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Medicilon assists Shijiazhuang No.4 Pharmaceutical's Class 1 new chemical drug SYN045 tablets obtain clinical approval

2024-02-28
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On January 26, SYN045, a Class I new drug developed by Shijiazhuang No.4 Pharmaceutical, received a clinical trial approval notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).  This marks another substantial step forward in the research and development of the company's second innovative drug.

Shanghai Medicilon Inc. (Medicilon), as a partner of Shijiazhuang No.4 Pharmaceutical, provided preclinical research services such as pharmacokinetics and safety evaluation for the development of SYN045 tablets, helping to successfully obtain approval.

SYN045 is a Class I new drug independently developed by Shijiazhuang No.4 Pharmaceutical.  SYN045 is a selective long-acting PGI2 receptor agonist and is intended to be used for pulmonary arterial hypertension.  Preclinical studies have shown that SYN045 has good target selectivity, compound activity, and safety.

Currently, Medicilon's preclinical research service platform has established a research operation process and quality system that complies with international standards and has a laboratory of 29,000 square meters.  Medicilon has also obtained NMPA drug GLP laboratory certification qualification and complies with the GLP laboratory standards of the US FDA, Australian TGA, and EU EMEA.  The animal experiment facility has passed the International Laboratory Animal Assessment and Accreditation (AAALAC) and can simultaneously raise non-human primates, dogs, rats, rabbits, guinea pigs, mini pigs and other experimental animals, and can provide services such as pharmacological efficacy, pharmacokinetic research and safety evaluation.

About Shijiazhuang No.4 Pharmaceutical

Shijiazhuang No.4 Pharmaceutical is a large-scale high-tech pharmaceutical enterprise that develops collaboratively with R&D and industrialization in multiple fields of the industry chain including innovative drugs, generic drugs, specialty APIs, high-end preparations and pharmaceutical packaging materials.  Shijiazhuang No.4 Pharmaceutical ranks among the top 100 enterprises in China's pharmaceutical industry and among the outstanding brand enterprises exporting preparations in China's chemical and pharmaceutical industry.  In 2007, the company was listed on the HKEX (SSY Group 02005.HK).

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 June 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 420 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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