Product Pipeline

产品管线

Advancing mRNA therapeutics across human and animal health

推进mRNA疗法在人类和动物健康领域的发展

Pipeline Overview

管线概览

Shelf Cancer Vaccine 货架肿瘤疫苗
临床前
S. aureus mRNA Vaccine 金葡菌mRNA疫苗
临床前
Enterobacteriaceae Vaccine 肠杆菌科疫苗
临床前
Malaria Polyvalent Vaccine 疟疾多价疫苗
临床前
Pet Cancer Vaccine 宠物肿瘤疫苗
商业化
Livestock Vaccines 禽猪反刍疫苗
IIT临床
IND/备案
PRECLINICAL

Off-the-shelf Cancer Vaccine

货架肿瘤疫苗

Indication
适应症
Shared Neoantigen
共享新生抗原
Stage
阶段
Preclinical
临床前
Partner
合作单位
Cancer Hospital, CAMS
Patient Coverage
患者覆盖率
20-40% per indication每个适应症

Key Features

关键特性

  • Regulatory path: NMPA biotherapeutic drug监管路线:作为治疗性生物制品向药监局申报
  • Estimated patient cost: ~¥20,000 per treatment预估终端费用:~¥20,000/人
  • Addresses significant cancer immunotherapy gap填补肿瘤免疫治疗空白
More experimental data coming soon 更多实验数据即将更新
PRECLINICAL

S. aureus mRNA Vaccine

金黄色葡萄球菌mRNA疫苗

Partner
合作单位
Renji Hospital, Shanghai
BD Interest
BD意向
Sanofi / MSD
China Market Size
中国市场规模
>¥1 Billion
Clinical Potential
临床潜力
Prevention + Treatment

Disease Burden & Market Opportunity

疾病负担与市场机会

13.7M
Bacterial infection deaths/year
细菌感染年死亡数 (2022)
#2
Leading infectious cause of death
全球第二大死因
8M+
Orthopedic surgeries/year (China)
中国年骨科手术数
Key Gap: No S. aureus vaccine currently approved globally. Traditional vaccines (e.g., Merck's V710) have failed due to immune imprinting. 关键空白:全球尚无获批上市的金葡菌疫苗。传统疫苗(如Merck V710)因免疫印迹问题而失败。

Innovation: Dual-Function mRNA Platform

创新:攻防兼备的mRNA疫苗

World's first dual-function mRNA vaccine: Prevention + Treatment 全球首创"攻防兼备"预防+治疗双效mRNA疫苗
Reverse Vaccinology Approach
反向疫苗学设计
Predicted novel protective antigens from 2,700 S. aureus genes using bioinformatics. Identified conserved epitopes across clinical isolates.
从2700个金葡菌基因中利用生物信息学预测全新保护抗原,鉴定临床分离株之间的保守表位。
Comprehensive Immune Response
综合免疫应答
Incorporates both humoral (antibody) and cellular (T-cell) immunity antigens. Overcomes limitations of single-epitope approaches.
包含体液免疫和细胞免疫抗原,克服单表位方法的局限性。
Immune Imprinting Solution
免疫印迹突破
mRNA vaccine platform is NOT affected by previous S. aureus exposure - solves the fundamental problem that caused Merck V710 Phase III failure.
mRNA疫苗不受既往金葡菌暴露影响 - 解决导致Merck V710 III期失败的根本问题。

Experiment 1: MRSA Prevention in Mice

实验1:小鼠MRSA预防模型

Study Design
研究设计
Model: Intraperitoneal MRSA infection
Groups: 3 mRNA vaccine designs vs PBS control
Schedule: Day 0 (prime) → Day 21 (boost) → Day 35 (challenge)
Assessment: Bacterial burden in blood, peritoneal fluid, spleen
模型:小鼠腹腔MRSA感染
分组:3种mRNA疫苗设计 vs PBS对照
免疫:D0初免 → D21加强 → D35攻毒
检测:血液、腹腔液、脾脏载菌量
3
Vaccine formulations tested
疫苗设计版本
100%
Protection rate (vaccinated)
疫苗接种组保护率
10-100x
Bacterial load reduction
载菌量降低倍数
Result: All three vaccine-immunized groups showed significantly reduced bacterial burden in blood, peritoneal fluid, and spleen compared to PBS controls. Multi-organ protection confirmed. 结果:所有疫苗免疫组血液、腹腔液、脾脏载菌量均显著低于PBS对照组。多器官保护得到证实。

Experiment 2: Overcoming Immune Imprinting

实验2:免疫印迹突破

The Immune Imprinting Problem
免疫印迹问题背景
Previous exposure to S. aureus creates "immune imprinting" - the immune system fails to mount effective response to new vaccine antigens. This is why Merck V710 failed in Phase III (patients with prior S. aureus exposure showed no benefit).
既往金葡菌暴露会产生"免疫印迹"现象 - 免疫系统对新疫苗抗原无法产生有效应答。这是Merck V710 III期失败的原因(曾暴露于金葡菌的患者无获益)。
Study Design
研究设计
Pre-sensitization: Day -28, -21, -14: sub-lethal MRSA infection to establish immune imprinting
Vaccination: Day 0, 21 (after pre-sensitization established)
Challenge: Day 35: lethal MRSA dose
Comparison: Pre-sensitized vaccine group (M) vs non-sensitized vaccine group (O)
预感染:D-28、-21、-14:亚致死低剂量感染建立免疫印迹
疫苗接种:D0、21(预感染后)
攻毒:D35:致死剂量MRSA
对比:预感染疫苗组(M) vs 未预感染疫苗组(O)
3
Pre-challenge exposures
预感染次数
M vs O
Comparison groups
对比分组
No Difference
Protection rate
保护率相同
Critical Finding: Pre-sensitized vaccine group (M) showed NO SIGNIFICANT DIFFERENCE in protection compared to non-sensitized vaccine group (O). mRNA vaccine efficacy is NOT diminished by prior S. aureus exposure. This proves the vaccine overcomes immune imprinting - solving the V710 problem. 关键发现:预感染疫苗组(M)与未预感染疫苗组(O)的保护效果无显著差异。mRNA疫苗不受既往金葡菌暴露影响。这证明疫苗解决了免疫印迹问题 - 破解V710失败原因。

Experiment 3: Chronic Osteomyelitis (Biofilm Penetration)

实验3:慢性骨髓炎模型(生物膜穿透)

Clinical Significance
临床意义
Chronic osteomyelitis is called "the cancer of orthopedics" - S. aureus forms biofilms in bone that are resistant to antibiotics. This is one of the most challenging infection types to treat.
慢性骨髓炎被称为"骨科的癌症" - 金葡菌在骨内形成生物膜,对抗生素耐受。这是最具挑战性的感染类型之一。
Study Design
研究设计
Model: Chronic bone marrow infection with biofilm
Treatment arms: mRNA vaccine vs Vancomycin (gold-standard antibiotic)
Mechanism: Evaluate immune cell infiltration and biofilm clearance
Outcome: Bacterial clearance and bone healing
模型:慢性骨髓炎生物膜感染
治疗组:mRNA疫苗 vs 万古霉素(金标准抗生素)
机制:评估免疫细胞浸润和生物膜清除
结果:细菌清除和骨愈合
2
Treatment arms
治疗分组
100%
Immune infiltration (vaccine)
免疫浸润率
Complete
Bacterial eradication
细菌清除
Result: mRNA vaccine-immunized animals showed complete immune cell infiltration into bone marrow and complete S. aureus eradication despite biofilm presence. This suggests vaccines can treat established infections - a major advantage over antibiotics alone. 结果:疫苗免疫组免疫细胞可完全浸润骨髓,彻底清除金葡菌。这表明mRNA疫苗可治疗已建立的感染 - 相比单纯抗生素具有重大优势。

Experiment 4: Pig Field Trial (Head-to-Head vs Antibiotics)

实验4:病猪临床试验(与抗生素头对头对比)

Translational Study
转化研究
Large animal model to evaluate vaccine efficacy in naturally infected animals with therapeutic potential assessment.
大动物模型评估自然感染动物中疫苗疗效和治疗潜力。
Study Parameters
研究参数
Vaccine group: 6 diseased pigs
Control group: 5 diseased pigs treated with conventional antibiotics + Chinese medicine
Vaccination: 50 μg/pig/dose, intramuscular (neck), Days 0/4/7/14/28
Assessment: Clinical symptoms, recovery timeline, treatment efficacy
疫苗组:6头病猪
对照组:5头病猪(抗生素+中药治疗)
免疫方案:50μg/头/次,颈部肌注,D0/4/7/14/28
评估:临床症状、恢复时间、疗效
6 vs 5
Vaccine vs antibiotic pigs
疫苗组vs对照组
5 doses
Immunization schedule
免疫次数
7-10 days
Therapeutic onset (vaccine)
疗效出现时间
Result: Vaccine-treated pigs demonstrated significant clinical improvement by days 7-10, with symptom improvement trajectory trending MORE FAVORABLY than the antibiotic-treated control group. This demonstrates therapeutic efficacy in naturally infected large animals. 结果:疫苗组病猪在第7-10天显示显著临床改善,症状改善趋势比抗生素对照组更明显。证明了自然感染大动物中的治疗效果。

Competitive Landscape

竞争格局

Candidate Phase Status 候选药物 阶段 状态
Merck V710 Phase III Failed (2010) III期 失败(2010)
LBT-SA07 (Lyons) Phase I Ongoing I期 进行中
SA4Ag (Merck) Preclinical Terminated 临床前 终止
GSK SA5Ag Phase III Active III期 进行中
rFSAV (Nuo) Phase III Active III期 进行中
TheraRNA S. aureus mRNA Preclinical Dual function 澄实金葡mRNA 临床前 预防+治疗
Competitive Advantage: TheraRNA's dual prevention/treatment platform with immune imprinting resistance differentiates from traditional protein vaccines that have failed or show limited efficacy in pre-sensitized populations. 竞争优势:澄实的预防/治疗双效平台具有免疫印迹耐受性,不同于已失败或在预感染人群中疗效有限的传统蛋白疫苗。
PRECLINICAL

Enterobacteriaceae mRNA Vaccine

肠杆菌科mRNA疫苗

Indication
适应症
E. coli & K. pneumoniae
Publication
发表
NPJ Vaccines (Nature)
Partners
合作单位
301 Hospital, Guangzhou 5th Hospital
BD Interest
BD意向
Xiamen Wantai
BD Value
BD价值
>$500M USD

Key Features

关键特性

  • Targets both E. coli and Klebsiella pneumoniae同时靶向大肠杆菌和肺炎克雷伯菌
  • Published in NPJ Vaccines (Nature sub-journal)在NPJ Vaccines (Nature子刊)发表
  • Major Gram-negative pathogens in nosocomial infections医院获得性感染的主要革兰氏阴性病原体
  • Significant partnership interest from vaccine industry获得疫苗行业的重大合作兴趣
Detailed experimental data coming soon 详细实验数据即将更新
PRECLINICAL

Malaria Polyvalent mRNA Vaccine

疟疾多价mRNA疫苗

Funding Status
资助状态
National Major S&T Project
Program
专项计划
Prevention & Control of Major Infectious Diseases
新发突发与重大传染病防控
Partner
合作单位
Nanjing Medical University
Global Status
全球地位
First mRNA malaria vaccine
全球首款mRNA疟疾疫苗

Clinical Significance

临床意义

  • Supported by national science and technology major project funding获批国家科技重大专项支持
  • Addresses persistent global health challenge affecting 249M people/year应对全球每年2.49亿患者的健康挑战
  • Polyvalent approach targets multiple Plasmodium species多价方法靶向多种疟原虫
  • mRNA platform enables rapid response to drug-resistant strainsmRNA平台可快速应对抗药性菌株
More experimental data coming soon 更多实验数据即将更新
COMMERCIALIZATION

Pet Cancer Vaccine

宠物肿瘤疫苗

Indication
适应症
Canine & Feline Tumors
Stage
阶段
Commercial Launch
Market Size
市场规模
¥38 Billion
Unit Price
终端价格
¥2,500 per dose

Pet Oncology Market

宠物肿瘤市场

  • Large and growing pet oncology market with high customer lifetime value大型且增长的宠物肿瘤市场,客户终身价值高
  • Pet owners increasingly willing to pursue advanced treatments宠物主人越来越愿意追求先进治疗
  • Faster regulatory pathway compared to human therapeutics相比人用疗法具有更快的监管审批
  • Enables translation of clinical data for human cancer vaccine development为人用肿瘤疫苗开发提供临床数据转化
More commercial data coming soon 更多商业数据即将更新
PRECLINICAL

Non-Surgical Sterilization & Toxoplasmosis Vaccine

绝育/弓形虫疫苗

Indication
适应症
Non-surgical sterilization + Toxoplasmosis prevention/treatment
非手术绝育+弓形虫预防/治疗
Combined Market
市场规模
¥158 Billion
Sterilization Market
绝育市场
¥2.8 Billion
Toxoplasmosis Market
弓形虫市场
¥13 Billion
Partner
合作单位
China Agricultural University
More experimental data coming soon 更多实验数据即将更新
CLINICAL & PRECLINICAL

Livestock Vaccine Matrix

禽猪反刍疫苗矩阵

Development Cost Advantage
开发成本优势
1/3 of traditional approach
传统技术路线的1/3
Individual Product Cost
单个产品成本
¥3-7 Million
Total Portfolio Value
组合市场规模
>¥50 Billion

Product Portfolio

产品组合

Product Indication Stage Market Size Partner 产品 适应症 阶段 市场规模 合作单位
Parrot Psittacosis Prevention/Treatment Field Trial ¥20M Liuhe Dachang 鹦鹉衣原热 预防/治疗 田间试验 ¥0.2亿 六合大昌
Swine Influenza Prevention IND filing Jun 2026 ¥350M Huawei Special 猪流感 预防 临床批件申报2026.06 ¥3.5亿 华威特
Foot & Mouth Disease Prevention IND filing Sep 2026 ¥400M Vaccine Control Center 口蹄疫 预防 临床批件申报2026.09 ¥4.0亿 疫控中心
Bovine Mycoplasma Prevention/Treatment Animal challenge ¥100M Ningxia University 牛支原体 预防/治疗 本动物攻毒 ¥1.0亿 宁夏大学
Salmonella Prevention/Treatment IND filing Jun 2026 ¥130M Jiangxi Grains 沙门氏菌 预防/治疗 临床批件申报2026.06 ¥1.3亿 江西粮油
Chicken Synovitis Mycoplasma Prevention/Treatment IND filing Jun 2026 ¥130M Jiangxi Grains 鸡滑囊支原体 预防/治疗 临床批件申报2026.06 ¥1.3亿 江西粮油
Chicken Septic Mycoplasma Prevention/Treatment Model animal study ¥130M 鸡败血支原体 预防/治疗 模式动物 ¥1.3亿
African Swine Fever Prevention Antigen design ¥1.5B Nanjing Agricultural U. 非洲猪瘟 预防 抗原设计 ¥15.0亿 南京农大
Toxoplasmosis Prevention/Treatment Animal challenge ¥700M China Agricultural U. 弓形虫 预防/治疗 本动物攻毒 ¥7.0亿 中国农大

Development Economics

开发经济学

¥3-7M
Per product R&D cost
单个产品研发成本
66%
Cost reduction vs traditional
相比传统方法成本削减
9
Active products
活跃产品数
Key Advantage: mRNA platform enables rapid, cost-effective vaccine development. Single product R&D cost of ¥3-7M is approximately 1/3 of traditional vaccine development costs (¥10-20M), creating significant economic value across the livestock portfolio. 关键优势:mRNA平台实现快速、经济高效的疫苗开发。单个产品研发成本¥3-7M约为传统疫苗开发成本(¥10-20M)的1/3,为禽畜疫苗组合创造重大经济价值。