Is the Time Right for NASH? First Approvals Imminent as Resmetirom and Ocaliva Lead the Race
NASH is widely recognized as a major disease area with significant unmet clinical needs. There are hundreds of clinical-stage pipelines globally, targeting dozens of mechanisms, with numerous participants ranging from multinational corporations (MNCs) to biotech companies.
Two drugs are expected to gain approval this year, with the first one on the verge of launch. Madrigal’s Phase III clinical trial results have drawn the most attention, and resmetirom may become the first approved drug; Intercept has resubmitted its New Drug Application (NDA) for obeticholic acid in the treatment of NASH-related liver fibrosis; Akero and Poxel have also reported positive progress in their Phase II clinical trials. However, there are several shared concerns regarding the development prospects of new NASH therapies:
What is the likelihood of successful development of new drugs for NASH?
What is the biggest challenge in the development of new drugs for NASH?
What is the current industrial landscape of new drug development for NASH?
What Are the Future Development Directions for New NASH Drugs?
At this time,March 31 (this Friday) 15:00-18:00 VBInsight, in collaboration with the Drug Hunter Club and Asymchem Laboratories, inviting outstanding industry partners to initiate offline salons, with the aim of discussing this high-profile sector and accelerating the availability of new NASH drugs to patients.
Xu Weiwei, Medical Director, Junshengtai Pharmaceuticals
Master of Clinical Medicine from Soochow University; MBA from the University of Manchester, UK. Previously served as an endocrinologist at a tertiary-level hospital, then transitioned to the pharmaceutical industry, where he spent over a decade in medical affairs departments at multinational pharmaceutical companies including Novo Nordisk, Sanofi, and Amgen. Currently serves at Junshengtai Pharmaceuticals, overseeing the development of metabolic drugs.
Xu Xiaodong, Founder & CEO of Yachuang Pharma
Ph.D. from New York University, with over 20 years of experience in drug R&D; authored 28 peer-reviewed articles and filed more than 20 patent applications. Publications include Journal of Medicinal Chemistry, Antimicrobial Agents and Chemotherapy, and Journal of Virology.
Shao Pengcheng, Co-founder and CSO of Bowang Pharma
With over two decades of experience in new drug R&D, I spent seventeen years conducting medicinal chemistry research at Merck & Co., a renowned pharmaceutical company in the United States. I participated in and led new drug development projects across multiple therapeutic areas, including cardiovascular disease, diabetes, cancer, central nervous system disorders, and antibiotics. I am a key inventor of four Preclinical Candidate Compounds (PCCs). I later joined Arrowhead Pharmaceuticals, where, as Head of Medicinal Chemistry, I was responsible for formulating and executing strategies for extrahepatic delivery of siRNA, making critical contributions to early-stage anticancer drug development projects. Subsequently, I joined Mitotherapeutix as Head of R&D, where I leveraged CRO partnerships exclusively to complete the entire siRNA drug development process for a novel target, from project initiation to PCC selection.
Chen HaigangManaging Partner, Xingze Capital
Former Senior Analyst in the Healthcare Sector at CICC and CITIC Securities
1st Place, Best Pharmaceutical Industry Research Team in Mainland China, Asiamoney (2014); 2nd Place, Best Pharmaceutical Industry Research Team in Greater China, Institutional Investor (2015)
Industry Mentor for the Master of Finance Program, Guanghua School of Management, Peking University; Social Mentor, MBA School, Zhejiang University of Finance and Economics
M.D. in Clinical Medicine, Peking Union Medical College Hospital; Pre-medical Studies, School of Life Sciences, Peking University
Junshengtai Pharmaceuticals:
HighTide Therapeutics Inc. is a globally integrated, innovative biotechnology company dedicated to addressing significant unmet clinical needs in metabolic diseases, digestive system disorders, and other therapeutic areas. Adopting a global clinical development strategy from the outset, and under the leadership of an experienced international executive team and Scientific Advisory Board, the company is concurrently developing first-in-class, multi-target, original novel drugs across multiple countries, including the United States, Australia, Canada, and China.
Junshengtai is committed to achieving comprehensive clinical benefits and overall health improvements for patients. Grounded in source innovation, the company leverages multi-functional, multi-pathway natural products to develop novel drugs, all of which are protected by 100% global intellectual property rights. Junshengtai has established a robust product pipeline and is advancing multiple mid- to late-stage clinical trials globally for indications including type 2 diabetes mellitus (T2DM), non-alcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC), and primary biliary cholangitis (PBC). Its core products have been granted two “Fast Track Designations” and one “Orphan Drug Designation” by the U.S. FDA. As the first NASH innovative drug from China to receive FDA Fast Track Designation, it is driving the modernization and internationalization of natural product-based therapeutics.
Yachuang Pharma:
Yachuang Pharma is a clinical-stage biotechnology company primarily focused on the development of innovative drugs for liver diseases. The company’s key areas of focus include non-alcoholic steatohepatitis (NASH), chronic hepatitis B, and rare liver diseases.
Bowang Pharmaceuticals:
Bowang Pharma was established in April 2021, focusing on the development of siRNA therapeutics. The company was founded by several returning Chinese scientists with extensive experience in siRNA drug development. Bowang Pharma is committed to developing next-generation siRNA therapeutics to provide better treatment options for patients worldwide. The team possesses years of specialized expertise across the entire RNAi drug development process, including nucleic acid sequence design, chemical modification, GalNAc delivery technology, extrahepatic delivery technology, oligonucleotide synthesis, and CMC (Chemistry, Manufacturing, and Controls). The company is actively advancing its pipeline, with two candidates already in Phase I clinical trials. It aims to rapidly develop globally leading products that effectively address unmet clinical needs, thereby safeguarding high-quality life for humanity.
Xingze Capital:
Xingze Capital was established in 2015. The name “Xingze” reflects its mission to leverage capital investment to integrate resources across the broader healthcare industry, promote development throughout the entire life sciences lifecycle, and benefit humanity. Currently, the firm manages five RMB-denominated funds, with total assets under management nearing RMB 5 billion. Its investment team comprises more than 20 professionals and advisors with extensive experience in healthcare investments worldwide, possessing diverse expertise in life sciences, pharmaceuticals, finance, and law. Since its inception, Xingze Capital has focused on investing in outstanding early- and growth-stage enterprises in the life sciences sector, covering areas such as biopharmaceuticals, medical devices, and healthcare services. Its portfolio includes over 60 high-growth star companies, including Junshi Biosciences (01877.HK), Akeso Biopharma (09926.HK), China Antibody (03681.HK), RemeGen Co., Ltd. (09995.HK), HeartCare Medical Technology (02160.HK), Sinocelltech, Liuhe Ningyuan, ImmuneOnco, Shenqi Medical, Shengsheng Logistics, and PharmaCube. Committed to fostering innovation and growth among Chinese enterprises and driving industrial progress and social development, Xingze Capital leverages its team’s rich industry experience, global resource network, and outstanding reputation to spare no effort in helping entrepreneurs realize their startup dreams.
About the Drug Hunter Club:
The Drug Hunters Club is a non-profit professional organization jointly initiated by founding partners of leading domestic venture capital funds, entrepreneurs, and scientists. It was established on November 5, 2021, in Zhangjiang “Pharma Valley,” Shanghai. Guided by our original aspiration to serve as “a hub for inspiration among pharmaceutical professionals,” and upholding the principles of “innovation, exchange, and sharing,” we foster a relaxed, enjoyable, free, and open artistic and cultural atmosphere. We organize and curate topic-driven events designed to spark ideas and stimulate innovation, providing a platform where the insights and expertise of pharmaceutical professionals can find a home.
About Asymchem Laboratories:
Asymchem is a globally leading, technology-driven one-stop integrated CDMO service provider. By providing one-stop CMC services throughout the entire drug lifecycle, as well as efficient and high-quality R&D and manufacturing services to pharmaceutical and biotechnology companies both in China and abroad, Asymchem accelerates the clinical research and commercial application of innovative drugs. According to Frost & Sullivan statistics based on 2020 revenue, the Company is the world’s fifth-largest CDMO for active pharmaceutical ingredients (APIs) of innovative drugs and the largest CDMO for chemically synthesized drugs in the commercialization stage in China. Leveraging profound industry insights accumulated over more than two decades of deep engagement in the sector, mature R&D and manufacturing capabilities, and a strong customer reputation, the Company has become an integral part of the global industrial chain for innovative drugs. Starting with “every individual, every product, and every service,” Asymchem provides excellent CDMO services and solutions covering the entire drug lifecycle from R&D to commercialization, striving to become the reliable preferred partner for the global pharmaceutical industry.
About ArteryMed:
VBioPharma is a media and research platform under VCBeat, dedicated to the biopharmaceutical sector. It delivers “in-depth” and “incremental” communication value to innovators and entrepreneurs through both content and operational initiatives. On the content front, key offerings include exclusive financing announcements, corporate interviews, the “Drug Developers” column, in-depth industry analyses, and sector reports. Operationally, its flagship program, “VB Think Tank,” focuses on practical challenges and industry trends, fostering tangible collaborations through intellectual exchange.
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