Inno Medicine’s YN001 (Targeted Therapy of Atherosclerosis) Receives Clinical Trial Approval from NMPA and Completes First Administration of Phase I in China

On September 15, Beijing Inno Medicine Co., Ltd. received a Drug Clinical Trial Approval Notice (ref. No. CXHL2300672) from the National Medical Products Administration (NMPA) in China for YN001, a targeted therapy of atherosclerosis developed by Inno Medicine, and obtained approval to conduct clinical trials. This milestone comes after YN001 obtained clinical trial approval from the U.S. FDA in November last year. On October 11, the Phase I of domestic clinical trials, involving the administration of YN001 to subjects, was successfully completed at the First Hospital of Jilin University.

Global statistics indicate that there are approximately 815 million patients with atherosclerosis (AS), and 17.5 million people die from cardiovascular events every year, accounting for 31% of global deaths. The death rate is rising year by year. The incidence of coronary heart disease and ischemic stroke in China is increasing year by year, with an estimated 270 million patients with carotid plaques in 2020. Notably, the detection rate of carotid plaques stands at 36% among residents aged 40-49 and increases to 49.44% among those aged 50 and above. There is presently no effective drug or treatment to reverse atherosclerosis, having a significant unmet clinical need.

The clinical trial Phase I for YN001 in China is divided into two parts. The part one is a double-blind randomized placebo-controlled trial of single-dose and multiple-dose escalation study in healthy subjects to evaluate the safety, tolerability, and PK of YN001 when administered intravenously. The part two is a multicenter, open-label, dose escalation, randomized and phase I trial in patients with atherosclerosis to evaluate the safety, tolerability, PK, and preliminary efficacy of multiple doses of YN001, helping determine the clinical efficacy dosage and providing evidence for pivotal phase II/III studies.

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.

Dr. Chen Ying, Senior Director of Clinical Development at Inno Medicine, mentioned that it took less than a month for YN001 to receive clinical trial approval and administer it to the first subjects in China. She highlighted that Inno Medicine overcome all kinds of difficulities and explained the determination and agility of Inno Medicine with its action. Dr. Kang Lisheng, Chief Technology Officer, emphasizes that atherosclerosis is known as the “No.1 Killer” of human health and a significant challenge in an aging society. YN001 has promising clinical application prospects, backed by a proprietary technology platform, and Inno Medicine hopes to expedite YN001’s market availability to benefit patients worldwide. Dr. Ma Qian, Chairman and CEO of Inno Medicine, described the approval of clinical trials of YN001 as a milestone of Inno Medicine. The successful progress of the project reflects the company’s innovation, wisdom, perseverance, and collaboration, and strong support from partners, laying a solid foundation for the advancement of other lines.

Previously, YN001 received Investigational New Drug (IND) approval from the U.S. FDA, becoming the first cardiovascular-targeted drug to enter clinical trials globally. It is anticipated to be the first cardiovascular drug approved for marketing by the FDA through an accelerated approval pathway, offering a revolutionary treatment approach in the field. The approval for YN001 from the NMPA to proceed with clinical trials and its successful completion of the first administration to human subjects represents a remarkable dual IND filing in both China and U.S., a significant milestone towards atherosclerosis treatment and extending human life, showing far-reaching significance.

About Inno Medcine

Founded in 2016, Beijing Inno Medicine Co. Ltd. is a national high-tech enterprise. 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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