The first domestic long-acting GLP-1 agonist has been approved

On May 7, the information on the official website of the State Drug Administration showed that PEGylated glycol losenatide injection, a kind of innovative drug made in China, was approved for listing through the priority approval procedure. The drug is a long-acting GLP-1 receptor agonist developed by Hawson. It is used to treat type 2 diabetes mellitus with only one injection per week. Losenatide is the first domestic long-acting GLP-1 formulation on the market and the third approved long-acting GLP-1 receptor agonist in China.

GLP-1 (Glucagon-like peptide 1) is a natural secretion of human gastrointestinal mucosa that binds to receptors on islet cells and stimulates INSULIN secretion. It has the effect of lowering blood sugar. The advantage of GLP-1 receptor agonists is that the incidence of hypoglycemic events is significantly lower than that of insulin, and it can reduce food intake and delay gastric emptying, which is conducive to weight control and protect the function of islet beta cells. It is known that GLP-1 receptor agonists include short-acting and long-acting hypoglycemic drugs. At present, the short-acting GLP-1 receptor agonists approved for market in China are exenatide (twice a day), liraglutide (once a day), benaru peptide (three times a day), and lisinopeptide (once a day); and the long-acting GLP-1 receptor agonists once a week are exenatide microspheres for injection, dulazeptin and losenatide.

The first approved long-acting GLP-1 receptor agonist in China is Essenathide microspheres for injection developed by AstraZenecan, which was approved on November 3, 2018, and its domestic sales rights and interests are held by Sansheng Pharmaceuticals. Esenatide microspheres, based on the micro-innovation of Esenatide, were launched in the United States in 2012, with global sales of $584 million in 2018.

Lilai Dura glycopeptide is the second long-acting GLP-1 receptor agonist landed in China, which was officially approved on February 26 this year. The drug was approved by the FDA on September 18, 2014, and then marketed in the European Union, Japan and other regions. Lilai's sales showed that in 2018, sales of Lactose Peptide were about 3.2 billion US dollars, with a growth rate of 58%. It was Lilai's highest sales revenue product. With the officially listing of Hawson's Losenatide, the domestic long-acting GLP-1 agonist market has shown a "tripod" pattern. However, the situation of "four parts of the world" may soon emerge. Novotel's long-acting GLP-1 receptor agonist Somalou peptide was tested in phase III clinical trials in China on August 2, 2017, and is expected to be approved for market in 2019. The drug was approved in the United States at the end of 2017 and has been approved in 11 countries in North America and Europe, with a global revenue of 1.796 billion Danish kroner in 2018.

 I believe that with the successive entry of Hawson, Novo Nord, the market competition of diabetic long-acting GLP-1 receptor agonists will be more intense. Facing the competition of AZ, Lilai, Novo and Nord, whether Hawson can break through the encirclement has become the focus of attention in the industry.

Global Diabetes Map shows that there are about 425 million adults suffering from diabetes in the world in 2017, and it is estimated that by 2045, the number of diabetic patients may reach 629 million. Among them, China ranks first, with 114.4 million diabetic patients (20-79 years old). According to the global market, the size of diabetes market in 2018 is about 45 billion US dollars, which is only 1.5% growth compared with 2017. Among them, the GLP-1 receptor agonist market reached 9.3 billion US dollars, with a growth rate of 25%. Industry analysis shows that the market share of domestic GLP-1 agonists is much lower than that of the international level, among which, weekly injection of long-acting GLP-1 receptor agonists is becoming the mainstream direction of future diabetes treatment, and the market potential is huge. At the same time, the clinical status of GLP-1 agonists has been further improved in China. In January 2018, the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China, compiled by the Diabetes Society of the Chinese Medical Association (CDS), clearly pointed out that patients who could not be controlled by Metformin alone could use GLP-1 for combined injection treatment at an early stage.

Minet Global Pharmaceutical Research and Development Library shows that, in addition to Hawson's Losenatide, there are eight GLP-1 receptor agonists on the market globally, including Novotel's Lilaruptide Injection and Somaluptide Injection, AstraZeneca Peptide Injection and Exenaptide Microspheres for Injection, GlaxoSmithKline's Abiruptide for Injection, Cypride for Injection. Nofelisinaptide injection, Benarooptide injection of Renhui Biology, Lilai Dura glycopeptide. Six of the eight GLP-1 receptor agonists have been sold in the Chinese market. Among the short-acting GLP-1 receptor agonist products, Renhui Biology's Benarooptide Injection is also a domestic product. In addition, Novotel's short-acting product, liraglutide, has entered the national health insurance catalogue in 2017 through negotiation. The price is 410 yuan (3ml: 18mg per unit, pre-filled injection pen), and patients with BMI (> 25) who are not well controlled by oral hypoglycemic drugs or insulin, such as metformin, need the prescription of specialists in secondary and higher medical institutions.