Gelonghui reported on December 18 that REGENT PACIFIC (00575.HK) announced that the company's strategic business partner Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. ("Jiangsu Wanbang Pharmaceutical", a wholly-owned subsidiary of Shanghai FOSUN PHARMA ("FOSUN")) submitted new drug application registration documents to the National Medical Products Administration on December 17, 2024, and approval is expected within 12 months from the submission date.
Jiangsu Wanbang Pharma must be responsible for independently obtaining new drug applications from the National Medical Products Administration and maintaining any and all regulatory approvals required for importing Senstend into the People's Republic of China ("China"). Additionally, it is important that Jiangsu Wanbang Pharma is fully responsible for the marketing, sales, and distribution of Senstend in China and contacts the manufacturer to procure and supply Senstend in order to achieve its sales objectives.
Although the group will provide reasonable assistance to Jiangsu Wanbang Pharma in obtaining regulatory approval in China, the group still relies on Jiangsu Wanbang Pharma to obtain the relevant approvals from the National Medical Products Administration and achieve its sales objectives. Furthermore, Jiangsu Wanbang Pharma signed an exclusive manufacturing and supply agreement on August 26, 2024, with (including) Genetic S.p.A. and Jiangsu Wanbang Pharma Marketing Co., Ltd. ("Jiangsu Wanbang Marketing," a subsidiary of Jiangsu Wanbang Pharma), under which Genetic will produce and supply Senstend based on the purchase orders received from Jiangsu Wanbang Pharma.