Chi-Med: Surufatinib on track for potential 2020 China approval
Hutchison China MediTech (Chi-Med) is one step closer to the commercialisation of its first wholly owned drug, surufatinib, in China. Early termination of the Phase III SANET-ep study in extra-pancreatic neuroendocrine tumours (epNET) - as it had already met its primary endpoint of progression-free survival (PFS) at the planned interim analysis - brings forward the timing of potential first surufatinib approval by c 12 months. While full SANET-ep data will not be available until presentation at a future scientific conference, this result enables Chi-Med to seek a pre-NDA meeting with the China NMPA to discuss next steps in the regulatory process. Reviewing our surufatinib assumptions, we now assume a 2020 approval/launch in non-pancreatic NET. Our upgraded valuation is $5.14bn ($38.55/ADS) or £3.95bn (£5.93/share).Hutchison China MediTech is engaged in researching, developing, manufacturing and selling pharmaceuticals and healthcare products. Co. has research and development facilities and manufacturing plants in Shanghai and Guangzhou in the People's Republic of China and sells its products mainly in the PRC and Hong Kong. Co. operates two operating segments. The Innovation Platform focuses on discovering and developing therapeutics in oncology and autoimmune diseases, and the provision of research and development services. The Commercial Platform involves the manufacture, marketing and distribution of prescription and over the counter pharmaceuticals as well as consumer health products.
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