Sinovant Sciences Announces Approval of Derazantinib’s Clinical Trial Application by the China National Medical Products Administration
Chinese registrational clinical trial for derazantinib to begin in 2H 2019
“This is an important step forward for derazantinib in
To read the full Sinovant Sciences press release announcing the approval, click here.
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.
About Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common malignancy in the liver after hepatocellular carcinoma (HCC).1 Depending 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.2 Reports show that in
Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in
Forward Looking Statements
This press release contains forward-looking statements regarding clinical trials with derazantinib under the Company’s license agreement with Sinovant Sciences. These statements are based on the Company’s current beliefs and expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information from early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development.In addition, derazantinib may not demonstrate an acceptable safety profile in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing derazantinib that could lead the Company or Sinovant Sciences to delay or discontinue its development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Regulatory authorities may disagree with the Company’s or Sinovant Sciences’ view of the data or require additional data or information or additional studies. If derazantinib is not successfully developed and as a result of any of the foregoing or other issues, risks or uncertainties, the Company may not receive future milestones or royalties under the license agreement.For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the
1 Welzel TM, et al. Impact of classification of hilar
cholangiocarcinomas (Klatskin tumors) on the incidence of intra- and
extrahepatic cholangiocarcinoma in
3 Banales JM, et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the
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