[비즈한국] As obesity treatments gain global popularity, MASH (Metabolic Dysfunction-Associated Steatohepatitis) treatments are also drawing attention. Because both obesity and MASH are metabolic diseases, the probability of them occurring simultaneously is high, and their treatment mechanisms partially overlap. With global pharmaceutical companies actively securing MASH treatments through technology transfers and M&A, we examined the development status of domestic pharmaceutical and biotech companies.
According to the industry, among domestic MASH treatment developers, Hanmi Pharmaceutical is expected to achieve the fastest results. "Efinopegdutide," for which the global development rights (excluding Korea) were licensed out to global pharmaceutical company MSD (Merck) in 2020 for a total of $870 million (1 trillion KRW), is currently in the phase 2b clinical trial stage. Efinopegdutide is a GLP-1 and GCG (glucagon) dual-agonist bio-drug candidate being developed as a once-weekly subcutaneous injection. MSD is conducting clinical trials that directly compare efinopegdutide with Wegovy. The clinical trials are set to conclude this December, with results expected to be announced in the first half of next year.
Another MASH treatment candidate from Hanmi Pharmaceutical, "Efocipegtrutide," is also in the global phase 2b clinical trial stage. Efocipegtrutide is a triple-agonist bio-drug candidate that simultaneously activates three receptors: GLP-1, GIP (gastric inhibitory peptide), and GCG. Hanmi Pharmaceutical expects to announce the phase 2b results for efocipegtrutide in the second half of next year.
A Field Where Even Global Pharmaceutical Companies Have Failed
Global pharmaceutical companies like Gilead and Novartis have repeatedly failed in developing MASH treatments. This is because it is not merely a problem of fat accumulating in the liver, but a complex disease involving metabolic abnormalities such as obesity, diabetes, and insulin resistance, as well as inflammatory responses and fibrosis. When fat accumulation causes liver cell damage, leading to cell swelling and inflammation, the MASH stage can progress to cirrhosis and liver cancer, potentially even leading to death. Global market research firm GlobalData projects that the MASH treatment market in the top 7 countries (US, France, Germany, Italy, Spain, UK, Japan) will grow at an average annual rate of 38.2%, from $802.3 million (1.143 trillion KRW) in 2022 to $20.3 billion (28.9214 trillion KRW) by 2032.
D&D Pharmatech347850 is also raising expectations for the success of its MASH treatment candidate "DD01," which is currently in phase 2 clinical trials in the US. Like Hanmi Pharmaceutical's efinopegdutide, it acts on both GLP-1 and GCG and is being developed as a once-weekly subcutaneous injection. D&D Pharmatech recently stated that it confirmed continuous improvement in fibrosis in patients at the 24th week of DD01 administration compared to the placebo group. The company expects to finish phase 2 clinical trials in June 2026 and announce the final results of major evaluation indicators. It plans to pursue technology transfer based on this data.
Dong-A ST170900 is taking on the challenge of developing an oral MASH treatment. It is developing "DA-1241" through its US new drug development subsidiary, Metabia, and has completed phase 2a clinical trials. The drug was confirmed to improve blood sugar and lipids by activating the "GPR119" receptor—which binds to cell membrane G-proteins in the pancreas, intestines, and liver—and to directly act on the liver to improve inflammation and fibrosis.
Olix226950 is receiving industry attention after a large-scale technology transfer of its MASH treatment candidate early this year. Last February, it licensed out global rights for its MASH and obesity treatment candidate "OLX75016 (development code name OLX702A)" to Eli Lilly. The contract is worth a total of $630 million (911.7 billion KRW). Once the phase 1 clinical trial currently underway in Australia is completed by this December, Eli Lilly is expected to take over from phase 2 trials. The biggest feature of OLX75016 is that it is expected to have efficacy equal to or greater than once-weekly competitors even if administered only once every 6 months. An official from Olix explained, "While even a single administration of OLX75016 every 6 months reduces liver fat by an average of 60–70%, and up to 90%, competitor drugs are understood to reduce liver fat by an average of only 50–60% even when administered once a week or taken daily."
Novo Nordisk, Roche, GSK, etc., "Actively" Securing MASH Treatments
Danish pharmaceutical company Novo Nordisk acquired MASH treatment developer Akero Therapeutics for up to $5.2 billion (7.3843 trillion KRW) on the 9th (local time). It is the largest M&A deal in the MASH sector this year. It is understood that Novo Nordisk, having tasted global success with its GLP-1 analog obesity treatment "Wegovy (ingredient: semaglutide)," has made this large-scale investment to expand its business portfolio into the MASH field. Although Novo Nordisk received FDA approval for Wegovy as a MASH treatment last August, it has additionally secured "efruxifermin," which is in phase 3 clinical trials and owned by Akero Therapeutics.
Prior to Novo Nordisk, Roche acquired the US biotech firm 89bio last month for up to $3.5 billion (4.85 trillion KRW). 89bio is developing MASH treatments for patients with moderate to severe fibrosis and cirrhosis. In May, GSK also secured the phase 3 MASH treatment candidate "epimosfermin" from Boston Pharmaceuticals for up to $2 billion (2.8 trillion KRW).
The reason global pharmaceutical companies are focusing on MASH treatments like this is the steep growth of Madrigal Pharmaceuticals' "Rezdiffra," now in its second year since launch. Rezdiffra is the world's first MASH treatment to receive FDA approval in March of last year. Its second-quarter revenue this year was $212.8 million (295.2 billion KRW), an increase of approximately 55% compared to $137.3 million (190.4 billion KRW) in the previous quarter. A pharmaceutical industry insider predicted, "Rezdiffra's revenue this year is expected to exceed $1 billion, allowing it to join the ranks of global blockbuster drugs."