)--Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced positive interim data from the Phase 2 trial of JK07 (RENEU-HF) in patients with heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF).

)--Salubris Biotherapeutics，Inc.（SalubrisBio）是一家致力于发现和开发新型复杂生物疗法的临床阶段生物技术公司，今天宣布了JK07（RENEU-HF）2期临床试验对射血分数降低（HFrEF）和射血分数保留（HFpEF）的心力衰竭患者的积极中期数据。

The objective of this pre-specified interim analysis was to assess the safety of multiple doses of JK07 at the 0.045 mg/kg dose prior to opening of the 0.09 mg/kg dose treatment arms. These interim results from the first 68 subjects randomized demonstrated a safe and tolerable profile at 0.045 mg/kg, clear and consistent target engagement with repeat administration, and positive preliminary signs of efficacy.

这项预先规定的中期分析的目的是在打开0.09 mg/kg剂量的治疗组之前，评估0.045 mg/kg剂量的多剂量JK07的安全性。随机分配的前68名受试者的这些中期结果显示，0.045 mg/kg的安全性和耐受性，重复给药的明确且一致的目标参与以及积极的初步疗效迹象。

Following the evaluation of the interim results, and in agreement with the Data Safety Monitoring Committee, the high dose of 0.09 mg/kg has opened for enrollment. JK07 is the first selective ErbB4 agonist to enter clinical development for heart failure..

在对中期结果进行评估后，并与数据安全监测委员会达成协议，0.09 mg/kg的高剂量已开放注册。JK07是第一个进入心力衰竭临床开发的选择性ErbB4激动剂。。

RENEU-HF (

雷努 HF

NCT06369298

NCT06369298

) is a randomized, double-blind, placebo-controlled, multiple-dose trial designed to evaluate the safety and efficacy of JK07 in patients with HFrEF and HFpEF. The study is expected to enroll 282 subjects who will be randomly assigned (2:1) to receive multiple doses of JK07 or placebo. The primary endpoint for HFrEF is improvement in ejection fraction, and the primary endpoint for HFpEF is safety and tolerability..

)。该研究预计将招募282名受试者，他们将被随机分配（2:1）接受多剂量的JK07或安慰剂。HFrEF的主要终点是射血分数的改善，HFpEF的主要终点是安全性和耐受性。。

As of the data cutoff, sixty-eight patients were enrolled. JK07 was safe and well tolerated with no meaningful differences in adverse event (AE) frequency and severity between active and placebo groups. Magnitude of target engagement was seen to be robust and consistent from the first to the last dose administered during the first six months of the study.

截至数据截止，共有68名患者入选。JK07安全且耐受性良好，活动组和安慰剂组之间的不良事件（AE）频率和严重程度没有显着差异。在研究的前六个月，从第一次给药到最后一次给药，目标参与的程度被认为是稳健和一致的。

Preliminary efficacy data show trends towards improvement at this early stage of the study. Primary endpoint analysis is planned to be presented in 2026..

初步疗效数据显示在研究的早期阶段有改善的趋势。。。

“We are encouraged by the safety profile and early efficacy trends from this interim analysis of RENEU-HF,” said Shalabh Singhal, Chief Medical Officer of SalubrisBio. “The data continue to suggest that JK07 has the potential to improve function and long-term outcomes in heart failure patients. We look forward to building on these promising findings and advancing a potential new treatment option that improves heart function and quality of life for heart failure patients.”.

SalubrisBio首席医疗官Shalabh Singhal说：“我们对RENEU-HF中期分析的安全性和早期疗效趋势感到鼓舞。数据继续表明，JK07有可能改善心力衰竭患者的功能和长期预后。我们期待着在这些有希望的发现的基础上，推进一种潜在的新治疗选择，以改善心力衰竭患者的心脏功能和生活质量。”。

About Heart Failure

关于心力衰竭

Heart failure affects an estimated 6.7 million Americans

据估计，670万美国人患有心力衰竭

and more than 64 million people worldwide

全世界有6400多万人

. Heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) each affect over 3 million patients in the US alone. Heart failure is a chronic condition in which patients experience progressively worsening symptoms and quality of life, hospitalizations and death.

射血分数降低的心力衰竭（HFrEF）和射血分数保留的心力衰竭（HFpEF）仅在美国就影响了300多万患者。心力衰竭是一种慢性病，患者的症状和生活质量逐渐恶化，住院和死亡。

In HFrEF, the left ventricle loses its ability to contract normally, and the heart cannot pump with sufficient force to push enough blood into circulation. In HFpEF the heart becomes stiff and loses its ability to function properly. JK07 is in development for the treatment of both HFrEF and HFpEF..

在HFrEF中，左心室失去了正常收缩的能力，心脏无法以足够的力量泵送足够的血液进入循环。在HFpEF中，心脏变得僵硬并失去正常功能。JK07正在开发用于治疗HFrEF和HFpEF。。

About JK07

关于JK07

JK07 is a recombinant antibody fusion protein consisting of an active polypeptide fragment of the human growth factor neuregulin [NRG-1] and a fully human immunoglobulin IgG1 monoclonal antibody targeting ErbB3. NRG-1 is a clinically validated growth factor that has shown promising activity in heart failure, but also undesirable side effects.

JK07是一种重组抗体融合蛋白，由人生长因子神经调节蛋白[NRG-1]的活性多肽片段和靶向ErbB3的全人免疫球蛋白IgG1单克隆抗体组成。NRG-1是一种临床验证的生长因子，在心力衰竭中显示出有希望的活性，但也有不良副作用。

Research has shown that NRG-1 induces signaling through interaction with two different receptors – ErbB3 and ErbB4. The ErbB4 pathway appears to be responsible for the regenerative effects in the heart, while the ErbB3 pathway appears primarily responsible for safety and tolerability limitations of recombinant NRG-1.

研究表明，NRG-1通过与两种不同受体ErbB3和ErbB4的相互作用诱导信号传导。。

By blocking ErbB3 signaling with an antibody fusion design, JK07 selectively stimulates the ErbB4 pathway with a favorable pharmacokinetic profile, which has the potential to significantly widen the therapeutic window of NRG-1 and yield better clinical effects..

通过用抗体融合设计阻断ErbB3信号传导，JK07选择性地刺激具有良好药代动力学特征的ErbB4途径，这有可能显着拓宽NRG-1的治疗窗口并产生更好的临床效果。。

About SalubrisBio

关于Salubrisbio

SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular disease and cancer. SalubrisBio was founded in August 2016 as a wholly-owned subsidiary of the China-based pharmaceutical company Shenzhen Salubris Pharmaceuticals Co. Ltd.

SalubrisBio是一家临床阶段生物技术公司，致力于发现和开发用于心血管疾病和癌症的复杂生物制剂。SalubrisBio成立于2016年8月，是中国制药公司深圳Salubris制药有限公司的全资子公司。

Headquartered in the US, SalubrisBio reflects Shenzhen Salubris Pharmaceuticals’ commitment to innovation and expansion into the global market and retains the core philosophy of developing therapeutics for large patient populations with significant unmet needs..

SalubrisBio总部位于美国，反映了深圳Salubris制药公司致力于创新和拓展全球市场，并保留了为大量未满足需求的患者群体开发治疗药物的核心理念。。