Inno Medicine's Investigational Drug YN001 for Atherosclerotic Cardiovascular Disease (ASCVD) Secures IND Approval from FDA

Lately, Inno Medicine's investigational drug for atherosclerotic cardiovascular disease (hereinafter referred to as "ASCVD") – YN001 received official IND approval from the FDA. A Phase I clinical trial was subsequently initiated in Australia to evaluate the safety, tolerance, and preliminary efficacy of the new drug.

ASCVD includes diseases such as coronary heart disease, ischemic stroke and peripheral arteriosclerosis. Being the leading cause of death in China and the world alike, these diseases are characterized by high prevalence, high fatality rates, high medical risks, and high patient burden. ASCVD is a chronic vascular diseases that arises from the accumulation of fat in the endothelial space which causes inflammation. It may impact all large and medium arteries, including the coronary artery, carotid artery, cerebral artery, aorta and its branches, as well as main arteries in the limbs. Atherosclerosis is the pathological basis for ASCVD by generating plaques that narrow the vessel lumen. In the case of plaque rapturing, thrombus may form and some organs will fail due to ischemic necrosis, inflicting irreversible damage. Currently, medication is the common therapy for ASCVD. Patients must take lipid-regulating medicine throughout their lives, as there is currently no clinical treatment available to reverse the formation of atherosclerotic plaques. The unmet medical need in this field is tremendous.

YN001 acts through encapsulating the API to form liposomal nano-drug, which is loaded with a targeting head that enables precise delivery to increase API concentration at inflammatory plaques. Pre-clinical data has demonstrated that in this way the formation of plaques can be significantly reversed within a short period of time.

YN001 has received IND approval from the FDA, making it the first targeted drug for cardiac and cerebrovascular diseases to have gained clearance for clinical study, as well as a strong contender to be the first cardiac and cerebrovascular drug worldwide eligible for expedited review by the FDA and hopefully a BTA therapy in the field. The successful IND submission of YN001 in both China and the US marks the beginning of Inno Medicine’s globalization course and has laid a sound foundation for the company to reach out to patients across the globe.

About YN001

YN001 is a proprietary targeted nano-drug for atherosclerotic cardiovascular diseases (ASCVD) independently developed by Beijing Inno Medicine. It is the world's first targeted delivery drug designed to actively and precisely reverse the formation of atherosclerotic plaques that has obtained IND approval. The development project was partly funded by the “Key R&D Programs in the Fourteenth Five-Year Plan” by the Ministry of Science and Technology of China.

About Inno Medcine

Founded in 2016, Beijing Inno Medicine Co. Ltd. is a high-tech company recognized by the Chinese state government. The company is committed to the discovery, development, and manufacturing of novel drugs. Our Chinese name “Yin Nuo” reveals our cultural values of benevolence and unwavering dedication to perfection. The company’s founder, Dr. Ma Qian, has extensive experience in clinical cardiology. Relying on the company’s in-house R&D center and its manufacturing facilities, she led the team to develop a targeted nano-drug delivery platform, which serves as foundation for establishing multiple product pipelines aimed at addressing the pressing unmet medical needs related to atherosclerosis, brain glioma, and more. Among our products, IND submission of YN001 was simultaneously made in China and in the US, and approval was granted by the FDA, making YN001 the world’s first targeted drug in cardiology to have gained clearance for clinical study. Currently a clinical study is being conducted in Australia.

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