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三叶草生物(02197) - 自愿公告三叶草生物公佈针对老年人群RSV疫苗重复接种的美国I期临床试验...
2026-03-24 23:41
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整 性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容所產生或因依賴該等內容而 引致的任何損失承擔任何責任。 • 相較於 AREXVY 同源重複接種,SCB‑1019 異源重複接種組的 RSV‑A 與 RSV‑B 中和抗體(nAb) 幾何平均滴度(GMT)呈現約 60–80%的上升趨勢;安慰劑組未觀察到 RSV 中和抗體出現顯著變 化; • 與三葉草生物先前針對未接種過 RSV 疫苗的老年人給予首劑 AREXVY 的臨床研究進行探索 性跨試驗比較後顯示,SCB‑1019 異源重複接種可將 RSV‑A 與 RSV‑B 的中和抗體幾何平均滴 度恢復至首劑 AREXVY 接種後峰值約 120%–135%「,而在該探索性跨試驗中的 AREXVY 同源 重複接種僅能恢復至峰值的約 75%; • AREXVY 的同源重複接種會產生增幅約 40 倍源自其自身 T4-foldon 三聚體標籤构造誘導的 "非特異性抗體"。 本公司RSV+hMPV±PIV3候選聯用疫苗,有望在這一人群中恢復RSV護效會,同時擴展對hMPV±PIV ...
GSK's RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk
Businesswire· 2026-03-13 15:44
Core Viewpoint - GSK's RSV vaccine, AREXVY, has received approval in the US for an expanded age indication, now including adults aged 18–49 years who are at increased risk [1] Group 1 - The approval of AREXVY marks a significant milestone for GSK in addressing respiratory syncytial virus (RSV) in a broader adult population [1] - The vaccine is specifically targeted at adults aged 18–49 years who are considered to be at increased risk, expanding its potential market [1]
三叶草生物-B高开逾5% 两项临床试验获得积极初步数据
Zhi Tong Cai Jing· 2025-10-15 01:35
Core Viewpoint - Clover Biopharmaceuticals-B (02197) experienced a significant increase in stock price, rising by 5.67% to HKD 2.98, with a trading volume of HKD 1.3738 million, following the announcement of positive preliminary data from two ongoing clinical trials [1] Group 1: Clinical Trials - The company announced positive preliminary data from two Phase I clinical trials [1] - One trial is being conducted in Australia to evaluate the respiratory combination vaccine candidates SCB-1022 and SCB-1033 against SCB-1019, targeting elderly individuals who have not previously received any RSV vaccine [1] - The second trial is taking place in the United States, assessing the head-to-head comparison of SCB-1019 with AREXVY in elderly individuals who had received at least two seasonal doses of AREXVY prior to enrollment [1] Group 2: Future Plans - Based on the positive results from the Phase I clinical trials, Clover Biopharmaceuticals plans to advance SCB-1022 and SCB-1033 to Phase II clinical trials in the first half of 2026 [1]
港股异动 | 三叶草生物-B(02197)高开逾5% 两项临床试验获得积极初步数据
智通财经网· 2025-10-15 01:32
Core Viewpoint - Clover Biopharmaceuticals-B (02197) experienced a significant stock increase of over 5%, reaching HKD 2.98, following the announcement of positive preliminary data from two ongoing clinical trials [1] Group 1: Clinical Trials - The company is conducting a Phase I clinical trial in Australia to evaluate the respiratory combination vaccine candidates SCB-1022 and SCB-1033 against SCB-1019, targeting elderly individuals who have not previously received any RSV vaccine [1] - In the United States, a Phase I clinical trial is underway to compare SCB-1019 with AREXVY in a head-to-head assessment, focusing on elderly participants who had received at least one dose of AREXVY in the two preceding flu seasons [1] - Based on the positive results from these Phase I trials, Clover Biopharmaceuticals plans to advance SCB-1022 and SCB-1033 to Phase II clinical trials in the first half of 2026 [1]
三叶草生物-B(02197.HK)公布其呼吸道联合疫苗(RSV-hMPV-PIV3)及RSV疫苗重复接种在老年人群的I期临床试验均获得积极数据
Ge Long Hui· 2025-10-14 10:28
Core Insights - The company announced positive preliminary data from two ongoing clinical trials for its proprietary Trimer-Tag vaccine platform, focusing on the RSV+hMPV±PIV3 candidates [1] Group 1: Clinical Trials Overview - In Australia, a Phase I trial compared SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (RSV) in elderly participants who had not previously received any RSV vaccine [1][2] - The trial showed that both SCB-1022 and SCB-1033 induced neutralizing antibody responses for RSV-A and RSV-B with a mean fold increase of approximately 6-8 times, comparable to the control group [2] - The hMPV neutralizing antibody responses were also significant, with mean fold increases of about 6-7 times for hMPV-A and 8-9 times for hMPV-B [2] Group 2: Safety and Tolerability - Both SCB-1022 and SCB-1033 demonstrated good overall tolerability, with adverse events being mild and comparable to the control group [4] - No serious adverse events related to the vaccines were reported, indicating a favorable safety profile [4] Group 3: U.S. Clinical Trial Insights - A Phase I trial in the U.S. is assessing the immunogenicity of SCB-1019 in elderly participants who previously received the GSK RSV vaccine (AREXVY) [5] - Preliminary results indicated that SCB-1019 induced RSV-A and RSV-B neutralizing antibody responses with a mean fold increase of approximately 3.0-3.3 times, significantly higher than the 1.8-1.9 times observed with AREXVY [6][7] - The proportion of participants showing at least a 2-fold increase in neutralizing antibodies was about 69-75% for SCB-1019, compared to 33-40% for AREXVY [6][7] Group 4: Future Plans - Based on the positive Phase I results, the company plans to advance SCB-1022 and SCB-1033 to Phase II clinical trials in the first half of 2026 [4][8]
三叶草生物-B(02197)公布其呼吸道联合疫苗(RSV-hMPV-PIV3) 及 RSV 疫...
Xin Lang Cai Jing· 2025-10-14 10:23
Core Viewpoint - Clover Biopharmaceuticals-B (02197) announced positive preliminary data from two ongoing clinical trials utilizing its proprietary and fully validated Trimer-Tag vaccine development platform for evaluating its PreF respiratory combination vaccine candidates (RSV+hMPV±PIV3) [1] Group 1: Clinical Trials - The first Phase I clinical trial is being conducted in Australia to evaluate the combination vaccine candidates SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (Clover's RSV candidate vaccine) in a head-to-head comparison, targeting elderly individuals who have not previously received any RSV vaccine [1] - The second Phase I clinical trial is taking place in the United States, assessing SCB-1019 (Clover's RSV candidate vaccine) against AREXVY (GSK's RSV vaccine) in a head-to-head evaluation, focusing on elderly individuals who have received at least two seasonal doses of AREXVY prior to enrollment [1]
三叶草生物-B(02197)公布其呼吸道联合疫苗(RSV-hMPV-PIV3) 及 RSV 疫苗重复接种在老年人群的 I 期临床试验均获得积极数据
智通财经网· 2025-10-14 10:16
Core Viewpoint - Clover Biopharmaceuticals-B (02197) announced positive preliminary data from two ongoing clinical trials utilizing its proprietary and fully validated Trimer-Tag vaccine development platform for evaluating its PreF respiratory combination vaccine candidates (RSV+hMPV±PIV3) [1] Group 1: Clinical Trials - The first Phase I clinical trial is being conducted in Australia to assess the combination vaccine candidates SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (Clover's RSV candidate vaccine) in a head-to-head comparison among elderly participants who have not received any RSV vaccine previously [1] - The second Phase I clinical trial is taking place in the United States, evaluating SCB-1019 (Clover's RSV candidate vaccine) against AREXVY (GSK's RSV vaccine) in a head-to-head assessment among elderly participants who have received at least one dose of AREXVY in the two preceding flu seasons [1]
三叶草生物-B公布其呼吸道联合疫苗(RSV-hMPV-PIV3) 及 RSV 疫苗重复接种在老年人群的 I 期临床试验均获得积极数据
Zhi Tong Cai Jing· 2025-10-14 10:15
Core Viewpoint - Clover Biopharmaceuticals-B (02197) announced positive preliminary data from two ongoing clinical trials based on its proprietary and fully validated Trimer-Tag vaccine development platform, evaluating the company's PreF respiratory combination vaccine candidates (RSV+hMPV±PIV3) [1] Group 1: Clinical Trials - An ongoing Phase I clinical trial in Australia is assessing the combination vaccine candidates SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) against SCB-1019 (Clover's RSV candidate vaccine) in a head-to-head comparison, targeting elderly individuals who have not previously received any RSV vaccine [1] - A Phase I clinical trial in the United States is conducting a head-to-head evaluation of SCB-1019 (Clover's RSV candidate vaccine) against AREXVY (GSK's RSV vaccine) in elderly individuals who have received at least two seasonal doses of AREXVY prior to enrollment [1]
三叶草生物(02197) - 自愿公告 - 三叶草生物公佈其呼吸道联合疫苗(RSV-hMPV-PIV...
2025-10-14 10:06
本公告由三葉草生物製藥有限公司(「本公司」或「三葉草生物」,連同其附屬公司統稱「本集團」)董事 (「董事」)會(「董事會」)自願作出,以知會本公司股東及潛在投資者本集團最新的業務發展狀況。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦不 發表任何聲明,並明確表示,概不就因本公告全部或任何部份內容所產生或因依賴該等內容而引致的任何損 失承擔任何責任。 自願公告 三葉草生物公佈其呼吸道聯合疫苗(RSV-hMPV-PIV3) 及 RSV 疫苗重複接種在老年人群的 I 期臨床試驗均獲得積極數據 本公司欣然宣佈兩項正在進行的臨床試驗的積極初步數據,基於公司自研獨有已获全面驗證的 Trimer-Tag ( 白質三聚體化)疫苗研發平台 ,於於估公公司的 PreF 呼吸道聯合疫苗候選產品(RSV+hMPV±PIV3),包括: 呼吸道聯合疫苗候選產品 RSV+hMPV±PIV3 I 期臨床試驗(澳大利亞):完整初步數據 在澳大利亞進行的一項 I 期臨床試驗中,老年人群受試者(60-85 歲)入組後被隨機分配接種 SCB-1022 (RSV+hMPV)、SCB-1033 (RSV+ ...
三叶草生物-B(02197.HK)启动呼吸道合胞病毒(RSV)+人偏肺病毒(hMPV)±副流感病毒3型(PIV3)呼吸道联合疫苗候选产品I期临床试验
Ge Long Hui· 2025-06-17 04:24
Core Viewpoint - Company announces the completion of the first cohort enrollment for Phase I clinical trials of SCB-1022 (RSV+hMPV) and SCB-1033 (RSV+hMPV+PIV3) respiratory combination vaccine candidates [1][2] Group 1: Clinical Trial Details - The ongoing Phase I clinical trial for the combination vaccine candidates will enroll up to 192 elderly participants (aged 60-85), who will be randomly assigned to receive either SCB-1022 (RSV+hMPV), SCB-1033 (RSV+hMPV+PIV3), or the control group SCB-1019 (RSV) [2] - The clinical study aims to evaluate safety, reactogenicity, and immunogenicity of the vaccine candidates [2] Group 2: Previous Clinical Trial Results - In October 2024, the company will announce results from a Phase I clinical trial of its adjuvant-free RSV PreF vaccine candidate (SCB-1019) conducted on 70 elderly participants (aged 60-85), which showed potential best-in-class immunogenicity and tolerability characteristics when compared head-to-head with GSK's RSV vaccine AREXVY using AS01E adjuvant [1] - The clinical results support the further development and evaluation of SCB-1019 in combination with hMPV and PIV3 fusion pre-F trimer antigen, also developed using the protein trimerization platform [1]