Exploring new drugs, China and India's emerging role, and the US Senate's scrutiny of Ozempic and Wegovy as the landscape of weight loss treatments transforms.
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The landscape of obesity treatment is undergoing significant transformations, driven by advances in medical science and a deeper understanding of metabolic disorders. GLP-1 RA (Receptor Agonist) drugs such as Semaglutide (active ingredient for Ozempic and Wegovy) and double powered dual RA drugs such as Tirzepatide (GLP-1 and GIP RA, active ingredient for Mounjaro and Zepbound) have set high benchmarks in the field, celebrated for their remarkable efficacy in weight loss and metabolic improvements.
As you can imagine, the vast weight loss market and the Ozempic frenzy has triggered an arm race in new drug development. According to the Daily Mail’s latest report, there will be 13 Ozempic-like medications coming in the next couple of years. And the global market is projected to hit $100 billion by 2030.
Higher efficacy drugs, oral pills, and other novo GLP-1 plus combinations are under intensive clinical trials and hopefully get it approved sooner. At the same time, pharma from China and India, usually with cheaper equivalent drugs, are also catching up on their own pace.
So what’s coming on the horizon? What’s going on in China and India? Any cheaper weight loss drugs incoming? Let’s take a look.
New Weight Loss Drugs Are in the Pipeline
Please note that the drugs mentioned below are at different stage of clinical trials, and there is no guarantee they will get through all stages and get approved by FDA.
I only list a few examples of incoming medications. Please go to this table for a thorough list of incoming weigh loss drugs published on International Journal of Obesity.
Pills instead of Shots in GLP-1 RA Universe
GLP-1 RA medications like semaglutide help you feel full, eat less, and slow down how quickly your stomach empties. They also help control your blood sugar by increasing insulin when needed and decreasing glucagon, which is a hormone that raises blood sugar levels. Currently approved medications such as Ozempic and Wegovy require patients to inject themselves under the skin, usually in areas like the abdomen, thigh, or upper arm, on a weekly basis. Not everyone is comfortable handling needles, especially so frequently. To address this, several oral pill versions of GLP-1 RAs are under clinical trials, and the early results seem promising.
Power of GIP
GIP, or Glucose-dependent Insulinotropic Polypeptide, is a hormone that plays a crucial role in managing blood sugar levels in the body (my article link). It is released from the intestines after you eat and helps stimulate the release of insulin, which is necessary for lowering blood sugar. GIP also influences how the body stores fat. In essence, it helps your body use the food you eat more effectively, converting it into energy and ensuring that blood sugar levels remain stable. Currently, researchers are testing potential drugs that target this hormone, exploring new ways to treat diabetes and obesity by harnessing GIP's functions.
Duo Power Emerging Contenders: GLP-1 RA + Multi-Modal Partners
We recognize tirzepatide by its brand names, Mounjaro and Zepbound, noted for its strong weight loss effects due to the GLP-1 and GIP RA combination. The pharmaceutical industry is exploring various combinations of GLP-1 RA with other agents such as GIP antagonists, glucagon co-agonists, amylin agonists, and peptide YY (PYY). A dozen of pharmaceuticals are developing new drugs in this area, but I won’t overwhelm you here with all the technical details.
The chart below displays GLP-1 related medications currently in development. It is sourced from the study "What is the pipeline for future medications for obesity?" published in the International Journal of Obesity in February 2024. The article also includes a comprehensive list of obesity drugs currently in the pipeline. Click here to check it out.
GLP-1 as the backbone of the pipeline for gut hormone-based obesity treatments
Source: Melson, E., Ashraf, U., Papamargaritis, D., & J. Davies, M. (2024, February 1). Glucagon-like peptide-1 as the backbone of the pipeline for gut hormone-based obesity treatments (By International Journal of Obesity). What Is the Pipeline for Future Medications for Obesity? https://www.nature.com/articles/s41366-024-01473-y/figures/2
Special Acknowledgements
This section was enriched by the valuable insights provided by Eka Melson, Uzma Ashraf, Dimitris Papamargaritis, and Melanie J. Davies in their publication titled "What is the pipeline for future medications for obesity?" which was published in the International Journal of Obesity on February 1, 2024. I highly recommend this article to anyone interested in gaining in-depth pharmacological knowledge about upcoming weight loss medications. I extend my gratitude to them for their exceptional contributions. You can access their article through the link provided below.
Ambitious Players from China and India are Entering the Market: Generic and Innovative Drugs
India’s Strategic Move into the Global Obesity Drug Market
Indian pharmaceutical powerhouses Sun Pharma, Cipla, Dr. Reddy's, and Lupin are gearing up to carve out a significant presence in the burgeoning global market for obesity treatments, currently led by popular drugs such as Novo Nordisk's Wegovy. As the global market for weight-loss drugs is forecasted to reach or exceed $100 billion annually by 2030, these Indian firms are keen on capturing a slice of this pie through strategic development of both generic and innovative drugs.
Anticipating the expiration of key patents—such as Wegovy's between 2026 and 2032 across various global markets—these companies are actively working on introducing more affordable generic versions as well as developing novel formulations. This move is strategically significant not just for global market penetration but also for addressing the escalating health crisis of obesity and type 2 diabetes back home in India. The Indian market itself presents a ripe opportunity with rising obesity rates and the world’s second-highest number of individuals with type 2 diabetes.
The approach varies among these companies. Sun Pharma is focusing on pioneering a novel drug that will undergo extensive clinical trials and seek patent protection, indicating a long-term vision for a unique market foothold. Conversely, Dr. Reddy's and Cipla are opting to replicate the success of existing therapies, aiming to produce cost-effective generic versions. This strategy not only positions them to capture a share of the massive diabetes drug market in India, valued at $2.34 billion in 2024 and expected to quadruple in the next decade, but also to compete globally as cost-effective solutions in a price-sensitive market.
Despite the opportunity, penetrating the Indian market poses significant challenges due to its price sensitivity. The affordability of obesity treatments is a crucial factor, as lower-income segments may struggle to access higher-priced drugs. Indian companies must therefore navigate a delicate balance between cost, effectiveness, and accessibility to develop a market for anti-obesity drugs in a region where low-cost alternatives and generic versions are favored by a large portion of the population. This market dynamic requires innovative pricing strategies and possibly government collaboration to make treatments both affordable and widely available.
This proactive involvement from Indian companies not only aims to meet immediate and growing global and domestic needs but also positions them as formidable players in the global arena of diabetes and obesity management. As they navigate through the complexities of drug development and market dynamics, these companies are not just eyeing immediate gains but are also setting the stage for long-term strategic dominance in the pharmaceutical sector.
China’s Obesity Drug Arms Race in its Domestic Market
On September 14 2023, Huadong Medicine, a pharmaceutical company in China, announced that the National Medical Products Administration (NMPA), FDA’s China equivalent, has approved a clinical trial application for HDM1002 tablets. This drug is an oral GLP-1 receptor agonist, aimed at weight management for overweight and obese individuals. Huadong Medicine also highlighted its ongoing development of several other products targeting GLP-1, including biosimilar semaglutide injections, dual-target agonist HDM1005 and SCO-094, and long-acting triple-target agonist DR10624, among others.
In the same month, another player, Hybio Pharmaceutical, also had its clinical trial application for semaglutide injection accepted by NMPA. The announcement also noted that other domestic companies involved in semaglutide production include Livzon Pharm, Huadong Medicine and Sinopep.
According to the PDB database, since its approval on April 29, 2021, the sales of semaglutide in Chinese hospitals have seen a rapid increase, reaching approximately 465 million Chinese Yuan ($64M in USD) in 2022.
Generic Drug Race Accelerates: Currently, Novo Nordisk is the only company selling semaglutide worldwide, as no generic versions are approved. Yet, the competition to create generic semaglutide is escalating. In 2023 alone, clinical trial applications from eight Chinese pharmaceutical companies for semaglutide were accepted by NMPA. These companies include Hybio Pharmaceutical, United Laboratories, Fosun Pharmaceutical, Huadong Medicine, CSPC Pharma Group, CR Double Crane, Huisheng Biopharmaceutical, and CTTQ Pharmaceutical.
Hybio Pharmaceutical stated in its mid-2023 semi-annual report that it has been deeply involved in the peptide industry for over 20 years, focusing on peptide preparations and raw materials. They are also exploring GLP-1 peptide drugs such as exenatide, liraglutide, semaglutide, and tirzepatide. They further announced an increase in investment for semaglutide research, with 76.65 million yuan allocated from a total fundraising goal of 254 million yuan for its development.
Innovative Drugs on the Way: The Chinese pharmaceuticals are also pushing hard on innovative drug development. Hengrui Medicine, a leader in innovative drugs, reported in its semi-annual update that it has three GLP-1 drugs under development, including HRS9531, a dual GLP-1/GIP target for type 2 diabetes and weight management, and HRS-7535, an oral GLP-1 medication for type 2 diabetes.
Zhongsheng Pharmaceutical is also making significant strides with its innovative drugs, according to executive Liu Wen (an alias). They are developing dual-target GLP-1/GIP drugs, which aims to compete with Eli Lily’s tirzepatide, which is the active Ingredient behind Mounjaro and Zepbound. Their RAY002, a long-acting structural polypeptide, has shown superior pharmacokinetic properties in preclinical studies, and a Phase I clinical study began in May 2023.
Global-local partnership is making significant progress in China market. Mazdutide, developed by Eli Lilly, is a dual-action drug aimed at treating obesity and type 2 diabetes by targeting GLP-1 and glucagon receptors. Mazdutide, an oxyntomodulin analogue with a fatty acid side chain, is administered once weekly. In 2019, Innovent Biologics, a Chinese pharmaceutical company, acquired the rights to Mazdutide from Lilly, targeting the obesity market in China. The drug has been approved by NMPA of China in Feb 2024 for weight management after successful clinical trials.
Chinse pharmaceuticals are not staying on generics lane as the innovative could capture a bigger market share into global obesity and diabetes market. Companies like Gan & Lee Pharmaceutical are making such progress in clinical trials for their long-term GLP-1RA for both China and US market.
The US Senate Investigates High Prices of Ozempic and Wegovy Amidst Rising Medicare Costs
In response to growing concerns over the affordability and accessibility of Novo Nordisk's flagship drugs, Ozempic and Wegovy, an US Senate committee has initiated an investigation in April 2024. Led by Sen. Bernie Sanders (I-VT.), the committee's scrutiny comes amid mounting criticism of the steep prices charged for these medications, which have been described as "exorbitant" and potentially prohibitive for millions of Americans seeking treatment, according to a letter sent by Sanders to the CEO of Novo Nordisk.
The cost differentials between the U.S. and other countries are particularly striking, with a four-week supply of Ozempic priced at nearly $1,000 and Wegovy at $1,349 in the United States, which is “up to fifteen times more” than the price in Canada, Europe, and Japan according to the letter from the committee. This stark contrast in pricing has raised questions about the underlying factors driving such disparities and has prompted calls for action to address them.
Recent research findings have further intensified the debate by revealing that the manufacturing costs of these drugs could be as low as $5 per month. This revelation has added fuel to the fire, with lawmakers exerting pressure on Novo Nordisk to justify its pricing strategies and consider lowering prices to enhance affordability and access for patients.
Meanwhile, Medicare spending on GLP-1 drugs, which include Ozempic and Wegovy, has witnessed a dramatic escalation in recent years. In 2022, Medicare's total expenditure on these medications surged to $5.7 billion, a staggering increase from a mere $57 million in 2018. While originally developed for the treatment of Type 2 diabetes, GLP-1 drugs have garnered increasing attention as potential therapies for obesity management.
Despite their therapeutic potential, Medicare currently faces legal constraints that prevent it from covering these drugs explicitly for weight loss purposes. However, recent guidance from the Centers for Medicare and Medicaid Services (CMS) suggests that Medicare Part D plans may provide coverage for GLP-1 drugs for other medically accepted indications, such as reducing cardiovascular risk.
The burgeoning demand for these drugs, coupled with their high treatment costs, has raised concerns about the sustainability of Medicare spending, as well as the financial implications for Part D plan expenses and coverage premiums. Lawmakers are actively considering legislative measures to address these challenges, with proposals to expand Medicare coverage to include obesity drugs under consideration.
Amidst these discussions, stakeholders emphasize the importance of transparency and dialogue to ensure that patients have access to essential medications without facing undue financial burdens. Striking a balance between affordability and innovation remains a central focus in navigating the complex landscape of healthcare access and drug pricing, with ongoing efforts aimed at promoting greater equity and accessibility in healthcare delivery.
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