AbClon announced on the 2nd that its CAR-T (Chimeric Antigen Receptor T-cell) therapy AT101 has been approved by the World Health Organization (WHO) with the International Nonproprietary Name (INN) 'Nespecabtagene autoleucel’ (Nespe-cel). This signifies the official registration of the therapeutics and 'Nespe-cel' will be used as the official name when AT101 is commercialized in the global market in the future.

The International Nonproprietary Name is officially approved by the WHO for specific ingredients or substances to prevent misuse of medicines and to enhance information delivery and ease of use. This name is utilized as a unique identifier in the approval processes and commercialization stages of each country. 'Nespe-cel' embodies the meaning of a CAR-T therapy derived from AbClon's proprietary antibody platform technology 'NEST (Novel Epitope-Screening Technique)'.

AbClon is currently conducting a Phase 2 clinical trial in South Korea for Nespe-cel in patients with diffuse large B-cell lymphoma (DLBCL) across seven institutions, with research funding of 7 billion KRW supported by the Korea Drug Development Fund. DLBCL accounts for approximately 50% of non-Hodgkin's lymphoma (NHL). Following an interim analysis of the clinical trial results, the company plans to apply for accelerated approval in June and is also establishing strategies for domestic commercialization. Recently, AbClon announced the initiation of clinical strategies to expand the treatment to patient groups with follicular lymphoma (FL) and marginal zone lymphoma (MZL), which account for approximately 30% of NHL.

To strengthen the competitiveness of its CAR-T therapy in the global market, AbClon is pursuing the grant of an independent patent in overseas countries. As a result of this effort, the company signed an agreement on April 28th with TCT Health Technology (TCT) in Türkiye (formerly Turkey) for the commercialization of Nespe-cel in Türkiye, aiming to accelerate its entry into the European and Middle Eastern markets.

Through this collaboration, AbClon plans to establish clinical and production infrastructure for Nespe-cel in Türkiye and pursue the approval process for blood cancer treatment. Given the recent active support of the Turkish government for the advanced biopharmaceutical industry, the collaboration between AbClon and TCT is expected to create positive synergy. Following education and production preparation, the first patient is expected to receive Nespe-cel treatment in 2026.

An official from AbClon stated, "The technology transfer agreement to TCT is a significant milestone for entering into the European and Middle Eastern markets, leveraging Türkiye as a hub," and added, "We are simultaneously pursuing technology transfer globally and country-specific strategies as well."

Meanwhile, TCT is building a CAR-T therapy manufacturing facility in collaboration with global company Cytiva. Through this, they plan to establish the production system for Nespe-cel win near future. Support from the Turkish government is also expected to be a crucial foundation for the rapid and stable production of Nespe-cel.

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