HUYABIO Validates Protective Mechanism for Antiarrhythmic Drug HBI-3000 in AF Patients, Paving the Way for a New Era in Atrial Fibrillation Treatment

HBI-3000 Aims to Fill Critical Gaps in Atrial Fibrillation Care; Key Data to be Presented at the American Heart Association Annual Meeting

HUYABIO Press Release

SAN DIEGO, Nov. 14, 2024 -- HUYABIO International today announced the presentation of new patient data for HBI-3000, an antiarrhythmic drug (AAD) with a unique protective profile for the treatment of atrial fibrillation (AF), one of the most common and serious heart conditions worldwide.

This promising drug will be highlighted in a moderated poster presentation in the session entitled "The Return of Antiarrhythmic Drug Therapy: A New Age with New Therapeutics" at the American Heart Association (AHA) Annual Meeting in Chicago, IL, from November 16-18, 2024.

Dr. Mireille Gillings, President, CEO & Executive Chair at HUYABIO, said, "Intravenous (IV) HBI-3000 and our second-generation oral form, HBI-3020, represent the first true control of AF in more than a decade. The opportunity for acute to chronic care protection has been missing from treatments. HUYABIO's goal is to provide clinicians with a safe, effective solution that puts total control of AF at the forefront."

Atrial fibrillation affects millions globally, with incidence rates expected to rise as populations age. The CDC estimates that 12.1 million people in the U.S. alone will have AF by 2030. While many current AADs are effective in controlling arrhythmias, they also may pose serious risks including fatal arrhythmias and sudden death. The active component of HBI-3000 and HBI-3020, sulcardine, has been developed to overcome these limitations by offering protection against the attendant risk of life-threatening arrhythmias, a significant and dangerous side effect of existing treatments. The AHA presentation highlights the mechanism of sulcardine's protective effect and successful demonstration of this activity in patients with active acute AF, marking a critical advancement in addressing the growing burden of this condition.

Dr. Jay Mason, Professor of Medicine Cardiology, University of Utah, said, "Availability of direct-current cardioversion has slowed development of new pharmacological interventions for recent-onset AF. HBI-3000 may mitigate that trend because of its safety and efficacy, as many patients want to avoid electrical cardioversion."

Addressing the Unmet Need for Innovative AF Therapies

AF has long been linked to a higher risk of stroke, and recent studies show that it also plays a significant role in contributing to heart failure. With the last rhythm control drug for AF approved over a decade ago and few candidates in late-stage development, patients and clinicians have been left with limited treatment options. The active molecule of IV HBI-3000 and oral HBI-3020, sulcardine, is a novel new AAD that exhibits robust protection against QT prolongation, a key cause of fatal arrhythmias. This unique

capability gives it great potential to change the treatment paradigm for rhythm control, addressing the high unmet need for safer and more effective AF therapies.

Dr. Denis Roy, lead investigator on the HBI-3000 Phase 2 trial and abstract author, said, "HBI-3000 has demonstrated a promising protective profile, with the potential to reduce the risk of life-threatening arrhythmias in AF patients, a concern that has long limited the use of AADs."

The poster presentation, titled "HBI-3000: Pharmacological Conversion of Atrial Fibrillation With Unique Defense Against Excessive QT Interval Prolongation", will be held on November 17, 2024, from 11:10 AM to 12:35 PM during the session "The Return of Antiarrhythmic Drug Therapy: A New Age with New Therapeutics." The presentation, led by Dr. Jay Mason, will focus on sulcardine's ability to mitigate prolonged QT intervals, a key risk factor associated with many AADs.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally.