Recently, the official website of the State Food and Drug Administration announced that the orally disintegrating tablets of Bilastine, which were submitted by Shandong Xinshidai Pharmaceutical, a subsidiary of Lunan Pharmaceutical Group, under the Class 3 chemical drug registration classification, have been approved for marketing and are deemed to have passed the generic drug quality and efficacy consistency evaluation. They are used for the symptomatic treatment of urticaria in adults and adolescents (12 years and above).
The original product, Bilastine, was developed by FAES Pharmaceuticals of Spain and first marketed in the EU in August 2010. In June 2023, Menarini's Bilastine tablets were approved for marketing in China. In 2024, Jiangsu Huayang Pharmaceutical secured the first domestic generic version of Bilastine tablets. This time, Lunan Pharmaceutical's Bilastine orally disintegrating tablets were approved for marketing, marking the first domestic generic version of this dosage form and the first to pass review.
In terms of drug development, several pharmaceutical companies, including Sichuan Kelun Pharmaceutical and Shandong Langnuo Pharmaceutical, have submitted Category 3 new generic registration applications for bilastine orally disintegrating tablets, all of which are currently under review and approval. This indicates that the domestic market potential of this dosage form has attracted industry attention, and a competitive landscape is emerging.

As a specialized dosage form, orally disintegrating tablets improve patient convenience and are particularly suitable for specific populations. Previously, Lunan Pharmaceutical has launched bilastine tablets (20mg). The approval of this orally disintegrating tablet will provide a new option for clinical use.

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