The first new drug to be marketed in China and the United States is expected to be born!
The first new drug to be marketed in China and the United States is expected to be born!
March 24, 2016 Source: 澎湃News
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, WuXi PharmaTech and US pharmaceutical giant Eli Lilly announced in Shanghai that they will jointly develop, produce and commercialize a small molecule oral hypolipidemic drug. This lipid-lowering drug is expected to become the first new drug in China and the United States.
The new small molecule hypolipidemic drug developed by WuXi PharmaTech and Lilly is a once-a-day oral preparation designed to reduce the risk of cardiovascular disease in low-density lipoprotein cholesterol and high-risk populations associated with elevated triglycerides. WuXi PharmaTech will be responsible for the development, production and registration of the drug in China, including the submission of new drug clinical trial applications. Lilly will be responsible for the marketing of the drug in China.
According to Gao Xin, deputy director of Shanghai Zhongshan Hospital, the originality of this small molecule lipid-lowering drug is to reduce the risk of hypertriglyceridemia into the treatment target. Prior to this, most of the general lipid-lowering drugs used only low-density lipoprotein cholesterol as an indicator of cardiovascular disease risk. This originality will enhance the treatment of cardiovascular patients with diabetes.
According to the World Health Organization, in 2012, ischemic heart disease and stroke were the world's leading and second leading causes of death, respectively. The data shows that the number of patients with cardiovascular disease in China has reached 290 million.
Lloyd Pharmaceuticals China President Andrew Hodge revealed at the press conference that the development of this lipid-lowering drug is currently in Phase I, and has completed toxicity research in the United States, and will begin clinical research in both China and the United States.
"China has a wide population of high cholesterol patients, which laid a good foundation for the next clinical research. Therefore, clinical trials of drugs are expected to be completed in China. We also expect China to become the first country in the world to register and approve this new drug. He said.
WuXi PharmaTech's senior vice president told reporters that China has now become the world's second largest pharmaceutical market, but China has long been unable to meet the people's demand for new drugs by relying on its own innovation. It is difficult for domestic patients to use the world with foreign patients. The latest innovative medicine. The cooperation between WuXi PharmaTech and Eli Lilly is to break this bottleneck, introduce international high-level drugs into China, carry out simultaneous development and listing, and bring biomedical technology representing the global level to China at the fastest speed.
Yang Qing, chief operating officer of WuXi PharmaTech, said that the strategic cooperation with Lilly is the first time that Chinese pharmaceutical companies have established a deep partnership with US pharmaceutical giants in drug development. This is a model that can be replicated and promoted. In the future, WuXi PharmaTech will have deeper and less extensive cooperation with Lilly, and will also actively seek other strategic partners.
In February this year, the State Food and Drug Administration announced a series of reform measures for the drug review and approval system, including: “Applications for registration of innovative drugs that are not marketed or sold in China or transferred to China for production will be given priority. Review and approval." Industry insiders predict that under the impetus of this policy, there will be more innovative drugs listed in the domestic market in the future.
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