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According to the Beijing News, since August this year, the "miracle drug for weight loss" semeglutide injection has been out of stock in major cities
.
On the other hand, on the Internet drug sales platform, the price of semeglutide has been hyped to thousands of yuan
.
And some merchants said: if there is no prescription, the merchant can provide prescriptions to help consumers successfully purchase semeglutide
.
Behind this chaos, all show the popularity of the diet drug market, today let's unveil the mystery of this "money-making effect" market
.
01 "Explosive" weight-loss drug semeglutide, and potentially the strongest telpotide
01 "Explosive" weight-loss drug semeglutide, and potentially the strongest telpotideIn China, weight loss drugs can currently be divided into three categories, including: appetite suppressant, hindering fat absorption and promoting metabolism
.
●
The representative drug of appetite suppression is sibutramine, which is a nerve center drug, which was first used to treat depression, and was later found to cause anorexia in patients and hit the market, further studies found that it will cause damage to cardiovascular and cerebrovascular diseases, central nervous system, liver and kidney function, etc.
, and stopped production and sales in China since 2010;
●
The representative drug that hinders fat absorption is oselstat, a product that inhibits the absorption of fat in the gastrointestinal tract, and was once popular nationwide
because it can be sold in retail channels.
However, because some fat will be excreted as it is not digested, the stool becomes "oily" and slips involuntarily, causing inconvenience
to the user's life.
● Metabolism promotion is Besunyen Changrun tea led by slimming tea, consumers will lose weight in the early stage of taking, but often reduce water, after stopping to quickly rebound, side effects include electrolyte confusion, shock, etc
.
According to WHO data, the number of obese patients in the world in 2021 was 650 million; according to Sullivan and Zhiyan consulting data, the number of obese people in China in 2020 was 220 million, accounting for 15.
6% of the total population of
the country.
From 2016 to 2020, the global market for weight loss drugs increased from US$1.
8 billion to US$2.
6 billion, and the Chinese market increased from RMB260 million to RMB1.
9 billion, with a significantly higher domestic growth rate than the world
.
However, in the domestic market, there is a significant mismatch between market demand and supply
.
.
At present, the FDA has approved 6 drugs for weight loss indications, while only oselitat has been approved
in China.
Because liraglutide and semeglutide have less fatal side effects and low degree, they are widely favored by the market, although the indications for weight loss have not been approved in China, it is still difficult to stop the enthusiasm
of patients & consumers.
In the field of weight loss, liraglutide and semeglutide achieved revenue of DKK 8.
4 billion in 2021, with shipments exceeding USD 1 billion; Considering that semeglutide has only begun to increase in volume in 21 years, there is broad
room for future growth.
Although both targets are GLP-1, compared with liraglutide, semeglutide has advantages in both compliance and effectiveness, and liraglutide needs to be injected daily in terms of compliance, while semeglutide only needs to be injected once a week; In terms of effect, clinical trial data showed that liraglutide and semeglutide lost an average of 6% and 16%,
respectively, within 68 weeks.
It is worth noting that the indications for weight loss of liraglutide and semeglutide were approved by the FDA in December 2014 and June 2021, respectively, which means that there is still a lot of room
for semeglutide.
for semeglutide.
Eli Lilly's GIP/GLP-1 receptor dual agonist Tirzepatide is regarded by the market as the strongest potential hypoglycemic weight loss drug
.
In May this year, telpotide was approved by the US FDA for the treatment of blood glucose control in adult patients with type 2 diabetes, and it is in the registration application stage
in China for two indications.
According to the data of SURMOUNT-1 in the phase III clinical phase of telpotide published by Lilly, after 72 weeks of treatment, the average weight loss of participants was up to 22.
5% (24kg), and telpotide was the first weight-loss drug in the world to reduce body weight by more than 20% on average in phase III clinical trials
.
.
In addition, telpotide has been carefully designed on the patent, which increases the difficulty of imitation of opponents, such as the product pre-filled in a patent-protected auto-injector, which is a combination
of drugs and devices.
02 Domestic generic drugs and innovation layout: around GLP-1
02 Domestic generic drugs and innovation layout: around GLP-1The competition in the research and development of generic drugs of liraglutide and semeglutide has gradually entered a fierce white heat stage
.
At present, the compound patent of liraglutide has expired in 2017, the crystal patent expires in 2022, and the generic drugs of domestic East China Medicine, Jiangsu Wanbang and Aimeke are all in the clinical stage, of which East China Medicine has the fastest progress and has submitted a marketing application
.
The sequence structure patent and use patent of semeglutide expired in China in March 2026, and there are currently 3 domestic companies that have declared clinical trials according to biosimilars, and since June this year, Zhuhai Federation, Jiuyuan Gene, and Lizhu Group have submitted clinical applications
.
In terms of innovative drugs, most of the R&D layouts of weight-reducing drug pipelines, whether from global or domestic, focus on GLP-1 receptor targets
.
According to the statistics of Medicine Cube, a total of 162 clinical trials around the world involve this target, accounting for 31.
5%
of all weight loss clinical trial targets.
There are several reasons why GLP-1 receptors are a hot area of research:
1) GLP-1 is a kind of incretin insulin, which can activate GLP-1 receptors throughout the body, enhance insulin secretion and inhibit glucagon secretion, delay gastric emptying, and reduce food intake through central appetite suppression, thereby achieving the effect
of lowering blood sugar and losing weight.
2) Based on the excellent target effect, GLP-1 long-acting has become an important development strategy for pharmaceutical companies, and historically the guidance of explosive drugs such as liraglutide and semeglutide has improved the success rate
of exploration.
Due to the short half-life of natural GLP-1 and the limitation of frequent administration, Renhui's benaglutide is homologous to natural GLP-1 and administered three
times a day.
Liraglutide and semeglutide are both modified from natural GLP-1, which prolongs the half-life
.
03 Layout of domestic pharmaceutical companies: Innovent Biologics leads the progress and East China Pharmaceutical has a comprehensive layout
03 Layout of domestic pharmaceutical companies: Innovent Biologics leads the progress and East China Pharmaceutical has a comprehensive layoutAt present, there are more than 10 pharmaceutical companies in the layout of GLP-1 receptor agonists in China, and it is expected that the fastest market approval is Huadong Pharmaceutical's liraglutide, Renhui Biologics' benaglutide, and Wanbang Pharmaceutical's liraglutide.
Recently, Innovent Biologics' GLP-1R/GCGR dual-target agonist IBI362 has initiated two Phase III clinical trials for patients with diabetes, overweight or obesity
.
Cinda IBI362 was introduced from Eli Lilly in August 2019 and has interests
in Chinese mainland, Hong Kong, Macau and Taiwan.
In 2022, Innovent Biologics announced the results of the Phase Ib study: the weight loss of IBI362 (Mazdutide) high-dose group for 12 weeks of administration exceeded 11.
5%, becoming one of
the best weight loss monotherapies in the early clinical stage.
In terms of diabetes treatment, in the data of phase II clinical practice, each dose group of IBI362 showed that it can significantly reduce the level of glycated hemoglobin in patients; Innovent selected head-to-head dulaglutide in the Phase III clinical design of IBI362, demonstrating full confidence
.
Dulaglutide has shown good sales momentum since its launch (approved in China in 2019), and its global sales in 2019 reached 4.
13 billion US dollars
.
According to the domestic clinical progress, Lilly's telpotide will become the first GLP-1R dual-target agonist on the market, and IBI362 is expected to become the first domestic GLP-1R dual-target agonist
.
Huadong Medicine has a rich layout in GLP-1 targets and strives to deepen the weight loss track
.
.
Huadong Pharmaceutical's marketing application for liraglutide weight loss indication was accepted in July 2022, and it is the product
with the highest progress in weight loss indication in China.
The data shows that the domestic sales of the benchmark upgrade product Simeglutide in the first three quarters of 2022 will be about 1 billion yuan
.
Huadong Medicine has integrated a pipeline system through self-research, acquisition, BD and other ways, and the clinical application of semeglutide (somaglutide) injection has been accepted, the TTP273 oral preparation 2022Q1 introduced from VTV has completed the last subject release group of phase II clinical trial, and the multiplex agonist DR10624 developed by subsidiary Doyle Biotech was approved for phase I clinical
trial in New Zealand in April 2022.
The commercialization ability of East China Medicine in the field of diabetes has long been recognized and tested
by the market.
According to data from Minai.
com, Huadong Medicine ranked eighth among the top 10 manufacturers of diabetes drugs in public hospitals in key cities in 2020, and ranked first
among local enterprises.
In addition, domestic manufacturers such as Hengrui Pharmaceutical and Wanbang Pharmaceutical also have GLP-1 products entering the late clinical stage, and the former's noli glycopeptide is not administered weekly, and there are defects in compliance; The latter's liraglutide progress is slower than that of Huadong Pharmaceutical, and it faces the commercial squeeze of competitors, and there is pressure
to seize market share.
Conclusion: The huge obese population and the short-term mismatch between supply and demand in the diet drug market determine the explosive gene of GLP-1 receptor agonists and the market value premium brought to related companies, and look forward to the emergence
of more excellent domestic hypoglycemic innovative drugs.
