-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
--It is expected to obtain the top-line data of the US Phase I clinical trial of ASC42 in July 2021 - Based on the approval of the US clinical trial and the FDA fast track qualification, ASC42 has good conditions to start the phase II clinical trial before the end of 2021.
China Shanghai, May 27, 2021—Gan Lai Pharmaceutical is a wholly-owned subsidiary of Golly Pharmaceutical Co.
, Ltd.
(Hong Kong Stock Exchange code: 1672) focusing on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis (NASH) .
The company announced today that the National Medical Products Administration (NMPA) of China has approved its drug candidate ASC42 to start clinical trials for the treatment of non-alcoholic steatohepatitis.
ASC42 is a new type of high-efficiency and selective non-steroidal farnesoid X receptor (FXR) agonist completely independently developed by Gan Lai and is expected to become the best-in-class.
ASC42 oral tablet is developed by Gan Lai's proprietary formulation technology and has the characteristics of being stable at room temperature.
ASC42 can be used as a single agent or in combination with the thyroid hormone β receptor (THR-β) agonist ASC41 or the fatty acid synthase (FASN) inhibitor ASC40.
In October 2020, ASC42 was approved by the U.
S.
Food and Drug Administration (FDA) to conduct clinical trials in patients with non-alcoholic steatohepatitis.
Related article: Gan Lai Pharmaceuticals FXR agonist ASC42 was approved to carry out US clinical trials for NASH indications.
In December 2020, ASC42 was approved by the US FDA for fast-track qualification.
Related article: Ganlai FXR agonist ASC42 was accredited by the US FDA Fast Track in July 2021, and it is expected to obtain top-line data from the US Phase I clinical trial of ASC42.
Dr.
Wu Jinzi, the founder, chairman and CEO of Geli, is very pleased that ASC42 has been approved by the National Food and Drug Administration and the US FDA for clinical trials.
ASC42 is expected to become the best-in-class FXR agonist.
We look forward to the top-line data of the US Phase I clinical trial of ASC42 and the Phase II clinical trial in patients with non-alcoholic steatohepatitis that will be launched before the end of 2021.
About Gale Gale is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.
HK).
Gale is committed to the research and development and commercialization of innovative drugs in the four major diseases of steatohepatitis, tumor (lipid metabolism and oral checkpoint inhibitors), viral hepatitis and AIDS, to meet the clinical needs of patients at home and abroad.
Under the leadership of a management team with deep professional knowledge and outstanding past achievements, Gerry has developed into an integrated platform company, covering the complete value chain from new drug discovery and development to production and commercialization.
Gale currently has three commercial products and seventeen products under development (11 of which are completely independent research and development).
1.
Non-alcoholic steatohepatitis: Gan Lai Pharmaceutical, a wholly-owned subsidiary of Golly Pharmaceutical Co.
, Ltd.
, focuses on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis.
Gan Lai Pharmaceutical has three clinical-stage drug candidates for fatty acid synthase (FASN), thyroid hormone receptor ß (THR-ß) and farnesol X receptor (FXR), and three combination therapies.
2.
Tumor (lipid metabolism and oral checkpoint inhibitors): focus on the pipeline of oral fatty acid synthase inhibitors that play a key role in tumor lipid metabolism and a new generation of checkpoint inhibitors-oral PD-L1 small molecule inhibitors Pipeline.
3.
Viral hepatitis: (i) Hepatitis B: Gale focuses on the research and development of innovative drugs for the clinical cure of hepatitis B.
Exploring a treatment plan that uses subcutaneous injection of PD-L1 antibody ASC22 and Pegasin® as cornerstone drugs, combined with other target drugs, is expected to bring a major breakthrough in the clinical cure of hepatitis B.
(ii) Hepatitis C: Golly has successfully developed and marketed two new class 1 drugs, Ganovo® and Xinlilai®, to form a full oral hepatitis C treatment plan; ASC18 fixed-dose compound preparation is an upgraded version of the hepatitis C treatment plan, and the bridging test has been completed.
4.
AIDS: ASC09F is a fixed-dose compound inhibitor of protease for the treatment of HIV.
The clinical trial application of ASC09F has been approved.
For more information, please visit the website:
China Shanghai, May 27, 2021—Gan Lai Pharmaceutical is a wholly-owned subsidiary of Golly Pharmaceutical Co.
, Ltd.
(Hong Kong Stock Exchange code: 1672) focusing on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis (NASH) .
The company announced today that the National Medical Products Administration (NMPA) of China has approved its drug candidate ASC42 to start clinical trials for the treatment of non-alcoholic steatohepatitis.
ASC42 is a new type of high-efficiency and selective non-steroidal farnesoid X receptor (FXR) agonist completely independently developed by Gan Lai and is expected to become the best-in-class.
ASC42 oral tablet is developed by Gan Lai's proprietary formulation technology and has the characteristics of being stable at room temperature.
ASC42 can be used as a single agent or in combination with the thyroid hormone β receptor (THR-β) agonist ASC41 or the fatty acid synthase (FASN) inhibitor ASC40.
In October 2020, ASC42 was approved by the U.
S.
Food and Drug Administration (FDA) to conduct clinical trials in patients with non-alcoholic steatohepatitis.
Related article: Gan Lai Pharmaceuticals FXR agonist ASC42 was approved to carry out US clinical trials for NASH indications.
In December 2020, ASC42 was approved by the US FDA for fast-track qualification.
Related article: Ganlai FXR agonist ASC42 was accredited by the US FDA Fast Track in July 2021, and it is expected to obtain top-line data from the US Phase I clinical trial of ASC42.
Dr.
Wu Jinzi, the founder, chairman and CEO of Geli, is very pleased that ASC42 has been approved by the National Food and Drug Administration and the US FDA for clinical trials.
ASC42 is expected to become the best-in-class FXR agonist.
We look forward to the top-line data of the US Phase I clinical trial of ASC42 and the Phase II clinical trial in patients with non-alcoholic steatohepatitis that will be launched before the end of 2021.
About Gale Gale is an innovative R&D-driven biotechnology company listed on the Hong Kong Stock Exchange (1672.
HK).
Gale is committed to the research and development and commercialization of innovative drugs in the four major diseases of steatohepatitis, tumor (lipid metabolism and oral checkpoint inhibitors), viral hepatitis and AIDS, to meet the clinical needs of patients at home and abroad.
Under the leadership of a management team with deep professional knowledge and outstanding past achievements, Gerry has developed into an integrated platform company, covering the complete value chain from new drug discovery and development to production and commercialization.
Gale currently has three commercial products and seventeen products under development (11 of which are completely independent research and development).
1.
Non-alcoholic steatohepatitis: Gan Lai Pharmaceutical, a wholly-owned subsidiary of Golly Pharmaceutical Co.
, Ltd.
, focuses on the development and commercialization of innovative drugs in the field of non-alcoholic steatohepatitis.
Gan Lai Pharmaceutical has three clinical-stage drug candidates for fatty acid synthase (FASN), thyroid hormone receptor ß (THR-ß) and farnesol X receptor (FXR), and three combination therapies.
2.
Tumor (lipid metabolism and oral checkpoint inhibitors): focus on the pipeline of oral fatty acid synthase inhibitors that play a key role in tumor lipid metabolism and a new generation of checkpoint inhibitors-oral PD-L1 small molecule inhibitors Pipeline.
3.
Viral hepatitis: (i) Hepatitis B: Gale focuses on the research and development of innovative drugs for the clinical cure of hepatitis B.
Exploring a treatment plan that uses subcutaneous injection of PD-L1 antibody ASC22 and Pegasin® as cornerstone drugs, combined with other target drugs, is expected to bring a major breakthrough in the clinical cure of hepatitis B.
(ii) Hepatitis C: Golly has successfully developed and marketed two new class 1 drugs, Ganovo® and Xinlilai®, to form a full oral hepatitis C treatment plan; ASC18 fixed-dose compound preparation is an upgraded version of the hepatitis C treatment plan, and the bridging test has been completed.
4.
AIDS: ASC09F is a fixed-dose compound inhibitor of protease for the treatment of HIV.
The clinical trial application of ASC09F has been approved.
For more information, please visit the website:
