New and Modified Applications

In new drug development, disease indications are typically selected for maximum efficiency in obtaining drug approval, while additional indications may be considered based on meaningful data supports from clinical trials or post-approval studies. This is particularly relevant when disease indications face significant challenges in the implementation of clinical trials, such as chronic diseases, secondary diseases, excluded patient sub-populations, organ dysfunction syndromes, and lethal or sporadic diseases.

Studies in non-human primates (NHPs) can provide an efficient means to convincingly demonstrate the feasibility of new applications in a setting that closely approximates the clinical environment.

• Spontaneous diseases in monkeys, such as obesity, fatty liver, diabetes, infertility, osteoarthritis, chronic diarrhea, coagulopathy, dysmenorrhea, depression, benign prostate hyperplasia, age-related diseases, etc.

• Sporadic and urgent diseases: acute organ failure, shock, stroke, and wound….

• Accompanying the primary disease, the indications of secondary disease can facilitate the study of targeted therapy as well as the beneficial effects in secondary disease treatment

• Differentiation and precision applications: allergy, organ transplantation, local immunity, and breast cancer….

• Medication applications in special populations: pregnancy, infantile, juvenile, and developmental, physiological, ….

• Medication applications in disease sub-populations: immune-deficiency, chronic diseases, organ function insufficient, and pre-disease stages….

• Medical devices: surgery procedures, organ local interventions, imaging analysis and examinations…

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