VyBio Therapeutics Announces U.S. FDA IND Approval for VB19055, a Highly Selective ASI for Uncontrolled Hypertension

HANGZHOU, China, Mar, 16, 2026 - VyBio Therapeutics (Zhejiang Yangli Pharmaceutical Technology Co., Ltd.), a clinical-stage biopharmaceutical company developing breakthrough therapies for cardiovascular, metabolic, and oncology diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application (IND: 180881) for VB19055, VyBio’s highly selective aldosterone synthase inhibitor, for the treatment of uncontrolled hypertension. This IND approval represents VyBio’s first innovative drug candidate entering clinical development stage in the United States, marking a pivotal milestone in the company's strategy to deliver novel therapeutic options to patients worldwide.

VB19055 is an orally available, small-molecule innovative drug candidate wholly owned by VyBio with best-in-class potential. It is designed to potently and selectively inhibit aldosterone synthase, the enzyme central to aldosterone production. By directly targeting this core pathological driver, VB19055 aims to reduce systemic aldosterone levels, addressing a key factor in hypertension pathogenesis. This mechanism is expected to effectively lower blood pressure and mitigate the chronic cardiac and renal damage associated with aldosterone dysregulation, offering a promising therapeutic approach for patients with uncontrolled hypertension, including those with treatment-resistant forms of the disease.

The Phase I clinical trial for VB19055 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy subjects. This study is designed to systematically evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of VB19055, laying the critical foundation for its subsequent global clinical development program. Following this milestone, VyBio plans to accelerate its global development of VB19055 for hypertension and related cardio-renal metabolic diseases.

"The FDA's approval of our IND for VB19055 is a significant achievementforVyBio.Itshowsourteam's development capabilities in innovative drugs and ambition to bring the innovative drugs to global" said Dr. Zhaozhong Ding, Founder and Chairman of VyBio. "As our first innovative candidate entering clinical development stage in US, VB19055 will address a substantial unmet need in the global hypertension landscape. Supported by its unique selectivity and compelling preclinical data, we are confident that VB19055 has the potential to emerge as a novel, targeted therapy for patients worldwide. We are committed to accelerating its clinical development to bring the new treatment to patients as fast as possible."

About VyBio Therapeutics

VyBio Therapeutics is an innovative biopharmaceutical company focused on two core therapeutic areas: cardiometabolic diseases and oncology. The company has built a fully integrated, in-house R&D platforms spanning from discovery to clinical development. VyBio's pipeline includes multiple drug candidates currently in Phase II/III clinical trials. Leveraging its world-class R&D engine, VyBio is advancing towards becoming a top-tier biopharmaceutical company with global innovation capabilities.

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of applicable securities laws. These statements include, but are not limited to, statements regarding the company's drug development plans, clinical trial activities, potential therapeutic effects, and the commercial potential of its product candidates. Actual results may differ materially from those indicated in these forward-looking statements due to a number of important factors, including inherent uncertainties in clinical development, changes in the timing or outcome of regulatory reviews, market conditions, and other risks and uncertainties. The company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

浙江扬厉医药技术有限公司

专注于前沿创新药物研发的高新技术企业

浙江省杭州市拱墅区东新街道皓章大厦1104,1105室

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