Drugs / JK07
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07221513 | Dec 2025 → Apr 2026 | diastolic heart failure, pulmonary hypertension, systolic heart failure | Salubris Biotherapeutics Inc | Withdrawn | No outcome recorded Stop: Business |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT05322616 Comparator | Oct 2022 → May 2023 | diastolic heart failure | Salubris Biotherapeutics Inc | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04210375 Comparator | Sep 2020 → Jun 2023 | symptomatic heart failure | Salubris Biotherapeutics Inc | Completed | No outcome recorded |
| Phase 2 | NCT06369298 Comparator | Mar 2024 → Oct 2026 expected | diastolic heart failure, symptomatic heart failure | Salubris Biotherapeutics Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-01-22 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Announces Positive Interim Data from the Phase 2 Trial of JK07 in Heart Failure salubrisbio.com ↗
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). |
| 2025-01-20 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Results 治疗慢性心衰的JK07 MRCT II期临床试验中期数据发布 salubris.com ↗
近日，信立泰宣布旗下子公司美国 Salubris Biotherapeutics, Inc. （下称“ Salubris Bio ”）自主研发的用于治疗成人慢性心力衰竭的 JK07 在 HFrEF （射血分数降低的心衰）和 HFpEF （射血分数保留的心衰）患者的 MRCT II 期临床试验中获得积极的中期数据。 |
| 2024-04-07 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Regulatory 用于治疗成人慢性心力衰竭的JK07获批境内Ⅱ期临床 salubris.com ↗
近日，信立泰宣布旗下子公司美国Salubris Biotherapeutics, Inc. 自主研发的 JK07 获得国家药品监督管理局批准，同意 JK07注射液开展治疗成人慢性心力衰竭（RENEU-HF）的Ⅱ 期临床试验。 |
| 2023-10-10 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Presents Positive 6-Month Data from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at The Heart Failure Society of America Annual Meeting 2023 salubrisbio.com ↗ |
| 2023-10-10 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Results 用于治疗慢性心衰（HFrEF）的JK07境外临床新进展 salubris.com ↗
公布JK07治疗HFrEF（射血分数降低的心衰）的美国Ib期临床试验的积极数据。 |
| 2023-05-22 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Presents Positive Updates from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at the European Society of Cardiology Heart Failure 2023 Congress salubrisbio.com ↗ |
| 2023-03-28 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Announces $35 Million Financing to Advance Development Activities and Provides Pipeline Updates salubrisbio.com ↗
Favorable Pharmacodynamic Activities Observed Across Cohorts |
| 2022-09-29 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Announces Updated Phase 1b Data Demonstrating that JK07, the First Investigational Antibody Fusion Protein for Heart Failure, Resulted in Clinically Meaningful Improvements in Ejection Fraction salubrisbio.com ↗ |
| 2022-09-19 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Results 用于治疗慢性心力衰竭的JK07临床新进展 salubris.com ↗
最新进展 近日，信立泰宣布旗下子公司美国Salubris Biotherapeutics, Inc.（下称“SalubrisBio”）自主研发的JK07（慢性心衰HFrEF适应症）获得美国Ib期临床试验中期正向的分析数据。 |
| 2022-07-27 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Regulatory 用于治疗慢性心衰的SAL007在国内获批临床 salubris.com ↗
近日，信立泰宣布，其重组人神经调节蛋白1-抗HER3抗体融合蛋白注射液（国内项目代码：SAL007）获国家药品监督管理局核准，可开展HFpEF（射血分数保留的心衰）适应症的I期临床试验。 |
| 2022-03-09 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Results 用于治疗慢性心力衰竭的JK07取得科研新突破 salubris.com ↗
I期临床第一组受试者（心衰患者）（n=5）的试验数据初步表明，与安慰剂组相比，JK07具有良好的安全性和潜在的临床获益信号，左心室射血分数绝对值相对基线最大改善达到18%（相对改善大于50%）。 |
| 2022-03-08 | Salubris Biotherapeutics Inc | Results Salubris Biotherapeutics Announces $32 Million Financing to Advance Novel Complex Biologics for Cardiovascular, Oncology, and Neurodegenerative Diseases salubrisbio.com ↗
Reports Promising Early Data from Lead Clinical Program, JK07, for the Treatment of Heart Failure with Reduced Ejection Fraction |
| 2020-09-21 | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Regulatory 信立泰慢性心衰新药SAL007在中国获批临床 salubris.com ↗
2020年9月18日，信立泰收到国家药品监督管理局核准签发的《临床试验批准通知书》，同意“重组人神经调节蛋白1-抗HER3抗体融合蛋白注射液”开展临床试验，申请适应症为：治疗射血分数降低的慢性心力衰竭（NYHA II-III类）。 |
All press releases naming this drug 14 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JK07 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04210375 ↗ |
| Action | Activate | “a selective ErbB4 agonist, JK07, in patients with heart failure with reduced ejection fraction (HFrEF).” PMID 40737710 ↗ Jul 2025 |
| Modality | Protein / enzyme biologic | “Recombinant fusion protein consisting of a fully humanized immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1” NCT04210375 ↗ |
| Route | Intravenous | “Single dose of JK07 administered by intravenous infusion over 60 minutes” NCT04210375 ↗ |
| Target | ERBB4 | “a selective ErbB4 agonist, JK07, in patients with heart failure with reduced ejection fraction (HFrEF).” PMID 40737710 ↗ Jul 2025 |