China's First Generic Drug Born -- Bilastine Tablets

Recently, according to the latest information released on the official website of the National Medical Products Administration (NMPA), four generic drugs submitted by Jiangsu Huayang Pharmaceutical Co., Ltd. have been approved and identified as equivalent to passing the evaluation, marking that the drug has become the first generic variety in China. According to the Moentropy Pharmaceutical database, Billastine has sales of more than $100 million worldwide.

Bilastine is made by FAES Farma S.A., Spain. A second generation non-sedative long-acting antihistamine drug developed by the company. The drug selectively antagonizes peripheral H1 receptors, exhibits strong affinity for histamine H1 receptors, does not inhibit other receptors, and has anti-inflammatory properties. China's anti-allergy drug market has a large volume, and the sales of antihistamine drugs account for 65% of the market. Antihistamine drugs have become one of the most widely used drugs, and the clinical safety requirements of drugs are increasing. The market potential of Pelastine has been favored by a number of international pharmaceutical companies, which have reached licensing agreements with the original research party for the sale of this product in different regions of the world, including Pfizer, Menarini, Takeda and other internationally renowned pharmaceutical companies have obtained sales authorization in their respective regions. According to the Moentropy pharmaceutical database, global sales of Pilastine in 2023 have exceeded $100 million.

Pilastine was initially approved for marketing in the European Union in August 2010 for the treatment of urticaria and allergic rhinitis in adults and adolescents over 12 years of age. In June 2023, Menarini's application for Bilastine tablets was approved for sale in China. The Bilastine tablet declared by Jiangsu Huayang Pharmaceutical Co., Ltd. was approved for listing, marking its success in becoming the first generic variety in China and the first to pass the evaluation.