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Medicilon Assists Toll Biotech's TollB-001 tablets, a new class 1.1 drug, to officially approve for clinical trials by the FDA

2023-06-21
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Recently, the IND application of TollB-001 Tablets, a class 1.1 new drug for rheumatoid arthritis by Toll Biotech, has been officially approved by the FDA, allowing clinical trials to be carried out in the United States.  This is another milestone after TollB-001 tablet of Toll Biotech was accepted by China CDE.  It is also an important step in Toll Biotech's international commercialization and expansion of overseas markets.

Shanghai Medicilon Inc. (Medicilon), as a partner of Toll Biotech, provided pharmaceutical research services, including raw materials and preparation, for TollB-001 tablets, which accelerated the research process.

Class 1.1 new drug TollB-001 tablet 

Drugs for Autoimmune Diseases with a New Mechanism

TollB-001 tablet is a class 1.1 small molecule new drug developed for rheumatoid arthritis launched by Toll Biotech.  Preclinical studies have shown that its efficacy and safety are significantly superior to clinical first-line drugs.  It is a class 1 of oral new drug independently developed by Toll Biotech with a new mechanism.  In addition, it is the only small-molecule drug that achieves target selectivity among competing products with the same target, which can specifically solve or improve the limitations of existing therapeutic drugs for rheumatoid arthritis.

The field of autoimmune diseases is the second largest drug market after oncology.  As a company focusing on the research and development of new drugs for autoimmune diseases, Toll Biotech has developed a number of candidate drugs for immune regulation with innovative mechanisms, and currently has multiple pipelines and is rapidly advancing.  The approval of TollB-001 tablets for clinical trials by the FDA is the result of nearly 20 years of research on immune regulation mechanisms and immunomodulatory drugs by the Toll Biotech team.  It is also another successful experience accumulation of Medicilon Pharmaceutical Research CDMO service platform.

Medicilon Pharmaceutical Research CDMO Service Platform 

 Integrated "API + Preparation" Layout

Medicilon's one-stop pharmaceutical research CDMO platform integrates API and preparation, and is committed to the technological innovation, optimization and commercial application of global pharmaceutical processes, from product development, quality research, control change, production and declaration, which assisting new drug research and development and saving time and cost for pharmaceutical companies.

Based on this, Medicilon will steadily expand into the field of biomacromolecules, establish R&D and production systems in the fields of small nucleic acid drugs and antibody drugs, collaborate with the improvement and innovation of salt form and crystal form screening, process safety research, and quality research systems, as well as the application of emerging technologies.  Medicilon will make efforts in the entire chain of pharmaceutical CDMO and expand the service level.

Medicilon congratulates Toll Biotech on its milestone progress and wishes the clinical trial of TollB-001 tablets to progress smoothly.  Empowering customers and growing together is an important task for Medicilon to maximize value, and it is also an inevitable requirement for fulfilling the mission of the industry.  In the battlefield of new drug research and development, Medicilon will continue to accompany innovative drug companies to create long-term value!

About Toll Biotech
Toll Biotech was founded in 2020 by Professor Hang Yin, School of Pharmacy, Tsinghua University.  It provides patients with innovative therapies to regulate the human immune response and solves the pain points of the global immune regulation drug market.  Based on nearly two decades of immune regulation mechanism research and immune regulation drug research accumulation, Toll Biotech has innovatively discovered a new immune regulation mechanism and multiple immune regulation small molecule drugs by utilizing leading new drug R&D technologies and platforms, and obtained a number of exclusive authorizations for small molecule drug patents.  The scope of patent coverage includes the world's major drug research and development worldwide.  Multiple pipelines have been formed and rapidly advanced in drug research and development around autoimmune diseases.  The company's first new small-molecule drug for rheumatoid arthritis has significantly better efficacy and safety than first-line clinical drugs, and clinical research has started.

Since its establishment, Toll Biotech has attracted wide attention from the industry, and has been selected into the National Key Special Project - Disruptive Technology Project Library, and the 2023 Zhongguancun Forum "List of 100 New Technologies and New Products".  Toll Biotech also obtained the certification of Science and Technology SMEs, Zhongguancun High-tech Enterprises and Beijing Innovative SMEs by the Ministry of Science and Technology.  Toll Biotech has successively completed angel round financing and A round financing, with a total financing of nearly RMB 200 million, and won the highest award in the finals of the National Disruptive Technology Innovation Competition held by the Ministry of Science and Technology, "2022 Most Potential Start-up Enterprise" and "2022 Most Attention Emerging Enterprise" in the "Golden Horse Award" of the 2022 China Biomedical Industry Chain Innovation Billboard, VB-Find Award 2022 Most Innovative Medical Technology Products (Solutions) TOP100, "Maker Beijing 2022" Innovation and Entrepreneurship Competition Beijing Regional Competition TOP150 and many other awards.

About Medicilon
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China.  Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research.  Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support.  By the end of 2022, Medicilon has provided new drug R&D services to more than 1,840 clients around the world, and participated in the R&D of 330 new drug projects that have been approved for clinical trials.  Medicilon is proud to contribute to human health in the globe.

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