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    Home > Active Ingredient News > Drugs Articles > One drop of water "leads directly to phase III clinical practice in the United States, the first case in China

    One drop of water "leads directly to phase III clinical practice in the United States, the first case in China

    • Last Update: 2016-10-18
    • Source: Internet
    • Author: User
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    Source: Suzhou daily, October 10, 2016-18 local time, the U.S Food and Drug Administration (FDA) approved conbercept ophthalmic injection to directly carry out phase III clinical trials in the United States It is reported that a class of new biological drugs independently developed in China have directly entered phase III clinical trials in the United States, which has not been preceded in China before Conbercept is the first monoclonal antibody drug with global intellectual property rights in China It was invented and developed by Dr Yu Dechao, a national distinguished expert of the "Thousand Talents Program" and a pioneering scientist in Jiangsu Province It lasted for 7 years and was approved by the State Food and Drug Administration of China for listing on December 4, 2013 The food and drug administration is one of the most authoritative organizations in the international medical audit Its certification opinions have high professional authority and market value In the field of international Biopharmaceutics, it is an important way for high-end biopharmaceuticals to enter the international market through the U.S Food and drug administration, but according to the practice, the application must start from the phase I and phase II clinical trials approved by the agency "The excellent efficacy and safety recognized by international experts is the most important reason for conbercept to break the practice of the U.S Food and drug administration," Yu said Yu Dechao told reporters that in February 2014, at the authoritative academic conference of world fundus diseases and the 11th Annual Conference of neovascularization held in Miami, the outstanding clinical performance of conbercept, which represented China's high-end biological drugs, was highly recognized by more than 300 top fundus disease experts in the world Good quality and low price is one of the characteristics of conbercept Conbercept is mainly used to treat wet age-related macular degeneration At present, fundus diseases such as macular degeneration and diabetic retinopathy are the main causes of blindness in adults over 45 years old in China There are tens of millions of such patients in China Yu Dechao introduced that before conbercept went on the market, the only drug used to treat wet age-related macular degeneration in China was rapunzumab imported from Novartis After conbercept went on the market, under the same treatment course, the vision of patients using conbercept improved more, and the annual treatment cost was only one quarter of rapunzumab At present, conbercept's market share in China is 52% The monopoly of imported drugs in China has been completely broken At the same time, conbercept has also broken the tradition that foreign patented drugs do not reduce prices during the patent period In July this year, Novartis, with a 10-year patent period for Rapunzel, was forced by market factors to reduce its price in the Chinese market, from the original 9800 yuan to 7200 yuan each Conbercept is the only innovative drug named by the World Health Organization (who) drug naming Committee so far in China It is a major landmark achievement of the "12th Five Year Plan" national "major drug creation" project in China It has been awarded "one of the largest scientific and technological breakthroughs in ophthalmology in China" and "the most clinically valuable innovative drug in China" and other honors.
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