Hanmi Pharmaceutical President: "Development of Previously Unavailable Treatments Progressing Smoothly"

[Asia Economy Reporter Choi Dae-yeol] Hanmi Pharmaceutical announced that it is dedicated to developing new drugs that have not existed domestically or internationally for conditions such as non-alcoholic steatohepatitis (NASH) and obesity.

On the 15th (local time), at the JP Morgan Healthcare Conference held in San Francisco, USA, Hanmi Pharmaceutical President Kwon Se-chang said, "Among 29 new drug candidates, we will focus on 8 key projects this year and create achievements such as technology exports." Attending this event, which gathers global pharmaceutical and bio industry stakeholders and investors, were President Kwon, Vice Chairman Lee Kwan-soon, and Research Center Director Seo Gui-hyun, who are in charge of research and development and global business.

The key projects highlighted by President Kwon include HM15211 targeting NASH, the dual-mechanism obesity treatment HM12525A, and HM15136, a new mechanism obesity treatment. NASH is a chronic liver disease with no current treatment, where it is important to simultaneously improve various indicators such as fatty liver, inflammation, and fibrosis. The company reported that multiple efficacies were confirmed in the Phase 1 multiple ascending dose clinical trial. They plan to enter a global Phase 2 clinical trial in the second quarter of this year targeting patients confirmed by biopsy.

HM12525A is a substance whose rights were returned to Hanmi Pharmaceutical last year after Janssen completed a global Phase 2 clinical trial. Janssen had aimed to develop it as a dual treatment for obesity and diabetes, but Hanmi Pharmaceutical plans to develop it as the world's first innovative dual-mechanism new drug with superior efficacy compared to existing drugs. Unlike existing obesity treatments administered daily, this drug is administered once weekly and has proven better weight loss effects than the existing treatment (Saxenda) in the global Phase 2 trial. HM15136, also being developed as an innovative new drug with a new mechanism, has completed the single ascending dose trial in Phase 1 and plans to complete the multiple ascending dose trial by the third quarter of this year.

In the oncology field, Hanmi Pharmaceutical is actively pursuing open innovation by introducing innovative technologies from overseas partners. Last year, they introduced an oral immuno-oncology candidate from the US biotech company Lapt and also introduced antibodies from the biotech company Pains, reporting that they are conducting immuno-oncology dual and multi-antibody development projects. The Pan-RAF inhibitor belvarafenib (HM95573, solid tumors), which was licensed out to Genentech, is progressing smoothly in clinical trials, and plans for expanding indications are also under review.

Additionally, clinical trials for a new drug treating acute myeloid leukemia are progressing smoothly, and the oral anticancer drug Oracsol is planned to apply for FDA approval in the US in the first half of this year. Rolontis, a neutropenia treatment licensed out to Spectrum, has started FDA main review, and marketing approval is expected around the end of October this year. Among the candidate substances being developed for rare and intractable diseases, five have received 12 orphan drug designations from domestic and international pharmaceutical regulatory authorities including the US and Europe. President Kwon said, "We are developing various innovative global new drugs through active open innovation and are dedicated to research and development."

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