South Korea's domestic pharmaceutical and biotech companies are ramping up their clinical development efforts for drug candidates targeting autoimmune diseases with significant unmet medical needs. Research And Markets, a global market research firm, projects the autoimmune disease therapy market to reach $153 billion by 2025.

Industry sources reported on September 6th that prominent companies including Daewoong Pharmaceutical, HanAll Biopharma, April Bio, NextGen Bioscience, IM Biologics, and Mirim Gene are actively involved in the development of therapies for autoimmune diseases.

In April, Daewoong Pharmaceutical signed a global technology export deal with Vitalli Bio, a subsidiary of the U.S. biotech investment firm Aditum Bio, at the 'Korea-US Digital and Biotech Health Business Forum' in Boston. This agreement involved Daewoong Pharmaceutical's new autoimmune disease drug candidate, 'DWP213388.'

Daewoong Pharmaceutical is transferring global development and commercialization rights for DWP213388 to Vitalli Bio, excluding some Asian regions, including South Korea. The agreement encompasses the clinical Phase 1 stage and has a total contract value of $477 million (approximately 6,391 billion Korean won), with an upfront payment of $11 million (approximately 147 billion Korean won).

In June, HanAll Biopharma announced that its Chinese partner, Harbour BioMed, had submitted a Biologics License Application (BLA) to the China National Medical Products Administration (NMPA) for approval of 'HL161 (active ingredient batoclimab)' in China.

Batoclimab is an antibody drug candidate that HanAll Biopharma exported to Harbour BioMed in 2017. The company is actively involved in the development of therapies targeting various autoimmune diseases, including myasthenia gravis (MG), thyroid eye disease (TED), immune thrombocytopenia (ITP), neuromyelitis optica (NMO), and chronic inflammatory demyelinating polyneuropathy (CIDP).

In August, April Bio successfully completed Phase 1 clinical trials for their autoimmune disease pipeline candidate, 'APB-A1.' During an online investor relations (IR) meeting on August 30th, a company representative announced, "Regarding CD40L-targeting APB-A1, our partner, Lundbeck from Denmark, mentioned plans to commence Phase 2 clinical trials in 2024 during their 2nd quarter performance announcement." The representative also noted, "Detailed data from the Phase 1 clinical trials is expected to be released by the end of this year or early next year."

NextGen Bioscience, a company focused on fibrosis treatment development, unveiled the results of Phase 1 clinical trials for their autoimmune disease pipeline, 'NXC736,' at the 'European Academy of Dermatology and Venereology (EADV) 2023' conference in May. NXC736 is a monoclonal antibody that selectively modulates sphingosine-1 phosphate receptors 1 and 4. Clinical trials for NXC736 commenced at Seoul National University Hospital in August 2021, following approval for the Phase 1 clinical trial plan (IND), and concluded in February of this year.

Last month, IM Biologics obtained approval for the Phase 1 Investigational New Drug (IND) application for 'IMB-101,' a dual-antibody-based candidate for autoimmune disease treatment, from the U.S. Food and Drug Administration (FDA). The company strategically incorporated a clinical design to assess pharmacokinetic properties and efficacy in patient groups, expediting the evaluation of IMB-101's competitiveness in Phase 1 trials.

While not yet in the clinical stage, other biotech companies with robust scientific foundations are also making strides in autoimmune disease therapy development. Mirim Gene is tackling the challenge of developing an autoimmune disease treatment targeting 'WARS1 (Tryptophanyl tRNA synthetase 1).' The company has completed the manufacturing process (CMC) stage for its lead pipeline 'M102AI' and plans to initiate non-clinical trials in the second half of next year.

The leading blockbuster drug in the autoimmune disease field remains 'Humira (active ingredient adalimumab),' developed by AbbVie in the United States. Humira generated approximately 28 trillion Korean won in global sales last year as a treatment for autoimmune diseases. Despite its blockbuster status, a significant number of patients do not respond to this treatment. Hence, domestic companies stress the imperative of developing new target drugs and adopting strategic approaches to address this issue in the realm of autoimmune diseases.

One industry insider emphasized, "Domestic autoimmune disease drug development companies need to possess distinct strengths and accurately discern the needs of the relevant market." They added, "While there is unmet demand for patients who do not respond to Humira treatment, competing with AbbVie is challenging, necessitating a strategic approach."

Another industry representative stated, "To pursue global technology transfer (L/O), domestic companies must venture into drug development that can effectively address drug-resistant patients." They further noted, "The pathogenesis of autoimmune diseases and drug resistance is intricate and diverse, underscoring the importance of exploring new control pathways and discovering drug targets."