The clinical trial application (IND) for the new drug "Dendrobium officinale Chewable Tablets", a Class 1.1 traditional Chinese medicine product developed by Hangzhou Danhe Pharmaceutical Co., Ltd., has been approved by the Drug Evaluation Center of the National Medical Products Administration (acceptance number: CXZL2300075). The proposed functional indications of this variety are nourishing yin and tonifying yang, clearing heat and lowering blood pressure, and it is used for the diagnosis and treatment of primary hypertension in traditional Chinese medicine, which belongs to yin deficiency and yang hyperactivity syndrome. (The specific indications are subject to the drug instructions approved by the Drug Evaluation Center.)

The Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. undertook the non clinical safety evaluation research of this variety. The research results indicate that the product has good safety characteristics under repeated administration conditions, providing supporting data for its clinical trial approval.

The company has project experience in the field of non clinical safety evaluation of traditional Chinese medicine. In terms of pediatric medication evaluation, the company has established a dosing technology system covering low age animals, including gavage administration methods for 4-day-old rats and 7-day-old beagle dogs, forming a non clinical safety evaluation platform for pediatric medication that can meet the evaluation needs of different age groups in clinical practice. The company's existing facilities and personnel configuration can support the simultaneous conduct of non clinical evaluation projects for no more than 20 traditional Chinese medicine varieties.

Operation of gavage administration in young rats

Certificate of Qualification for Toxicity Pathological Diagnosis Capability Verification

Animal dissection site

Test substance management system (scan code to identify test substance)

Pathological wax block display

Bone marrow endoscopy system

Blood sample transfer system

Shandong Xinbo Phase II Building Facilities