New drug candidates developed in Korea are steadily being recognized for their value in the global market. Cases are increasing in which they prove commercial viability based on clinical data and are evaluated as promising pipelines drawing attention from the global pharmaceutical industry.
HanAll Biopharma(009420)'s autoimmune disease treatment candidate "aymeropruvate (HL161ANS·IMVT-1402)" is a prime example. Aymeropruvate was recently included in the "top 10 major research and development (R&D) projects" selected by EvaluatePharma, a global market research firm. Among domestic corporations, only HanAll Biopharma made the list.
Aymeropruvate is an FcRn antibody new drug candidate discovered in-house by HanAll Biopharma. After being licensed out to Roivant in the United States in 2017, Immunovant, Roivant's subsidiary, is now responsible for 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 aymeropruvate's concurrent efficacy and safety as its competitive edge. While other FcRn therapies under development generally show about a 60%–70% reduction in autoantibodies (IgG), aymeropruvate 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 drops in albumin often appear," adding, "Aymeropruvate is focused on achieving a high IgG reduction effect while minimizing these safety issues."
Dosing convenience is also cited as a strength. Considering autoimmune disease patients who require long-term treatment, the company is reviewing applying 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 is currently no approved FcRn therapy, if development succeeds, it is highly likely to become a first-in-class treatment.
Immunovant then plans to expand indications to refractory rheumatoid arthritis, Sjogren's syndrome, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and cutaneous lupus erythematosus. The number of potential patients in the United States for the six indications under development is estimated at about 630,000.
Market expectations are also evident in the numbers. EvaluatePharma valued aymeropruvate'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 corporate value could rise another notch depending on future clinical results. In the second half of this year, topline results from a phase 2 trial in cutaneous lupus erythematosus and a phase 2b trial in difficult-to-treat rheumatoid arthritis (D2T RA) are scheduled to be released. Next year, clinical data for key indications such as Graves' disease and myasthenia gravis will also be announced in succession.
If aymeropruvate 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 for each development stage, such as regulatory approval, also remain, but the specific amounts have not been disclosed under the contract.