Han Xu

Delivered Respiratory, CNS, MPC projects in both strategic and executional aspects by providing effective project management. 1. Good tracking record on project management for drug development programs ranging from early development strategy evaluation, clinical trial to NDA approvals and post marketing studies. 1）Worked together with the team and delivered 4 NDA approvals plus 1 BE study approval, 1 NDA sub. several INDs and pre-IND consultations, 1 on-going pivotal ph3 clinical trial, 3 study start-up, 2 Ph4 studies, and early engagement with global for China development plan and internal governance reviews. 2）Led team closely monitoring regulatory evolving polices and taking smart risk to bring innovative and efficient development strategies for early and cost saving registrations in China, e.g bridging design…. 3）Broken the record to register one indication with failed Ph3 study via proactive engagement with authority and the key investigators. 2. Demonstrated operational leadership, and strategic thinking and matrix management capabilities in both Respiratory TMT and CEP TMT management. Played a key role for X-function alignment, and good team culture creation. 3. Gained cross therapeutic area PM experiences from Respiratory, CNS and MPC (Metabolic Pathways & Cardiovascular) programs management 4. Shown risk management skills and the resilience in some challenge programs especially on the CDE interactions, internal X-functions alignment….

1. Lead and motivate the team to provide quality and efficient service on recombinant proteins and antibodies production. 2. Business alignment between Wuxi and Shanghai sites to enhance the cross-region communication, technology transferring and strategies implementation. 3. Be responsible for the communication with clients, providing quotations for the projects, and expanding business etc.

 Lead and motivate the team to provide quality and efficient service on recombinant proteins and antibodies production.  Business alignment between Wuxi and Shanghai sites to enhance the cross-region communication, technology transferring and strategies implementation.  Be responsible for the communication with clients, providing quotations for the projects, and expanding business etc.

Studied the protease Matriptase roles in breast cancer and elucidated its mechanisms. 1. Using biochemical approches to study how matriptase activation is initiated, regulated and their impact on the progress of cancer. 2. The anti-cancer agents screening assay was also developed based on the matriptase activation systems.

Research Focus: 1. Bioactivity-guided isolation of the active components from two Traditional Chinese Medicines. 2. Phamacologic activities(anti-complementary) of the TCMs on ARDS rat model and its mechnisms.

The anti-endotoxcity of Isatis Indigotica Fort.