Overview

1. Introduction

2. Major Stakeholder Engagement

2.1 Researcher
2.2 Industry Experts
2.3 Public & Patients

3. The impact of our project

3.1 SDG 3: Good Health and Well-being
3.2 SDG 8: Decent Work and Economic Growth
3.3 SDG 9: Industry, Innovation and Infrastructure
3.4 SDG 15: Life on Land

4. long-term impact and monitoring

4.1 Regulations of GMOs and Biopharmaceuticals in China
4.2 Assessment Methods
4.3 Goals
4.4 Implementation Phases
4.5 Possible Barriers and Strategies

Reference

Overview

Allergic diseases affect millions of people worldwide, reducing quality of life and increasing healthcare burdens. Current allergen immunotherapy (AIT) treatments often carry risks of severe allergic reactions due to the strong IgE-binding activity of natural allergens. To address this challenge, our project focuses on designing hypoallergenic protein vaccines by engineering recombinant allergens with reduced IgE reactivity while preserving T-cell immunogenicity. This approach enhances safety, efficacy, and accessibility of AIT, reducing treatment time and improving patient compliance.

Our solution aligns with several Sustainable Development Goals (SDGs): SDG 3 (Good Health and Well-being) by providing safer allergy therapies, SDG 8 (Decent Work and Economic Growth) through potential biopharmaceutical innovation and new therapeutic markets, SDG 9 (Industry, Innovation and Infrastructure) by advancing biotechnology-based healthcare solutions, and SDG 15 (Life on Land) by reducing reliance on animal-derived allergens and supporting biodiversity protection.

To strengthen the sustainability and societal impact of our project, we have engaged with diverse stakeholders including clinicians, pharmaceutical researchers, and biotech investors. These collaborations have provided critical insights into patient needs, regulatory challenges, and commercialization pathways. By integrating scientific innovation with real-world perspectives, we aim to develop a scalable, safe, and sustainable hypoallergenic protein vaccine platform that can benefit patients globally.

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Figure 1 Overview of SDG Icons

Stakeholder/Activity

Institution

Interaction/Feedback

SDGs

Questionnaire Survey (Public, Patients, Product)

Public participants (806 responses)

Found low awareness of allergy management (35.4% didn’t know how to respond to reactions). 71.3% demand more effective treatments, 39.3% want more convenient ones. High prevalence (75.8% reported personal or close allergies). Guided focus on painless, effective microneedle vaccines and educational outreach.

SDG 3 (Health), SDG9 (Innovation), SDG 15 (Life on Land)

Interview with Dr. Chen (Allergy Expert)

Nanshan People’s Hospital, Shenzhen

Confirmed rising allergy burden in China, limitations of traditional desensitization therapy. Emphasized lack of public knowledge and need for innovative, safer approaches. Inspired educational activities (comic books, campus activities, lectures)

SDG 3 (Health), SDG 4 (Quality Education)

Street Interviews

WanXiangHui Mall

Engaged public with quizzes & Q&A. Identified misconceptions (68% underestimated peanut allergy lethality). Collected data on triggers and cost expectations. Increased awareness of synthetic biology’s role in safer allergy treatments.

SDG 3 (Health), SDG 9 (Innovation)

Interview with Dr. Lu (Pharmacist Expert)

Clinical Pharmacy, Hubei University graduate

Provided insights into allergen vaccine approvals in China, highlighted feasibility of microneedles (painlessness, convenience). Recommended materials (HA, PLGA, chitosan). Linked HA use to eco-friendly impact.

SDG 3 (Health), SDG 15 (Life on Land)

Interview with Dr. Huang (Microneedle Expert)

Zhejiang Pharmaceutical Co., Ltd.

Explained microneedle safety, usage, and limitations. Highlighted contribution to SDG 3 through safer, less invasive therapy. Guided focus on safety education and patient compliance.

SDG 3 (Health), SDG 9 (Innovation)

Interview with Dr. Zhang (Pharma Investment Expert)

Haifa Baocheng Financial Leasing Co., Ltd.

Confirmed microneedle therapy’s strong market potential (painless, cold-chain reduction, pediatric/geriatric use). Shared investor criteria (40% technology, 30% market, 30% team). Helped refine commercialization strategy.

SDG 8 (Economic Growth), SDG 9 (Innovation)

Interview with Mr. Suzuki (Japan Expert)

Japan Pharma Market

Highlighted unmet allergy needs (dust mite, hay fever, pet). Emphasized regulatory barriers, need for local data, and regional commercialization strategies. Recommended focusing on China/US as entry markets.

SDG 3 (Health), SDG 8 (Economic Growth), SDG 9 (Innovation)

Field Visit to Creative Sciences Co. (Mr. Lv)

Kangliming Biotechnology Co., Ltd.

Learned about R&D → clinical trial process, stability/performance testing, and pricing strategies. Advised academic engagement (conferences, competitions) for product recognition.

SDG 9 (Innovation), SDG 8 (Economic Growth)

1. Introduction

Our group employed genetic engineering and nanotechnology to develop a long-acting, bivalent allergy microneedle targeting pollen seafood, and dust allergies (two allergens from the same category). By engineering hypoallergenic variants of key allergens, including modified pollen proteins (mPhlp1, mBetv1), dust proteins (mDerp1, mDerp2),and seafood proteins(mMet e1, mCyp c1), we constructed recombinant plasmids for expression in Escherichia coli Origami DE3, followed by protein purification and characterization. To enhance therapeutic efficacy, we further fused allergens within the same category (e.g., pollen or dust) using flexible peptide linkers and tested their reduced IgE-binding affinity. This dual-target approach addresses critical gaps in allergen immunotherapy (AIT), such as limited allergen variety within specific allergy groups, long treatment duration, and safety concerns, while enabling simultaneous desensitization to two allergens from the same category. We actively engaged with clinicians, allergy patients, and biotech experts throughout the project to align our design with real-world needs.

2. Major Stakeholder Engagement

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Figure 2 Major Srajeholder Mind Map

2.1 Researcher

Dr. Siqing Chen

• Institution: Nanshan People’s Hospital, Shenzhen

• Field: Allergy & Clinical Medicine

• Contribution: Confirmed the increasing allergy burden in China, and the limitations of traditional desensitization therapies.

• Suggestions and Conclusions: Emphasized the lack of public knowledge and the urgent need for safer, innovative approaches. Inspired educational activities such as comic books, campus events, and lectures.

• Relative SDGs: SDG 3 (Good Health and Well-being), SDG 4 (Quality Education)

Dr. Lu

• Institution: Clinical Pharmacy, Hubei University graduate

• Field: Pharmacology & Allergen Vaccines

• Contribution: Shared insights into allergen vaccine approvals in China, as well as the feasibility of microneedle therapy.

• Suggestions and Conclusions: Recommended using HA, PLGA, and chitosan as microneedle materials. Linked HA use to eco-friendly impacts. Confirmed microneedles’ advantage in painless, convenient delivery.

• Relative SDGs: SDG 3 (Good Health and Well-being), SDG 15 (Life on Land)

Dr. Huang

• Institution: Zhejiang Pharmaceutical Co., Ltd.

• Field: Microneedle Technology

• Contribution: Provided technical insights into microneedle safety, usage, and limitations.

• Suggestions and Conclusions: Stressed patient safety and compliance, guiding our focus on educating the public on correct microneedle use.

• Relative SDGs: SDG 3 (Good Health and Well-being), SDG 9 (Industry, Innovation and Infrastructure)

2.2 Industry Experts

Dr. Zhang

• Institution: Haifa Baocheng Financial Leasing Co., Ltd.

• Field: Pharmaceutical Investment

• Contribution: Assessed microneedle therapy’s market potential and investment feasibility.

• Suggestions and Conclusions: Confirmed advantages such as painless delivery, reduced cold-chain costs, and suitability for children and elderly. Shared investor evaluation criteria (40% technology, 30% market, 30% team). Helped refine commercialization strategy.

• Relative SDGs: SDG 8 (Decent Work and Economic Growth), SDG 9 (Industry, Innovation and Infrastructure)

Mr. Suzuki

• Institution: Japan Pharma Market Expert

• Field: International Regulation & Commercialization

• Contribution: Explained allergy therapy needs in Japan and highlighted regional differences in market demand.

• Suggestions and Conclusions: Pointed out regulatory barriers and emphasized the need for local data. Recommended Japan/US as potential entry markets.

• Relative SDGs: SDG 3 (Good Health and Well-being), SDG 8 (Decent Work and Economic Growth), SDG 9 (Industry, Innovation and Infrastructure)

Mr. Lv

• Institution: Kangliming Biotechnology Co., Ltd.

• Field: Biotechnology R&D and Commercialization

• Contribution: Explained the R&D → clinical trial process, testing standards, and product pricing strategies.

• Suggestions and Conclusions: Advised us to participate in academic conferences and competitions to improve recognition and credibility.

• Relative SDGs: SDG 9 (Industry, Innovation and Infrastructure), SDG 8 (Decent Work and Economic Growth)

2.3 Public & Patients

Questionnaire Survey (806 participants)

  • Institution: General Public (patients, parents, citizens)
  • Field: Public Health Feedback
  • Contribution: Collected data on allergy awareness, treatment demand, and patient experiences.
  • Suggestions and Conclusions: Revealed low awareness (35.4% didn’t know how to respond to allergic reactions). Identified strong demand for more effective (71.3%) and more convenient (39.3%) treatments. Guided us toward painless, effective microneedle vaccines and education campaigns.
  • Relative SDGs: SDG 3 (Good Health and Well-being), SDG 9 (Industry, Innovation and Infrastructure), SDG 15 (Life on Land)

Street Interviews

  • Institution: WanXiangHui Mall, Shenzhen
  • Field: Public Awareness & Education
  • Contribution: Collected public opinions via quizzes and Q&A. Raised awareness of allergy risks.
  • Suggestions and Conclusions: Identified major misconceptions (68% underestimated peanut allergy lethality). Helped us design more effective educational activities.
  • Relative SDGs: SDG 3 (Good Health and Well-being), SDG 9 (Industry, Innovation and Infrastructure)

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Figure 3 Photos of Street Interview

3. The impact of our project
3.1 SDG 3: Good Health and Well-being

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Figure 4 SDG 3

3.1.1 SDG 3.4 – Reduce premature mortality from NCDs

Our hypoallergenic bivalent vaccine directly aligns with SDG 3.4 by addressing the global burden of chronic respiratory allergies, which are non-communicable diseases (NCDs) that affect up to 40% of the global population. By consolidating treatment for two common aeroallergens (dust mites and pollen) into a single microneedle-based vaccine, we simplify therapy, lower patient burden, and reduce risks of severe complications like asthma attacks. This improves life expectancy, reduces mental health stressors (anxiety, social isolation), and enhances overall well-being.

3.1.2 SDG 3.8 – Achieve universal health coverage

Our microneedle allergy vaccine supports SDG 3.8 by making healthcare more affordable and accessible. Conventional allergen immunotherapy requires 3–5 years of repeated injections, imposing heavy time and financial costs. In contrast, our biodegradable microneedle patch delivers a safe, pain-free, and self-administrable solution. With simplified manufacturing and lower delivery costs, the vaccine is designed to reach underserved regions. Collaboration with healthcare providers and governments will further integrate it into public health programs, moving closer to universal health coverage.

3.1.3 SDG 3.b – Support research and access to vaccines and medicines

Our project pioneers an innovative microneedle-based AIT platform, advancing SDG 3.b by strengthening biomedical research and expanding access to modern therapies. Designed for equitable distribution, the vaccine enables home-based, pain-free administration, reducing reliance on clinical infrastructure. By integrating recombinant allergen design with biodegradable microneedle technology, we demonstrate scalable innovation that bridges global gaps in allergy treatment and reduces the healthcare burden, especially in developing regions.

3.2 SDG 8: Decent Work and Economic Growth

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Pictue 5 SDG 8

3.2.1 SDG 8.2 – Economic productivity through innovation

Our bivalent allergy vaccine introduces high-value biotechnological innovation, contributing to SDG 8.2. By improving patient productivity through better allergy control, the vaccine alleviates economic losses from absenteeism and reduced workforce performance. At the industrial level, microneedle vaccine production stimulates job creation in biopharmaceutical R&D, manufacturing, and clinical services, driving sustainable growth in health-tech sectors.

3.2.2 SDG 8.5 – Full and productive employment, equal opportunities

Allergic diseases disproportionately affect young professionals, and people with chronic conditions, reducing their ability to participate fully in the workforce. By reducing allergy-related health barriers, our vaccine promotes more equitable access to employment opportunities. The biotechnological field also provides new jobs for unemployed graduates, women in STEM, and professionals with biosynthesis expertise, strengthening inclusive economic growth.

Interview groups:

1. Young professionals with chronic allergies → documenting career barriers.

2. Workers in allergy-prone environments (e.g., seafood, agriculture).

4. Occupational health experts assessing productivity impacts of allergies.

3.2.3 SDG 8.8 – Protect labour rights and safe working environments

Our product reduces allergy triggers in occupational environments (e.g., pollen, dust, seafood proteins), ensuring safer working conditions. By minimizing allergic reactions, the vaccine protects vulnerable groups like migrant workers, seasonal agricultural laborers, and individuals in high-risk industries, contributing to fair and safe workplaces.

Short-term impact (Shenzhen & Dongguan): Estimated 5,400 microneedles supplied annually; ~3,500 workers benefit.

Mid-term (China-wide): Supply expanded 30×; broader adoption with government partnerships.

Long-term (Global): Distribution in allergy-prevalent countries (e.g., Japan, Australia), scaling worker health protection worldwide.

3.3 SDG 9: Industry, Innovation and Infrastructure

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Figure 6 SDG 9

3.3.1 SDG 9.3 – Financial access for MSMEs & integration into markets

Our project enhances the biotechnology sector by promoting novel allergen-specific vaccines via microneedle delivery. The technology integrates genetic recombination and biodegradable hydrogel microneedles, creating opportunities for small- and medium-sized enterprises (SMEs) to join global value chains in healthcare and biopharma.

3.3.2 SDG 9.5 – Strengthen scientific research

Through advanced allergen engineering and microneedle development, our project expands scientific knowledge in immunotherapy. Investment in this innovation boosts local R&D capabilities, enabling sustainable industrial upgrading and positioning our region as a hub for biomedical research.

3.3.3 SDG 9.b – Sustainable industrialization and technology transfer

By establishing localized microneedle production lines and sharing recombinant allergen design techniques, our project supports the transfer of green biotechnology to developing countries. This promotes cost-effective healthcare access, enhances resilience of medical supply chains, and drives eco-friendly industrialization in global health.

3.4 SDG 15: Life on Land

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Figure 7 SDG 15

3.4.1 SDG 15.1 – Protect and restore terrestrial ecosystems

Our project indirectly supports SDG 15.1 by reducing reliance on animal-derived allergens, which traditionally involve resource-intensive extraction from mites or pollens. Recombinant hypoallergenic proteins minimize ecological disruption and preserve biodiversity. By adopting biodegradable microneedle materials, we also reduce biomedical waste, ensuring a more sustainable health system.

4. long-term impact and monitoring

We prioritize both the health and societal benefits of our project. Therefore, it is essential to consider medical, regulatory, and social factors to ensure a lasting and meaningful impact.

4.1 Regulations of GMOs and Biopharmaceuticals in China

Our hypoallergenic protein vaccine project follows Chinese biosecurity regulations, pharmaceutical approval processes, and international frameworks for vaccine development, aligning with the SDGs for public health and sustainable innovation.

The approval process for genetically engineered vaccines in China is governed by the Biosecurity Law, the Drug Administration Law, and the Regulations for the Administration of Human Genetic Resources. Clinical translation involves three main phases: preclinical research, clinical trials (Phases I–III), and final market approval by the National Medical Products Administration (NMPA).

At each stage, vaccine safety, immunogenicity, stability, and risk of allergenicity will be carefully assessed. Only after receiving safety and efficacy approval can the product enter clinical use, supported by labeling transparency and strict pharmacovigilance requirements.

4.2 Assessment Methods

To ensure safety, effectiveness, and sustainability, we have established long-term evaluation methods over the next five years. Assessments will be performed quarterly, annually, and at milestone endpoints:

• Efficacy testing: Monitoring immune responses in model systems and later in clinical trials, with special focus on IgE-binding reduction and T-cell response retention.

• Safety testing: Regular allergenicity assays, toxicity tests, and stability analysis to confirm hypoallergenic properties.

• Regulatory compliance: Adherence to Chinese NMPA guidelines, WHO vaccine safety frameworks, and global Good Manufacturing Practices (GMP).

• Environmental and social monitoring: Evaluating how production aligns with China’s green biotech policies and measuring patient accessibility and affordability.

4.3 Goals

• Short term (Year 1): Complete lab-scale protein engineering and validation of reduced allergenicity. Begin preclinical safety and immunogenicity testing.

• Medium term (Years 2–3): Scale up protein expression and purification in bioreactors, initiate early-phase clinical trials, and apply for regulatory approval for clinical use. Establish collaborations with biotech firms and hospitals.

• Long term (Years 4–5): Achieve regulatory approval for clinical use in allergy treatment and prevention. Ensure large-scale vaccine production, transparent labeling, and equitable distribution to patients. Ultimately, reduce allergy incidence and improve public health outcomes globally.

4.4 Implementation Phases

1. Development Phase: Engineer and validate the hypoallergenic protein, ensuring retained immunogenicity and reduced IgE reactivity.

2. Preclinical Phase: Conduct animal studies and in vitro tests to confirm efficacy and safety.

3. Regulatory Phase: Submit applications to the NMPA and undergo the multi-stage safety evaluation process.

4. Clinical Phase: Carry out Phase I–III clinical trials in hospitals and allergy research centers.

5. Industrial Rollout Phase: Scale up vaccine production under GMP conditions, implement monitoring programs, and distribute to healthcare providers nationwide and globally.

4.5 Possible Barriers and Strategies

• Technical challenges: Optimizing protein expression and ensuring stability during storage. Strategy: Partner with research institutes and leverage advanced protein engineering platforms.

• Financial constraints: High costs of clinical trials and production. Strategy: Seek funding from government biotech innovation programs and international health organizations.

• Public acceptance: Concerns about GMOs and new vaccines. Strategy: Implement transparent labeling, public education campaigns, and collaborations with medical associations to build trust.

• Regulatory hurdles: Long approval timelines. Strategy: Maintain continuous dialogue with NMPA and align development with international vaccine safety standards.

Reference
  1. United Nations Sustainable Development, United Nations, www.un.org/sustainabledevelopment/. Accessed July 2025.
  2. “Industry, Innovation and Infrastructure - United Nations Sustainable Development.” United Nations, United Nations, www.un.org/sustainabledevelopment/infrastructure-industrialization/. Accessed July 2025.
  3. “Resources.” World Allergy Organization, WAO, 28 Aug. 2025, www.worldallergy.org/resources#medical-journal-reviews.