Controversy Surrounding Improper Use of Semaglutide Triggers Concerns over GLP-1 Production: A Deep Dive

In recent days, the pharmaceutical market has been buzzing with new developments. First, the withdrawal of the PDC drug Pepaxto by the FDA prompted a reevaluation of the characteristics and advantages of PDC in the CMC field, highlighting the challenges of post-approval indications. Following this, BeiGene achieved a significant milestone with its drug Zebrutinib, generating $1.3 billion in revenue in 2023 and becoming the first domestic "billion-dollar molecule." Now, the GLP-1 market has become the center of attention due to the polarizing discussions on the improper use of semaglutide, which has surged in popularity among users. Simultaneously, Viking, a rising star in the GLP-1 market, announced successful Phase II clinical trials of VK2735, showing superior weight loss effects compared to other drugs, such as exenatide, causing a 123% increase in stock price.

Clear demand for clinical weight loss, but difficult risks to control:

There is no denying the clear demand for weight loss in clinical practice, as evidenced by the popularity of discussions surrounding the improper use of semaglutide. However, it is worth contemplating why a drug that has not been approved for weight loss in China frequently dominates the trending topics related to weight loss. Despite the complex national approval process, no GLP-1 drug for weight loss has been officially launched in the domestic market. Nevertheless, due to the high prevalence of obesity in China and the proven efficacy and safety of semaglutide, it has been included in the "off-label use directory" by provincial pharmaceutical societies, serving as the "only" legitimate channel for obese patients to access semaglutide. However, it is important to note that the standards for off-label use are stringent. For example, the Guangdong Provincial Pharmaceutical Society stipulates that semaglutide can only be used off-label in two scenarios: when a patient's BMI is greater than 30 or when their BMI is between 27 and 30, accompanied by obesity-related complications such as hypertension, dyslipidemia, or fatty liver. However, the abuse of semaglutide extends beyond severely obese patients who meet the off-label use criteria. Many individuals who do not meet the criteria are the primary abusers of this drug, which can exacerbate side effects such as nausea, vomiting, malnutrition, and acute gastritis, leading to more severe health issues. Additionally, the abusers often hold the misguided belief that weight loss is a simple trade-off, considering the cost of semaglutide as minimal compared to the time and money spent on exercise or surgery. Unfortunately, this overlooks the potential health risks associated with medication side effects and the serious consequences of abusing drugs for weight loss.

Strained GLP-1 production and prioritizing diabetes treatment:

GLP-1 has become the hottest area of drug development in recent years, with many companies seeking a share of the market. However, unlike the competitive landscape in the research and development field, the main challenge on the market side stems from "production capacity anxiety." Since 2017, Novo Nordisk has been expanding its production capacity, and news of its investment in new factories and expansions has been frequent. The aim is to increase the production capacity of GLP-1 drugs. However, these efforts have been unable to effectively alleviate the global shortage of semaglutide. In April 2022, the Australian Therapeutic Goods Administration started receiving continuous feedback from patients and doctors about the shortage of Ozempic. In October 2022, the European Medicines Agency also reported intermittent shortages of semaglutide, which were expected to persist into the following year. In March 2023, the European Medicines Agency issued another statement, indicating that the shortage of semaglutide was expected to continue throughout the year and urged doctors to prioritize semaglutide injections for diabetes patients rather than selling it as a weight loss drug. In light of this situation, it seems that governments worldwide have recognized that although the target audience for semaglutide in weight loss is much larger than the diabetes market, it is equally important to promote the approval of more GLP-1 drugs for diabetes treatment while restricting some of the production capacity to prioritize diabetes medications. Furthermore, in the case of unapproved weight loss indications in China, it may be necessary to consider tightening the standards for off-label use of semaglutide.

The improper use of semaglutide has sparked controversy and raised concerns about the production capacity of GLP-1 drugs. While the demand for weight loss is evident in clinical practice, the risks associated with improper use must be carefully controlled. The abuse of semaglutide by individuals who do not meet the off-label use criteria can lead to exacerbated side effects and serious health consequences.