舒泰神(300204.SZ)：STSA-1002注射液開展用於針對治療重型新型冠狀病毒肺炎的臨牀試驗獲批
格隆匯9月27日丨舒泰神(300204.SZ)公佈，近日，公司取得國家藥品監督管理局簽發的STSA-1002注射液用於治療重型新型冠狀病毒肺炎適應症的《藥物臨牀試驗批准通知書》(CXSL2101278)，同意本品開展用於針對治療重型新型冠狀病毒肺炎的臨牀試驗。
STSA-1002注射液是以補體蛋白分子之C5a為靶點的重組抗人C5a IgG1全人源單克隆抗體，通過特異性結合過敏毒素C5a，使C5a喪失結合受體的能力，阻斷C5a誘導的生物學功能，如中性粒細胞趨化、脱顆粒和氧呼吸爆發等，同時不影響C5 裂解及膜攻擊複合物(MAC)的形成，保留補體系統的溶菌、殺菌功能，從而達到治療新型冠狀病毒(SARS-CoV-2)導致的嚴重肺炎、急性肺損傷或急性呼吸窘迫綜合徵等。
病毒感染機體後，補體激活產生促炎性多肽C3a和C5a，並招募中性粒細胞和單核細胞。活化的中性粒細胞產生的網狀細胞外陷阱(NETs)使宿主體內補系統被迅速激活以清除感染的病原體。在補體激活過程中，產物C5a是最強的過敏毒素之一。高濃度的C5a是中性粒細胞、嗜酸性粒細胞和單核細胞的趨化劑，可誘導這些細胞沿着濃度梯度方向移動。另外高濃度的C5a也可刺激中性粒細胞和單核細胞的氧化代謝，提高其cGMP的水平，有利於促進溶酶體與細胞膜的融合，釋放進溶酶體。此外，C5a還可刺激中性粒細胞黏附及增強其產生超氧化物的能力。C5a對免疫應答有明顯增強作用，可誘導單核細胞分泌IL-1、IL-6、IL-8及TNF-α等細胞因子，增強血管通透性。C5a的上述生物活性有利於增強機體的防御功能，但大量C5a產生通常會導致炎症反應加重，並可能在感染後對宿主造成直接傷害。
近年來隨着基礎研究的不斷深入，補體系統在多種重大疾病中的作用越來越受到重視和肯定。C5a是補體系統中的“明星分子”，針對C5a靶點開發的多種治療性藥物正在不同的疾病領域展開探索性研究。德國InflaRx公司的藥物IFX-1和舒泰神及其子公司開發的BDB-001均是抗人C5a高親和力IgG4單克隆抗體，這兩種藥物與STSA-1002具有相同的治療靶點。InflaRx正在開展IFX-1用於治療化膿性汗腺炎(HS)、 ANCA相關性血管炎(AAV)、COVID-19等5項適應症的臨牀試驗。BDB-001注射液正在開展治療化膿性汗腺炎(HS)、 COVID-19和ANCA相關性血管炎(AAV)共3項適應症的臨牀試驗。
STSA-1002注射液由公司自主研發，發明專利已在國內和國際進行申請。公司於2021年6月向美國食品藥品監督管理局(FDA)提交STSA-1002注射液用於治療重型COVID-19的臨牀試驗申請，並於2021年7月獲准開展臨牀試驗。STSA-1002注射液項目是公司首個實現中美雙報雙批的項目，標誌着公司研發能力的國際化更進一步。
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