Recently, Salubris has announced phase progress in two of its independently developed innovative biologic drugs, JK07 and JK06, according to a notice received from its U.S. subsidiary, Salubris Biotherapeutics, Inc. [1].
JK07 Clinical Trial Progress[1]
JK07 (recombinant human neuregulin-1 (NRG-1) - anti-HER3 antibody fusion protein injection) is an independently developed NRG-1 fusion antibody drug with global intellectual property rights. It is a pioneering antibody fusion protein and selective ErbB4 agonist in the field of heart failure.
1. Chronic Heart Failure Indication
JK07 is currently undergoing a Multicenter, Randomized Controlled Trial (MRCT) Phase II clinical trial (RENEU-HF) for patients with HFrEF (heart failure with reduced ejection fraction) and HFpEF (heart failure with preserved ejection fraction). Currently, patient enrollment for the HFrEF cohort has been fully completed, and top-line data for the primary endpoint is expected in the first half of 2026. Patient enrollment for the HFpEF cohort is proceeding smoothly, with overall progress meeting expectations.
The Phase II clinical trial (RENEU-HF) for JK07 is a randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and efficacy of JK07 in patients with HFrEF and HFpEF.
2. cpcPH Indication
Based on JK07's potential to target both myocardial dysfunction and the pulmonary vasculature, its clinical trial application for pulmonary hypertension due to left heart disease (RENEU-PH) has been approved by the FDA, and a Phase IIa clinical study has been initiated.
The Phase IIa clinical trial (RENEU-PH) for JK07 is an open-label, multiple-dose studies designed to evaluate the safety, efficacy, and tolerability of JK07 in patients with combined pre- and post-capillary Group 2 pulmonary hypertension (cpcPH) due to left heart disease.
Chronic pulmonary hypertension (PH) due to left heart disease represents a significant complication in patients with HF. Epidemiologic studies suggest that up to 50% of patients with HFrEF or HFpEF exhibit some degree of PH, and cpcPH is associated with markedly worse outcomes, including increased hospitalizations and mortality[2][3].
· JK06 Clinical Trial Progress[1]
JK06 is a biparatopic antibody drug conjugate (ADC) selectively targeting the 5T4 antigen. Its intended indications include solid tumors such as lung cancer and breast cancer. It is currently undergoing a Phase I clinical trial in Europe, with a dose expansion phase study to follow. Preliminary data from the Phase I clinical trial of JK06 are scheduled to be presented at the European Society for Medical Oncology (ESMO) Congress in October 2025.
The ongoing Phase I, open-label, dose-escalation and expansion study of JK06 is designed to evaluate its safety, pharmacokinetics, and preliminary efficacy in a cohort of patients with solid tumors known to express the protein 5T4.
· Regarding Heart Failure[2]
"Heart failure is the end-stage of various cardiac diseases, characterized by features such as high prevalence and high mortality rates. It has become a significant public health problem impacting public health. Based on the left ventricular ejection fraction (LVEF) level measured by echocardiography during the initial assessment, heart failure is classified into three basic types: heart failure with reduced ejection fraction (HFrEF, LVEF ≤40%), heart failure with mildly reduced ejection fraction (HFmrEF, 40% < LVEF < 50%), and heart failure with preserved ejection fraction (HFpEF, LVEF ≥50%)."
· Regarding cpcPH[4]
"cpcPH (Combined Post- and Pre-capillary Pulmonary Hypertension) is a specific subtype of pulmonary hypertension (PH), primarily associated with left heart disease. Its core feature involves the simultaneous presence of elevated post-capillary pressures (originating from left heart disease) and pre-capillary pulmonary vascular pathology, leading to a significant increase in pulmonary vascular resistance. It is considered an important marker of poor clinical outcomes in heart failure patients. Currently, there are no targeted therapeutic methods specifically approved for cpcPH."
· Regarding 5T4[5]
"5T4 is an oncofetal protein with restricted expression in normal adult tissues. However, it demonstrates a high expression rate in various solid tumors such as lung cancer, breast cancer, renal carcinoma, and genitourinary cancers, and is closely associated with poor prognosis and tumor progression.
The upregulation of 5T4 expression plays a significant role in tumor heterogeneity, invasion, and metastasis, making it an ideal target in the field of tumor immunotherapy."
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on Overseas Clinical Trial Progress of JK07 and JK06.
[2] National Center for Cardiovascular Diseases, et al. National Heart Failure Guidelines 2023 (Abridged Edition). Chinese Journal of Heart Failure and Cardiomyopathy, 2023, 7(3): 145-178.
[3] Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension (2021 Edition).
[4] Lu M, Wang B, Rong C, et al. Therapeutic challenges and new therapeutic targets for combined capillary pulmonary hypertension: a review [J]. Frontiers in Medicine, 2025, 12(000).
[5] Stern P. Immunotherapies Targeting a Tumor-Associated Antigen 5T4 Oncofetal Glycoprotein [J]. Cancer Immunology, 2020.
Disclaimer:
1. This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
2. The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
| About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.
