Inno Medicine's YN001 Phase 1b/2a Clinical Data Makes Global Debut at ESC 2025

September 1, 2025– At the ESC Congress 2025 held in Madrid, Spain, Beijing Inno Medicine Co., Ltd. (“Inno Medicine”) presented the global debut of its Phase 1b/2a trial of YN001, a first-in-class investigational therapy designed to reverse atherosclerotic plaque. The results were released during an oral presentation delivered by clinical investigators. The presentation, titled “Active-target liposomal drug shows significant atherosclerotic plaque regression effect: A Proof-of-Concept Phase 1b/2a Clinical Trial,” showcased for the first time the compelling efficacy and favorable safety profile of YN001 in this early-stage clinical study.

Landmark studies have demonstrated that the total coronary atheroma burden is a powerful predictor of major adverse cardiac events (MACE). Yet for decades, excessive emphasis on ischemia and acute cardiovascular events has diverted attention from the root cause of disease. In reality, most myocardial infarctions arise from plaque rupture or erosion. Yet, current diagnostic and preventive approaches fail to address this critical mechanism, resulting in repeated missed opportunities for early detection and intervention. Effective management of coronary artery disease must therefore evolve toward early, proactive prevention and plaque regression—expanding the clinical paradigm from a narrow focus on “ischemia” to a comprehensive strategy centered on “atheroma.”

    The Lancet Commission on Rethinking Coronary Artery Disease: Shifting Focus from Ischemia to Atheroma

YN001 is an innovative drug candidate designed to actively target and reverse atherosclerotic plaques. Its core mechanism centers on the precise delivery of the active agent to atherosclerotic lesions, enabling localized accumulation and direct therapeutic action at the site of plaques. This targeted approach reduces plaque volume and increases plaque stability, offering significant potential to lower the risk of MACE.

YN001 received Investigational New Drug (IND) clearance from the U.S. FDA in 2022 and from China’s NMPA in 2023. In Phase 1a PK/PD studies conducted in Australia and China, YN001 demonstrated a favorable safety profile in healthy subjects. Subsequent Phase 1b/2a clinical trials further demonstrated encouraging efficacy and safety in patient populations.

Results from the Phase 1b/2a clinical trial demonstrated that treatment with YN001 led to significant reduction in both total atheroma volume (TAV) and percent atheroma volume (PAV) from baseline compared to the control group, as assessed by intravascular ultrasound (IVUS) and coronary computed tomography angiography (CCTA). TAV was reduced by 10% to 50%, while PAV decreased by 10% to 30% from baseline. In addition, patients exhibited a marked reduction in carotid and peripheral vascular plaque areas.

Landmark studies have established a clear correlation between plaque characteristics—such as total atheroma volume, PAV, and carotid intima-media thickness (IMT)—and the risk of MACE. Evidence show that each 1% absolute reduction in PAV is associated with a 25% decrease in MACE risk, while every 0.01 mm reduction in IMT corresponds to a 9% risk reduction. By driving significant reductions in key imaging biomarkers including PAV and IMT, YN001 has demonstrated a remarkable ability to reverse atherosclerotic plaques, positioning it as a promising therapeutic candidate  for substantially  mitigate risk of MACE in patients with cardiovascular disease. These compelling outcomes provide a strong scientific rationale for a paradigm shift in atherosclerosis management - from merely slowing disease progression to achieving genuine disease regression. As one of the first investigational drugs to show significant plaque regression in clinical trials, YN001 stands out as a groundbreaking therapy for  the prevention and management of atherosclerotic cardiovascular disease.

YN001’s clinical results received high acclaim from leading experts at the conference. Professor Lina Badimon, Director of the Cardiovascular Science Program at the Hospital de la Santa Creu i Sant Pau in Barcelona, Spain, and Vice-President of Scientific Affairs of the European Society of Cardiology, praised its “… highly valuable targeted delivery system, which effectively encapsulates and precisely delivers the active agent to the intended site.” and spoke highly of the clinical outcomes achieved by YN001, noting that “… such significant plaque regression has never been observed within such a short treatment period.” 

Dr. Qian Ma commented, “The Phase 1b/2a results of YN001 are highly encouraging. This represents not only a major milestone in Inno Medicine’s R&D, but also brings new hope to hundreds of millions of patients worldwide suffering from atherosclerosis. Inno Medicine has already begun accelerating the subsequent development of YN001, maintaining close communication with regulatory authorities, and plans to promptly initiate global multi-center Phase 2b/3 pivotal clinical trials to further validate its efficacy. We are committed to making this transformative therapy available to patients around the world as soon as possible.”

    Dr. Qian Ma and YN001 clinical research experts at the ESC conference venue

About European Society of Cardiology Congress 2025

August 29 to September 1, 2025 – The ESC Congress 2025, held together with the World Congress of Cardiology, took place in Madrid, Spain, as one of the largest and most influential academic gatherings in the global cardiovascular field. Under the theme “Cardiology Beyond Borders,” this year’s congress brought together experts to explore cardiovascular disease trends and solutions within the context of global health.

About Atherosclerosis

Atherosclerosis is a major chronic condition that poses a serious threat to human health and serves as the primary cause of cardiovascular and cerebrovascular events, such as myocardial infarction and stroke. Currently, the global prevalence of atherosclerosis reaches 21%, affecting over 800 million people worldwide, with its disease burden continuing to grow.

In China, cardiovascular diseases account for 40% of all deaths, exceeding mortality rates from malignant tumors and ranking as the leading cause of mortality. However, there remains a critical lack of therapies capable of effectively curing the disease. Current clinical strategies primarily rely on palliative approaches, including lipid-lowering and antihypertensive treatments, which may slow disease progression but cannot achieve plaque reversal or a definitive cure. As a result, there remains a significant and urgent unmet clinical need for effective treatments targeting atherosclerotic cardiovascular disease.

About Inno Medicine

Beijing Inno Medicine Co., Ltd., founded in 2016, is dedicated to the research, development, and industrialization of innovative drugs. Based on years of clinical experience in cardiology, Dr. Qian Ma, the founder, keenly recognized that atherosclerotic plaques are a key trigger of MACE(Major Adverse Cardiovascular Events) such as myocardial infarction. Leading the team through a decade of groundbreaking research, Inno has successfully developed the world's first targeted drug for reversing atherosclerotic plaques.

Inno Medicine has established a comprehensive vascular health pipeline spanning cerebrovascular, peripheral vascular, and microcirculatory systems, starting with cardiovascular disease treatment. We have developed a full-lifecycle solution encompassing "plaque prevention—precision diagnosis—targeted therapy," pioneering a new treatment paradigm from vascular rejuvenation to organ rejuvenation. The core product, YN001, has successfully obtained clinical trial approvals from both FDA and NMPA, making it the world’s first atherosclerosis-targeted drug to enter clinical trials. Demonstrating excellent safety and remarkable efficacy, YN001 is now advancing into Phase II/III international multicenter clinical trials.

Inno Medicine has successfully established a proprietary Active-Targeted Liposome (ATL) delivery technology platform and constructed a GMP-compliant production base. This will accelerate the R&D and commercialization of multiple innovative drug pipelines, bringing transformative therapies to patients worldwide.