Gan Lai announced that the farnesol X receptor agonist ASC42 for the treatment of primary biliary cholangitis Phase II and III clinical trial protocol was approved by the China National Food and Drug Administration

Shanghai, China, November 15, 2021/PRNewswire/ ---Gallery Pharmaceutical Co.
, Ltd.
(Hong Kong Stock Exchange code: 1672), a wholly-owned subsidiary of Gan Lai Pharmaceutical Co.
, Ltd.
, announced today that ASC42 treats primary biliary bile ducts The Phase II and Phase III clinical trials of PBC have been approved by the National Medical Products Administration (NMPA) of China
.

PBC is another new indication for ASC42 to treat chronic hepatobiliary diseases

Based on the Phase II and Phase III clinical trial protocol of ASC42 for the treatment of PBC approved by the National Food and Drug Administration of China, Gan Lai will conduct phase II clinical trials in 100 patients with insufficient or intolerance to ursodeoxycholic acid (UDCA).

.

The Phase II clinical trial consists of three active drug groups and a placebo control group.

ASC42 is a new type of high-efficiency and selective non-steroidal farnesoid X receptor agonist that is completely independently developed by the company, has global intellectual property rights, and is expected to become the best-in-class (best-in-class)
.

Data from the US Phase I clinical trial of ASC42 showed that in the human body with an effective dose of 15 mg, once a day, for a period of 14 days, no pruritus symptoms were observed and FXR targeted activated biomarker fibroblast growth factor 19 (FGF19) The increase was as high as 1,780% on the 14th day of dosing

Ursodeoxycholic acid (UDCA) is currently the only approved drug for the treatment of PBC in China
.

However, about 40% of PBC patients have insufficient response or intolerance to UDCA

Professor Jia Jidong, Director of the Liver Disease Center of Beijing Friendship Hospital Affiliated to Capital Medical University and Deputy Director of the National Digestive Diseases Clinical Research Center, said: “There is a high degree of unmet medical needs in the field of PBC treatment.
According to the data from Phase I, the effective dose of ASC42 in humans is 2 There was no itching during Zhou's treatment.
I am very happy to lead the clinical study of ASC42 primary biliary cholangitis (PBC) as the principal investigator
.

"

Dr.
Wu Jinzi, Founder, Chairman of the Board of Directors and Chief Executive Officer of Geli, said: “The third indication for hepatobiliary disease of ASC42, namely primary biliary cholangitis, has been approved by the China National Medical Products Administration.
The drug ASC22 is another milestone after the breakthrough in the research and development of the functional cure for hepatitis B.
We are working hard to become a global leader in the research and development of hepatobiliary disease drugs
.

"

About songli

Gale is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.
HK), covering the complete value chain from new drug discovery and development to production and commercialization
.

Gale is committed to the development and commercialization of innovative drugs in the fields of viral diseases, non-alcoholic steatohepatitis/primary biliary cholangitis, tumors (oral tumor metabolic checkpoints and immune checkpoint inhibitors) to solve domestic problems.

1.
Viral diseases: (1) Hepatitis B (functional cure): Explore a treatment plan that uses subcutaneous injection of PD-L1 antibody ASC22 and Peloxin® as cornerstone drugs, combined with other target drugs, and is expected to be a functional cure for hepatitis B Bring a major breakthrough
.

(2) AIDS: immunotherapy ASC22, used for AIDS-specific immune reconstruction, in order to achieve functional cure for AIDS-infected patients

2.
Non-alcoholic steatohepatitis/primary biliary cholangitis: Gan Lai Pharmaceutical, a wholly-owned subsidiary of Golly, focuses on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis
.

Gan Lai Pharmaceutical has three clinical stage non-alcoholic steatohepatitis drug candidates and three fixed doses for fatty acid synthase (FASN), thyroid hormone ß receptor (THRß) and farnesol X receptor (FXR).

3.
Oncology (oral tumor metabolism checkpoints and immune checkpoint inhibitors): Gerry has an innovative and differentiated pipeline in the field of tumor treatment, focusing on oral fatty acid synthase inhibitors that play a key role in tumor lipid metabolism Pipeline and a new generation of immune checkpoint inhibitors-oral PD-L1 small molecule inhibitor pipeline
.

4.
Expanding indications: acne: ASC40 has been approved to enter Phase II clinical trials for new acne indications following non-alcoholic steatohepatitis and solid tumor indications
.
For more information, please visit the website:
.

Source: Golly Pharmaceutical Co.
, Ltd.