Botanical Drug Preclinical R&D

• Medicilon Botanical Drug Preclinical R&D Technology Service Platform is established based on the existing drug pharmacokinetic and safety evaluation research platform of the company with over decade of research and development experience.
  It is dedicated to providing customized preclinical trial service solutions for clients, with a professional technical service team specializing in drug metabolism, pharmacokinetics, efficacy research, and toxicology.
  Meanwhile，Shanghai Medicilon Inc. (referred to as Medicilon) can assist clients to overcome the bottlenecks in botanical drug development. Medicilon provides high-quality data and rapid turnover to support various drug development and preclinical research activities, in order to help clients select high-value candidate botanical drug for clinical trial applications.
  

Research on the Pharmacology of Botanical Drugs

• In vivo pharmacological studies comprehensively assess the pharmacological effects of test substances through analysis and evaluation using homologous/heterogeneous animal models, transgenic models, and humanized immune system animal models.
  

Pharmacokinetic/Toxicokinetic Studies of Botanical Drugs

• The complex composition of botanical drugs has always been a challenge in preclinical research, and it is also one of the technological barriers for botanical drugs to get accepted overseas.
  Different types of botanical drugs have different requirements for pharmacokinetics/toxicokinetics. For single-component varieties, it is necessary to fully study their pharmacokinetics, toxicokinetics, and DMPK characteristics. For complex varieties, it is essential to determine whether there are clear active ingredients and toxic components before deciding on the approach for pharmacokinetic and toxicological studies. This involves thoroughly considering the basis of their pharmacological or toxicological properties before proceeding with drug metabolism and toxicology research.
  Study the relationship between toxic reactions and exposure, as well as the ADME of the target components.
  Determine and analyze the toxic components of botanical drugs and study the changes of in vivo exposure after repeated administration.

Preclinical Safety Evaluation of Botanical Drugs

• Safety pharmacology experimentsAcute toxicity testsAcute toxicity testsReproductive toxicity testsGenetic toxicity testsCarcinogenicity testsLocal tolerance tests

Key Technologies for Preclinical Research of Botanical Drugs

• The Medicilon Botanical Drug Preclinical R&D Technology Platform has a laboratory for preclinical research on new drug development and reevaluation of botanical drugs, and conducts research on key technologies, including:
  Study of the substance basis and mechanism of toxic substances;Study of the substance basis of hepatotoxicity of botanical drugs;Determination of biomarkers for botanical drugs;Quality control and analysis of test substances in botanical drugs;Pharmacokinetic and toxicokinetic studies of botanical drugs;Study of biotoxicity biomarkers and toxicological mechanisms in target organs/tissues of botanical drugs;Key technologies for studying allergic reactions to botanical drugs;……
  

High-level Preclinical Research Laboratory

• Medicilon Preclinical Research Laboratory has been certified by AAALAC and meets the GLP standards of both FDA in U.S. and NMPA in China. The preclinical safety evaluation conducted by Medicilon complies with the GLP regulations of the Organization for OECD.
  With a comprehensive animal model library, Medicilon meets the diverse demands of clients in the development of new drugs. The non-human primate experimental facility at Medicilon is the largest in Shanghai, with the highest number of monkeys in captivity.
  Medicilon has extensive experience in establishing efficacy tumor allograft/xenograft models, with a high success rate in modeling and a wide range of tumor cell lines. The platform is internationally leading in this field. In addition, Medicilon also has rich experience in other experimental animal disease models, such as ophthalmic disease models, respiratory system models, arthritis and immune disease models, and cardiovascular disease models.

The Cases of Medicilon

• Shugan Jieyu Capsule

  In September 2022, the National Medical Products Administration announced that Shugan Jieyu Capsule which is produced by Sichuan Jishengtang Pharmaceutical Co., Ltd.(referred to as Jishengtang), became the first second-class protected botanical drug variety. In October 2022, an application for expanding clinical trials to include the treatment of generalized anxiety disorder associated with liver depression and spleen deficiency was approved by the NMPA. The symptoms include irritability, excessive worrying, and palpitations.
  As the partner of Jishengtang, Medicilon provided support for the non-clinical safety evaluation of Shugan Jieyu Capsule, including single-dose and repeated-dose toxicity studies in SD rats for the NMPA application. Medicilon's Pharmacology Department has established various evaluation techniques for psychiatric disorder models, including antidepressants, anti-Alzheimer's drugs, sedatives, hypnotics, anesthetics, anti-Parkinson's disease medications, and antipsychotics. It has made contributions to the development of botanical drugs for new indications.

• Xiao Chai Hu Granules for Children

  In May 2023, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd.(referred to as Baiyunshan Guanghua) obtained the clinical trial approval for the first domestic and international improved Xiao Chai Hu Granules for children. The medicine belongs to the 2.3 class of improved botanical drugs in China. It is an improved formulation based on the classic formula of Xiao Chai Hu Granules and is the first innovative formulation specifically developed for children. The new product optimizes the formulation process for pediatric medication patterns, improves quality control based on the efficacy needs of the pediatric population, evaluates the efficacy and safety based on the growth and development characteristics of children, and precisely identifies clinical indications for the pediatric population.
  As a partner of Baiyunshan Guanghua, Medicilon provided a series of pharmacological and toxicological studies for the development of Xiao Chai Hu Granules for children, including single-dose and repeated-dose toxicity studies in early-age SD rats and efficacy studies in young rats. Through rigorous experimental design, professional research techniques, standardized project management, compliant test operations, and efficient communication, Medicilon accelerated the process of product launch, helped to create exclusive products, and met the growing health needs of the pediatric population.

• 所有研究均在同一园区内实验室有序完成，切实保证实验进度和项目沟通的高效性，占据数据获取和评估的行业优越性。