According to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration and public information, Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Shandong Xinbo") has assisted Yabao Pharmaceutical in obtaining an implied clinical trial license (IND) for its traditional Chinese medicine class 2.2 pediatric drug "ZY-A001".

As an important partner in the research and development process, Shandong Xinbo strictly follows the guidelines of NMPA and ICH. With its rich project experience and mature pediatric drug evaluation platform, it has undertaken the systematic preclinical safety evaluation research of "ZY-A001", helping partners to obtain implied clinical trial licenses smoothly.

ZY-A001
ZY-A001 has the effects of clearing heat and detoxifying, calming the mind, and is mainly used for the treatment of acute upper respiratory tract infections in children.

Pediatric medication safety evaluation platform

Shandong Xinbo has established a mature platform for evaluating the safety and pharmacodynamics of pediatric drugs. Based on the special physiological and metabolic characteristics of children, a young animal model suitable for pediatric drug evaluation has been used. The gavage administration technology for rodent rats at 4 days old and non rodent dogs at 7 days old has been established, and multiple safety evaluations of pediatric drugs have been completed. This provides professional, safe, and compliant non clinical research support for the development of new and generic drugs for children, and helps promote the safe development of pediatric drug research.
Single dose toxicity test (rodent, non rodent)

Repeated administration toxicity test (rodent, non rodent)

■ Toxicokinetics test (rodent, non rodent)

■ Growth and development testing of young animals

■ Detection of reflex development in young animals

■ Detection of behavioral indicators in young animals

Assessment of Immune System Development in Young Animals

■ Detection of skeletal structure and metabolism in young animals

CNS assessment of young animals

■ Pharmacokinetic testing

Establishment of pituitary model