May 5, 2025 – TenNor’s new drug for H. pylori infection, Rifasutenizol (TNP-2198) made its debut at Digestive Disease Week (DDW) 2025 in San Diego, USA. A conference abstract titled “The Efficacy and Safety of Rifasutenizole (TNP-2198) Based Triple Regimen as First-Line Therapy For Helicobacter pylori Infection: A Multicenter, Double-Blind, Randomized, Controlled, Phase 3 Trial”, submitted by Professor Zhou Liya and Professor Song Zhiqiang from Peking University Third Hospital, along with Professor Wang Weihong from Peking University First Hospital, was selected for presentation at the Distinguished Abstract Plenary Session..

2025年5月5日，TenNor公司针对幽门螺杆菌感染的新药利福苏特尼唑（TNP-2198）在美国圣地亚哥举行的2025年消化疾病周（DDW）上首次亮相。由北京大学第三医院周丽雅教授和宋志强教授，以及北京大学第一医院王蔚虹教授提交的题为“基于利福苏特尼唑（TNP-2198）三联疗法作为幽门螺杆菌感染一线治疗的有效性与安全性：一项多中心、双盲、随机、对照的III期试验”的会议摘要入选并在杰出摘要全体会议上进行展示。

Rifasutenizol is the first new drug specifically developed for Helicobacter pylori (H. pylori) infection in 40 years since its discovery. It possesses a unique multi-targeting synergistic mechanism of action, exerting antibacterial activity by inhibiting bacterial RNA polymerase and generating reactive species by nitroreductase.

利法舒特尼唑是自幽门螺杆菌（H. pylori）发现以来，40年间首个专门针对幽门螺杆菌感染开发的新药。它具有独特的多靶点协同作用机制，通过抑制细菌RNA聚合酶发挥抗菌活性，并通过硝基还原酶生成反应性物种。

Rifasutenizol demonstrates potent antibacterial activity against Hp clinical isolates (including drug-resistant strains) and exhibits an extremely low frequency for spontaneous resistance mutation (<10⁻¹¹). In early-stage clinical development, a rifasutenizol-based triple therapy (RTT) showed excellent efficacy for H.

利福苏特尼唑对幽门螺杆菌临床分离株（包括耐药菌株）表现出强效的抗菌活性，并且自发耐药突变的频率极低（<10⁻¹¹）。在早期临床开发中，基于利福苏特尼唑的三联疗法（RTT）显示出对幽门螺杆菌感染的卓越疗效。

pylori eradication, and identified as a promising first-line treatment for Hp infection..

幽门螺杆菌根除，并被确定为Hp感染的有希望的一线治疗方案。

Professor Song Zhiqiang, on behalf of all investigators, presented the key findings from a randomized, double-blind, bismuth-quadruple therapy (BCTT) controlled phase III trial (EVEREST-HP). conducted in 40 centers in China. The trial screened 1,267 patients, with 700 successfully randomized. The H.

宋志强教授代表所有研究人员，报告了一项随机、双盲、铋剂四联疗法（BCTT）对照的III期试验（EVEREST-HP）的关键结果。该试验在中国的40个中心进行，筛选了1267名患者，其中700名成功随机分组。

pylori culture success rate was 83.1%. Antimicrobial susceptibility testing revealed resistance rates of 40.8% for clarithromycin, 68.2% for metronidazole, 35.1% for levofloxacin, and 8.1% for amoxicillin. Alarmingly, 85.1% of these clinical isolates were resistant to at least one guideline-recommended antibiotic, and 46.3% were multidrug resistance (MDR), underscoring the urgent need for new antimicrobial agent for Hp infection.

幽门螺杆菌培养成功率为83.1%。抗菌药物敏感性测试显示，克拉霉素的耐药率为40.8%，甲硝唑为68.2%，左氧氟沙星为35.1%，阿莫西林为8.1%。令人担忧的是，85.1%的这些临床分离株对至少一种指南推荐的抗生素耐药，46.3%为多重耐药（MDR），突显了对幽门螺杆菌感染开发新抗菌药物的迫切需求。

All clinical isolates remained susceptible to rifasutenizol..

所有临床分离株对利福苏特尼唑仍然敏感。

In the modified intention-to-treat (mITT) analysis, the eradication rates were 92.0% (RTT) vs. 87.9% (BCTT), difference of 4.2% (95% CI: -0.3% to 8.3%, P for non-inferiority <0.0001), confirming RTT’s non-inferiority to BCTT. The advantage of RTT was more pronounced in antibiotic-resistant subgroup analyses, particularly in MDR populations, where eradication rates were 89.9% (RTT) vs.

在改良意向治疗（mITT）分析中，根除率分别为92.0%（RTT）和87.9%（BCTT），差异为4.2%（95% CI：-0.3%至8.3%，非劣效性P值<0.0001），证实了RTT与BCTT相比的非劣效性。RTT的优势在抗生素耐药亚组分析中更为明显，特别是在多重耐药（MDR）人群中，根除率分别为89.9%（RTT）和

81.2% (BCTT), difference of 8.7% (95% CI: 0.1% to 17.1%, P for superiority = 0.023). The incidence of treatment-emergent adverse events (TEAEs) was lower in the RTT group (37.3% vs. 53.2%), with most being mild to moderate and no serious adverse events (SAEs) reported..

81.2%（BCTT），差异为8.7%（95% CI：0.1% 至 17.1%，优效性 P 值 = 0.023）。治疗中出现的不良事件（TEAEs）发生率在 RTT 组较低（37.3% 对 53.2%），大多数为轻度至中度，且未报告严重不良事件（SAEs）。

H. pylori infection, affecting around half of the world population, causes chronic gastritis, which can further progress to severe gastroduodenal pathologies, including peptic ulcer, gastric cancer (GC), and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infected individuals have a 2 to 6-fold higher risk of GC.

幽门螺杆菌感染影响全球约一半人口，引发慢性胃炎，还可能进一步发展为严重的胃肠疾病，包括消化性溃疡、胃癌（GC）以及黏膜相关淋巴组织（MALT）淋巴瘤。感染幽门螺杆菌的人群患胃癌的风险高出2至6倍。

The causal relationships of H. pylori infection to GC have been demonstrated by studies conducted in the first-degree relatives or in high-risk regions of GC. The incidence rates of GC decreased by 14%~72% during 9~26 years of follow up after H. pylori eradication. H. pylori infection appeared to be a more important risk factor for GC than the germline pathogenic variants in cancer-predisposing genes.

幽门螺杆菌感染与胃癌之间的因果关系已通过在胃癌一级亲属或高风险地区进行的研究得到证实。在根除幽门螺杆菌后的9至26年随访期间，胃癌的发病率降低了14%~72%。幽门螺杆菌感染似乎比癌症易感基因中的种系致病变异更为重要的胃癌风险因素。

In China, H. pylori was associated with the highest disease burden among 85 leading pathogens, causing 7.21 million disability-adjusted life-years (DALYs) in 2019. A study estimated that up to 35.5% of the 10 million new GC cases projected to occur between 2021 and 2035 in China could be avoided by implementing H.

在中国，幽门螺杆菌在85种主要病原体中与最高的疾病负担相关，2019年导致了721万伤残调整生命年（DALYs）。一项研究估计，在2021年至2035年间中国预计发生的1000万例新发胃癌病例中，通过实施H策略，可避免高达35.5%的病例。

pylori screening-eradication strategies..

幽门螺杆菌筛查-根除策略。。

Digestive Disease Week (DDW) is the world’s premier GI conference, co-hosted by the American Association for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), and Society for Surgery of the Alimentary Tract (SSAT)..

消化疾病周（DDW）是全球顶尖的胃肠病学会议，由美国肝病研究协会（AASLD）、美国胃肠病学协会（AGA）、美国胃肠内镜学会（ASGE）和消化道外科学会（SSAT）共同主办。

About TenNor Therapeutics

关于TenNor Therapeutics

TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products in diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development pipeline with global IP protection.

十年诺制药是一家临床阶段的公司，专注于发现和开发针对细菌感染和代谢相关疾病的差异化新药产品。十年诺拥有独特的多靶点药物偶联技术平台，以及具有全球知识产权保护的强大新药研发管线。

Several products are currently in late stage of clinical development or marketing application stage, targeting H. pylori infection, implanted medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. .

目前有几个产品处于临床开发后期或上市申请阶段，针对幽门螺杆菌感染、植入式医疗器械感染、肝性脑病和腹泻型肠易激综合征。该公司致力于满足这一疾病领域的未满足需求，为中国乃至全球患者提供安全有效的治疗方案。

For more information, please visit:

欲了解更多信息，请访问：

www.tennorx.com

www.tennorx.com