Dongkook Pharmaceutical, known for its Madecassol and Insadol brands, is accelerating development of a long-acting obesity injection that could maintain efficacy for three months with a single dose. The company has already obtained meaningful data from animal studies and plans to complete non-clinical trials by the end of this year, entering a pilot clinical study in early 2026. A full-scale clinical trial is expected to follow later that year, potentially through technology transfer or joint research to globalize the project, according to Park Joon-sang, head of Dongkook's Central Research Institute.
Current market-leading obesity injections require weekly administration, which is inconvenient. Oral alternatives have lower absorption rates and potential gastrointestinal side effects. Extending the injection interval to three months could reduce inconvenience while addressing oral drug drawbacks, the company said.
The core technology behind the three-month injection is microspheres—biodegradable polymer spheres tens of micrometers in size that encapsulate drugs and release them slowly as the polymer degrades in the body. Since Takeda Pharmaceutical launched the first microsphere drug, Lupron Depot, in 1989, only 14 microsphere drugs have received U.S. FDA approval, highlighting the high technical barriers.
Domestic competitors in microsphere technology include Daewoong Pharmaceutical, Peptron, G2GBio, and Inventage Lab. When asked about Dongkook's strengths, Park emphasized its commercialization experience: "We have already commercialized three microsphere products. Our differentiation lies in having the most stabilized technology from R&D to production." He noted that reproducing lab-scale quality at factory scale is extremely challenging, as micro-level control is required and spheres can easily break during scale-up.
Dongkook has built a reputation as a "microsphere powerhouse" over more than 30 years. It launched Korea's first microsphere product in 1999 and has since succeeded with products like the prostate cancer treatment Lorelin Depot. Current annual sales from microsphere and microemulsion product lines reach 65 billion KRW (approximately $49 million).
The company expects further revenue growth. Beyond the three-month obesity injection, it has high hopes for MB101, a one-month formulation of the immunosuppressant tacrolimus, one of six microsphere pipelines under development. According to Global Market Insights, the relevant global market was valued at $7.3 billion (approximately 10.77 trillion KRW) last year.
Dongkook plans to continue investing to lead in microsphere technology. It recruited Park, a veteran in drug delivery systems (DDS), about two years ago and operates a separate DDS-dedicated research institute, DK Pharmaceutical Research Institute—the first such institute among domestic pharmaceutical companies. The company is also focusing on liposome R&D, a next-generation DDS technology that serves as the foundation for lipid nanoparticle (LNP) technology used in COVID-19 vaccines, essential for efficiently delivering challenging drugs like mRNA.
Park added that a new plant in Jincheon, North Chungcheong Province, with an investment of 60 billion KRW (approximately $45 million), will be completed this year. "With production capacity roughly tripling, we will launch products such as Lorelin Depot three-month formulation and the acromegaly treatment octreotide three-month formulation annually," he said.
Source: Read the original report | Published: May 25, 2025