[Edaily Reporter Kim Seung-kwon ] As the era of “oral” GLP-1 therapies officially begins in the global obesity treatment market, observers are suggesting that K-Bio companies may need to rethink their survival strategies. This is because going head-to-head with Big Pharma—which holds an overwhelming advantage in capital, development speed, and global clinical infrastructure—offers little realistic chance of success.

Amid this trend, domestic pharmaceutical and biotech companies are setting their sights on niche markets that Big Pharma has not yet fully dominated. Their top priorities now include “cost competitiveness” in the face of drug price cuts, “innovation in long-acting formulations” that eliminate the hassle of weekly injections, and seizing the lead in the trend toward next-generation triple-action agents.

Big Pharma’s “Speed and Capital”… Entering a Battle to Secure the Supply Chain Amid Ultra-Low-Price Competition

Currently, the global obesity drug market is rapidly shifting its competitive focus from “efficacy competition” to a “price and infrastructure battle,” driven by the introduction of oral medications. The emergence of oral drugs, which are cheaper than injectables, is not only explosively expanding the market size but also serving as a powerful catalyst for breaking the high-price structure of original new drugs. Furthermore, with the expiration of patents for existing original obesity drugs, generic versions are expected to enter the market, and price competition is projected to become even more intense.

Next month, the substance patent for semaglutide—the key ingredient in Novo Nordisk’s global mega-blockbuster “Wegovy”—will expire in China. This is expected to serve as a signal for an influx of ultra-low-cost generics and copycat drugs based on inexpensive local raw materials in China. Experts predict that this tsunami of drug price cuts originating from China—the world’s second-largest pharmaceutical market—will spread globally via India and Brazil, completely overturning the current market structure—which is dominated by “high-priced innovative drugs”—into a system of “cutthroat price competition.”

The U.S. Food and Drug Administration (FDA) is also moving full steam ahead with the approval process for GLP-1 generics whose patents are nearing expiration. The semaglutide injection (Ozempic, Wegovy) submitted by Canadian generic drugmaker Apotex has received “Tentative Approval” from the FDA. Tentative Approval means that technical reviews—including safety and equivalence—have been completed, but final market authorization is pending because the original manufacturer’s patent term has not yet expired.

Sandoz, the world’s leading generic drug company, and China’s Haibio Pharmaceutical have submitted applications to the FDA for approval of generic versions of “Mounjaro and Zepbound” (active ingredient: tirzepatide). Big Pharma companies are also tightly building preemptive defense lines in preparation for this. A prime example is Eli Lilly’s recent decision to invest a staggering $3 billion (approximately 4 trillion won) in its Chinese manufacturing hub, ostensibly to expand its oral drug supply capacity.

An industry insider in the obesity treatment sector stated, “Given the many patent and regulatory variables before actual GLP-1 generics are launched, the competitive landscape between the original drug and the new drug pipeline is likely to continue for the time being.”

Technology Trends for the Next 5 Years… “Long-Acting Formulations and Multi-Acting Agents Will Reshape the Market”

The differentiation strategies adopted by South Korean “K-Bio” companies, as latecomers to the market, are “long-acting injectables” and multi-action agent platforms. In particular, the long-acting platform is known to offer alternatives to the side effects of existing treatments, enable patent-avoidance market entry, and help mitigate clinical and production risks.

Peptron, Inc.(087010)Last month at the American Diabetes Association (ADA 2026) conference, the company unveiled the latest preclinical and safety data for “PT403,” a once-monthly semaglutide candidate utilizing “SmartDepo” technology. The group administered at 2–3-week intervals showed approximately 30% weight loss at the 4-week mark. Notably, in an evaluation of healthy adults, the single-dose PT403 group showed no vomiting or nausea compared to the existing once-weekly semaglutide, and adverse reactions were limited to mild injection-site reactions and reduced appetite, reaffirming its superior tolerability.

It also has strengths in terms of mitigating clinical and manufacturing risks. While novel triple-action agents with new mechanisms—such as Retatruotide—face many variables on the path to approval, including a lack of statistical significance in cardiovascular data, long-acting formulations are based on already-validated ingredients like semaglutide. As a result, the risk of clinical failure is relatively low, and industry sources note that there is sufficient time to secure a “convenience premium” market share before the expected commercialization of triple-action agents after 2028.

In fact, #G2GBIO, Inc. is competing for the lead by leveraging its proprietary drug delivery platform, “InnoLamp.” The company presented preclinical data at ADA 2026 for Cagrisema, Tuzepatide (Mounjaro), and Retatruotide at ADA 2026. The company stated that in rodent studies, the initial excess release rate was suppressed to less than 5% within 24 hours after administration, and blood drug concentrations were maintained for more than 28 days, securing pharmacokinetic data sufficient to support the development of a once-monthly formulation.

According to the company, Inolamp can incorporate a high concentration of peptide components—over 50%—thereby overcoming the existing limitation of dosage constraints associated with subcutaneous injections. G2GBIO, Inc. has signed a joint research and licensing agreement with Samsung Bioepis for a long-acting obesity treatment and is currently developing the manufacturing process. The company is also expanding its collaboration with global big pharma, including a joint research project with Boehringer Ingelheim on long-acting peptide therapies for diabetes and obesity. The company plans to submit an application for a clinical trial of a once-monthly GLP-1-based obesity drug in the first half of next year.

An official from G2GBIO, Inc. stated, “Long-acting injectables are a field where trial and error is inevitable due to numerous variables and long experimental cycles,” adding, “If AI trained on accumulated data via deep learning can preemptively suggest the optimal direction for formulation research and process analysis, we can concentrate our research capabilities on promising candidate compounds.”

Celltrion(068270) DaewonPharmaceutical(003220)has also entered the race to develop a quadruple-action obesity treatment that is one step ahead of the global market. CT-G32, currently under development by Celltrion, is a next-generation obesity treatment candidate that simultaneously targets four metabolism-related receptors. The company is focusing on addressing issues identified as limitations of existing GLP-1 agonists, such as variability in weight loss among patients, muscle loss, and the duration of therapeutic effect. It has recently begun toxicity testing in non-human primates, and preclinical studies reportedly confirmed superior weight loss effects compared to previously developed drugs at the same dosage, along with the potential to preserve lean body mass (LBM), including muscle. The company aims to submit a clinical trial plan in the first half of next year.

DaewonPharmaceutical has also entered the race to develop a quadruple agonist. The candidate compound, currently under joint development with Pharmus Bioscience, is designed as a quadruple agonist that combines GLP-1, GIP, glucagon (GCG), and gastrin. It is characterized by its aim to go beyond simple weight loss to protect pancreatic beta cells and improve kidney function.

Yoo Sang-gu, CEO of Glaseum, which transferred the technology for the obesity treatment candidate to DaewonPharmaceutical, emphasized, “While current obesity treatments focus on suppressing appetite, the essence of treating obesity lies in reducing body fat,” adding, “GLP-1-based drugs handle appetite suppression, while our drug can play a role in reducing fat.”