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-- Ganlai plans to initiate Phase III clinical trials in China, the United States and the European Union immediately after the completion of Phase II clinical trials in China .
--The 2010 Chinese epidemiological study showed that the number of PBC patients in China was about 656,000 , of which 440,000 were female patients over the age of 40 .
SHANGHAI , April 10, 2022 /PRNewswire/ -- Gan Lai Pharmaceuticals Co.
This phase II clinical trial (clinical trial number: NCT05190523) consists of three ASC42 drug treatment groups (5 mg, 10 mg and 15 mg) and a placebo control group, and plans to enroll 100 patients with ursodeoxycholic acid ( UDCA) patients with poor response or intolerance, the enrollment ratio is 1:1:1:1, and the course of treatment is 12 weeks, which is expected to be completed by the end of 2022
In November 2021, the China National Medical Products Administration ("NMPA") approved a Phase III clinical trial protocol for 210 PBC patients
ASC42 is a novel and highly selective non-steroidal farnesoid X receptor (FXR) agonist, which is completely independently developed by the company, owns global intellectual property rights, and is expected to be the best-in-class
Ursodeoxycholic acid (UDCA) is currently the only drug approved for the treatment of PBC in China, however, about 40% of PBC patients have poor response or intolerance to UDCA [1]
A Chinese epidemiological study in 2010 showed that the number of PBC patients in China was about 656,000, of which 440,000 were female patients over the age of 40 [2]
Dr.
[1] Lindor KD, Bowlus CL, Boyer J, et al.
About Song Li
Ascletis is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.
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