嘉和生物-B(06998.HK)公佈年度業績 研發開支達6.13億元 將聚焦潛在FIC/BIC創新管線
格隆匯3月30日丨嘉和生物-B(06998.HK)公吿，2021年度，公司研發開支為人民幣6.13億元，有關支出主要歸因於(i)公司的新藥研發費及正在進行的臨牀試驗開支及(ii)公司的員工薪金及相關福利成本。
公司成功搭建了發現全球同類首創( FIC)╱同類最佳( BIC)潛力的免疫腫瘤雙╱多特異性抗體研發平台。2021年1月，韓淑華博士加入集團並擔任首席科學官。此後快速搭建團隊，建立新藥研發體系，成立團隊近30人，專注開發有FIC/BIC潛力的靶點和項目。報吿期內已有超過5個FIC/BIC潛力的雙╱多抗分子發現項目啟動，其中至少1個即將進入IND-enabling開發階段。
2021年10月，梁其斌先生加入集團並擔任首席技術官，着力推動了嘉和生物在CMC及藥品生產質量管理規範（GMP）生產等層面的高效創新與發展。?報吿期內，公司CMC團隊解決了許多行業工藝難題，尤其是製造優質雙特異性╱多特異性抗體產品方面，如通過上下游工藝優化減少同質配對雜質及聚集體，通過配方（包括高濃度配方）開發穩定最終產品，通過開發及應用產品特定方法（尤其是效力測定）進行可靠的質量控制等。CMC團隊亦曾致力於通過技術創新及材料本地化以降低製造成本。
集團將聚焦潛在FIC/BIC創新管線，以解決中國乃至全球尚未滿足的醫療需求，同時通過制定和執行全方位戰略來豐富現有產品組合。公司亦將集團潛在FIC/BIC早期候選資產快速推向臨牀階段，並將繼續加快集團的主要後期候選產品的監管審批、臨牀開發和商業化。
預期2022年度內將有至少1個早期研發管線進入IND-enabling階段，2023年及之後每年將有至少1個潛在的FIC/BIC自研新藥研發候選藥物遞交IND。此外，公司將繼續推進多款雙特異性及三特異性抗體候選藥物，公司計劃於未來的6至12個月，在中國提交GB261和GB263T IND申請，開展臨牀試驗，進一步推進GB261和GB263T臨牀1期試驗及臨牀概念驗證（POC）。
公司將繼續尋求geptanolimab (GB226)用於其他適應證的批准，併發掘新聯合療法的潛力，包括進一步推進與STING激動劑(GB492)聯合治療的臨牀1期試驗及POC。
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