Sienna Appoints Chinese Distributor

07-Aug-2018
  • GaoYuan In-Vitro Reagents Co. appointed as exclusive distributor for mainland China.
  • China is a fast growing consumer of in-vitro diagnostic (IVD) tests.
  • GaoYuan to lead regulatory and approval process with China Food and Drug Administration (CFDA).

Sienna is pleased to announce it has appointed Shaanxi GaoYuan In Vitro Diagnostic Reagents Co. (“GaoYuan”) as the Company’s exclusive distribution partner for mainland China. 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.

Matthew Hoskin, CEO of Sienna Cancer Diagnostics, commented: “This milestone agreement follows months of due diligence by both parties. We have been very deliberate in selecting a partner which has the adequate size, reach and capability to penetrate the Chinese market effectively, but also one that regards Sienna’s test as a real growth opportunity for the Company, and will put strong promotional support behind our product.”

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.

Mr Wenguang Yan, General Manager of GaoYuan said: “GaoYuan has significant experience selling invitro diagnostic cancer tests to pathology laboratories across China, including our own biomarker-based test for cervical cancer. We understand the needs of this market, have well-established relationships to help drive uptake, and have a skilled team in place to promote, sell, and support this new product. The market opportunity for this product in China is significant, and GaoYuan is pleased to be introducing a product that adds real clinical value to the diagnostic process which will help patients, while at the same time creating growth for our business.”

The ASX announcement can be found here.



 
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