_edited.png)
Bladder cancer treatment device
The client's class 3 device was already in active use in UK and Europe but they were keen to investigate access to the Chinese market in collaboration with a local partner.
They were willing to consider all partnership options ranging from out-right investment to licensing, distribution and manufacturing.
Solution:
After working with the client to fully understand their product and strategic goals, we engaged with them in 2018 to identify suitable Chinese partner organisations. This led to opening up contractual negotiations with Shanghai’s largest private hospital that had a urology specialism. An MOU was signed in October 2019 that included specific reference to co-financing and management of Chinese clinical trials using equipment and consumables supplied from the UK.
Outcome:
Trials:
Before COVID restricted travel, we had progressed the project through to ethics committee submission plus dispatch of equipment and consumables to Shanghai and a parallel site in Beijing. Initial patient trials started in Beijing in September 2020.
Licencing and manufacture:
As part of the project scope, we sought to establish to practical issues of licensing, manufacture and distribution of the device and consumables in China. Research is ongoing as to scalability due to initial price point being higher than national reimbursement policy and regulatory pathway for this hybrid device/pharma product.