Shize Biopharmaceuticals

About Shize Biopharmaceuticals

Shize Biopharmaceuticals (士泽生物, XellSmart) is a Chinese biopharmaceutical company, with operations in Suzhou and Shanghai, that develops clinical-grade, allogeneic, off-the-shelf cell drugs derived from induced pluripotent stem cells for central nervous system diseases with no effective clinical solution, led by Parkinson's disease, the world's second most common neurodegenerative disease. Its culture is summarised as patients first, scalpel second, shareholders third, and its mission is to bring innovative stem cell medicines to families affected by serious disease.

The pipeline consists of universal iPSC-derived neural cell therapies that have reached registered clinical trials in China and the United States. Programmes cover primary Parkinson's disease, early-onset Parkinson's disease, spinal cord injury, and amyotrophic lateral sclerosis, with approvals from China's NMPA and the US FDA for multiple clinical trials, and the company reports that it was the first Chinese company to have an independently developed iPSC-derived cell drug cleared by the FDA and granted orphan drug designation.

The company builds on four underlying technology platforms for cell-drug development and production and holds dozens of granted and pending patents worldwide. It has been recognised in national and provincial innovation competitions and as a potential unicorn in China, and it presents clinical follow-up data from its Parkinson's programme at international cell and gene therapy meetings.

XellSmart is a clinical-stage cell therapy developer whose business model is to advance proprietary allogeneic cell drugs through registered trials toward approval, and to pursue business cooperation with investors and strategic partners, in the regenerative medicine and neurology market in China and globally.