The distribution agreement for mainland China is a milestone in Sienna’s geographical expansion strategy. The agreement gives GaoYuan the exclusive right to sell Sienna’s in-vitro diagnostic hTERT test to pathology labs where it will be used as an adjunct to urine cytology, assisting pathologists and urologists in the diagnosis of bladder cancer.
China has a population of approximately 1.4 billion people and is one of the fastest growing consumers of IVD products globally. GaoYuan has significant reach across China through both direct sales and distribution networks, both of which are key sales channels for the market.
Prior to sales commencing, the product must first be approved and registered with the China Food and Drug Administration (CFDA). The process will be led and managed by GaoYuan with support provided by Sienna. The timeframe is dependent on the medical device classification type selected by the CFDA and will be announced separately upon commencement of the process.
While regulatory approval is being sought, Sienna will commence training the GaoYuan sales, marketing and technical support staff so the product launch within mainland China can commence as soon as registration is complete.