Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, announced that the Company has completed the phase I clinical trial for its broad-spectrum neutralizing antibody product, the Anti-COVID-19 Antibody SA55 Injection ("SA55 Injection") in Beijing and has entered the phase II clinical trial in Shanghai after successfully enrolling its first participant recently.
SINOVAC's SA55 Injection, which is intended for the treatment of COVID-19 infections, was approved for clinical trial in China on May 24, 2023. The phase I clinical trial has confirmed its preliminary safety profile in 40 healthy adults aged 18 to 65 in China.
The phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled study. It is expected to enroll 150 patients aged 18 and above with mild to moderate COVID-19 infection from nearly 20 medical institutions in China. Participants will be randomly assigned to groups receiving different dosages of SA55 Injection or placebo to evaluate its ability to decrease SARS-CoV-2 virus loads and alleviate clinical symptoms, while assessing its safety. Preliminary results are anticipated by the year's end.
中國領先的生物製藥產品供應商科興生物技術有限公司(“科興” 或 “公司”)(NYSE:SVA)宣佈,該公司已在北京完成其廣譜中和抗體產品抗COVID-19抗體SA55注射液(“SA55注射液”)的I期臨床試驗,並在最近成功招募首位參與者後,已進入上海的二期臨床試驗。
科興的SA55注射劑用於治療 COVID-19 感染,已於2023年5月24日獲准在中國進行臨床試驗。該I期臨床試驗已證實其在中國40名年齡在18至65歲之間的健康成年人中的初步安全性。
II期臨床試驗是一項多中心、隨機、雙盲、安慰劑對照研究。預計將招收來自中國近 20 家醫療機構的 150 名 18 歲及以上的輕度至中度 COVID-19 感染患者。參與者將被隨機分配到接受不同劑量SA55注射劑或安慰劑的組,以評估其降低SARS-CoV-2病毒載量和緩解臨床症狀的能力,同時評估其安全性。初步結果預計將在年底公佈。