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Subject ViroMed, VM202 Phase III for CLI Approved in China
Writer ViroMed
Date 2017/10/12

ViroMed, VM202 Phase III for CLI Approved in China

Oct 12 2017 - SEOUL, Korea- ViroMed (KOSDAQ 084990) announced on 11 October that its Phase III IND for critical limb ischemia (CLI) has been approved by the China Food and Drug Administration (CFDA).

Yongsoo Kim, CEO of the company, noted that a speedy process as such is very unusual, adding that, “The Phase III IND had passed the Beijing Municipal Food and Drug Administration review in June, and got approval from the CFDA in less than four months after its submission.” Kim went on to say that, “I think this shows the strong will of the Chinese government to bring benefit to people in China who suffer from CLI which has very limited treatment options for surgery and symptom relief. The Chinese government certainly has high expectations towards VM202 as it has designated VM202 as part of its Significant New Drugs Development Project. Besides, the Chinese government recently revised its guide line for new drug development approval involving clinical outcomes from trials overseas, which may help and give advantage to the potential commercialization of VM202 in China. We are expecting the Phase III to be successful, particularly through the collaboration with our Chinese partner, Beijing Northland Biotech.”


Critical limb ischemia refers to an advanced stage of peripheral artery disease (PAD) caused by lack of blood flow to the lower limb such as thigh, calf, and foot, whose condition may deteriorate by factors such as smoking, hypertension, and diabetes, and even further develop into arterial insufficiency ulcers or gangrene, conditions called critical limb ischemia (CLI). VM202, when intramuscularly injected, may provide a fundamental solution to the condition as it promotes new blood vessel formation and improves blood circulation in the affected area.


According to a report by Sage Group, about 42-60 million Chinese citizens suffer from PAD, and CLI patients account for 5.6-6.3 million of them. [1] During the last two decades in China, the number of patients with PAD has surged along with that of patients with diabetes, hypertension, and chronic renal diseases, almost to a level on a par with the US.


A representative from ViroMed remarked that, “We were certainly able to see, through our Phase I and II clinical trials conducted in China, that there, indeed, is a need for CLI treatment in China. Our anticipation is that the number of CLI patients and their need will continue to grow as the Chinese government pushes forward its healthcare innovation policies, together with its efforts to expand healthcare coverages and facilities for medical and healthcare services in China.”



[1] China Peripheral Artery Disease and Critical Limb Ischemia Prevalence and Incidence. THE SAGE GROUP 2017: A new analysis published by The Sage Group has concluded that 42–60 million Chinese citizens are afflicted by peripheral artery disease (PAD), with 5.6–6.3 million suffering from the most severe form of PAD, critical limb ischemia (CLI). [link] 


Translated by English Editor