創勝集團-B(06628.HK)公佈年度業績,CDMO業務收入顯著增加,繼續執行全球化戰略
格隆匯3月30日丨創勝集團-B(06628.HK)公佈,截至2022年12月31日止年度,公司收入為人民幣1.02億元,同比增長102.80%,增長主要由於CDMO服務收入增加。由於公司的管線進展及資源優化配置,2022年度研發開支增至人民幣3.50億元。
2022年對公司而言是收穫頗豐的一年,公司實現了幾個重要的臨牀和監管里程碑,擴大了公司的產品組合,推進了公司的管線。公司的主要資產,靶向Claudin18.2抗體osemitamab (TST001),於正在進行的Ib期化療聯合試驗中取得了令人鼓舞的臨牀療效和良好的安全性,現在正準備對一線不可切除局部晚期或轉移性胃癌或胃食管連接部(G/GEJ)癌進行全球關鍵性III期試驗。一種專有的Claudin18.2伴隨診斷也已開發出來,以支持關鍵性試驗的患者篩選。關鍵性試驗的材料已經生產出來,並通過了美國食品藥品監督管理局(FDA)和藥品審評中心(藥審中心)等監管機構的審批。
作為一傢俱有高度整合能力和全球化戰略的生物製藥公司,公司致力於開發osemitamab(TST001),作為治療Claudin18.2表達的實體瘤的新典範的基石,包括胃癌或胃食管連接部(G/GEJ)癌、胰腺癌(PDAC)和非小細胞肺癌(NSCLC)。此外,公司的其他管線項目取得了重大進展。公司完成了四個劑量隊列的評估,並開啟TST005全球I期劑量遞增研究最後一個且為最高劑量水平隊列的招募。公司亦已完成TST002三個劑量隊列的招募,並觀察到令人鼓舞的骨密度(BMD)增幅。公司獲得了TST003(抗Gremlin1抗體)及TST004(抗MASP2抗體)的臨牀試驗申請批准。我們的研究團隊還開發了多種用於治療癌症和自身免疫性疾病的新型候選治療藥物。
2022年,公司與百時美施貴寶("BMS")建立了全球臨牀合作,測試osemitamab (TST001)與歐狄沃®(納武利尤單抗)聯合治療Claudin18.2陽性一線不可切除局部晚期或轉移性胃癌或胃食管連接部癌。公司還收到了來自跨國公司和其他行業參與者的強烈意向,希望與公司就管線分子藥物(如osemitamab (TST001)、TST002及TST003)進行合作。
在公司實現的生產里程碑中,公司進一步提升了連續流生物工藝平台技術,完成了內部和外部項目的後期工藝開發和關鍵性試驗材料的生產,CDMO業務收入顯著增加。
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