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The following is the text of this article—
Oral tablets in East China are worth looking forward to
【Core Viewpoint】
1. The main effect of GLP-1 is to reduce glucose. Only 8 models are marketed in the world, and 27 are in clinical trials, and their core is mainly the treatment of type 2 diabetes.
2. GLP-1 cross-border weight loss out of the circle is mainly because of the efficacy, followed by compliance and convenience, and relatively low adverse reactions.
3. There are three dosage forms, daily preparations, weekly preparations and oral, but oral products are more convenient to use, and there should be relatively large application prospects in the future. Oral tablets in East China have progressed relatively quickly.
4. Short-acting generic drugs will soon be approved one after another, and both long-acting weekly preparations are foreign-funded production, and it is difficult to return to a normal supply level this year due to production capacity and supply problems.
5. Novo Nordisk's liraglutide selling point is mainly in the flexibility of its product dose table adjustment and its advantages in clinical data.
6. Lilly's dulaglutide, single bottle design is the weekly standard dose. The selling point is that the patient's use is simple and convenient, there is no need to adjust the dose, you can play directly when you take it back, and the operation will be relatively simple.
7. The effect of semeglutide in controlling blood sugar and weight management is still better than that of dulaglutide.
8. Now the production capacity and supply of weekly preparations abroad are not enough, so in the hospital channel, doctors are definitely more inclined to meet the needs of these diabetic patients who just need it. Therefore, the domestic Hausen has been relatively fast recently.
9. The manufacturers with earlier layout in China include Huadong Pharmaceutical, Renhui Biotechnology, Innovent Biologics, Hengrui Pharmaceutical, etc. Now companies that look earlier will taste the sweetness, but in the long term, there will be a lot of clinical practice, and the track will become more and more crowded.
One. GLP-1 indications
There are two main indications: the big one is the treatment of diabetes, and the second is the management of weight.
In addition to the hypoglycemic effect, the product also has obvious advantages in weight control, and GLP-1 has obvious advantages for patients with obesity or cardiovascular disease that needs to be managed;
Another advantage is that the risk of hypoglycemia is lower, and the safety profile in the process of blood glucose management is relatively good; Now that doctors prescribe this product on a large scale, there will be a lot of room for growth in the future.
Two. Market space for GLP-1 targets
Let's start with an example of market space.
Orlistat's market in 2016 was only 300 million, and it has reached 1.9 billion in 2020, and it is expected that there will be a market of nearly 15 billion by 2033.
Novo Nordisk's products (Saxenda and Wegovy) sold $4.1 billion in 23Q1.
Based on GLP-1 target products, only 8 are marketed in the world, and 27 are in clinical trials, and their core is mainly based on the treatment of type 2 diabetes.
For companies that started early, GLP-1 faces not only a market for diseases, but also an incremental market for consumption in the future.
According to relevant industry reports, it is expected that the compliance market of diet drugs in mainland China is expected to exceed 12 billion yuan by 2025.
But objectively speaking, we must also see that there are currently 516 research projects related to obesity projects, and the future track will become more and more crowded.
Three. Advantages of GLP-1 "crossover" slimming circle
First look at the efficacy. The effect of traditional orlistis weight loss is not so ideal, and the weight loss effect of traditional hypoglycemic drugs is about 10%;
The foreign approved semeglutide, after 40 weeks, the weight can be reduced by 6.5 kg, in the study specifically for weight loss people, after 68 weeks, the weight loss is about 15%-18%, the effect is remarkable.
The second is compliance and convenience, currently the only approved orlistat in mainland China, taking three times a day, compared with GLP-1 one injection a week, there are still differences in patient experience, compliance and convenience.
The third is adverse reactions, GLP-1 in the current clinical research, adverse reactions are not many, mainly concentrated in the gastrointestinal tract, etc., adverse reactions are relatively low.
Four. GLP-1 dosage form
Dosage forms are mainly divided into three categories:
1. Injections of daily preparations that require injections every day; 2. Weekly preparation, one injection per week; 3. Tablets for oral administration.
Domestic listing:
Both short-acting and weekly preparations have been approved for marketing, and oral tablets will also enter the domestic market in the future. From the perspective of clinical application, all kinds of preparations are still relatively comprehensive.
From the research feedback of the terminal, for patients who switched to insulin before, the acceptance of short-acting daily preparations is still acceptable;
For new patients, or patients whose symptoms are not very serious, the economic conditions are also good, and weekly preparations are also a good choice;
Oral products are more convenient to use, and there should be relatively large application prospects in the future.
Five. Comparison of listed products
Short-acting product liraglutide is the most mainstream, several domestic manufacturers for liraglutide bioanalogues have applied for marketing, will be approved later, so short-acting products, now manufacturers are relatively small in number, but in the future, if a large number of approved for marketing, may be the domestic supply will be relatively fast.
For long-acting weekly preparations, the hot ones sold now are mainly two products, one is dulaglutide, the other is semeglutide, the products of these two foreign-funded enterprises are now due to the impact of production capacity, the supply is relatively small, this year it is relatively difficult to return to a normal supply level; The long-acting product of polyethylene glycol rosenatide produced by domestic Hausen has recently been put up in rapid quantities. Weekly preparation products are still in the stage of gradually meeting domestic demand in the production capacity of foreign-funded enterprises and domestic enterprises.
Oral administration is still in the stage of R&D application.
Domestic has been on liraglutide and dulaglutide, they have certain differences in use:
Novo Nordisk's liraglutide, single package is a monthly dose design, so patients in the early adaptation process of this product, can have a dose climbing process, can be through the injection pen to adjust the dose of each shot, the selling point is mainly in its product dose table adjustment flexibility, and its clinical data advantages;
Dula glycopeptide (Eli Lilly) is a weekly injection of packaging, is a standard dose, in the flexibility of dose adjustment is a little worse, but it is simple and convenient to use, no need to adjust the dose, directly take it back can be played, the operation will be relatively simple, no need to convert.
Due to this obvious difference, it may be that in the process of clinicians' prescription, different doctors' usage habits will be different, and some doctors may pay more attention to the dose adjustment and adaptability of this product in the early stage of the patient, and may prefer to buy prescription Novo Nordisk's products; Some doctors feel that once such a relatively large dose, the patient's tolerance is good, the cost of early patient education is relatively low, and they may be willing to use Lilly's products. Therefore, both manufacturers have their own specific prescription of the doctor population, and then superimposed dulaglutide is indeed for some specific patients, the effect will be better, the tolerance performance will be better, and there will be a need for some special prescriptions.
Six. Domestic R&D progress
Dual-target products
Compared with the original product, whether it is blood sugar control or weight loss effect, it is more obvious, and it is also the direction to focus on in the future.
Now the fastest in the dual-target layout is the foreign-funded Lilly, and the domestic Cinda has reached the late stage of research and development.
Long-lasting products
Hausen's products have been on the market a few years ago, and there may be biosimilars such as semeglutide in the back, and several have entered the clinical phase III research stage, and the research and development is relatively advanced.
Short-acting products
As far as the bioanalogues of liraglutide are concerned, several have submitted marketing applications, and the research and development is relatively fast.
Oral tablets
Novo Nordisk has a domestic listing plan for this product, for other manufacturers, because of the patent problem of the excipients of the product, so now only East China has made a small molecule of drugs, but also oral tablets, the progress will be relatively faster, it can be seen that the relative layout of tablets will be less.
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Special reminder: This article is an investment logic sharing and does not constitute investment advice.
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