Release date: 2016-10-18
On October 10th, US local time, the US Food and Drug Administration (FDA) approved Compaqip Ophthalmic Injection to conduct Phase III clinical trials directly in the United States. It is reported that a new class of biological drugs independently developed by China has entered the phase III clinical trial in the United States directly. There has been no precedent in China.
Compaqip is China's first monoclonal antibody drug with global intellectual property rights. It was invented and led by Dr. Yu Dechao, a specialist in the “Thousand Talents Programâ€, and was founded in December, 2013. The company was approved by the State Food and Drug Administration of China for listing.
The US Food and Drug Administration is one of the most authoritative organizations for international medical audits, and its certification has a high degree of professional authority and market value. In the field of international biopharmaceuticals, high-end biopharmaceuticals are an important way to enter the international market through the US Food and Drug Administration, but by convention, applications must begin with Phase I and Phase II clinical trials approved by the agency.
Compaqip is the world's first high-end biopharmaceutical that has been successfully developed outside the United States. Yu Dechao said: “The excellent efficacy and safety recognized by international experts is the most common practice for Compaqip to break the US Food and Drug Administration. Important reasons." Yu Dechao told reporters that in February 2014, at the World Congress of Fundamental Diseases in Miami, the 11th Annual Meeting of New Blood Vessels, the outstanding clinical performance of Compaqip, which represents China's high-end biopharmaceuticals. The performance has been highly recognized by more than 300 experts in the world's top fundus diseases.
Good quality and low price is a major feature of Compaqip. Compaqip is mainly used to treat wet age-related macular degeneration. At present, the fundus diseases such as age-related macular degeneration and diabetic retinopathy in China 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 the listing of Compaq Xipu, the only drug used in China to treat wet age-related macular degeneration was ranibizumab imported from Novartis, Inc., after Compaqip was listed, using Compaq under the same course of treatment. Patients in Xipu have more visual acuity, and the annual treatment cost is only a quarter of that of ranibizumab.
At present, Compaqip's Chinese market share is 52%, and the monopoly of imported drugs in China has been completely broken. At the same time, Compaqer has also broken the tradition of foreign patent medicines not reducing prices during the patent period. In July of this year, the United States Novartis company in the case of Raymond monoclonal antibody has a 10-year patent period, forced by market factors to actively reduce the price in the Chinese market, each from the original 9,800 yuan to 7,200 yuan.
Compaqip is by far the only innovative drug named by the World Health Organization (WHO) Drug Nomenclature Committee in China. It is a major landmark achievement of the “Major Drug Creation†project in China’s “Twelfth Five-Year Plan†and was awarded “China Ophthalmologyâ€. One of the biggest technological breakthroughs and "China's most clinically valuable innovative drugs" and other honors.
Source: Suzhou Daily
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