開拓藥業-B(09939.HK)公佈中期業績 研發成本增加90.2% 平湖生產設施預計第四季度開始建設
格隆匯8月27日丨開拓藥業-B(09939.HK)發佈公吿,截至2021年6月30日止六個月及截至2020年6月30日止六個月,公司並未產生任何收益。公司研發成本增加90.2%至截至2021年6月30日止六個月的人民幣2.82億元。
公司的在研藥物組合用於治療COVID-19、主要癌症及其他未滿足臨牀需求的疾病領域。公司擁有風險平衡且多元化的產品管線,並戰略性地專注於COVID-19、主要癌症及有巨大市場潛力的其他AR相關疾病。
於本公吿日期,公司已開發出七種臨牀階段藥物,並在中國(包括台灣)、美國、巴西及其他國家和地區取得開始臨牀試驗批准。該等臨牀階段在研藥物包括兩款雄激素受體(AR)拮抗劑、ALK-1單抗、mTOR激酶靶向抑制劑、Hedgehog抑制劑、AR-PROTAC化合物和PD-L1/TGF-β雙靶點抗體。
公司計劃使用公司在中國蘇州及平湖的自有生產設施生產API以及普克魯胺及福瑞他恩最終產品。公司亦通過與CDMO公司合作擴展普克魯胺的產能。於2020年8月28日,公司在蘇州的生產研發基地投入運營,為普克魯胺的生產進行準備。於2020年11月,公司的蘇州設施獲江蘇省藥品監督管理局頒發藥品生產許可證。於2021年4月,公司與CDMO公司海南華益泰康藥業有限公司就擴大普克魯胺產能訂立戰略合作協議。公司在平湖的生產設施目前處於項目設計階段。平湖的生產設施預計於2021年第四季度開始建設。
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