China National Medical Products Administration Approves Sinovant's Clinical Trial Application for Derazantinib

- Chinese registrational clinical trial for derazantinib to begin in 2H 2019

BEIJING and SHANGHAI,April 29,2019 --Sinovant Sciences today announced that its Clinical Trial Application (CTA) for derazantinib has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA),enabling the initiation of a registrational clinical trial in patients with second-line intrahepatic cholangiocarcinoma (iCCA) in the second half of 2019.

"iCCA is one of the greatest unmet needs in oncology,particularly in China," said Dr. Rae Yuan,President of Sinovant. "Patients in the second-line setting are poorly served by existing treatment options,none of which meaningfully extend survival or reduce disease burden. Derazantinib has the potential to be the first approved treatment in China for this devastating disease state,and we look forward to begin enrolling patients in our registrational program later this year."

Derazantinib is an oral pan-FGFR (fibroblast growth factor receptor) inhibitor being developed as a potential treatment for iCCA and other tumor types with high rates of FGFR mutation. The People's Republic of China has one of the world's highest incidence rates of iCCA.

"We are very pleased by the approval of this CTA,which brings Sinovant a step closer to delivering derazantinib to Chinese patients," said Dr. Xinan Chen,Executive Chairman of Sinovant. "Sinovant's advancement of derazantinib for patients with iCCA underscores our commitment to addressing major public health priorities in China."

About Derazantinib

Derazantinib is a potent,orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family,a key driver of cell proliferation,differentiation,and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions,treatment with derazantinib resulted in an objective response rate of 21%,nearly 3 times higher than standard-of-care chemotherapy.Sinovant's partner Basileais conducting a similar global registrational study of derazantinib in American and European patients with FGFR2 fusion-positive second-line iCCA. More information on that program is availablehere.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common malignancy in the liver after hepatocellular carcinoma (HCC).1Depending on the anatomic location,CCA is classified as intrahepatic (iCCA),perihilar (pCCA),and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer,with a median 5-year survival rate of only 15% for patients diagnosed with early-stage disease.2Reports show that in China's most populous cities the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people,and a majority of cases are intrahepatic.3

About Sinovant

Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information,please visitwww.sinovant.com.

1Welzel TM,et al. Impact of classification of hilar cholangiocarcinomas (Klatskin tumors) on the incidence of intra- and extrahepatic cholangiocarcinoma inthe United States.Journal of the National Cancer Institute2006; 98(12),873-875.

2American Cancer Society

3Banales JM,et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from theEuropean Network for the Studyof Cholangiocarcinoma (ENS-CCA).Nature Reviews: Gastroenterology & Hepatology2016; 13,261-280.

Contact

Qi Gu

Email: qi.gu@sinovant.com