Micot Announces FDA IND Approval for NASH Drug MT2004 and Files Hong Kong IPO Prospectus

Following the initiation of Phase II clinical studies for MT1002, Micot has officially announced that the Investigational New Drug (IND) application for its novel NASH therapeutic, MT2004, has successfully passed review by the U.S. Food and Drug Administration (FDA). Micot plans to enroll the first patient in the fourth quarter of 2019. This marks the second consecutive IND approval from the U.S. FDA for Micot’s innovative drugs within the same year, both of which are protected by global intellectual property rights.

This drug is a small-molecule therapeutic with a novel chemical structure, independently developed by Micot, primarily indicated for the treatment of non-alcoholic steatohepatitis (NASH). Non-alcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide, encompassing a spectrum that includes non-alcoholic fatty liver (NAFL), NASH, cirrhosis, and hepatocellular carcinoma (HCC). The mechanisms of action for NASH therapeutics mainly involve lipid metabolism modulation as well as antioxidant and anti-inflammatory effects. In terms of lipid metabolism, these agents primarily inhibit lipogenesis, particularly by targeting farnesoid X receptor (FXR) in the bile acid pathway—such as obeticholic acid (OCA)—to hinder FXR activation, thereby reducing de novo lipogenesis. MT2004 is a drug that targets FXR.

Currently, there are no approved specific drugs for NAFLD/NASH worldwide. Non-clinical data indicate that MT2004 has a favorable safety profile. In vivo studies demonstrate that, in addition to reducing the overall histological score of NASH, MT2004 attenuates hepatic fibrosis, inhibits further progression of NASH, lowers serum transaminase levels (ALT and AST), and ameliorates liver injury. MT2004 is expected to outperform obeticholic acid (OCA), currently in Phase III clinical trials, in addressing hepatocellular degeneration and necrosis, inflammation, and hepatic fibrosis, while also alleviating pruritus-related adverse effects and reducing the incidence of hepatobiliary events.

Therapeutic drugs for NASH hold considerable market prospects and potential in both China and the global pharmaceutical market. According to relevant data, once NASH medications are launched, the global market size is projected to reach USD 35–40 billion by 2025, reflecting substantial clinical demand.

It is reported that Micot’s product pipeline primarily focuses on cardiovascular and cerebrovascular diseases, metabolic disorders, neurological conditions, and analgesic and anti-inflammatory therapies. Earlier this year, the company completed a Pre-A financing round of RMB 115 million, which will be mainly used to advance the clinical development of multiple candidates in its new molecular entity drug pipeline.

Micot Technology Co., Ltd., established in 2007, is a Sino-foreign joint venture innovative drug R&D company with a global outlook. The company is dedicated to the research and development of new molecular entity drugs featuring bifunctional and multifunctional specific peptides, striving to become the No.1 player in the niche segment of novel peptide drugs and the No.1 in innovative cardiovascular medicines. Guided by a strategy of global innovation in drug R&D, the company adheres to its mission of “serving doctors and patients, creating new drugs, saving lives, alleviating suffering, improving quality of life, and addressing unmet clinical needs.” It focuses on the development of new drugs in the fields of cardiovascular diseases, metabolism, and anti-inflammatory and analgesic therapies.

After more than a decade of development, Micot has established a product pipeline comprising 17 new drug candidates, covering five major therapeutic areas: ischemic heart disease, stroke, anticoagulation and antithrombosis, nervous system injury and degeneration, and diabetes. Among these, three candidates have been selected for the National "Major New Drug Creation" Special Project; three have been approved to enter clinical trials by the China Food and Drug Administration (CFDA); two have been approved to enter clinical trials by the U.S. Food and Drug Administration (FDA); three are undergoing preclinical studies in the United States; and eight are planned for submission to the U.S. FDA for Investigational New Drug (IND) applications as new molecular entities.

Currently, the company’s research base in Xi’an covers a total area of over 3,000 square meters and features fully equipped, modern laboratories for new drug research. It is capable of independently conducting new drug design and synthesis, raw material studies, quality control studies, formulation development, and pharmacological and efficacy evaluations. The company plans to launch the construction of a new R&D center in Suzhou next year, aligned with its strategic roadmap, as well as a GMP-compliant manufacturing facility to meet commercial production needs following New Drug Application (NDA) approval. Additionally, it intends to establish branch offices in Beijing, Suzhou, and Boston, USA. Meanwhile, the company aims to enter the capital market in 2022.