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励晶太平洋(00575.HK)向中国国家药品监督管理局提交Senstend的新药申请

REGENT PACIFIC (00575.HK) submitted a new drug application for Senstend to the National Medical Products Administration of China.

Gelonghui Finance ·  Dec 18 04:15

On December 18, Ge Longhui Pacific (00575.HK) announced that the company's commercial strategic partner Jiangsu Wanbang Biochemical Group Co., Ltd. (“Jiangsu Wanbang Pharmaceutical”, a wholly owned holding company of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun”)) has submitted a new drug application registration file to the State Drug Administration on December 17, 2024, and is expected to be approved within 12 months from the date of submission.

Jiangsu Wanbang Pharmaceutical is responsible for obtaining applications for new drugs from the State Drug Administration at its own expense and maintaining any and all regulatory approvals required to import Sensent in the People's Republic of China (“China”). Additionally, it is important that Jiangsu Wanbang Pharmaceutical is solely responsible for Senstend's marketing, sales and distribution in China, and contacts manufacturers to purchase and supply Senstend to achieve its sales goals.

Although the Group will provide reasonable assistance to Jiangsu Wanbang Pharmaceutical to obtain regulatory approval in China, the Group still relies on Jiangsu Wanbang Pharmaceutical to obtain relevant approval from the State Drug Administration and achieve its sales goals. Furthermore, on August 26, 2024, Jiangsu Wanbang Pharmaceutical signed an exclusive manufacturing and supply agreement with (among others) Genetic S.p.A. and Jiangsu Wanbang Pharmaceutical Marketing Co., Ltd. (“Jiangsu Wanbang Marketing”, an affiliate of Jiangsu Wanbang Pharmaceutical). According to this, Genetic will manufacture and supply Senstend to Jiangsu Wanbang Pharmaceutical in accordance with the purchase order obtained from Jiangsu Wanbang Pharmaceutical.

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