Congratulations to Hikma and Vectura's cooperation product Seretide generic drug FDA approval. This is the project started by our company's Dr. Chen Yongqi as the earliest employee in Vectura. A few days ago, Hikma issued an announcement stating that its company's salmeterol and ticasone inhalation powder aerosols (specifications: 100mcg/50mcg and 250mcg/50mcg) reported for production as generic drugs have been approved by the FDA for marketing. The project was led by Dr. Chen Yongqi, the founder of Respley, during his work at Vectura, and was authorized to be transferred to Hikma by means of technical service + sales commission. With the approval of the product, Dr. Chen Yongqi, the founder of Respuli, has added a blockbuster inhalation preparation product generic drug to his career, laying a solid foundation for Zhuhai Respuli Biopharmaceutical Co., Ltd. on the road to inhalation preparations. Technical basis. Vectura also received a $11 million milestone with the approval of the product, and will receive a mid-term royalties from the net sales of the product [1]. The approval of this product is also the second FDA-approved generic drug for Seretide after Mylan. The imitation of inhaled preparations is extremely difficult, and this may be the only two generic drugs for Seretide that will remain in the future for a long time.
Dr. Chen Yongqi was a pharmaceutical expert of Vectura Co., Ltd. in the United Kingdom. He has deep and extensive knowledge and practical management experience in the chemical industry and pharmaceutical industry. Among the 17 products that have been marketed, 13 mainstream varieties have been successfully developed by Dr. Chen Yongqi, including GSK's latest Ellipta® series has been successfully approved and authorized by the European Union and the United States. In particular, the successful inhalation of high-end complex preparations of Symbic® and Seretide®. Among them, the generic drug AirBuFo® of Sympic® is the only generic drug approved for marketing in the EU, and the generic Seretide® is the only one currently approved. Generic drugs approved by the EU and FDA for marketing.
According to data, salmeterol and ticasone inhalation powder is a combination medication form (bronchodilator and inhaled corticosteroid) for the conventional treatment of reversible obstructive airway diseases, including asthma in adults and children. Inhalation therapy is the first choice for the prevention and treatment of respiratory diseases such as asthma and COPD. Inhaled drugs can directly reach the respiratory tract and lungs, so it has the advantages of fast onset, small dosage, and small side effects.
Reference ：
[1]Vecturaearns $11m milestone as Hikma receives US FDA approval for generic AdvairDiskus®.Retrieved December 17,2020,from
https://www.vectura.com/about/news/vectura-earns-11m-milestone-as-hikma-receives-us-fda-approval-for-generic-advair-diskus/