Media Spotlight | Analysis of Biopharmaceutical Industry Trends in the 15th Five-Year Plan Period: The Intersection of Cutting-Edge Antiserum Technologies and China’s Capabilities

Source: Health Circle

 

When algorithms reign AI Applications, the third energy revolution toward carbon neutrality, biosafety, and the secure supply of critical resources and industrial resilience have all been incorporated into the strategic defense frameworks of countries worldwide, underscoring that the significance of technology now transcends the boundaries of any single domain. At the outset of the 15th Five-Year Plan period and 2026 In the Government Work Report, a proposition that is both more closely aligned with people’s livelihoods and equally robust is being frequently emphasized: “Safeguarding national biosafety and enhancing core industrial competitiveness.”

 

Strategic deployments for biosafety defense are being comprehensively upgraded across multiple countries.

 

Amid the complex and intertwined global biosafety risks, many countries and international organizations are elevating “public health protection” to a higher priority.

 

Domestically, the 15th Five-Year Plan calls for strengthening national security capabilities in key areas and emphasizes “enhancing security capabilities in emerging fields such as biotechnology”; the Third Plenary Session of the 20th CPC Central Committee has made strategic arrangements for “improving the regulatory, early-warning, and prevention-and-control system for biosafety.” ^[1] It is worth noting that, 2026 For the first time, the Government Work Report has included “biopharmaceuticals.”   Designated as an “emerging pillar industry.”

 

Overseas, the United States is stepping up its long-term strategic deployment for biosafety through a combination of short- and medium-term measures, as outlined in the Department of Defense’s “Biodefense Posture Assessment” ( Biodefense Posture Review ) Clearly states, “Assessment to” 2035 “The overall bio-defense strategic posture for the year” ^[2] ; the United Kingdom announced an investment of approximately 10 £1 billion is being invested in the construction of a National Biosafety Centre, with substantial funding and close collaboration with a high-level biosafety laboratory network, to enhance preparedness and response capabilities against biological threats and pandemics. ^[3] 。

 

Figure: The UK announces an investment of approximately 10 £1 Billion to Build National Biosafety Centre ^[3]

 

On the international organizational front, the European Union has committed resources on the order of one billion euros to advance the European Commission’s Health Emergency Preparedness and Response Agency ( The European Health Emergency Preparedness and Response Authority, HERA ) , and 2025 In [year], the “EU Strategy for Health Countermeasures” was issued ( Medical Countermeasures Strategy ) Elevate medical countermeasures to the strategic level, with comprehensive coverage spanning the entire pharmaceutical lifecycle, including emergency critical medicines in the reserves. ^[4] 。2025 year 5 month 20 On [date], the World Health Organization ( WHO ) The Pandemic Agreement ( The Pandemic Agreement ) Received the ...th 78 Adopted at the World Health Assembly, it strengthens global capacity to respond to pandemics, bridges gaps in global equity in pandemic prevention and control, and launches the Access and Benefit-Sharing regime for pathogens. PABS ) ^[5] 。

 

In summary, biosafety is evolving from a public health issue into a matter of national security and industrial competitiveness. Countries and international organizations are increasingly recognizing that isolated, single-point breakthroughs are often “lone and weak,” and that it is platform-level, systemized capabilities that truly determine the effectiveness of defense. The so-called “platform war” essentially extends countermeasures from “R&D capabilities” to end-to-end delivery capabilities spanning manufacturing, stockpiling, allocation, and supply accessibility.

 

As international organizations promote resource sharing and countries accelerate the upgrading of their capabilities across the entire lifecycle of biopharmaceuticals, the global biosafety defense architecture is increasingly focused on “rapidly developing scalable countermeasures in the face of complex pathogens—such as viral variants or bacteria that secrete multiple exotoxins—and evolving environmental conditions.” Consequently, “emergency response” has evolved from ad hoc, temporary measures into a sustainable, system-wide undertaking.

 

Under the systemic engineering upgrade of the emergency response platform   Polyclonal Antibody Technology Remains Highly Effective

 

At present, newly emerging and sudden infectious diseases worldwide have not yet subsided, with clear trends of cross-species transmission, regional spread, and cumulative mutations. According to data from Frost & Sullivan, by SARS-CoV-2 Caused by a virus COVID-19 Having a profound impact worldwide, as of 2025 year 2 Its global death toll has exceeded 700 Ten thousand, with the cumulative number of confirmed cases exceeding 7 hundred million ^[6] ; and COVID-19 Influenza, which shares similar modes of transmission, also exhibits high morbidity and mortality rates, with approximately ... cases reported worldwide each year. 10 One hundred million cases of seasonal influenza, among which nearly 500 Ten thousand cases are severe. ^[6] . After WHO Antimicrobial resistance, listed as one of the top ten global public health threats ( Antimicrobial resistance ， AMR ) Predicted to be obtained 2050 Will Become the “Leading Cause of Death Worldwide” ^[7] ，2021 Approximately the number of deaths worldwide caused by antimicrobial resistance each year is 114 Ten thousand ^[6] Affected by global climate change and the spread of invasive mosquito species, chikungunya fever and dengue fever—once regarded as “exclusively tropical diseases”—are now exhibiting a trend of geographic expansion. According to publicly available surveillance data, as of 2025 year 9 By the end of the month, more than 44.5 Ten Thousand Cases of Chikungunya Fever ^[8] , United Kingdom 2025 Record Number of Imported Cases in First Half of Year ^[9] , during which multiple provinces and municipalities across China were affected. ^[10] 。

 

“The unknown and the uncertain” have become the new normal. Even more concerning is that, in resource-constrained settings, preventable and treatable threats continue to result in avoidable severe illness, disability, or death due to inadequate access and affordability. Consequently, countries and international organizations are placing greater emphasis on upgrading biosafety defense research to encompass “large-scale replication.” + Building platform-level capabilities for “accessibility of supply.”

 

Against this backdrop, polyclonal antibody technology has emerged as one of the key capability modules under the “Global Biosecurity Defense” platform-level strategy. Compared with evolution... 50 Years of monoclonal antibody technology have already emerged in more than 130 Polyclonal antibodies have broad application advantages in global biomedical research and disease diagnosis and treatment.

 

Polyclonal antibodies possess a comprehensive “defense system,” consisting of multiple antibody molecules that recognize different epitopes on pathogens, thereby inherently exhibiting unique properties for combating infectious diseases. When confronting complex pathogens, the multi-target binding properties of polyclonal antibodies confer exceptional robustness. Even if a pathogen undergoes a localized mutation that renders a particular epitope nonfunctional, other antibodies within the polyclonal repertoire can still maintain overall neutralizing efficacy, effectively circumventing the “immune escape” phenomenon commonly observed with monoclonal antibodies. ^[11] Furthermore, polyclonal antibodies can significantly enhance complement activation by forming large immune complexes ( Complement Activation ) and regulatory phagocytosis ( Opsonization ), thereby enhancing the overall efficiency of the organism in clearing pathogens. This synergistic effect ( Synergism ) This enables polyclonal antibodies to achieve deeper neutralization and broader protective coverage than monoclonal antibodies in the context of highly virulent infectious diseases and complex pathogens. ^[11] 。

 

Cutting-Edge Practices in Polyclonal Antibody Engineering from a Global Biosecurity Perspective

 

Overseas, polyclonal antibody technology for horses and other large animals has been elevated to the level of a national biosecurity strategy. The U.S. Defense Advanced Research Projects Agency ( DARPA ) Pandemic Prevention Platform ( P3 ) Project Proposal 60 Responding to the goal of the heavens ^[12] , the project emphasizes the use of nucleic acid technology to induce transient immunity in the body ( Transient Immunity ), and as a reserve strategy, a highly mature animal polyclonal antibody platform is key to achieving rapid, large-scale antibody supply. ^[13]

 

The most representative business case is SAB Biotherapeutics Developed DiversitAb™ The platform leverages transgenic technology by knocking out endogenous antibody genes in animals and introducing human antibody gene clusters, thereby generating transgenic animals (such as TcBovine , transchromosomic cattle) have become “biological factories” for the production of fully humanized polyclonal antibodies. ^[14] . This technological approach has been employed in responding to Ebola and Middle East Respiratory Syndrome ( MERS ) and COVID-19 In clinical trials, it demonstrated higher neutralizing titers and a faster response compared with human convalescent plasma. ^[15] 。

 

Antiserum, as a representative of polyclonal antibodies, constitutes the most quintessential “emergency technological platform” in immune defense. Its technical advantage lies in its ability to bind to multiple targets and structural epitopes on pathogens, thereby exhibiting enhanced neutralizing capacity and resistance to immune evasion. In the context of emerging and frequently mutating infectious diseases, antiserum can swiftly assume the role of “rapid defense.” In SARS-CoV-2 During the pandemic, convalescent plasma therapy—a form of antiserum therapy—was incorporated into clinical treatment protocols and used for emergency treatment of critically ill patients. ^[6]  

 

It is worth noting that antiserum itself is undergoing a clear path of modernization. In fact, the birth and evolution of antiserum have been almost synchronous with the development of modern immunology. Since 1890 Year Emil von Behring ( Emil von Behring Since Shibasaburo Kitasato’s discovery that immune animal serum could neutralize diphtheria and tetanus toxins, antiserum has ushered in an era in which this “life-saving drug” has become humanity’s principal weapon against virulent infectious diseases. This technological journey spanning more than a century can be clearly divided into four pivotal stages of development, each marked by a qualitative leap in both safety and efficacy.

 

Table: Overview of the Evolution of Antiserum Technology

 

In the early days, antiserum was mostly “crude serum,” which, although capable of saving lives, often contained heterologous protein impurities that could trigger serum sickness and allergic reactions. ^[16] With the advancement of biochemical technologies, 20 In the mid-20th century, a second phase emerged, centered on “gastric enzyme digestion and ammonium sulfate precipitation.” Gastric enzyme digestion was used to remove the highly immunogenic components from antibody molecules. Fc Fragments that retain biological activity F(ab') ₂ fragment, which has greatly enhanced the safety and tolerability of the drug. This technological breakthrough has made tetanus antitoxin ( TAT ) and antivenom serum have been widely adopted in primary healthcare. ^[16]

 

Enter 21 In the 20th century, with the maturation of chromatographic techniques such as ion-exchange chromatography and affinity chromatography, the production of antiserum entered the era of “highly purified, specific antibodies.”   Phase Three. Modern manufacturing processes can reduce heterologous protein impurities to extremely low levels, thereby fundamentally enhancing the purity and specific activity of the formulation. ^[14]

 

In the current and future fourth phase, the antiserum technology roadmap is transitioning toward “humanization” and “genetic engineering.” Using transgenic horse and cattle platforms, researchers are working to produce fully human polyclonal antibodies that contain no heterologous sequences. This approach not only preserves the inherent broad-spectrum advantages of polyclonal antibodies but also completely overcomes the immunogenicity bottleneck caused by heterologous proteins. ^[14] 。

 

China’s “Global Strength” in Antiserum: Antiserum Technology Fortifies the Defensive Barrier

 

At “speed” - Broad-spectrum - Cost - Under the four-dimensional emergency-defense constraints of “accessibility,” polyclonal antibody systems—with antiserum as their representative—offer a platform-level solution: leveraging multi-target, broad-spectrum engagement to address uncertainty; employing end-to-end industrial-chain support to enable large-scale production and thereby shorten response times; and enhancing safety and accessibility through standardized manufacturing processes and robust quality-system development. Meanwhile, with advances in cutting-edge approaches such as humanization, codification, and recombinant engineering, this “time-honored tool” of antiserum is being reimagined and reengineered by modern bioengineering, evolving from an emergency life-saving agent into a strategic technological cornerstone for national biosafety.

 

For China, the comparative advantage of therapeutic serum lies not in a handful of isolated technological breakthroughs, but rather in its systematic capabilities: upstream, it has established a robust organizational foundation anchored in large-animal resources and an advanced immunization system; midstream, it has developed integrated manufacturing capabilities spanning immunization, plasma collection, purification, and formulation; and downstream, driven by emergency demand, it has continuously strengthened reserve management and supply-chain efficiency. Frost & Sullivan notes that Chinese antiserum manufacturers, exemplified by Jiangxi Institute of Biological Products Co., Ltd. (referred to as “Jiangxi Bio”), have amassed extensive expertise in the field of equine-derived polyclonal antibodies, enjoying cost advantages and large-scale, standardized production capabilities. ^[11] Moreover, Chinese manufacturers of antiserums boast product quality and production efficiency that are highly conducive to international market penetration. As global countermeasures shift from R&D to supply-chain resilience, such end-to-end capabilities are increasingly poised to serve as a “hard core” within national biopharmaceutical strategies. It is worth noting that Jiangxi Bio is one of the few anti-serum manufacturers in China—and indeed worldwide—to achieve full-industry coverage, and is currently the only company globally that uses recombinant proteins, mRNA Companies that develop serum-free antigens for the production of antisera are at the forefront of quality enhancement and technological advancement in the antisera industry.

 

As a quintessential resource- and technology-intensive industry, the antiserum sector places extremely high demands on raw-material supply security, platform capabilities, and industrial synergy, thereby giving China a certain first-mover advantage in the development of a national-level biosafety emergency response and reserve system. ^[11] From the perspective of emergency response scenarios, antiserum, as a quintessential polyclonal antibody preparation, remains most mature and best suited for emergency use in the neutralization and treatment of biological toxins, as well as in passive immunization following exposure to certain high-risk pathogens with high fatality rates (such as tetanus and rabies). A common characteristic of these applications is a narrow therapeutic time window, high case-fatality rates, and the urgent need for rapid access to effective treatment strategies.

 

Meanwhile, as emerging and sudden-onset infectious diseases overlap with the growing risk of antimicrobial resistance, the “platform-based expansion” of antiserums is opening up broader possibilities: on the one hand, in the face of threats posed by novel and emergent pathogen infections, broad-spectrum neutralization and robustness against viral variants provide mechanistic advantages for “early foundational deployment”; on the other hand, in the case of respiratory syncytial virus ( Respiratory Syncytial Virus ）、 AMR In the realm of complex infectious diseases, research and development efforts are also advancing in areas such as multi-target immune modulation and neutralization of virulence factors. Looking further ahead, studies on antiserums for immunomodulation and inflammation-related indications—such as organ transplantation, rheumatoid arthritis, and systemic lupus erythematosus—and their translational applications may emerge as a potential bridge between “emergency” and “chronic” disease management.

 

Conclusion

 

At the juncture of the start of the 15th Five-Year Plan and a global reassessment of biosafety capabilities, biological defense is shifting from “single-technology sprint” to “platform-capability competition.”   With Polyclonal technologies, exemplified by antiserum, are characterized by multi-target broad-spectrum activity, scalability, and the ability to be stockpiled and allocated as needed, enabling rapid — Cost — Under accessibility constraints, it provides a platform-level solution and continuously enhances security and consistency along the path of modernization, thereby serving as a reliable strategic foundation for upgrading public health safety defenses in increasingly complex and uncertain risk environments.

 

Data source:

[1] People's Daily Online .  Improving the National Biosafety Regulatory Early Warning and Prevention System . 2025.04.18.  http://theory.people.com.cn/n1/2025/0418/c40531-40462843.html . 

[2] U.S. Department of Defense. 2023 Biodefense Posture Review. https://media.defense.gov/2023/Aug/17/2003282337/-1/-1/1/2023_biodefense_posture_review.pdf . 

[3] GOV.UK. Greater security delivered for the British people with record billion-pound investment in new national biosecurity centre. 2025.06.24. https://www.gov.uk/government/news/greater-security-delivered-for-the-british-people-with-record-billion-pound-investment-in-new-national-biosecurity-centre . 

[4] European Commission. EU Stockpiling and Medical Countermeasures Strategies to strengthen crisis readiness and health security. 2025.07.09. https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1728 .

[5] World Health Organization. World Health Assembly adopts historic Pandemic Agreement to make the world more equitable and safer from future pandemics. 2025.05.20. https://www.who.int/news/item/20-05-2025-world-health-assembly-adopts-historic-pandemic-agreement-to-make-the-world-more-equitable-and-safer-from-future-pandemics . 

[6] Frost & Sullivan .  Global Antiserum Market Research . 2025.

[7] Tang KWK, Millar BC, Moore JE. Antimicrobial Resistance (AMR). Br J Biomed Sci. 2023 Jun 28;80:11387. doi: 10.3389/bjbs.2023.11387. PMID: 37448857; PMCID: PMC10336207.

[8] World Health Organization. Chikungunya virus disease—Global situation. 2025.10.03. https://www.who.int/emergencies/disease-outbreak-news/item/2025-DON581 . 

[9] The Paper .  Climate warming is driving the northward spread of chikungunya, and most of Europe now meets the conditions for transmission. . 2026.02.19.  https://www.thepaper.cn/newsDetail_forward_32632079 . 

[10] CCTV.com .  Chikungunya Outbreak Spreads Globally; Climate Warming Fuels the Spread of Tropical Mosquito-Borne Infectious Diseases . 2025.07.30.  https://news.cctv.cn/2025/07/30/ARTIrqzW4Abg63Lgal1FTIY2250730.shtml .

[11] Frost & Sullivan .  The supply–demand gap in the antiserum market is widening, with product diversification and expansion of indications emerging as the primary drivers. . 2025.8.13.  https://mp.weixin.qq.com/s/lyv9oulfXcu_gIODIAniVA .

[12] Duke Human Vaccine Institute. Duke DARPA Pandemic Prevention Platform (P3). https://dhvi.duke.edu/programs-and-centers/pandemic-preparedness/duke-darpa-pandemic-prevention-platform-p3 .

[13] DARPA. Pandemic Prevention Platform (P3) – DARPA. https://www.darpa.mil/research/programs/pandemic-prevention-platform .

[14] SAB BIO. SAB Biotherapeutics Awarded $27M Contract to Develop Novel Rapid Response Capability for U.S. Department of Defense. March 31, 2020. https://www.sab.bio/2020/03/31/sab-biotherapeutics-awarded-27m-contract-to-develop-novel-rapid-response-capability-for-u-s-department-of-defense/ .

[15] SAB BIO. SAB Biotherapeutics’ Pharm Groundbreaking Highlights Broad Impact. 2017.10.05. https://www.sab.bio/2017/10/05/post-13/ .

[16] Wikipedia .  Polyclonal antibody .  https://en.wikipedia.org/wiki/Multi-knockout_organism