新加坡 ASLAN亞獅康 來台上櫃 增資7.42億 (Varlitinib, pan-HER抑制劑/ 獲FDA膽管癌、胃癌 孤兒藥資格認定)

外資生技掛牌首例 亞獅康8月底申請 2016年07月25日 【江俞庭╱台北報導】新加坡新藥研發公司亞獅康（6497）規劃8月底遞件申請、明年在台上櫃，將創下純外資生技公司來台掛牌首例。亞獅康執行長傅勇（Carl Firth）表示，與韓國現代藥品簽署腫瘤增生路徑抑制劑Varlitinib（ASLAN001）簽約金100萬美元（約3217萬元台幣），已於上半年認列，與日本、中國、歐洲授權也正洽談中，近期可望有結果。亞獅康專注免疫療法與標靶抗癌藥物，包括ASLAN001（pan-HER抑制劑）與ASLAN002為RON（免疫檢查點）和cMET抑制劑等。 其中，以ASLAN001進度最快，除進入2期臨床試驗，並取得美國FDA（食品藥物管理局）以膽管癌、胃癌為適應症的孤兒藥資格認定。為何選擇台灣掛牌？傅勇表示，3年前來台時，原僅將台當做臨床試驗據點，並未考慮作為業務營運或籌資市場，後來認為台灣生技人才豐沛、新政府上台後大力扶持生技業，且可成進軍中國跳板。此外，傅勇說，公司專注於亞洲盛行抗癌藥物，定位為亞洲型生技公司，短期內不會赴美納斯達克掛牌。

短期不赴美掛牌 亞獅康經營團隊持股2成，8成由法人股東持有，包括國際千驥創投（Cenova）、新加坡商BioVeda等，國內則有益鼎創投、凱基創投等，已增資2300萬美元（約7.42億元台幣），預計8月底遞件申請後，明年可望上櫃。

ASLAN's Varlitinib Receives Orphan Drug Designation For Gastric Cancer Varlitinib previously received orphan drug designation for cholangiocarcinoma in August 2015. Asian Scientist Newsroom | June 28, 2016 | Pharma AsianScientist (Jun. 28, 2016) - The pan-HER inhibitor varlitinib, which is being developed by Singapore-based biotech company ASLAN Pharmaceuticals, has received orphan drug designation by the US Food and Drug Administration (FDA) Office of Orphan Products Development for gastric cancer. Varlitinib previously received orphan drug designation for cholangiocarcinoma in August 2015. Gastric cancer is an aggressive cancer that is most often diagnosed when it is already in advanced stages. Prognosis for the disease remains poor, despite it being the third leading cause of cancer deaths globally. Worldwide, gastric cancer has one of the highest incidence rates, with 952,000 new cases diagnosed in 2012. In Asia, gastric cancer is the third most common cancer after breast and liver, and is the second most common cause of cancer deaths in Asia. The FDA awards orphan drug designation to advance the evaluation and development of drugs and products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. ASLAN is currently conducting Phase II studies of varlitinib in gastric cancer, cholangiocarcinoma and breast cancer. Its portfolio of drugs include immunotherapies and targeted agents for tumor types prevalent in Asia. Read more from Asian Scientist Magazine at: http://www.asianscientist.com/2016/06/pharma/aslan-varlitinib-orphan-drug-designation-gastric-cancer/