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Medicilon assists Biotime obtain approval for its first dual-filing innovative drug in China and the United States

2024-03-19
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On March 1, Biotime Biotechnology (Biotime) BIOT-001 tablets obtained the implicit clinical trial approval from the Drug Evaluation Center of the National Medical Products Administration (NMPA), and the indication is ulcerative colitis.  This is a new milestone for the BIOT-001 project of Biotime after it obtained implicit approval for clinical trials from the US FDA. It is also the first innovative drug product to be dual-filing in China and the United States.

(Biotime) BIOT-001 tablets.webp

Shanghai Medicilon Inc. (Medicilon) provides one-stop preclinical R&D services from target to IND application for the research and development of BIOT-001, and fully empowers BIOT-001 tablets to obtain the approval in China and United States.

Another successful case of dual declaration between China and the United States
Medicilon’s one-stop service helps innovative drugs go global

Nowadays, it is time for innovative drugs to set sail to the sea, and dual reporting between China and the United States has become an important trend.  Medicilon is one of the earliest CRO companies in China to provide a complete set of new drug clinical research applications that comply with both Chinese GLP and US GLP standards.  The preclinical experimental base has established a research operation process and quality system that are in line with international benchmarks.  It now has a laboratory of 29,000 square meters, has obtained the NMPA drug GLP laboratory qualification, complies with the GLP laboratory standards of the US FDA, Australian TGA, and the European Union EMEA, and has passed ABSL-2 filing.  The animal experiment facility has passed AAALAC certification and can simultaneously raise non-human primates, dogs, rats, rabbits, guinea pigs, mini pigs and other experimental animals.  The Provantis data acquisition system, EMPOWER chromatography workstation management system, Chromeleon chromatography data system and LIMS laboratory sample management system can ensure research compliance and data authenticity and credibility, as well as SEND conversion of research data to meet the US FDA declaration requirements.

By the end of 2023, 421 new drugs and generic drug projects that Medicilon participated in the research and development have been approved for clinical use, of which 41 INDs have been approved by the US FDA.

About Biotime Biotechnology

Biotime Biotechnology is a national high-tech enterprise specializing in the research, development, production and sales of in vitro diagnostic reagents and instruments.  It has won the titles of National Specialized and New “Little Giant” Enterprise, Top 500 Private Enterprises in China’s Manufacturing Industry, Outstanding Private Enterprises in Fujian Province, Leading Industrial Enterprises in Fujian Province, Top 100 Private Enterprises in Fujian Province and Top 50 Manufacturing Enterprises in Fujian Province.  In addition, Biotime has dozens of honorary qualifications and titles such as the Provincial New R&D Institution, Fujian Province Science and Technology Little Giant Leading Enterprise, and Fujian Province High-Growth Enterprise in the Industry and Information Technology Field.

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 2023, Medicilon has provided new drug R&D services to more than 2,000 clients around the world, and participated in the R&D of 421 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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