(Source: China Swine Industry)
On May 15, Jinyu Bio-technology Co., Ltd. (hereinafter referred to as Jinyu Bio), a leading listed enterprise in China's veterinary biopharmaceutical sector, unveiled the latest progress in its research and development of African Swine Fever (ASF) vaccines. The jointly developed ASF subunit vaccine is advancing steadily in clinical trials. The second virus challenge test has verified its excellent protective efficacy, marking a major breakthrough in phased research achievements.
Recently, Jinyu Bio (600201) responded to inquiries regarding the results of the second-round virus challenge test of the ASF vaccine on an interactive platform, stating: "The second round of virus challenge test for the ASF subunit vaccine has been completed as scheduled. Unblinded data indicates the test results fully meet the evaluation criteria of this clinical trial, and the vaccine efficacy is in line with expectations. The company will subsequently finish the statistical analysis of all clinical trial data and submit an official registration application."
Protective Effect Validated from Large-scale Vaccination to Two Rounds of Virus Challenge
Highly contagious and lethal, African Swine Fever virus has long hindered the stable development of China's pig breeding industry. Safe and effective preventive vaccines represent a crucial area urgently needing breakthroughs for the sector. Since 2019, aligning with the national animal biosafety strategy, Jinyu Bio has launched a special R&D program for ASF vaccines. After seven years of continuous technological research, the company has invested nearly 600 million yuan in relevant development.
To diversify research approaches and mitigate technical risks, the enterprise has proactively established a multi-dimensional R&D system, simultaneously developing four technical routes: gene-deleted live vaccine, vector vaccine, subunit vaccine and mRNA vaccine. The subunit vaccine that achieved the phased clinical trial breakthrough is a vital outcome of the company's parallel multi-technology development strategy.
Reviewing the research and testing process, Jinyu Bio (600201) completed large-scale immunization vaccination at its first clinical trial site in October 2025, officially entering the in-vivo observation phase. In January 2026, the firm finished the first high-dose virus challenge test. The test adopted oral spraying to simulate natural infection, with an ultra-high challenge dose of 8000 HAD50, rigorously examining the vaccine's protective performance under extreme experimental conditions.
Test data showed that within the 28-day observation period, pigs in the immunized group reached qualified protection indicators. In contrast, all pigs in the non-immunized control group contracted the disease and died, registering a 100% mortality rate, which strongly confirmed the vaccine's protective effect.
The phased clinical trials of the vaccine have been successfully completed. The company will conduct systematic statistics and in-depth analysis on trial data, compile clinical trial summary reports, and submit new veterinary drug registration applications with complete documents in accordance with regulations. Pursuant to relevant veterinary drug approval rules, the vaccine has to go through statutory procedures including technical review, on-site verification of clinical trial data and production site inspection. Only after passing all reviews can it obtain the veterinary drug registration approval and be put into production and market launch.
Relevant officials of Jinyu Bio told journalists, "The entire clinical trial was carried out in strict compliance with Good Clinical Practice guidelines for veterinary drugs. We have built a sound data recording and traceability system. The clinical manifestations, physiological indicators and viral load changes of experimental pigs were monitored at multiple time points over a long period, fully ensuring the authenticity, rigor and traceability of trial data."
ASF Subunit Vaccine Suits Regular Epidemic Prevention Needs of Large-scale Pig Farms
Industry insiders stated that technically different from traditional inactivated vaccines and gene-deleted vaccines, the ASF subunit vaccine developed by Jinyu Bio contains no live virus components. It poses no biosafety risks such as virus virulence reversion and virus shedding and spread in breeding environments. The vaccine fits China's large-scale and intensive pig breeding model, striking a balance between safety and protective effectiveness fundamentally.
Furthermore, the successful 120-day immune duration test proves the vaccine's long-term protective capacity. Matching the growth cycle of pigs, it can effectively satisfy regular epidemic prevention demands of large-scale pig farms.
From the industrial perspective, China boasts a huge pig breeding market with strong rigid demand for ASF prevention, leaving a long-term supply gap for high-quality vaccines. Once approved, the vaccine will further improve domestic pig disease prevention and control systems, cut down infection risks in the breeding industry and reduce economic losses of the sector.
For the enterprise itself, this research achievement will enrich its product portfolio, strengthen core industrial competitiveness and drive medium and long-term business growth, presenting promising commercial prospects.
(Source: Cls.cn, Securities Daily, Sina Finance)