三葉草生物-B(02197.HK)公佈中期業績，研發開支增加至8.55億元
格隆匯8月24日丨三葉草生物-B(02197.HK)發佈公吿，截至2022年6月30日止六個月，集團的其他收入及收益增加人民幣370萬元至人民幣1180萬元，主要是由於(公司融資所得款項帶來)更高平均現金結餘所賺取的利息增加及地方政府機構的研發補助增加。研發開支由上年同期的人民幣6.338億元增加人民幣2.215億元至人民幣8.553億元。該增加主要由於為籌備商業上市，合約開發及製造機構(“CDMO”)產生的服務費以及相關原材料和耗材的大幅增加。公司增加了研發人員數量，引致員工成本上升，而整體研發開支部分被臨牀試驗(II/III期SPECTRA試驗)開支減少所抵銷。
公司的使命是依託Trimer-Tag™技術平台和公司的生產製造能力，發現、開發及商業化新型疫苗及生物療法。報吿期內，公司於管線產品及業務運營方面取得進展。具體而言，公司宣佈公司領先的新冠疫苗項目SCB-2019(CpG 1018╱ 鋁佐劑)的有效性、安全性、耐受性及持久性達到關鍵數據里程碑，對長興生產基地進行改進以為2022年第三季度的藥品生產質量管理規範(“GMP”)檢查做好準備，與全球領先的CDMO生產基地合作，推進向中國國家藥品監督管理局、歐洲藥品管理局(“EMA”)和世界衞生組織(“WHO”)遞交滾動註冊申請，並通過推進SCB-2020S及SCB-219M進入I期臨牀研究使公司的臨牀階段管線多樣化。公司積極專注於開發新型疫苗及生物療法，預計將於2022年下半年達到多個里程碑。
2022年6月，公司宣佈長興基地的改進取得重大進展。公司預計長興基地將於2022年第三季度做好準備接受GMP檢查。於2022年1月，公司與一家全球領先的CDMO合作及正在使用他們的一處生產基地(熟悉EMA及WHO註冊機構)，以支持並協助推進向EMA及WHO遞交註冊申請。公司一直積極與各監管機構溝通。公司預期於2022年下半年向國家藥監局、EMA及WHO完成註冊申請，並已進行籌備工作，將於收到附條件批准後開始啟動SCB-2019(CpG 1018╱鋁佐劑)的商業上市。
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