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Asiahong Pharma (stock code: 688176.
SH) announced on November 7 that its drug for the diagnosis and surgery of bladder cancer has completed the enrollment of the first patient in the phase III clinical trial
.
This study is a prospective, subject-controlled, multicenter phase III.
clinical trial to investigate the additional detection rate and safety
of Hectiv combined with blue bladder endoscopy versus white light cystoscopy for non-muscle-invasive bladder cancer (NMIBC) (carcinoma in situ (CIS), Ta, T1).
The study was led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and led by Professor Li Hanzhong, head of the Department of Surgery of Peking Union Medical College Hospital, as the main investigator, leading a team of authoritative experts in the field of bladder cancer in China
.
In the future, the company will submit a product marketing application
to the National Medical Products Administration based on the progress of the clinical trial and valid data.
In January 2021, Rainbow signed a Distribution Agreement with Photocure ASA (OSE: PHO), a bladder cancer specialist based in Oslo, Norway, to obtain exclusive registration and commercialization rights
for Hect in Chinese mainland and Taiwan.
In December 2021, the drug landed in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, and was approved by the National Medical Products Administration (NMPA) of China to carry out phase III clinical trials in the first quarter of 2022, and was included in the pilot
of real-world data application in drug clinical trials.