ASLAN Receives Orphan Drug Designation In Korea For Varlitinib (ASLAN001) In Biliary Tract Cancer

Singapore, 20 February 2017 – ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced the designation as an Orphan drug of its pan-HER inhibitor varlitinib (ASLAN001) by the Korean Ministry of Food and Drug Safety (MFDS), for the treatment of advanced biliary tract cancer after first line systemic therapy. This is the third Orphan Drug Designation for varlitinib which has previously received orphan status for cholangiocarcinoma and gastric cancer from the United States Food and Drug Administration (FDA).

The MFDS awards Orphan Drug Designation to advance the development of drugs targeted for treating rare diseases that do not have any available treatments in Korea. Biliary tract cancer is a heterogeneous cancer and has over 5,000 newly diagnosed patients per year in Korea[1].

The Orphan Drug Designation will provide ASLAN certain incentives including faster regulatory approval for clinical trials involving varlitinib in biliary tract cancer in Korea, as well as marketing exclusivity in Korea for 10 years.

ASLAN is currently conducting pivotal studies of varlitinib in biliary tract cancer, and phase 2 trials in gastric and breast cancers.

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