Preliminary Exploration of Project Initiation and Development Strategies for High-end Formulations in Class 2.2 New Chemical Drugs

Class 2.2 is a Chinese registration classification for new chemical drugs, referring to modified new drugs that are positioned between innovative and generic drugs. Some of their efficacy and safety evidence can be referenced from already marketed drugs. Highend formulations within this classification, due to their high technical barriers and significant market potential, have become a key focus for pharmaceutical research and development. These drugs need to be developed based on clinical needs by constructing highend formulation platforms, screening suitable active molecules and optimizing development pathways to achieve efficient validation of their clinical advantages. However, how to precisely match clinical needs, technology platforms, and molecular characteristics remains a pain point and challenge in the industry. This article defines high-end formulations, analyzes the connotations of clinical advantages, and innovatively proposes a "Five-Stage" clinical development assistance tool. It comprehensively elaborates on the development strategies of high-end formulations from clinical value positioning, molecule screening, and formulation platform optimization to clinical development pathway design. The aim is to provide insights and references for domestic pharmaceutical companies to overcome formulation technology bottlenecks and achieve industrial upgrading.