Kubota Pharmaceutical Holdings Co.,Ltd. [4596.T]
TOKYO, Apr 07 (Pulse News Wire) – Kubota Pharmaceutical Holdings CO.,LTD. (4596.T) announced today that its subsidiary, Kubota Vision Inc., has completed technology transfer for the production process of Emicstator hydrochloride, a drug candidate for treating Stargardt disease.
As a result, Kubota Vision plans to commence Good Manufacturing Practice (GMP)-compliant active pharmaceutical ingredient (API) manufacturing from April 2026. This development follows the supply and licensing agreement announced on March 02, 2026, which aims to establish a supply system for compassionate use programs in France. Under the contract, Kubota Vision will handle raw material procurement, API manufacturing, final product formulation, and regulatory affairs, while Laboratoires KÔL will manage storage, distribution, interactions with the French health authority ANSM, and certain medical affairs activities. This milestone marks significant progress towards advancing the practical application of Emicstator and ensuring quality and supply stability.
Stargardt disease is a rare genetic disorder affecting the retina, leading to gradual vision loss in young individuals. It results from mutations in the ABCA4 gene, causing damage to photoreceptors and subsequent visual impairment. Emicstator hydrochloride utilizes Kubota's Visual Cycle Modulation (VCM) technology to inhibit key enzymes in the visual cycle, reducing harmful metabolic products and potentially slowing disease progression. Kubota Vision remains committed to collaborating with stakeholders to ensure continued advancement of Emicstator’s development and commercial activities.
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