Goliath subsidiary NASH Drug was approved by the FDA Fast Track

On December 14, 2020, Ganley, a wholly owned subsidiary of Goliath Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) had granted fast-track qualification to the company's NASH candidate drug, ASC42.
fda's fast-track program aims to accelerate drug development and rapid review for serious illnesses to address unsolved medical needs.
fast-track accreditation through asscertic ASC42 demonstrates the FDA's recognition of its potential to address the unseeded medical needs of NASH patients.
ASC42 ASC42 is a new highly effective nonsteroidal nifer X-subject (FXR) agonist that is fully self-developed and is expected to be best in class, and ASC42 was approved by the FDA in October to conduct clinical trials in NASH patients.
, asC42 showed significant improvements in liver fat degeneration, inflammation and fibrosis in two NASH animal models.
FXR is mainly expressed in the hepatocellular nucleus, by binding with ligands, inhibits bile acid synthesis and re-absorption, regulates the concentration of bile acid in the liver and circulatory system, and also inhibits fat synthesis to promote fatty acid oxidation, regulate liver lipids and blood lipids, while promoting liver glycogen synthesis, inhibiting hepatic sugar heterogeneity, maintaining the body's blood sugar balance.
FXR regulates bile acid balance by affecting gene expression involved in bile acid synthesis, secretion, concatenation, transport, absorption and detoxification.
because bile acids play an important role in liver inflammation and fibrosis, and glycolipid metabolism disorders can lead to fatty livers, FXR is an ideal target for drugs to improve liver fat degeneration, inflammation and fibrosis.
addition to Ganlai Pharmaceuticals, Intercept, Torto Bio, etc. also laid out the target.
Figure 1. Global FXR agitant research and development progress (partially) Ganlai: The leading member of the domestic market for NASH innovative drugs in the world According to epidemiological statistics, non-alcoholic fatty liver disease (non-alcoholic fatty liver disease, NAFLD) affects 25% of the world's adults.
and NASH is NAFLD, where inflammation and fibrosis occur, and 15%-25% of NAFLD patients develop NASH.
huge commercialization potential from the huge patient base, with Datamonitor Healthcare predicting that the global NASH market could reach $21 billion (about 177.8 billion yuan) by 2027.
hundreds of billions of dollars of market space to make NASH one of the few "super-blue sea" markets in the field of innovative pharmaceuticals.
Figure 2.No new NASH drug has been approved for sale in the developed global market to date, compared with some of the targets of NASH drugs and related leading drugs and huge market space.
public information shows that only Intercept's OCA has completed Phase III, and a small number of drug candidates are in Phase III clinical phase.
domestic NASH research and development force is gradually rising at the same time as overseas companies are fast-paced.
and GANNEX is the main player in the domestic sound of local NASH innovative pharmaceutical companies entering the global market horn.
As a Listed Company of Hong Kong Stocks, Geli Pharmaceuticals (1672. HK), a wholly owned subsidiary of Ganlai Pharmaceuticals, owns all the assets or interests of Goliath's NASH pipeline.
in the NASH pipeline, in addition to ASC42, Ganley has two clinically-staged drug candidates, ASC40 and ASC41.
, ASC40 represents better relative response rates and safety than Other Postclinical Products Phase II data worldwide.
according to the company's official website, in animal experiments, ASC41 achieved the same degree of improvement in liver fatty degeneration, inflammation and fibrosis at a dose of 1/10 MGL-3196.
ASC41, the third-largest TTHR-β astrist in NASH research and development worldwide, has also taken on more of the industry's expectations for this target in the space for safety and clinical improvement.
there is a huge unsolt demand in the field of NASH treatment, and huge demand means a huge market.
Evaluate Pharme predicts that the global NASH drug market will reach $40 billion by 2025.
and in this NASH beach fight, domestic enterprises have been deeply involved.
In addition to Ganlai, Zhengda Qing, Jun Santai, All Life Pharmaceuticals, Microcore Creatures, GuangshengTang, Paige Biology, Kangzhe Pharmaceuticals, Dongsan, etc. have also been laid out.
face NASH huge market prospects, the major enterprises who will take the lead, the first to share this cake, it is worth looking forward to.
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