Genovate Biotechnology Co., Ltd. announced New Drug Application (NDA) of the company's NCE new drug DBPR108 for the treatment of diabetes mellitus has been filed in mainland China. The name or code of the new drug under development: DBPR108. Indication: Treatment of diabetes mellitus.

All stages of research and development expected to be carried out: New drug application. The current research and development stage: (a). The company and CSPC Pharmaceutical Grouop Limited (CSPC) have signed the agreement on technology licensing and co-development of DBPR108 in mainland China.

Following the agreement, the parties would jointly conduct research, registration, promotion, sales and production of the drug in mainland China. (b). CSPC has completed phase III clinical trials, and a pre-NDA meeting with the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China.

The NDA for DBPR108 tablets including clinical data preparation and submission were made in accordance with the pre-NDA meeting minutes, and the application was officially accepted by CDE a few days ago. Accumulated research and development expenses that have been invested: Not applicable (Clinical development expenses in mainland China are solelyborne by CSPC). The next stage of research and development will be carried out: N/A. (a).

Estimated completion time:CSPC will lead the planning of the development schedule of this product. Estimated responsibilities: The company shall collaborate with the National Health Research Institutes (NHRI) and assist CSPC in its clinical development work for DBPR108.