absence of other critical antigens.

Therefore, the influenza virus split vaccine of Kunqin Biotechnology is developed based on the inactivated whole-virus influenza vaccine. It involves selecting appropriate splitting agents and conditions to break down the influenza virus, removing viral nucleic acids and large molecular proteins while retaining the effective antigen components HA and NA, as well as some M proteins and NP proteins. Subsequent purification processes remove the splitting agent and purify the effective antigen components. The vaccine is highly safe, contains no live pathogens, and cannot cause infection, making it suitable for individuals with weaker immune systems (e.g., children and the elderly). It also has fewer side effects, with a lower incidence of adverse reactions such as fever or localized redness and swelling compared to whole-pathogen vaccines.

Kunqin Biotech's market vision does not stop at a single product. Based on insights into unmet clinical needs, it has built a dual-driven business pipeline of "human vaccines + cell growth factors."

In the vaccine field, Kunqin Biotech is advancing simultaneously.Influenza Vaccine (Split Virion, Adjuvanted), Human Diploid Cell Rabies Vaccine, Recombinant Herpes Zoster Vaccine, Recombinant HPV VaccineAnd a series of other products.

In the field of regenerative medicine, Kunqin Biotech leverages the long-term accumulation of Li Xiaokun's team in the field of cell growth factors to establish a strategic layout.A growth factor product line for indications such as burns, trauma, chronic wounds, and diabetic complications.The company hopes to form a regenerative medicine technology platform centered on cell growth factors, which will complement its vaccine business.

This "prevention + treatment" closed-loop layout enables Kunqin Biotech to possess stronger risk resistance and long-term growth potential in the face of fierce market competition.

From "Zero Breakthrough" to "Dual-track Progress," every step taken by Kunqin Biotech has been extremely pragmatic. With the in-depth advancement of Phase I clinical trials, this rising star in Northwest China's biopharmaceutical industry is expected to inject more certainty into China's biopharmaceutical sector.

References:

[1] [First Release] Kunqin Biotech Completes Tens of Millions in Financing, Exclusively Invested by Shaanxi Venture Capital

[2] Project Dynamics | Clinical Trials of Kunqin Biotech's Vaccine Product Officially Launched, Driving "Zero Breakthrough" in Human Vaccine Independent R&D in Shaanxi