[Edaily Reporter SONG YOUNG-DOO ] NIBEC CO., LTD.(138610)has obtained Qualified Person (QP) certification for the supply of its self-developed peptide active pharmaceutical ingredient (API) for use in European clinical trials. Having secured the foundation to supply its self-produced new drug candidates to European clinical trials—following the U.S.—the company is now moving to expand its peptide contract development and manufacturing (CDMO) business.

NIBEC CO., LTD. announced on the 31st that it has finally obtained European QP certification for the API of “NP-201,” a drug candidate it developed in-house for the treatment of idiopathic pulmonary fibrosis.

This QP compliance certification is the final result of an on-site inspection conducted in March in accordance with EU-GMP standards. The inspection confirmed that the production facilities, manufacturing processes, quality management systems, and related documentation for the NP-201 API—which NIBEC CO., LTD. produces at its own GMP facility—comply with European pharmaceutical manufacturing and quality standards.

NP-201 is a drug candidate for the treatment of idiopathic pulmonary fibrosis currently under development by NIBEC CO., LTD. Following approval from the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial, the company has also submitted a Clinical Trial Application (CTA) for a concurrent clinical trial in Europe. With this QP certification, NIBEC CO., LTD. is now able to supply its in-house produced NP-201 API for European clinical trials.

This QP certification is particularly significant because it confirms that NIBEC CO., LTD. produced a new drug candidate—which it developed in-house—at its own GMP facility and received confirmation of compliance with European standards, rather than relying on contract manufacturing of external materials.

QP compliance verification is conducted on a per-product basis. However, for peptide APIs, there are numerous common elements across the production and quality control processes—including the synthesis process, raw material and impurity management, analytical methods, process control, and documentation systems. NIBEC CO., LTD. explains that by securing QP status for NP-201, it has demonstrated production and quality control capabilities that can be applied to the future production of other peptide drugs.

The company believes that, among domestic peptide drug development firms, NIBEC CO., LTD. is the only one that produces APIs for its own drug candidates at its own GMP facilities and has secured European QP compliance for its manufacturing and quality management system.

NIBEC CO., LTD. independently handles the entire process, from the discovery and design of peptide candidates to process development, scale-up, GMP production, and quality control. Since the quality characteristics of peptide drugs can vary depending on amino acid sequences and synthesis conditions, it is crucial to establish both the production process and the quality control system from the early stages of development.

NIBEC CO., LTD. plans to leverage this QP certification not only for the global clinical trials of NP-201 but also to expand its peptide CDMO business. The company’s strategy is to combine its proprietary peptide design and synthesis technologies, GMP production facilities, and experience in meeting European regulatory requirements to target the demand for clinical-grade API production from external peptide drug developers.

A company official stated, “Securing this QP compliance is significant because it means we have established a production and quality system that allows us to directly manufacture the API for our in-house developed NP-201 and supply it for European clinical trials,” adding “By securing QP compliance following approval for a U.S. FDA Phase 2 clinical trial and the submission of a European CTA, we have laid the groundwork for conducting simultaneous clinical trials in the U.S. and Europe. Building on this, we will expand our global clinical supply capabilities and grow our peptide CDMO business.”