Will biosynthic drugs impact the diabetes drug industry in the future?

the competition for the species will begin as CDE begins to seek advice on guidelines for clinical trials of liraglutide biosynthic drugs. East China Pharmaceuticals, Tonghua Dongbao, Shenzhen Hanyu, Zhengda Tianqing, Dongsan, etc. all hope to get a piece of the NO.1 drug in the field of diabetes. But it is worth noting that recent policy disturbances in drug prices in the diabetes sector are clear, and what will the GLP-1, SGLT-2 and DPP-4 markets behind liraglutide and its backs do in the future?Yesterday, CDE publicly solicited its views on the Guidelines for the Design of Clinical Trials of Biosynthic Drugs for Liraglutide Injections. This opinion paper expounds the general requirements of liraglutide biosynthic drug research and development from three aspects: overview, clinical research and development requirements, and clinical trial design points.Liraglutide (commodity name: No. 1) was developed by Danish company Noor and Nord, listed in the United States in 2010 and entered the Chinese market in 2011.Liraglutide has become the best-selling GLP-1 perceptogen since its launch, with global sales of $3.85 billion in 2018, ranking No. 1 among all sugar-lowering drugs in the world. In China, the amount was released quickly after health care negotiations in 2017.But looking around the diabetes drug market in 2019, the situation is becoming more and more complex: the State Council requires urban and rural diabetics in the scope of the medical insurance catalogue of outpatient medication into the medical insurance payment, reimbursement ratio increased to more than 50%;

the health care negotiations be disrupted if Lillaglutide is unique?According to statistics, the global diabetes market reached US$45 billion in 2018, down from 1.5% the previous year, mainly due to the expiration of three generations of insulin patents and the decline in overall insulin sales due to competition for biosics. But at the same time, the GLP-1 perseor agonist market is expanding rapidly, reaching $9.3 billion in 2018, with a compound annual growth rate of 35.7%, making it the main driver of the entire diabetes market.In the future, the diabetes drug market may be hit by GLP-1 biosynthic drugs.Currently, there is currently no biosynthic drug for lilaglutide on the market worldwide. But the GLP-1-1-subjected astrogen, storaccharide peptide, sold nearly $3.2 billion in 2018, followed by Lilly's largest product to this day.Although liraglutide has been a global sell-off of sugar-lowering drugs, but because of price reasons, has not been able to open up the Chinese market. Six years after entering China in 2017 through negotiations into the national health care directory, liraglutide in the Chinese market has a relatively significant volume, 2018 sales revenue increased 73% to 521 million Danish kroner (about $82.5 million), has accounted for 87% of China's entire GLP-1 drug market share, but also accounted for only 1.3% of the entire diabetes drug market share.Data show that the mainstream
hospitals in China are still dominated by oral anti-sugar drugs, represented by insulin and metformin. In 2017, innovative drugs such as DPP-4 inhibitors, GLP-1 inhibitors and SGLT-2 inhibitors had total sales of RMB1.8 billion in China, accounting for only 3.4% of the market share, while the total sales of these three drugs
in the U.S. were $14.7 billion, accounting for 42.6% of the total market share, according to Rubik's Cube.It can be seen that in China's diabetes market, GLP-1 accounted for a very low proportion, and the global pattern is far from. But its future growth rate and space can be seen. That's why many biosynthic drugs are attracted to the market.In January 2018, the China Type 2 Diabetes Prevention and Control Guidelines, prepared by the Diabetes Society of the Chinese Medical Association (CDS), promote GLP-1 to one of the secondary treatment options, i.e. patients who cannot be controlled by metformin monodone can be treated with GLP-1, DPP-4, SGLT-2 or insulin at an early stage. In addition, if the blood sugar control of the secondary treatment is still not up to standard, three different mechanisms of sugar-lowering drugs can be used in a joint. This is partly to improve the status of GLP-1 in the treatment of diabetes drugs.Liraglutide, doraglutide and Noor and Nord's latest Somaglutide account for about 90% of the global GLP-1 market. At home, Insight database shows that there are currently 7 approved GLP-1 subjectors, namely, the short-acting agent Essena peptide (AstraZenecon), benaglutide (Renhua bio), liraglutide (no and Nord) and lisnapeptide (Sanofi);But because only liraglutide entered health insurance before, the release effect is obvious, occupying the vast majority of the market.But in this year's health-care negotiations, AstraZeneta's Essena peptide, Sanofi's Lisna peptide negotiations have been successful, but it is hard to say how the landscape will change under the clinical data of liraglutide and doraglutide, as well as the future entry of Somalutide.

biosypolysed drugs or will impact 　　According to Insight data, there are at least 11 enterprises that have declared Lilaglutide, including Tonghua Dongbao, East China Pharmaceuticals
, Federal Pharmaceuticals, Zhengda Tianqing, Shenzhen Hanyu, Sanno Pharmaceuticals, Guangdong Dongsian and so on. 　　China Drug Clinical Trial Registration and Information Disclosure Platform data show that Tonghua Dongbao is in the process of comparing phase III clinical trials with Noor and Nord's Liraglutide, East China Pharmaceutical Phase III clinical has also been fully launched in the first quarter of this year, is expected to be completed by the end of the year, early next year declared for listing. 　　In addition, the progress is faster also Shenzhen Hanyu Pharmaceuticals, November 20, its product listing application by the Drug Review Center, this time in accordance with the new 4 classes of generic drugs reported listing. 　　In addition, last month, Dongsan Pharmaceuticals said it intends to acquire coke glutamate Rongglie and liraglutide for 2,057 million yuan, of which the national class 1 new drug, SGLT-2, is currently preparing to conduct Phase III clinical trials, the biological agent liraglutide is preparing to carry out Phase I and Phase III clinical trials simultaneously. 　　It is foreseeable that in the next two years, biosimilar drugs will be on the market, and generic drugs are not only liraglutide, in SGLT-2, DPP-4 and other innovative anti-sugar drugs, there are also chasers. 　　But it is important to be aware that the diabetes sector has experienced multiple policy impacts in 2019. First of all, at the beginning of this year, the Prime Minister in this year's "Government Work Report" proposed to do a good job in the prevention and treatment of common chronic diseases, high blood pressure, diabetes and other outpatient drugs into the medical insurance reimbursement. Subsequently, the State Council proposed that more than 300 million people with hypertension and diabetes who participated in basic medical insurance for urban and rural residents should be integrated into their medical insurance payments within the scope of the national basic medical insurance drug catalogue, and the reimbursement ratio should be raised to more than 50%, and policies should be followed up by various places. 　　One of the more striking is Hebei, the province of urban and rural residents of hypertension diabetes outpatient drugs for centralized procurement
. The purchase involved six diabetes drugs, such as metformin, Grebenzene, Gretain, acabo sugar, thirst-quenching pills, among them, the stone drug European-Italian metformin tablets quoted 0.043 yuan / tablet, a drop of up to 94.7%, the NorthLand Pharmaceuticals "Gremezier tablets" decreased by 79.5%, East China Pharmaceuticals Akapo sugar tablets decreased by 59.3%. 　　Immediately after, insulin, the main drug used in diabetes, also suffered from harvesting. In December, the Wuhan City belt procurement was announced to incorporate insulin. In 2018, the market size of chemical diabetes drugs in key provincial and municipal public hospitals rose to 6.77 billion yuan, according to Minanet data. Insulin and similar drugs as the main therapeutic drugs, market share of more than 37%, in 2018 in key provinces and cities of public hospital terminal sales of more than 2.5 billion yuan. In 2018, the combined market share of the chemical insulin and its similar drug Top 10 brand in key provincial and municipal public hospitals remained at about 95%. Foreign-owned companies accounted for 7
top 10 brands. 　　Predictably, the price system of insulin will also be disturbed, while the trend of domestic substitution may accelerate. 　　With the launch of the domestic GLP-1 and its likenesses, will Liraglutide experience the same situation? But at least for now, the domestic GLP-1 has not posed much of a threat, and Novo Norfoy's long-lasting GLP-1 Somaglutide not only performs better clinically, but will also be available by oral dosage form. 　　But in this year's health-care negotiations, The Dagly Net, which suffered a soul-slashing price cut, ended up slashing prices, and its first copy or will be settled in Lusan, whose listing application was submitted in the middle of the year. 　　On the one side is the continuous good health insurance, liraglutide, Dagley net original research into health insurance, but at the same time, with a large number of biosimilar drugs, generic drug follow-up, the future of this slow disease field will be widely included in the collection, again touch the price, it is difficult to say. But at least in terms of the structure of drug use abroad, the GLP-1 domestic market is far from being developed. (
E drug manager
)