New drug candidates developed in Korea are increasingly being recognized for their value in the global market. There is also a growing number of cases where, based on clinical data, they are proving their commercial viability and being evaluated as promising pipelines drawing attention from the global pharmaceutical industry.
HanAll Biopharma(009420)'s autoimmune disease treatment candidate "Imeropruvat (HL161ANS·IMVT-1402)" is a prime example. Imeropruvat was recently included in "the top 10 major research and development (R&D) projects" selected by the global market research firm EvaluatePharma. Among domestic corporations, HanAll Biopharma was the only one to make the list.
Imeropruvat is an FcRn antibody new drug candidate originally discovered by HanAll Biopharma. After being out-licensed to U.S.-based Roivant in 2017, Roivant's subsidiary Immunovant is now in charge of clinical development and commercialization in the United States and Europe. As the original developer, HanAll Biopharma continues research and development and technical collaboration.
The market cites the concurrent securing of efficacy and safety as Imeropruvat's competitive edge. While other FcRn-class therapies under development generally show about a 60%–70% reduction in autoantibodies (IgG), Imeropruvat is being developed with a goal of a 70%–80% reduction.
A HanAll Biopharma official said, "As the IgG reduction rate increases, side effects such as rises in LDL cholesterol or decreases in albumin often occur," and added, "Imeropruvat focuses on achieving a high IgG reduction effect while minimizing these safety issues."
Dosing convenience is also cited as a competitive strength. Considering autoimmune disease patients who require long-term treatment, the company is reviewing the use of an autoinjector for patient self-administration at the commercialization stage.
The first commercialization target is Graves' disease. It is a representative autoimmune disease that causes thyroid dysfunction, and the number of patients in the United States is estimated at about 330,000. As there are currently no approved FcRn-class therapies, if development succeeds, it is highly likely to become a first-in-class treatment.
Immunovant then plans to expand indications to refractory rheumatoid arthritis, Sjögren's syndrome, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and cutaneous lupus erythematosus. The potential number of patients in the United States for the six indications currently under development is estimated at about 630,000.
Market expectations are also evident in the numbers. EvaluatePharma valued Imeropruvat's net present value (NPV) at about $16.9 billion (about 25.5 trillion won). NPV is an indicator that discounts the cash flows a new drug is expected to generate in the future to their present value.
The industry is watching the possibility that the corporate value could rise another notch depending on future clinical results. In the second half of this year, topline results for the phase 2 trial in cutaneous lupus erythematosus and the phase 2b trial in difficult-to-treat rheumatoid arthritis (D2T RA) are set to be released. Next year, clinical data for major indications such as Graves' disease and myasthenia gravis will also be announced in succession.
If Imeropruvat succeeds in commercialization, HanAll Biopharma will receive royalties that increase stepwise in line with sales scale. The royalty rate is known to be in the mid-single-digit to mid-teen range. Milestones by development stage, such as for regulatory approval, also remain, but the specific amounts have not been disclosed under the contract.