Domestic Pharmaceutical and Bio Industry Targets 200 Trillion Global Autoimmune Disease Market... "Competing with Injectable Formulations"

Celltrion Gains Attention as Remsima SC Game Changer
HanAll Biopharma's 'HL161' Subcutaneous Injection
Phase 3 Topline Results Imminent... Advantage Over Competitors
Daewoong Pharmaceutical Receives US Approval for Oral Treatment Phase 1 Trial

[Asia Economy Reporter Lee Gwan-joo] Competition among global new drug companies for the development of autoimmune disease treatments is intensifying. According to market research firm Allied Market Research, the global autoimmune disease market, which was $109.8 billion (approximately 142 trillion KRW) in 2017, is expected to grow to $153.3 billion (approximately 200 trillion KRW) by 2025. Global big pharma companies such as Johnson & Johnson and AstraZeneca have already rushed into the development of new autoimmune disease treatments.

Domestic pharmaceutical companies are also accelerating the development of autoimmune disease treatments. A representative product is Celltrion's 'Remsima.' Remsima is the world's first antibody biosimilar and is currently a key contributor to Celltrion's growth. According to pharmaceutical market research firm IQVIA and Celltrion Healthcare, Remsima's market share in Europe reached 52.3% in the first quarter of this year. In the U.S., Remsima's market share surpassed 30%, and especially the subcutaneous injection (SC) formulation RemsimaSC achieved a 9.1% market share in Europe in the first quarter of this year, just two years after its launch.

In the industry, the formulation of injections is regarded as a key competitive factor that will determine the market competition landscape. Whether it is an intravenous injection (IV) that must be administered directly into a vein or an SC injection that can be administered just under the skin makes a significant difference in patient discomfort, cost, and administration time. Multinational pharmaceutical companies are gradually expanding the development of subcutaneous injection drugs. Among injection formulations approved by the U.S. Food and Drug Administration (FDA), the proportion of SC formulations was around 15-20% from 2010 to 2014 but increased to 30-40% from 2015 onward.

Aerial view of HanAll Biopharma Daejeon Plant.

HanAll Biopharma is considered a leading company in the development of new autoimmune disease drugs in Korea. HanAll Biopharma's 'HL161' (active ingredient Batoclimab) is currently undergoing clinical trials targeting various autoimmune diseases including myasthenia gravis, thyroid eye disease (TED), immune thrombocytopenia (ITP), neuromyelitis optica (NMO), and chronic inflammatory demyelinating polyneuropathy (CIDP). It is currently in Phase 3 clinical trials for myasthenia gravis, with plans to submit a Biologics License Application (BLA) after topline results are obtained.

Notably, HL161 is being developed as a self-administered subcutaneous injection, which is expected to greatly enhance patient convenience. Although Belgium's Agenex's 'Vibgart,' an FcRn (neonatal Fc receptor) inhibitor with the same mechanism, received FDA approval in December last year, it differs from HL161 in that it is an intravenous injection formulation. A HanAll Biopharma official stated, “FcRn inhibitors will be innovative treatments in autoimmune disease areas such as myasthenia gravis and immune thrombocytopenia, where there are no clear treatments. Among them, HL161 is being developed as a self-administered subcutaneous injection, so it is expected to have superior convenience and competitiveness compared to competing products.”

Daewoong Pharmaceutical has also recently accelerated its development of autoimmune disease treatments by obtaining FDA approval for the Phase 1 clinical trial plan of its autoimmune disease new drug candidate 'DWP213388.' DWP213388 is an innovative oral treatment for autoimmune diseases currently under development. It is a dual-target inhibitor that simultaneously inhibits B cells and T cells, selectively inhibiting Bruton's tyrosine kinase (BTK) and interleukin-2-inducible T-cell kinase (ITK). Preclinical studies have confirmed its safety and excellent efficacy. The company explains that since most autoimmune disease patients have excessively activated B cells and T cells, simultaneously inhibiting both can effectively treat autoimmune diseases.

This content was produced with the assistance of AI translation services.