打新直播間 | 海創藥業科創板過會:創新之路能否走通?
海創藥業成立於2013年,是一家專注於癌症和代謝疾病的全球化創新藥物企業。公司基於氘代技術和PROTAC靶向蛋白降解等技術平台,構建了豐富的產品管線。
據美國癌症協會(ACS)的最新研究報吿預測,2022年美國男性高發腫瘤中,前列腺癌發病人數居首位。早期前列腺癌患者主要通過雄激素剝脱治療,但大多數患者仍會發生病情復發,演變成去勢抵抗性前列腺癌(CRPC),如不採取有效的治療手段,CRPC自然病程的中位生存時間僅為12-18個月。目前我國治療CRPC的非化療藥物主要包括比卡魯胺(AR抑制劑)、阿比特龍(雄激素合成CYP17抑制劑)、恩扎盧胺(AR抑制劑)和阿帕他胺(AR抑制劑)。
公司核心產品HC-1119系恩扎盧胺的氘代藥物,而恩扎盧胺的仿製藥已於2021年8月底於中國境內獲批上市。雖然恩扎盧胺仿製藥獲批的適應症與HC-1119於中國境內開展III期臨牀的適應症並不相同,但恩扎盧胺及其仿製藥仍可能與公司產品展開競爭。
此外,HC-1119的50%項目權益系從四川海思科受讓取得,且公司尚未完成第三期付款。根據《付款安排調整協議》,公司需在2022年12月31日前合計向四川海思科支付1.5億元人民幣,鑑於支付金額相對較高,屆時會對公司2021年度及2022年度的貨幣資金等報表科目造成影響,進而對公司經營產生一定不利影響。另外,海思科也是公司的前十大股東,發行前持有公司4.37%股權。
目前公司核心產品尚處於臨牀階段,尚未取得生產批件亦未實現商業化生產。2018年度、2019年度及2020年度及2021年1-6月,公司歸屬於母公司普通股股東的淨利潤分別為-3,857.87萬元、-11,170.46萬元、-48,984.95萬元及-14,808.36萬元,由於未來一段時間內,公司仍會持續增加研發投入,預計仍將存在累計未彌補虧損。
國內創新藥行業格局暫未定型,大多數BioTech都有成長為Pharma的目標,不斷擴充自己的研發管線,擴展疾病治療領域,催化估值增加。值得注意的是,在估值時需要甄別能夠帶來營業收入的“收入管線”和用於提高估值的“花瓶管線”。另外BioTech的資源有限,對核心管線的投入、開發策略、臨牀進度尤其重要,首要任務應該是儘快獲得收入,使公司能夠持續運轉。在創新藥行業,贏家永遠是少數。
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