海辰藥業(300584.SZ)：NMS集團PARP抑制劑NMS-03305293膠囊獲批臨牀
格隆匯11月17日丨海辰藥業(300584.SZ)公佈，根據此前披露，公司與公司控股股東曹於平、一村資本、合肥東城產投等相關合作方出資收購意大利Nerviano Medical Sciences Group(下稱“NMS集團”)90%股權。
截至該公告披露日，中方聯合收購方設立的境內SPV-合肥高研歐進生物醫藥有限公司間接持有意大利NMS集團90%的股份。公司間接持有合肥高研歐進生物醫藥有限公司18.71%的股份，公司控股股東曹於平及其指定的關聯方合肥聚辰投資管理合夥企業(有限合夥)間接持有合肥高研歐進生物醫藥有限公司合計31.16%的股份。
NMS集團下屬子公司Nerviano Medical Sciences S.r.l.於近日收到國家藥品監督管理局(NMPA)簽發的關於NMS-03305293膠囊的《藥物臨牀試驗批准通知書》。國家藥監局同意Nerviano Medical Sciences S.r.l.及國內臨牀試驗服務方締脈生物按照提交的方案開展臨牀試驗。
該藥品名稱：NMS-03305293膠囊，申請適應症：NMS-03305293膠囊將作為單藥在可能對PARP抑制敏感的、選定為晚期/轉移性實體瘤(HER2陰性乳腺癌、上皮性卵巢癌、去勢抵抗性前列腺癌和胰腺癌)患者中進行初步試驗。
NMS-03305293為第二代PARP抑制劑，對PARP1亞型有高選擇性，DNA捕獲效應較低，可特異性殺傷BRCA突變的腫瘤細胞。臨牀前研究表明NMS-03305293具備穿透血腦屏障的能力，因此具有治療中樞神經腫瘤和腦轉移腫瘤的潛力。
2019年6月，該產品獲得美國食品藥品監督管理局(“FDA”)藥物臨牀試驗資格，目前正在美國德州大學MD安德森癌症中心等4家臨牀機構開展I期臨牀試驗。該次申請國內I期臨牀試驗，為該產品後續開展國際多中心臨牀試驗創造條件，以進一步加快研發進程。截止目前，全球共有4款PARP抑制劑上市。
另外，NMS集團下屬子公司Nerviano Medical Sciences S.r.l於近日收到美國FDA回覆。FDA已經完成NMS-812項目安全性審查，同意進行多發性骨髓瘤適應症臨牀研究。NMS-812為PERK抑制劑，目前無同類產品上市，目標適應症為多發性骨髓瘤等血液腫瘤。
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