"One needle per week, 20 pounds a month thin"?CDE has not yet released!GLP-1 hypoglycemic drugs have become the "underground darling" of the weight loss
Author:Daily Economic News Time:2022.07.01
"One fat destroys everything, a need to solve your heart."
How attractive is Smeglugan peptide to weight loss group? This propaganda is exaggerated, but it undoubtedly hit the psychological pain point of this group.
In June 2021, the FDA (US Food and Drug Administration) approved Smegugu peptide for chronic weight management, and immediately, the "dark line" of hypoglycemic drugs turned into a weight loss needle began to expand its market in China.
Even if the drug was approved by the CDE (Drug Review Center of the State Drug Administration), only the indication of the treatment of only type 2 diabetes, but in the "convenient" and "safety" remarks, the use of the population quietly expanded from obese patients to slimming to lose weight person. A number of people who came into contact with "Daily Economic News" reporters who aimed to lose weight said that they got drugs from a public hospital. In addition, third -party drug sales platforms and purchasing drug channels have been discovered by more people, and under some concepts of thin beauty, the boundary of the compliance red line is even more blurred.
When will the "ground market" be released to end the chaos? This may not be far away. In the moment when Nuo and Nord (NVO, the stock price of NVO, $ 110.08, a market value of $ 249.4 billion) will lose patent rights in less than one year, and drug research and development of many domestic pharmaceutical companies has entered the later clinical clinical period. The upgrading of domestic GLP-1 diet pills is starting.
Photo source: Photo Network-500802625
The weight loss needle in the purchasing mouth: BMI can be used by exceeding the standard, and it can be used normally
It is three poisonous medicines, let alone diet pills with frequent safety events?
The post -95 girl Jiang Li (pseudonym) knew this, but when she was 166cm tall and weighed 80kg, she heard a friend talk about a "strong wind" on social platform.
That is a hypoglycemic drug called "Smegutu". In the graphic shared by users, the basic information of the product is rarely mentioned. More display is " Dry goods. Descriptions such as self -injection, weekly needle, no pain, decreased appetite, and ten pounds of lunar monthly are all about the desire to buy weight loss people such as Jiang Li.
Therefore, even though some users said that during the early stage of use, they had side effects such as dizziness, nausea, and constipation, and Jiang Li still consulted with friends who were nurses in the Third Hospital. After learning that some medical staff were also using this drug to lose weight, she finally finally used this drug. She finally finally used this drug. She finally finally used this drug. Make up to start.
Registered in the endocrinology department of the regular public hospital, the thyroid examination, and obtained the suggestion of the doctor ... Jiang Li, who has a slight fatty liver, finally got the Smegugu peptide injection with a specification of 1.34mg. In accordance with the dose of the doctor, she injected herself every week. With diet and exercise, she weighed more than 10 pounds in the first month. After the second month was discontinued, she continued to control the diet and exercise, and she did not rebound.
However, for Cheng Mei (pseudonym), which is more rich in weight loss, the effect of weight loss needle seems a bit "high or low."
She is 160cm tall and weighs 65kg now. She is now a fat crowd, and the BMI value is not far from the standard value. Cheng Mei has tried most of it, including the use of a ductin peptide injection that made her 7 catties of weight lighter in one month.
Cheng Mei told the reporter of "Daily Economic News" that this product is the same as the "weight loss needle" as Simi Gulu peptide, but the weight loss effect is neither as good as fitness and healthy, so it does not continue to use it.
The reporter noticed that although Chengmei's attitude towards weight loss injections was inconsistent with Jiang Li, she also chose to go to the public triple hospital for consultation, and successfully took medicine after thyroid examination. "I don't believe them (purchasing), it is medicine."
In fact, many people choose to purchase or third -party pharmaceutical platforms. However, the reporter of the Daily Economic News found that these channels may also have a cross -line operation in operation, that is, contemporary purchaser or platform party cannot or at all will not review the prescriptions of buyers.
On June 26, a "weight loss needle" (Smeglugan injection) user recommended the purchasing purchasing he had contacted to the Daily Economic News. "This is a subcutaneous injection that can be injected by itself, the effect is very good, many people are using it."
According to the person, BMI is generally greater than 24 (Reporter Note: In fact, 24 ~ 27.9 is fat, greater than or equal to 28 as obesity). For the case of BMI consulted by reporters Weight loss needle, it is recommended to get 3, each one can be used for one month, injected once a week on the stomach, and used for 3 months in a row to judge subsequent medication according to the effect of use. The side effect is that it may be disgusting and constipation at first. And when the reporter asked the purchasing agent if he could use the medicine with BMI as 21, the purchasing purchase also gave a positive answer, and said that "two stitches in injection, you can lose ten pounds in about two months."
That is to say, in this purchasing mouth, as long as he wants to lose weight, Smeglugin peptide can be called "universal medicine".
Image source: Purchase provided pictures
However, unlike the exaggerated publicity of "20 pounds of weight loss per month" circulating on the market, the weight loss needle is not once and for all. The person said that in terms of diet, users should control the intake of sugar and cooperate with the campaign such as jogging to speed up metabolism.
In addition, patients and patients with a history of thyroid cancer and pancreatitis cannot use the Smeguglitan peptide injection, but go to the hospital to see a doctor for a doctor. It seems that it is not necessary in the description of the purchasing purchase. "You can do a thyroid examination. Generally speaking, there is not much problem." In order to persuade the reporter to buy, the purchasing agent also appeared that he was also using it. BMI had dropped from 21 to 20. If necessary, you can send the product to the user's home.
The "weight loss needle" that the hospital can also open has not been approved for weight loss indications
"Daily Economic News" reporter further investigated found that the phenomenon of Smegugan peptide injection as "weight loss pills" was used in grass -roots hospitals.
On June 27, an endocrinologist who has worked in the county -level public hospital for decades in an interview with the reporter of "Daily Economic News" reported that he was approved by the FDA in June last year from Smeglugin injection. After chronic weight management, in the past year, the consultant went to the hospital to take the GLP-1 receptor agonist drug for weight loss.
The doctor told reporters that Smeglugin was mainly used for patients with type 2 diabetes combined with ASCVD. The domestic and foreign diabetes guidelines were highly recommended and have primary evidence evidence evidence. At present, such drugs have not been approved by CDE for patients with pure obesity. Doctors are super -adaptable drugs for non -diabetic patients who have weight loss demands. However, in the hospital where it is located, patients who have exceeded BMI and patients who have reached a certain standard for blood lipid examinations will be given the premise that the patient knows the consent of the patient (including informing the patient's related indications in the country without approval). Postering a month of medicine, and it is recommended that patients review blood lipids, liver and kidney function one month later, and then decide whether to continue medication.
It is worth noting that, as a "weight loss needle" user who took medicine from the public hospital/three hospitals, Jiang Li and Cheng Mei said they did not know that their weight loss -related indications were not approved by the CDE. The reaction was reminded.
"I think the three hospitals can be approved." This is also the cognitive blind zone of most people's cognitive diet pills in China, that is, although the obesity market is vast, Bishengyuan, green and thin Chinese pills, etc. are promoted a lot, and even Bishengyuan (HK00926, HK $ 2.38, a market value of HK $ 96.974 million) The Hong Kong stock market was listed, but in fact, CDE only approved one drug, namely Olisa Capsule, for patients with obesity or overweight.
Olis is a gastrointestinal lipase inhibitor. By forming a covalent bonding binding with the active liponine in the gastrointestinal cavity and pancreatic lipase, the lipase can not live the fat in the food (mainly the glycerin Triglysis is decomposed into absorbable free fatty acids and monoclonal glycerin, thereby reducing calorie intake, controlling weight gain, and achieving the purpose of controlling weight, hypoglycemic, and lowering blood pressure.
According to Mine.com data, as of June 28, there were 21 criteria for different dosage forms and specifications of Oli Sinic. The production enterprises include Zhi En Pharmaceutical and Roche Pharmaceutical (RHHBY, with a stock price of $ 41.81, with a market value of 360.64 billion US dollars. ), Haizheng Pharmaceutical (SH600267, stock price 12.81 yuan, market value of 15.349 billion yuan), East China Pharmaceutical (SZ000963, stock price 45.16 yuan, market value of 79.021 billion yuan), China, the United States, East China and Watson Pharmaceutical.
According to Bi Shengyuan's 2021 annual report, the company passed the subsidiary Zhongshan Wanhan Pharmaceutical and Zhongshan Wanyuan R & D, production and sales of Bishengyuan Olis, in 2021, the company's Oli Siwan product sales sold 855 million yuan, accounting for 28.85 market share 28.85 %.
However, on the black cat complaint platform, there are also many complaints about Olis, including diarrhea, oily stools, and excretion of incontinence. The above -mentioned endocrinologists also told reporters that many patients have caused a large amount of oil, staining clothes, and even affecting normal work because of taking Olis. Because the drug mainly controls the absorption of fat in the gastrointestinal tract, if the patient usually has less oil and water, the weight loss effect is not great.
Therefore, the secret explosion of "weight loss needles" such as Smeglugan injection stems from seemingly better experience and effects, but also related to the time difference between drug -related indications at home and abroad.
At present, multiple weight control drugs have been approved to be listed globally. In the United States, the related drugs that FDAs have approved include Oli, chlorocarlin, Fenming, Finteming, and Toporane Smooth Capsules, Natatone Hydrochloride and Pharium Hydrochloride, and Licoluta peptide , Simi Glugin, Tirzepatide.
Among them, Leralugin, Smeglugin, and Tirzepatide are all GLP-1 receptor agonist drugs, which can inhibit appetite, and generally injection of subcutaneous injection. The first two manufacturers are Novosho, and the year of approved is 2014 and 2021, respectively, with the target of GLP-1R; TirzePatide manufacturer is Lilly Pharmaceutical (Lly, a stock price of 323 US dollars, a market value of US $ 3060.02 billion). The approval time of the drug is May this year, acting on the target GLP-1R and GIPR.
Taking the Smeglugin peptide used by Jiangli as an example, the specific approval situation is for chronic weight management, as a diet that reduces calories and increases exercise weight loss. It is suitable for obese adults (weight index BMI ≥ 30) or Patients with BMI ≥ 27 and at least 1 type of weight -related complications (such as hypertension, type 2 diabetes or abnormal blood lipids). Photo source: Photo Network -501311358
A number of domestic enterprises have deployed dual targets and oral dosage type competition upgrades of weight loss pills
At present, the obesity market in my country is almost uns development, and there are few choices for patients with obesity, but this does not mean that weight loss drugs lack the market.
According to the "Report of the Nutrition and Chronic Diseases of Chinese Residents (2020)", more than 50%of adult residents in my country are overweight or obese, and children and adolescents under the age of 17 and under 6 years of age are overweight/obesity rates reached 19%and 10.4%respectively; 18 The obesity rate of residents over the age of 16.4%, an overweight rate of 34.3%. The weight control of overweight and obese patients has become an urgent clinical needs.
Obesity patients are eager to get rid of fat, and this "market fat" also makes many drug development companies dream. At present, Tirzepatide, a Tirzepatide of Nordan's Smegugu and Lili Pharmaceutical, has been conducted in the related clinical trials of China to stage III, and Bollinger's BI456906 injection liquid is in phase II.
As the earliest GLP-1-type weight loss patent patent patent approved by the world will fail from 2022 to 2023, many domestic pharmaceutical companies have also launched a layout.
Among them, East China Medicine's first application for listing of similar drugs for Liculace peptides, but the application for the first submitted to control blood glucose indications. In April of this year, East China Pharmaceutical (SZ000963, a stock price of 45.16 yuan, and a market value of 79.021 billion yuan) stated on investor interactive platform that the weight loss indication of Liculugin has completed the clinical clinical of III and is in the Pre-NDA stage. It is expected to be this year in this year. Submit a listing application in the second quarter. In addition to East China Medicine, Tonghua Dongbao (SH600867, stock price of 10.34 yuan, market value of 20.779 billion yuan), Hanyu Pharmaceutical (SZ300199, stock price 13.87 yuan, market value 12.718 billion yuan) and other listed companies also lay out the Licula -peptide pipeline.
On June 23, East China Pharmaceutical announced that Hangzhou China and the United States East China Pharmaceuticals and well -known enterprises in the Middle East Gulf Pharmaceutical Inustries PJSC reached a strategic cooperation to award the latter two indications of the latter Leraru peptide injection product diabetes and weight loss in the Middle East and North Africa. The development, production and commercialization of 17 countries.
Licuru peptide injection picture source: screenshot of third -party platform
In terms of Smegugan peptide, East China Medicine also ran ahead. Up to now, the Domestic Federation of Zhuhai, Hangzhou Jiuyuan Gene, Lizhu Group (SZ000513, shares of 36.21 yuan, a market value of 33.852 billion yuan), Hangzhou China -US East China Pharmaceutical/Chongqing Pharmaceuticals and Qilu Pharmaceuticals have submitted clinical trial applications. Among them, Hangzhou Jiuyuan Gene and Chongqing Pai Gold are all participating companies in East China Pharmaceutical.
In addition to Leratum peptides and Smegutlin, there are also Shanghai Renhui Biological, Hengrui Pharmaceutical (SH600276, stock price of 37.09 yuan, market value of 236.597 billion yuan), Cinda Bio (HK01801, HK $ 34.9, a market value of HK $ 511.191 billion ), Ganli Pharmaceuticals (SH603087, stock price 47.97 yuan, market value 26.937 billion yuan) and other enterprises such as GLP-1 receptor agonies, involving Benanutan peptides, Norolgosaccharides, and ductal peptides.
Among them, the Benitan peptide, which is developed by Shanghai Renhui Bio, was reported to be produced in March this year. However, because Benanugin needs to be injected 3 times a day, there is some restrictions on patient compliance.
At the same time, the competition for domestic GLP-1 drugs is also being upgraded, and some pharmaceutical companies have arranged the dual-target or multi-target GLP-1 receptor agonist. For example, the Mazdutide (R & D code: IBI362) jointly developed by Cinda Bio and Lili Lili is the GLP-1/GCG dual receptor agonist. In June of this year, Cinda Bio announced a phase II clinical results of the drug reached the main clinical end and all key secondary clinical end. The results of the study showed that the dose of Mazdutide showed a significant weight loss effect among China ’s overweight or obesity subjects, and presented dosage dependence.
In addition, compared with the injection type, oral drugs are more convenient to use, which can improve the compliance of patients and achieve better weight loss effects. Therefore, major pharmaceutical companies are full. Market status to grab the opportunity.
To cope with possible competition, Novo Nord has been in his hands. According to media reports, on April 21, 2021, Novo Nordon announced that it would start a key 3A phase of clinical trials in patients with about 1,000 obesity or overweight patients with complications. Effectiveness and safety. This 68 -week global trial is planned to launch in the second half of last year.
On June 29, East China Pharmaceutical told the reporter of "Daily Economic News" through WeChat that from the perspective of patients, oral drugs are more convenient to use and have higher dependence than injection drugs. In addition, dual-target, multi-target agonist, and long-acting preparations are becoming one of the popular directions of the GLP-1 new drug research and development. At present, East China Pharmaceutical has differentiated layouts in the field of obesity and overweight treatment around the GLP-1 target. In addition to Olis's oral drug weight loss products, the company may also lay out oral GLP-1 weight loss products in the future.
Is it safe to use the drug? Doctor: This is not a fool -type weight loss drug, advocate "tube mouth"
Before the relevant indications for developing drugs in domestic pharmaceutical companies were approved, the weight loss effects of various types of hypoglycemic drugs were spread among the weight loss groups. So, does the situation of super -adaptable drugs existing in public hospitals, users through purchasing or third -party platforms to purchase drugs, do you imply risks?
On June 27, Professor Yuan Qun, the former director of the Department of Endocrinology of the PLA Air Force General Hospital (Diabetes Research Center), said in an interview with the reporter of "Daily Economic News". safe".
Specifically, regardless of the drug, the scope of use should be subject to national approval and instructions. Smeglugin is currently only approved by the CDE approval of diabetes. It is used as a weight -loss drug. First of all, for doctors who prescribe drugs, they may involve illegal. For users who obtain drugs from internal or outdoor channels, risks also require individuals to bear.
"Any drug to enter the country and get new indications for new indications should first be applied for a long time in the real world. The second is that it must be strictly clinical trials in China. Without approval, there is no approved indications, and there is no approved indications. Even if it is indeed overweight or obese patients, it should not use Smeglugin peptide for the purpose of controlling weight. "Yuan Qun said.
He said that in the past, a large number of drugs proved that the effectiveness of different ethnic groups, different links and living habits may be inconsistent. Although drugs and other drugs such as Smeglugin are approved abroad to lose weight, it remains to be proved to whether it can be used in the same safety and effectiveness in domestic people.
As a biological preparation, Simi Gutan has stricter regulations for transportation and use, and the scope and long -term role should be strictly observed. For example, Yuan Qun said that Smeguti peptide should be preserved and transported by the whole process, and users may not even know these precautions during the process of obtaining the drug in violation of regulations, resulting in the drugs may have deteriorated during use. Secondly, Smeglugin peptide is different as a hypoglycemic drug, which is different from the dose of weight loss drugs. The use of different individuals is not consistent. Blind drugs are very easy to generate risks.
Photo source: Photo Network-500313289
"This is not a fool -type weight loss drug. There may be risks and problems in any link." As Yuan Qun reminded, the instruction manual of Smegugu peptide also clearly reminds -the drug should be stored in the refrigerator (before the first use of this drug (the drug should be stored in the refrigerator for first use ( 2 ℃), stay away from the frozen element, do not use it after freezing. After the first use, it should be stored in an environment below 30 ° C or in the refrigerator (2 ° C to 8 ° C), and it should be saved when not in use. It can be seen that the Smegugi peptide has strict requirements on the environment from storage and transportation to use, and it is not possible to use it from the hospital or purchasing department.
Among the restrictions and disable people, the use instructions also make clear reminders of pregnant women and lactating women, children, and elderly people. At the same time, Smegugu peptide may interact with heating dyspitic drugs and oral contraceptives.
The reporter noticed that even the weight -loss drugs that have been approved were faced with many tests. CDE's "Principles of the Technical Guidance of the Clinical Test of Drug Control Drugs" (hereinafter referred to as "Principles") released by CDE at the end of last year, specifically pointed out that because the overweight and obesity are chronic metabolic diseases, long -term drug intervention needs to focus on investigating liver, kidneys, and heart The influence of blood vessels and other systems. In recent years, a variety of weight -loss drugs that have been withdrawn in recent years have exposed addiction, dependence, and increased safety risks of cardiovascular.
The use of weight loss drugs should not be blind. The "Principles" clearly stipulates that 28kg/㎡ ≥ BMI ≥ 24kg/㎡ is overweight and BMI ≥ 28kg/㎡ is obesity. Only BMI ≥ 24kg/㎡ and have complications, or BMI ≥ 28kg/㎡, whether or not there are complications or not, can not lose weight by 5%after 3 months to 6 months. , Consider weight loss drug treatment. In order to regulate the clinical trials of instructors to control drugs, the "Principles" provisions on the symptoms of drug treatment, clinical trial design points, and safety.
Yuan Qun lamented that the most reliable way to lose weight is still "relying on yourself, holding his mouth, and opening his legs." Yuan Qun said that obesity is divided into pathological obesity and physiological obesity. If it is pathological obesity, it needs to be treated at the corresponding diagnosis room. If it is physiological obesity, the best way is to adjust lifestyle.
The nutritional department, endocrinology, and traditional Chinese medicine department of regular hospitals can play the role of guiding and controlling weight. If you want to achieve a shortcut weight loss by taking medicine, it is undoubtedly "drinking and quenching thirst." Yuan Qun emphasized: "Don't imagine that you can eat and drink every day without exercise, you can lose weight with a shot."
Daily Economic News
- END -
On July 5th, there were no new cases of new coronary pneumonia in Nanjing
Epidemic noticeAccording to the Provincial Health Commission released on July 6, at 0-24 on July 5, 2022, there were no new local confirmed cases in our city, and there were no new local infections.re
Notice of the General Office of the National Health and Health Commission on issuing unknown reasons for children's serious acute hepatitis diagnosis and treatment (trial)
National Health Office doctor [2022] No. 206Provincial, autonomous regions, municipalities, and Xinjiang Production and Construction Corps Health and Health Commission:Since March 2022, many countries