国家科技重大专项 National Key S&T Program

疟疾多价mRNA疫苗

Polyvalent mRNA Malaria Vaccine

全球首款mRNA疟疾疫苗 · 依托国家科技重大专项 · 服务全球公共卫生

World's first mRNA malaria vaccine · National Key S&T Program · Global public health impact

项目概述

Project Overview

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重大公共卫生挑战

Major Public Health Challenge

疟疾仍是全球重大公共卫生挑战,现有防控手段存在显著局限,亟需高效疫苗。每年2.49亿感染病例,超过60万人死亡,现有疫苗保护率有限。

Malaria remains a critical global health challenge. Current control measures have significant limitations, urgently requiring effective vaccines. 249M annual cases, 600K+ deaths, limited efficacy of existing vaccines.

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战略举措:独立子公司运营

Strategic Initiative: Independent Subsidiary

澄实生物拟成立项目公司,专注于疟疾mRNA疫苗的研发与商业化,独立运营以确保资源聚焦和战略灵活性。

TheraRNA plans to establish a dedicated project company focused on malaria mRNA vaccine R&D and commercialization, operating independently for strategic focus and agility.

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核心价值:社会与商业共赢

Core Value: Social & Commercial Impact

依托成熟mRNA技术平台及国家专项支持,服务全球公共卫生并创造商业回报,实现社会价值与商业价值的双重目标。

Leveraging a mature mRNA platform and national program support, serving global public health while generating commercial returns — achieving both social and business goals.

疟原虫mRNA疫苗:预防发病+阻断传播的双重作用机制

Plasmodium mRNA Vaccine: Dual Mechanism for Prevention & Transmission Blocking

01

多阶段靶向

Multi-Stage Targeting

靶向疟原虫生命周期的多个关键阶段——肝期、红细胞期和蚊体期,实现全方位免疫覆盖,突破单一靶点疫苗的局限性。

Targets multiple critical stages of the Plasmodium life cycle — liver stage, blood stage, and mosquito stage — achieving comprehensive immune coverage beyond single-target vaccine limitations.

02

阻断传播链

Transmission Blocking

通过诱导针对配子体表面抗原的抗体,阻止疟原虫在蚊体内发育,从根本上切断"人-蚊-人"传播链条。

Induces antibodies against gametocyte surface antigens, preventing Plasmodium development in mosquitoes and fundamentally breaking the human-mosquito-human transmission chain.

03

协同免疫效应

Synergistic Immune Response

多价mRNA设计同时激活体液免疫和细胞免疫,产生协同效应,显著增强疫苗保护力和持久性。

Polyvalent mRNA design simultaneously activates humoral and cellular immunity, producing synergistic effects that significantly enhance vaccine protection and durability.

04

适应复杂流行区

Adapted for Endemic Regions

针对不同流行区域的疟原虫亚型差异进行优化设计,mRNA平台的灵活性可快速响应抗原变异和抗药性演变。

Optimized design addressing Plasmodium subtype variations across endemic regions, with mRNA platform flexibility enabling rapid response to antigen drift and drug resistance evolution.

市场机遇

Market Opportunity

2.49亿
2022年全球疟疾病例
2022 Global Malaria Cases
60万+
年度死亡人数
Annual Deaths
$100亿+
2030年市场规模
2030 Market Size
2.6亿
一带一路沿线高风险人口
Belt & Road High-Risk Population

全球区域市场

Global Regional Markets

非洲

Africa

$60-80亿/年

核心市场,疾病负担最重

Core market, highest disease burden

东南亚

Southeast Asia

$15-20亿/年

快速增长,耐药问题突出

Rapid growth, drug resistance hotspot

南亚

South Asia

$8-12亿/年

人口基数大,需求持续增长

Large population, growing demand

中东/拉美/大洋洲

MENA / LatAm / Oceania

$5-10亿/年

新兴市场,增长潜力大

Emerging markets, high potential

核心技术优势

Core Technology Advantages

AI+mRNA全栈平台

AI + mRNA Full-Stack Platform

自研AI驱动的mRNA序列设计与优化系统,从抗原筛选到递送体系的全链条自主可控,保障快速迭代与成本优势。

Proprietary AI-driven mRNA sequence design and optimization system, with full-chain control from antigen screening to delivery systems, ensuring rapid iteration and cost advantages.

自研脂质递送系统

Proprietary Lipid Delivery System

自主研发的新型可电离脂质,突破专利壁垒,性能对标国际领先水平。

Novel proprietary ionizable lipids overcoming patent barriers, with performance benchmarked against global leaders.

澄实生物自研LNP
TheraRNA Proprietary LNP

自主知识产权,成本可控
热稳定性优异,适合热带地区

Own IP, cost-effective
Superior thermal stability for tropical regions

Moderna SM-102

专利保护,授权费用高昂
冷链要求严格

Patent-protected, high licensing costs
Strict cold chain requirements

冻干技术突破

Lyophilization Breakthrough

独有的mRNA冻干制剂技术,实现2-8°C稳定保存2年以上,彻底摆脱超低温冷链依赖,大幅降低疫苗在热带地区的分发成本。

Proprietary mRNA lyophilization technology enabling stable storage at 2-8°C for 2+ years, eliminating ultra-cold chain dependency and dramatically reducing distribution costs in tropical regions.

关键质量指标

Key Quality Specifications

纯度 ≥90% Purity ≥90% 粒径 80-120nm Particle Size 80-120nm 包封率 ≥90% Encapsulation ≥90% 日产能 20万份 Daily Capacity 200K doses

临床前数据

Preclinical Data

小鼠肝期感染模型预防试验

Mouse Liver-Stage Infection Prevention Study

在小鼠肝期感染模型中,mRNA疫苗候选物显著清除肝脏疟原虫,并成功诱导高水平的特异性抗体应答,为从实验室迈向临床提供了坚实的科学基础。

In the mouse liver-stage infection model, the mRNA vaccine candidate significantly cleared hepatic Plasmodium parasites and successfully induced high-level specific antibody responses, providing a solid scientific foundation for the transition from laboratory to clinical development.

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显著清除肝脏疟原虫
Significant Hepatic Parasite Clearance
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诱导特异性抗体应答
Specific Antibody Response
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坚实科学基础
Robust Scientific Foundation
重点标识HIGHLIGHT
国家科技重大专项 National Key Science & Technology Program
依托国家战略,获得最高级别科技项目支持,加速疫苗研发与产业化进程。 Backed by national strategy with top-tier S&T project support, accelerating vaccine R&D and industrialization.
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国家科技重大专项正式立项

Official National Key S&T Project Approval

获批"新发突发与重大传染病防控"科技重大专项,这是国家最高级别的科技计划体系之一,体现了国家对疟疾mRNA疫苗研发的高度重视和战略支持。

Approved under the "Prevention & Control of Emerging and Major Infectious Diseases" national program — one of the highest-level national S&T initiatives, reflecting strategic national support for mRNA malaria vaccine development.

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中检院合作

NIFDC Partnership

与中国食品药品检定研究院(中检院)建立深度合作,参与疟疾mRNA疫苗质量标准的制定,掌握行业标准话语权,为后续注册审批奠定坚实基础。

Deep collaboration with NIFDC (National Institutes for Food and Drug Control) to establish quality standards for malaria mRNA vaccines, gaining regulatory standard-setting authority and laying a solid foundation for future approvals.

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监管快通道支持

Regulatory Fast Track

国家科技重大专项背书为疫苗注册审批提供绿色通道,有望显著缩短审评审批周期,加速疫苗上市进程。

National Key S&T Program endorsement provides a regulatory green channel for vaccine approval, potentially significantly shortening review timelines and accelerating time-to-market.

开发里程碑

Development Milestones

2026.3 — 2026.8
Phase 1:抗原设计
Phase 1: Antigen Design
基于AI平台完成多价抗原组合筛选与mRNA序列优化设计,确定候选疫苗构型。
AI platform-based polyvalent antigen combination screening and mRNA sequence optimization, establishing candidate vaccine constructs.
2026.9 — 2027.2
Phase 2:概念验证
Phase 2: Proof of Concept
完成关键概念验证实验,验证疫苗候选物的免疫原性和保护效力。
Complete key proof-of-concept experiments validating immunogenicity and protective efficacy of vaccine candidates.
BD退出窗口 / BD Exit Window
2027.3 — 2027.8
Phase 3:中试工艺
Phase 3: Pilot-Scale Process
完成中试规模生产工艺开发,建立质量控制标准体系。
Complete pilot-scale manufacturing process development and establish quality control standards.
2027.9 — 2028.2
Phase 4:药理学评价
Phase 4: Pharmacological Evaluation
系统性药理学评价,包括药效学、药动学和免疫持久性研究。
Systematic pharmacological evaluation including pharmacodynamics, pharmacokinetics, and immune durability studies.
2028.3 — 2028.8
Phase 5:安全性评价
Phase 5: Safety Evaluation
GLP安全性评价,完成急性毒性、重复给药毒性等关键安全性试验。
GLP safety evaluation including acute toxicity, repeated-dose toxicity, and other key safety studies.
2028.9 — 2029.2
Phase 6:IND申报
Phase 6: IND Filing
整理全部临床前研究资料,完成IND申报并争取进入临床试验阶段。
Compile all preclinical data, file IND application, and initiate clinical trial phase.

商业模式

Commercial Model

独立子公司运营

Independent Subsidiary Operation

通过设立独立子公司进行疟疾疫苗项目的研发与商业化运营,实现风险隔离与资源聚焦,并为投资者提供清晰的退出路径。

R&D and commercialization through an independent subsidiary, achieving risk isolation and resource focus, with clear exit pathways for investors.

2000万元
20M RMB
计划融资
Planned Funding
2亿元
200M RMB
投后估值
Post-Money Valuation

投资亮点 Investment Highlights

  • 国家科技重大专项背书,显著降低研发风险National Key S&T Program backing reduces R&D risk
  • 中检院合作,掌握行业标准话语权NIFDC partnership for industry standard-setting
  • 短周期BD退出窗口(概念验证后即可启动)Short-cycle BD exit window (post proof-of-concept)
  • 轻资产出海模式,技术授权+里程碑分成Asset-light global model: tech licensing + milestone royalties
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国家重大专项背书

National Program Endorsement

最高级别国家科技支持,增强行业公信力与合作伙伴信心。

Highest-level national S&T backing, enhancing credibility and partner confidence.

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中检院合作

NIFDC Collaboration

参与质量标准制定,建立先发优势与监管护城河。

Quality standard-setting participation, establishing first-mover advantage and regulatory moat.

短周期BD

Short-Cycle BD

概念验证后即可启动BD退出,投资回收周期短。

BD exit available post proof-of-concept, shortening investment recovery cycle.

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轻资产出海

Asset-Light Globalization

技术授权+里程碑分成模式,降低海外运营风险。

Tech licensing + milestone royalty model, minimizing overseas operational risk.

携手共创全球公共卫生未来

Join Us in Shaping Global Public Health

了解更多关于疟疾mRNA疫苗项目的合作与投资机会。

Learn more about collaboration and investment opportunities in our malaria mRNA vaccine program.

联系我们Contact Us