A weight loss drug is about to be born A shares and related listed companies list (shares)

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Xiao e has always had an invisible dream. "I don't eat braised pork this year, I will watch my catwalk next year."... The first half of the small e did it, but the second half has not been realized.

After listening to a lot of truths, a lot of sweat, still can not become a secret.

I have heard a lot of truths.

Please ignore the last one, I really love my job.

Flowing a lot of sweat

Just after the life of the Nth Singles Day, Xiao e decided to face the bleak self, summing up the reasons are nothing more than three points, short, ugly, fat.

Dwarf is nothing, when a gnome version of the secret is my goal, ugly is also a good solution, I heard that fitness is comparable to plastic surgery, but the small e that has not eaten braised pork in a year is still very fat, despite a lot of iron .

Yes, fat should be the reason why Xiao e is still single, but it may also be the relationship between WeChat and the dog (but I love my job).

Just a few days ago, Xiao e suddenly discovered a dose of weight loss medicine when he started WeChat. To sum up this magical medicine with three words is - hypoglycemic! lose weight! Heart care! Three effects in one, you said that the shock is not shocking!

Xiao e is not a micro-business possessed to sell diet pills, Xiao e did a lot of homework, this is a new drug approved by the FDA (US Food and Drug Administration) very high time ago.

The weight loss medicine is about to be born

The three-in-one weight loss new drug called semaglutide, developed and produced by Novo Nordisk.

In addition to fairy tales, Denmark also has Novo Nordisk. Novo Nordisk is a global pharmaceutical giant in the field of diabetes and obesity treatment, listed on the New York Stock Exchange.

Some time ago, Novo Nordisk announced that the FDA Expert Committee on Endocrine and Metabolic Drugs recommended the approval of the application for the somaglutide listing with a 16:0 vote, and one expert abstained.

In December last year, Novo Nordisk submitted a request for the marketing of somaglutide to the United States and the European Union. In March of this year, it also submitted an application for this new diabetes drug to Japan.

Somatoglutide is a long-acting GLP-1 receptor agonist hypoglycemic agent that is used once a week for the treatment of type 2 diabetes.

Why is this a future medicine? Be aware that good glycemic control, weight loss, and reduced risk of cardiovascular events remain major challenges in treating type 2 diabetes.

Sumarupin in a 2-year SUSTAIN clinical study project in more than 8,000 patients with type 2 diabetes showed that somalupin compared to sitagliptin, sustained-release exenatide, once a day Insulin and placebo have a more pronounced and long-lasting glycemic control.

At the same time, somaglutide was combined with standard therapy to significantly reduce cardiovascular risk in patients with type 2 diabetes with higher risk than placebo. And very importantly, somaglutide can significantly reduce body weight compared to the control group.

This is the above mentioned small e, hypoglycemic, weight loss, heart care, three effects.

Novo Nordisk announced the results of a Phase II study in June this year, subcutaneous injection of somaglutide 0.05-0.4mg / d once a day, 52 weeks of treatment and 7 weeks of follow-up, the average baseline weight of 111kg Obese people lost 16.2% (17.8 kg), while exercise and diet combined with placebo only lost 2.3%.

No diet, no iron, if you are not lucky, the common adverse reactions are only nausea, and the incidence of this adverse reaction can disappear with time, this may be the legendary lying down to lose weight...

The principle of weight loss of somaglutide is that it can slow down the rate of gastric emptying and induce weight loss by reducing appetite and reducing food intake.

Global giants fight

There are currently five GLP-1 types of hypoglycemic agents in the world, namely AstraZeneca's Exenatide, Novo Nordisk's Liraglutide, GlaxoSmithKline's albendide, and Lilly's Duraru. Peptide, sirolifi's lixisenatide.

These can be giant-level global pharmaceutical companies, the birth of somaglutide is destined to set off a bloody hurricane in the industry.

In August of this year, Novo Nordisk announced the results of SUSTAIN 7 (one of the large clinical research projects of SUSTAIN). Whether it is hypoglycemic or weight loss, somaglutide is the best performing GLP on the market. 1 hypoglycemic drug larupeptide is better.

In these drugs, both albendide and dulaglutide are long-acting doses once a week. Duraglutide has become the market share of GLP-1, which is second only to liraglutide in a short period of time. Drugs, together to feel the strong growth momentum of the next degree of lalutide.

(Image from the drug Rubik's Cube)

But the birth of somaglutide may have to break this situation.

The study of SUSTAIN 7 mainly compares the efficacy and safety of somaglutide 0.5mg and degree laruptide 0.75mg, and somaglutide 1.0mg and dulaglutide 1.5mg after 40 weeks of treatment. A few simple excerpts.

In terms of hypoglycemic, in 8.2% of patients with HbA1c baseline level, once or 0.5 mg of somaglutide once a week for 40 weeks reduced blood glucose levels by 1.5% and 1.8%, respectively; The 0.75 mg or 1.5 mg group decreased by 1.1% and 1.4%, respectively. (Note: HbA1c is glycated hemoglobin, used for diabetes monitoring, the higher the blood sugar, the higher the glycated hemoglobin).

In terms of weight loss, in patients with type 2 diabetes with baseline weight of 95 kg and BMI ≥ 33.5 kg/m2, somaglutide can reduce weight by 4.6 kg and 6.5 kg after 0.5 mg and 1.0 mg once a week for 40 weeks. Larupeptide loses 2.3 kg and 3.0 kg, respectively, 0.75 mg or 1.5 mg per week.

The proportion of patients who received 0.5 mg and 1.0 mg of somaglutide once a week in the 0.5 mg and 1.0 mg groups was 44% and 63%, respectively, and in the group of 0.75 mg or 1.5 mg once a week, 23% and 30%, respectively. %.

All in all, the experimental data show that somaglutide is stronger than duralin in terms of hypoglycemic and weight loss, and this new drug has a killer - heart. As we all know, diabetes increases the risk of heart disease, stroke and other diseases, and is accompanied by cardiovascular complications. Experimental data indicate that somaglutide significantly reduces the risk of major cardiovascular events in patients with type 2 diabetes and is statistically significantly lower.

It is understood that somaglutide is the third hypoglycemic agent with cardiovascular benefit after nglipepsin and liraglutide. After 2 years of treatment, somaglutide significantly reduced the risk of nonfatal stroke by 39%, reduced the risk of nonfatal myocardial infarction by 26%, and reduced the risk of cardiovascular death by 2%. This is undoubtedly another advantage of somaglutide compared to other GLP-1 drugs.

Let's just say that somaglutide not only tears its peers, but also knocks over its own brother liraglutide (Victoza, also known as "Nuoheli"), which is another heavyweight developed by Novo Nordisk. Hypoglycemic agents. At the end of 2014, Novo Nordisk's liraglutide was approved by the FDA and entered the US diet drug market under the trade name “Saxenda”. Saxenda and Victoza contain the same active ingredient, liraglutide, but at different doses, it is an injection. liquid.

Lennon and Nord's chief operating officer said that he believes that daily injection of liraglutide is the most powerful GLP-1 drug, but we all strongly believe that somaglutide is the most powerful weekly injection of GLP. -1 drug. Good, the two most powerful products are from your home~

The launch of somaglutide is expected to become Novo Nordisk's new growth engine and ignite the competition for GLP-1 hypoglycemic drugs. Interestingly, once listed, somaglutide will become a strong contender for dulaglutide, and dulaglutide has grabbed market share from liraglutide since its listing last year, and the momentum is very strong.

Novo Nordisk predicts that somaglutide may be marketed from other GLP-1 drugs at the beginning of its market, including Novo Nordisk's own product, liraglutide, but the company says its goal is to attract those from Patients who have not used GLP-1 drugs have achieved the goal of expanding the market.

Novo Nordisk plans to price other GLP-1 drugs to price somaglutide, while other GLP-1 drugs are high-end prices... high-end efficacy stacks high-end prices, EvaluatePharma believes that somalupin will be 2017 One of the most important new drugs, it is estimated that sales of somaglutide will reach $2.2 billion by 2022.

The giants are tearing, how is the performance of Chinese medicine?

Diabetes is one of the three major chronic diseases today, especially the high incidence of type 2 diabetes mentioned above has driven the explosive growth of the diabetes treatment market.

The GLP-1 drug introduced by Xiao e above is one of the diabetes drugs. Diabetes drugs generally include insulin for injection, biguanides, thiazolidinediones, sulfonylureas, glinides, proprietary Chinese medicines, and DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2, etc. New drug targets, etc.

In general, pre-diabetes is controlled by exercise and diet. The initial oral hypoglycemic agent represented by metformin controls blood sugar. When the oral hypoglycemic agent is used in large doses, the patient's glycated hemoglobin still exceeds 7, and insulin is required.

To put it bluntly, insulin is the last line of defense for the later use of diabetes patients. Once the blood sugar is uncontrollable, a series of complications may occur, such as the cardiovascular complications mentioned in the small e.

The diabetes giants mentioned above, including Novo Nordisk, Lilly, Sanofi, Merck, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, etc., totaled approximately $37.7 billion in sales in 2015. The market for diabetes drugs is $60 billion, and the Novo Nordisk family's sales in 2015 reached $12 billion, accounting for 20% of the global market.

The sales growth rate of traditional diabetes drugs such as biguanides and thiazolidinediones has become slower and slower, and even negative growth. New target drugs like GLP-1 are rapidly gaining market share. These drugs include Novo Nordisk's liraglutide, Lilly's laurapeptide, and AstraZeneca's Ai. Senamin, albendin of GlaxoSmithKline, lixisenatide from Sanofi, and the like.

GLP-1 (glucagon-like peptide-1) is a kind of "incretin" secreted by the human gastrointestinal mucosa. It can bind to receptors on islet cells and stimulate insulin secretion, which can lower blood sugar. effect. The advantage of GLP-1 receptor agonist hypoglycemic drugs 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 beneficial for weight control.

In the global hypoglycemic market, new target drug GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors have grown at a rapid rate in recent years, but insulin still accounts for more than 50% of the global market share.

International insulin manufacturers are represented by Connaught and Nord, Lilly and Sanofi. Domestically, Tonghua Dongbao (600867.SH), Federal Pharmaceuticals (03933.HK) and Ganli Pharmaceutical are the representatives. Gan Li Pharmaceutical is a non-listed company. Last year 6 The IPO prospectus was submitted to the Shanghai Stock Exchange.

The development of insulin has gone through four generations. According to the research of Guojin Securities, insulin produced by international companies represented by Enoch and Nord, Eli Lilly and Sanofi accounted for 70% of the domestic market.

At present, there is very little generation of insulin (animal-derived insulin) on the market. In the second generation of insulin (recombinant human insulin) echelon, foreign-funded enterprises have transferred market share in recent years, and domestic enterprises have accelerated their rise. Among them, Tonghua Dongbao’s second-generation insulin price The system is best maintained.

The third-generation insulin (insulin analogue) is currently a star product in the international market, accounting for 85% of the global insulin market, and is firmly defended by foreign companies. Four generations of insulin (ultra-long-acting) specifically refers to Novo Nordisk's Degu insulin.

The iterative nature of insulin basically means that the higher the price, the higher the profit margin. The second generation of insulin entered the national Class A medical insurance catalog in 2017, which has a price advantage and is mainly used in the grassroots market, and this echelon of foreign companies is gradually shrinking.

In the domestic second-generation insulin market, Tonghua Dongbao is the leader, and the company is actively deploying in the third-generation insulin field.

Gan Li Pharmaceutical is the only pharmaceutical company in China that has three generations of insulin listed products. The company's products are mainly composed of three generations of insulin, accounting for 95%.

According to the announcement of Tonghua Dongbao on November 9, the company's research and development of the recombinant Laiwu insulin bulk drug and recombinant Laiwu insulin injection clinical trial application was accepted; the company also announced on October 11 that its insulin glargine, insulin glargine The application for injection of production is also accepted; in addition, the company recently obtained clinical trial approvals for insulin detemir and injection, and the company's insulin aspart and insulin aspart 50 clinical trials have entered a later stage, and clinical trials are expected to be completed next year. These are the star products of the three generations of insulin, all of which indicate that the layout of Tonghua Dongbao in the third generation insulin market has been fully rolled out.

As mentioned above, the growth of traditional first-line drugs for diabetes treatment has been weak. Instead, insulin and GLP-1 drugs have maintained rapid growth. International pharmaceutical giants pay special attention to the development and sales of new target drugs such as GLP-1. The proportion has also increased rapidly in the past five years.

Judging from the sales of the top 15 major hypoglycemic drugs in the world in 2016, there are 7 drugs that target new targets such as DPP-4, GLP-1, and SGLT2.

Source: IMS, Guojin Securities Research Institute

All in all, new target drugs such as insulin and GLP-1 have slammed the global diabetes drug market. What about the domestic market for GLP-1 drugs?

Novo Nordisk's liraglutide patent expired in August this year. On September 28 this year, Hanyu Pharmaceutical announced that it has obtained clinical trial approval for liraglutide. The company visited the National Food and Drug Administration in December 2014. The General Administration submitted an application for the production of generic drugs for the injection of liraglutide and liraglutide.

According to the data of the website of the State Food and Drug Administration, only the imported products of the original research enterprise are listed in the domestic market of liraglutide injection. At present, no domestic enterprises have obtained the approval of the drug production.

In addition to Hanyu Pharmaceutical, Tonghua Dongbao is currently conducting preclinical efficacy, pharmacokinetic studies and safety evaluation of liraglutide injection. In June this year, China-US East China, a wholly-owned subsidiary of Huadong Medicine (000963), announced the release of the new drug technology of liraglutide owned by Hangzhou Jiuyuan Gene. Hangzhou Jiuyuan Gene is a joint stock company of East China and East China. In August 2016, the clinical trial of liraglutide injection was obtained, which is the first in China.

In addition, Hanyu Pharmaceutical has reported to produce exenatide (Byetta) and injection, which is currently in the review stage. Sansheng Pharmaceutical (01530.HK), a Hong Kong stock company, owns 20 years of exclusive sales rights to AstraZeneca's exenatide. Exenatide is also a GLP-1 drug that needs to be injected subcutaneously twice a day.

Seeing here, everyone should understand that the more powerful GLP-1 drug somaglutide will be on the market soon. The new target drugs in the international market can no longer be said to be competing, but oligarchy, and domestic pharmaceutical companies are only in this respect. Just getting started.

Well, I have said so much. In fact, it is very painful to really reach the level of need to lose weight through the drug route, and it requires a doctor's prescription, which is not something that you can buy at will. For example, the two diet pills, sibutramine and rimonabant, which have been used by doctors, have been used clinically for a long time, but they have been withdrawn from the market due to serious adverse events such as cardiovascular events, stroke, depression and suicidal tendencies. Doctors are also generally more inclined to let patients lose weight through exercise and diet control.

Therefore, weight loss is risky, and it is reduced and cherished. Of course, fat is not fat and is not a single dog is not necessarily linked, we must not go to take medicine.

Enter [Sina Finance and Economics Unit] Discussion