Hanmi's new drug licensed to MSD, greenlight for entering Phase 3 trial?

In Q4 of last year, export sales 15%↑ compared to the previous year…83%↑ of the prior quarter

Increased supply of clinical samples to MSD…in preparation for Phase 3 clinical trials, exports expanded

In 2020, MASH treatment was licensed…Phase 2 trials were completed in December of last year

It is likely that 'efinopegdutide,' a novel treatment for metabolic dysfunction-associated steatohepatitis (MASH) licensed from Hanmi Pharmaceutical to MSD, would proceed to Phase 3 clinical trials. MSD concluded Phase 2 clinical trials at the end of last year and has significantly expanded its supply of clinical samples from Hanmi to prepare for Phase 3 studies. Improvements in export performance contributed to Hanmi Pharmaceutical recording an operating profit margin of nearly 20% in Q4 of last year.

According to Hanmi Pharmaceutical, on the 6th, the company's Q4 exports last year reached KRW 54.2 billion, a 15.3% year-on-year increase. This represents an 83.0% jump from the KRW 29.6 billion recorded in Q3. While Hanmi's export volume had declined for two consecutive quarters after reaching KRW 68.2 billion in Q1 of last year, it rebounded sharply in Q4.

Hanmi Pharmaceutical's Quarterly Export Performance (unit: KRW 1 million, source: Hanmi Pharmaceutical)

The company explained that the export expansion was driven by a significant increase in the supply of efinopegdutide clinical samples to MSD, produced at Hanmi's Pyeongtaek Bio Plant.

Efinopegdutide is a MASH treatment candidate that Hanmi Pharmaceutical licensed to MSD in August 2020. The deal was valued at up to $870 million, including a $10 million upfront payment.

The drug is a dual agonist that simultaneously activates GLP-1, which aids insulin secretion and appetite suppression, and glucagon, which increases energy metabolism. It utilizes Hanmi's proprietary LAPSCOVERY technology to extend the drug's half-life.

A Hanmi Pharmaceutical official stated, "Export volumes grew in Q4 as clinical samples were supplied to prepare for MSD's Phase 3 clinical trials."

Following the licensing of efinopegdutide, MSD conducted Phase 2 trials comparing efinopegdutide with Novo Nordisk's semaglutide and a placebo. Results from a Phase 2a analysis presented at the 2023 European Association for the Study of the Liver (EASL) in Vienna showed that efinopegdutide reduced liver fat content by 72.7% relative to baseline at week 24. This significantly outperformed semaglutide, which showed a 42.3% reduction over the same period. 

Industry experts interpret MSD's purchase of clinical samples as a "green light" to enter Phase 3, suggesting that MSD is preparing for the next stage as positive outlooks were shown for Phase 2 results.

MSD completed the Phase 2b trial for efinopegdutide in December last year and is expected to announce the results this year.

According to ClinicalTrials.gov, the Phase 2b study began on June 23, 2023, and concluded on December 29, 2024, with 381 participants enrolled. 

MSD completed the Phase 2b trial for efinopegdutide in December 29 of last year. (source: ClinicalTrials.gov)

In its recent Q4 earnings report, MSD listed efinopegdutide in its Phase 2 pipeline for cardiovascular, metabolic, and respiratory diseases. This report indicates that efinopegdutide is categorized as a core pipeline.

Hanmi Pharmaceutical is showing a recurring pattern of surging exports tied to the supply of clinical samples of efinopegdutide. In Q1 of last year, exports rose 45.1% compared to the previous quarter. At that time, Hanmi announced that "Increased revenue from clinical samples delivered to MSD contributed to 'etc. regional volume' increases."

Meanwhile, efinopegdutide is a candidate that was previously licensed to Janssen in December 2015 (as JNJ-64565111). The total contract volume amounted to $915 million with an upfront payment of $105 million. After Janssen returned the rights of JNJ-64565111 in 2019, Hanmi re-licensed it to MSD for NASH (now MASH) treatment within a year.

The increase in exports of clinical samples significantly improved Hanmi's overall financial performance. In Q4 of last year, operating profit reached KRW 83.3 billion, up 173.4% year-on-year, while revenue grew 23.1% to KRW 433 billion. The operating profit margin for the quarter hit 19.2%, the highest in ten years since the 29.1% recorded in Q4 of 2015, when Hanmi secured a blockbuster licensing deals. In Q4 of 2015, Hanmi recorded sales of KRW 589.9 billion and an operating profit of KRW 171.5 billion.