**: Pharmaceutical Intelligence Headlines***
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In recent days, the hot spots of the new drug market have been constantly changing.
First of all, the first PDC drug Pepaxto was withdrawn from the market by the FDA, which triggered the industry to re-examine the characteristics and advantages of PDC in the field of CMC, and at the same time, the self-certification problem after the launch of the new drug indication reappeared.
Immediately afterwards, BeiGene reported good news, and its drug "zanubrutinib" recorded a revenue of $1.3 billion in 2023, ranking among the ranks of "blockbuster" drugs and becoming the first "billion-dollar molecule" in China.
Nowadays, the polarized content of GLP-1 market and user has become a new hot spot, on the one hand, on the user side, the topic of semaglutide abuse has successfully rushed to the hot search; On the market side, GLP-1 rookie Viking announced that the phase II clinical study of VK2735 had reached the primary endpoint, and the weight loss effect far exceeded that of the drug "tirpatide" with the same mechanism of action, with a stock price of **123% on the day.
Hot search, ** pass.
The need for clinical weight loss is clearBut the risks are difficult to control
It is undeniable that the clinical demand for weight loss is very clear, otherwise there would be no topic of semaglutide abuse, but at the same time, a drug that has not been approved for weight loss in China is frequently searched for weight loss, but it is also worth pondering.
As far as the current access to semaglutide is concerned, due to the complexity of the national approval process, there is currently no GLP-1 approved for weight loss on the domestic market, but due to the high incidence of obesity in China, and semaglutide does have good efficacy and safety, the provincial medical society has been included in the "off-label use list", which is also the "only" formal channel for obese patients to obtain semaglutide.
However, it is obvious that the standard for off-label use of drugs is undoubtedly very strict, such as the Guangdong Pharmaceutical Association, only the following two situations can be used off-label semaglutide:
When the patient's BMI is greater than 30;
When the BMI is greater than 27 and less than 30, but obesity-related complications, such as hypertension, hyperlipidemia, fatty liver, etc., occur;
In fact, the abuse of semaglutide is not limited to severely obese patients. In fact, many people who do not meet the criteria for off-label medication are the main groups of drug abuse, which can not only lead to the exacerbation of the drug, such as nausea, vomiting, malnutrition and acute gastritis, but also lead to more serious health problems.
Second, people who abuse semaglutide often have the wrong idea that ** must be an equivalent exchange process. They believe that semaglutide is the least expensive compared to the time and money costs of exercise, surgery, etc. However, this notion ignores the potential threat of drugs*** to physical health, as well as the serious consequences that can result from substance abuse.
In the end, more and more people choose to compromise on the drug weight loss of semaglutide, and a large number of overweight patients gather in the weight management department of the hospital, which consumes a large proportion of production capacity, resulting in the situation that diabetic patients in some areas even have "no medicine available".
GLP-1 production capacity is tight, and priority should be given to diabetes medication
As we all know, GLP-1 is the hottest new drug R&D direction in the past two years, and many companies want to get a piece of the pie, but unlike the R&D side of the major pharmaceutical companies competing for efficacy, the biggest challenge in the market is "capacity anxiety".
Since 2017, Novo Nordisk has begun to expand its production capacity, and last year, Novo Nordisk frequently invested in the construction of factories and factory expansions, aiming to expand the production capacity of GLP-1 drugs, but it has not been able to effectively alleviate the global shortage of semaglutide.
In April 2022, the Therapeutic Goods Administration of Australia began receiving feedback from patients and physicians on the Ozempic shortage.
In October 2022, the European Medicines Agency also said that semaglutide has been intermittently out of stock, and the shortage will continue until the following year.
In March 2023, the European Medicines Agency issued another statement that the shortage of semaglutide is expected to continue throughout 2023, asking doctors to prioritize semaglutide injections for diabetic patients rather than as a drug.
In this case, compared with the world, the world may have realized that although the audience of semaglutide in the field of weight loss is much larger than that of the diabetes market, on the one hand, it is equally important to limit part of the production capacity to give priority to diabetes drugs while promoting the approval of more GLP-1 marketing in order to seek "open source".
glp-1The "domestic substitution" is the future
Of course, since the market demand, it is not advisable to blindly restrict the market, and for the domestic market, how to achieve "local **" will also be carried out simultaneously.
According to a report by Qiushi Pharmaceutical Society, by the end of 2023, there are as many as 102 GLP-1 drugs under clinical development worldwide, of which 47% (48 102) are from domestic pharmaceutical companies. Among them, 30 were GLP-1R single-target agonists and 18 were GLP-1R multi-target agonists. In addition to old diabetic players such as Tonghua Dongbao and Gan & Lee Pharmaceutical, big-name pharmaceutical companies such as East China, Hengrui, and Xinda are vying to enter the game.
Data**: Collation of pharmaceutical intelligence data and public data.
Manual sorting, mistakes are expected to be corrected).
The backbone of the GLP-1 field
Hengrui Pharmaceutical: 5 new drugs have entered the clinic
If you want to say that the country with the most R&D volume in the world, it must be China, and for Hengrui Pharmaceutical, which is committed to the transformation of innovative drugs, GLP-1 is naturally impossible to let go, as of now, Hengrui Pharmaceutical has 5 new GLP-1 drugs have entered the clinical research stage.
1.Pipeline 1: Nolis glycopeptide
"Noli glycotide" is currently the most advanced new drug product developed by Hengrui, jointly developed by Hengrui and Haosen, and has entered the phase III clinical stage, as a derivative of liraglutide, compared with liraglutide, the probability of adverse reactions is lower, but compared with semaglutide, both in terms of effectiveness and drug cycle, there are disadvantages (noliglutide is a daily injection, semaglutide is a weekly preparation).
2.Pipeline 2: HRS9531
"HRS9531" is a new drug under development targeting GIPR GLP-1R by Hengrui, which in principle belongs to the same target drug as Eli Lilly's tirpatide, and is currently in the phase II clinical stage, and in its recently published phase Ib clinical data, its pharmacokinetics and pharmacodynamics have shown good data, with good safety, tolerability and hypoglycemic efficacy. Coupled with the market recognition of tirpatide, HRS9531 has a great future.
3.Pipeline 3: HRS-7535
"HRS-7535" is a new oral small molecule GLP-1RA from Hengrui, which has also entered the phase II clinical stage, compared with traditional macromolecule drugs, its oral properties have a huge advantage in patient compliance, and its phase I study results show that the adverse reactions during the ** period are mild (liver metabolism and gastrointestinal reactions are one of the safety challenges of GLP-1RA).
Biotech rookie in the field of GLP-1
Xianweida Biotech: Focus on GLP-1
As a rookie of GLP-1 in China, it has been committed to the research and development of GLP-1 drugs since its establishment, and currently has 6 drugs under development, of which five drugs are GLP-1RA drugs, except for XW014, which is a small molecule GLP-1, and the rest are peptide GLP-1.
1.XW003: Long-acting injection of GLP-1RA
XW003 (ECNOGLUTIDE) is a novel, long-acting and targeted GLP-1 receptor agonist developed by Xianweida Biotech, which is optimized to improve biological activity, reduce production costs, and meet the needs of weekly dosing. In its phase and phase clinical studies, XW003 has demonstrated good safety and tolerability, and has benefited both patients with type 2 diabetes and obesity, and multiple phase registration clinical trials are currently ongoing.
2.XW004: Long-acting oral formulation
XW004 is an oral formulation of ECNOGLUTIDE, a new long-acting GLP-1 peptide drug independently developed by Xianweida, which can prevent the degradation of the active substance ECNOGLUTIDE in the gastrointestinal tract and help it enter the bloodstream by combining with an oral absorption enhancer, so as to achieve oral administration once a day or even longer, further improving patient compliance. It has now initiated a Phase I clinical study in China and Australia.
3.XW014: Oral small molecule GLP-1RA
XW014 is a novel oral small molecule GLP-1 receptor agonist being developed for the treatment of obesity (Phase I) and type 2 diabetes (Phase I). XW014 has now initiated a Phase I clinical study in the United States. The best feature of XW014 is that it is not only easier to produce, but also has a high degree of oral bioavailability. At the same time, XW014 also has the potential to co-develop combination formulations with other oral drugs with complementary mechanisms to achieve better clinical efficacy.
Summary
In fact, in the eyes of most people, whether to rely on GLP-1 drugs such as semaglutide to lose weight is actually not so concerned. But if there is no medicine available for diabetics because of a large amount of production capacity invested in weight loss, it seems to be putting the cart before the horse.
Now, on the one hand, the off-label drug requirements and specifications for GLP-1 are gradually tightened, so that more GLP-1 production capacity can serve more urgent diabetic patients; On the other hand, it is best to accelerate the "homegrown**" development of GLP-1 drugs to achieve both weight loss and diabetes.
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