Targets hypoglycemic agents export new opportunities | 'Peptide' | Drugs spring is approaching

Figure 2016 China's hypoglycemic bulk drugs exports accounted for the proportion of the amount

Medicine Network January 9 hearing hypoglycemic drugs have always been 'blockbuster' club seat off: 2017, annual sales of 1 billion US dollars drug , 12 kinds of hypoglycemic drugs ranked among them, the total sales scale of nearly 30 billion US dollars.And similarly, hypoglycemic APIs market has also attracted much attention.

At present, the hypoglycemic APIs in our country have not yet formed a strong export pattern for two main reasons. First, China has not yet taken advantage of multinational pharmaceutical companies in the production of the "blockbuster" star product - insulin raw material medicine Second, the market scale of veteran products needs to be expanded.With metformin bulk drugs, for example, although China's annual export scale of about 2,000 tons, but lost to India, can not share the global market tens of thousands of tons of soup .Another veteran product range ZIT Slightly better: This is the only one that has exported tens of millions of U.S. dollars.

At present, the opportunities for export of hypoglycemic new drug raw materials are beginning to emerge in our country. In recent years, the newly listed global heavy drugs such as' Net List 'and' enterprise Rapid development and the formation of a certain scale; another global hot spot is liraglutide and other peptide products, China's rapid development of related businesses, the future can be expected.

The DPP-4 inhibitors ('Lutetin') and SGLT-2 inhibitors ('nets') are the hottest small-molecule oral antidiabetic drugs in the past 10 years. External accounting for the largest market share of hypoglycemic drugs.

In 2006, Merck claims to be the world's first sitagliptin, the world's first such drug, with annual sales in the global market of nearly 4 billion U.S. dollars for the past three years and annual sales of its metformin compound with 22 The series also includes: Vildagliptin, 2019 patent expires; Saxagliptin, 2021 patent expires; Linagliptin, the patent expires in 2023. It is speculated that once the patent expires , The export of therapeutic drugs of lendegradis will be heavy volume growth.With sitagliptin, for example, although its patent will expire in 2022, but in the past three years, its raw material and intermediate export growth trend has been opened, is expected in 2017 Exports will exceed 40 million US dollars.

The earliest listed "net" type of hypoglycemic product is Cagliopin, originally researched by Tanabe Mitsubishi Pharma. In 2012, Johnson & Johnson's Johnson & Johnson Pharmaceutical obtained the drug's marketing authorization in the United States and the EU. In 2013, the drug was approved by the U.S. Food and Drug Administration FDA), with global sales of 1.4 billion U.S. dollars in 2016. Also in the same series are dapagliflozin and enzaprine, etc. With higher cardiovascular benefit expectation, 'nets' drugs will gradually It is noteworthy that there is still a long period of time before Cigarette patent expires in Europe and the United States, but the compound patent in China is not authorized and the patent of crystal form is also rejected , So the higher enthusiasm declared by domestic enterprises.China's Cogobet net and its intermediate exports in 2016 more than 60 million US dollars, becoming the largest export amount of hypoglycemic varieties.

GLP-1 (glucagon-like peptide-1) is a polypeptide synthesized by intestinal cells and its mechanism of action is to stimulate insulin secretion, suppress appetite, reduce glycogen output, reduce gastric emptying time, and thus help to reduce Blood sugar. Since the drug works only when blood sugar is elevated, it does not cause hypoglycemia and is confirmed to have lose weight Role of these drugs have been widely recognized by doctors.Currently the most representative products are the earliest listing of exenatide (AstraZeneca's products) and later liraglutide (Novo Nordisk Product).

Liraglutide is currently the world's most popular polypeptide variety and was listed in Europe by Novo Nordisk in 2009. It will soon be listed in the United States, China and other countries and regions. From 2014 to 2015, Indications of weight loss were approved in the United States and Europe, and the global performance of the product in 2016 reached 2.9 billion U.S. dollars.

The main compound patent of liraglutide expires in August 2017, and the overseas Teva company has already submitted the generic application. At present, there are two institutions in Shenzhen, namely, Han Yu Pharmaceutical and Hangzhou Jianyuan Gene, , Has been through the sale of bulk drugs in the international market to dig the 'first pot of gold' and the world to do card-type pen Ypsomed reached a strategic cooperation in the future Shenzhen Han Yu Pharmaceutical is expected to occupy half of this market.At present our country's major Liraglutide APIs export enterprises are Shenzhen Han Yu Pharmaceutical and Chengdu Sino Biological Pharmaceutical.

Insulin APIs have become the most difficult type of APIs for Chinese enterprises to obtain export breakthroughs. In 2016, their exports were only over 800 million USD. The major manufacturers are Gan Li Pharmaceutical, Jiangsu Wanbang and Tonghua Dongbao.

Metformin is the most classic and the most widely used old product in hypoglycemic agents, and metformin is the preferred and first-line drug in the Guide to Prevention and Treatment of Type 2 Diabetes in China (2017 Edition), which is predicted to be Demand for APIs is in the tens of thousands of tons, but in foreign countries, India and other manufacturers account for a large share of China's export of metformin in 2000 to maintain the upper and lower exports, the major manufacturers Shouguang Beverly Pharmaceutical Co., Ltd. It is noteworthy that the current domestic There are a number of enterprises exporting metformin has formed a certain scale, such as Shijiazhuang Pharmaceutical Group.

Taken together, the opportunities for export growth of hypoglycemic APIs in China are mainly focused on the products listed in Listin and Net peptides, and from the perspective of terminal demand, the potential for development of hypoglycemic drugs is mainly concentrated in what is called 'Intelligent' blood glucose control drugs 'Lupin' class, 'net out' small molecule oral hypoglycemic agents and peptide drugs, especially peptides, not only in the field of diabetes treatment, large health The field also has broad prospects for development.