Workflow
LZ901
icon
Search documents
绿竹生物-B(02480)于美国成功完成LZ901的I期临床试验
智通财经网· 2025-10-09 11:13
LZ901是该集团自主开发的在研重组带状疱疹疫苗,并且是集团的核心产品,旨在预防年龄为40岁及以 上成人带状疱疹及带状疱疹引致的相关并发症的发生(包括带状疱疹后遗神经痛)。LZ901于中华人民共 和国的III期临床试验已达到临床预设目标,并取得符合预期的临床结果。截至本公告日期,LZ901的生 物制品许可申请已获中国国家药品监督管理局受理,目前正在接受评估。 智通财经APP讯,绿竹生物-B(02480)公布,于美利坚合众国进行的 LZ901的I期临床试验已于2025年9月 成功完成。根据该临床试验结果,LZ901疫苗高剂量组和低剂量组较安慰剂组而言,均表现出良好的安 全性和免疫原性,为后续临床研究奠定了基础。 根据于美国进行的LZ901的I期临床试验结果,LZ901疫苗高剂量组和低剂量组较安慰剂组而言,均表现 出良好的安全性和免疫原性。本次临床试验主要研究目标为验证疫苗的安全性,其中仅LZ901疫苗低剂 量组出现与疫苗相关的轻度不良反应(4.35%),LZ901疫苗高剂量组和安慰剂组均未出现与疫苗相关的不 良反应。 ...
绿竹生物-B(02480.HK)于美国成功完成LZ901的I期临床试验
Ge Long Hui· 2025-10-09 11:09
根据于美国进行的LZ901的I期临床试验结果,LZ901疫苗高剂量组和低剂量组较安慰剂组而言,均表现 出良好的安全性和免疫原性。本次临床试验主要研究目标为验证疫苗的安全性,其中仅LZ901疫苗低剂 量组出现与疫苗相关的轻度不良反应(4.35%),LZ901疫苗高剂量组和安慰剂组均未出现与疫苗相关的不 良反应。 格隆汇10月9日丨绿竹生物-B(02480.HK)公告,于美利坚合众国进行的LZ901的I期临床试验已于2025年9 月成功完成。根据该临床试验结果,LZ901疫苗高剂量组和低剂量组较安慰剂组而言,均表现出良好的 安全性和免疫原性,为后续临床研究奠定了基础。 于美国进行的LZ901的I期临床试验于2023年2月开始,为一项随机、双盲、安慰剂对照及剂量递增研 究,旨在评估LZ901在50至70岁健康受试者中的安全性及耐受性。于美国进行的LZ901的I期临床试验合 共招募66名受试者。 LZ901是集团自主开发的在研重组带状疱疹疫苗,并且是集团的核心产品,旨在预防年龄为40岁及以上 成人带状疱疹及带状疱疹引致的相关并发症的发生(包括带状疱疹后遗神经痛)。LZ901于中华人民共和 国III期临床试验已达到临床 ...
迫近现金红线核心品种难挑大梁,绿竹生物-B(02480)何时重返市场聚光灯下?
智通财经网· 2025-09-11 09:14
Core Viewpoint - Green Bamboo Bio-B (02480) announced that its core product LZ901 demonstrated superior cellular immunogenicity and safety compared to GSK's Shingrix® in a head-to-head clinical trial for adults aged 50 and above [1] Market Reaction - Following the announcement, Green Bamboo Bio's stock rose over 8% on August 18 and 19, reaching a peak price of 28 HKD, the highest in 15 months [1] - Despite the positive news, trading volume remains low, with 11 months in the past 21 recording less than 200,000 shares traded [1] Financial Performance - For the first half of 2025, the company reported zero revenue from product commercialization, with other income at 4.85 million RMB, a 50.2% decrease from the previous year [2][3] - The net loss narrowed to 77.57 million RMB, a 29.4% reduction year-on-year, while R&D expenses decreased by 37.5% to 5.03 million RMB [2][4] Clinical Data and Product Potential - LZ901 showed a CD4⁺ T cell response rate of 83.0% and a CD8⁺ T cell response rate of 46.8%, significantly outperforming Shingrix® [4] - The adverse reaction rate for LZ901 was 41.1%, much lower than Shingrix®'s 87.9%, indicating a strong safety profile [4][5] Market Challenges - The market for shingles vaccines is expected to grow to 12.6 billion USD by 2030, driven by an aging population and increasing awareness [8] - However, the penetration rate of shingles vaccines in China remains low due to weak public awareness and high prices [8][9] Competitive Landscape - Currently, the shingles vaccine market is dominated by GSK's Shingrix, with a significant drop in domestic approvals for shingles vaccines [9] - Green Bamboo Bio plans to price LZ901 between 500 to 800 RMB per dose, potentially impacting initial commercialization profits [9]
绿竹生物-B(02480):重组带状疱疹疫苗LZ901与Shingrix头对头临床研究读出
Guoxin Securities· 2025-09-02 11:57
Investment Rating - The report maintains an "Outperform" rating for the company [5][11]. Core Insights - The company has successfully completed a head-to-head clinical trial of its recombinant shingles vaccine LZ901 against Shingrix, showing superior cellular immunogenicity and better safety in adults aged 50 and above [1][9]. - The adjusted loss for the first half of 2025 narrowed to 0.78 billion yuan from a loss of 1.10 billion yuan in the same period last year, with R&D expenses decreasing by 37.5% to 0.80 billion yuan [1][8]. - The company has a robust pipeline with several products in various stages of development, including K3, a biosimilar to Humira, and K193, a bispecific antibody for treating B-cell leukemia and lymphoma [2][10]. Financial Projections - Revenue projections for 2025 to 2027 are 0.22 billion yuan, 4.39 billion yuan, and 9.71 billion yuan respectively, with net profits expected to be -1.46 billion yuan, -1.27 billion yuan, and 1.16 billion yuan [3][11]. - The company anticipates a significant revenue increase in 2026, with a projected growth rate of 1857.4% compared to 2025 [4]. Pipeline Overview - As of June 30, 2025, the company has six products in preclinical stages, including vaccines for varicella, RSV, HSV-1, HSV-2, and two bispecific antibodies for leukemia and lymphoma [2][10]. - The LZ901 vaccine is expected to receive commercial approval in the first half of 2026 [9].
绿竹生物-B(02480.HK)中期研发开支减少约37.5%至约5030万元
Ge Long Hui· 2025-08-26 08:41
Summary of Key Points Core Viewpoint - Green Bamboo Bio-B (02480.HK) reported a significant decrease in other income and R&D expenses, while also showing a reduction in pre-tax losses for the six months ending June 30, 2025, primarily due to decreased government subsidies and clinical trial costs [1]. Financial Performance - Other income decreased by approximately 50.2% to around RMB 4.9 million, mainly due to a reduction in government subsidies [1]. - R&D expenses decreased by approximately 37.5% from about RMB 80.4 million for the six months ending June 30, 2024, to about RMB 50.3 million for the same period in 2025, primarily due to reduced costs associated with the LZ901 Phase III clinical trial in China [1]. - Pre-tax losses decreased by approximately 29.4% from about RMB 109.9 million for the six months ending June 30, 2024, to about RMB 77.6 million for the same period in 2025 [1].
绿竹生物-B(02480)发布中期业绩,净亏损7757万元,同比收窄29.4%
智通财经网· 2025-08-26 08:41
Core Viewpoint - Green Bamboo Bio-B (02480) reported a significant decline in other income and a narrowed net loss for the six months ending June 30, 2025, while achieving key milestones for its core product LZ901 [1] Financial Performance - Other income amounted to 4.85 million RMB, representing a year-on-year decrease of 50.2% [1] - The net loss was 77.57 million RMB, which is a 29.4% reduction compared to the previous year [1] - Basic loss per share was 0.39 RMB [1] Product Development - In January 2025, the company submitted a Biologics License Application (BLA) for LZ901 to the National Medical Products Administration, which was accepted in February 2025 [1] - Following the acceptance of the BLA, the National Medical Products Administration will conduct further evaluations, including technical reviews and inspections [1] - The company successfully completed a head-to-head comparative study for LZ901, showing superior cellular immune response and better safety compared to the HZ/su vaccine (Shingrix) in adults aged 50 and above [1] - The board believes these positive results lay a solid foundation for the future commercialization of LZ901 [1]
绿竹生物-B:LZ901头对头比较研究的积极临床数据
Zhi Tong Cai Jing· 2025-08-17 23:57
Core Insights - The company announced positive immunogenicity and safety data for its core product LZ901 in a head-to-head comparison with the HZ/su vaccine in adults aged 50 and above [1] Group 1: Study Details - A randomized, active-controlled, non-inferiority trial was conducted, enrolling 301 healthy adults aged 50 and above, with at least 291 receiving two doses of either LZ901 or HZ/su vaccine [1] - Results indicated that LZ901 induced superior cellular immunogenicity and demonstrated better safety compared to the HZ/su vaccine in the target demographic [1] Group 2: Product Information - LZ901 is a recombinant shingles vaccine developed by the company, aimed at preventing shingles and related complications in adults aged 40 and above [1] - The biological product license application for LZ901 has been accepted by the National Medical Products Administration of the People's Republic of China and is currently under review [1]
绿竹生物-B(02480):LZ901头对头比较研究的积极临床数据
智通财经网· 2025-08-17 23:53
Core Insights - The company, Green Bamboo Bio-B (02480), announced positive immunogenicity and safety data from a head-to-head comparison trial of its core product LZ901 against the HZ/su vaccine (Shingrix®) in adults aged 50 and above [1] Group 1: Trial Details - The study was a randomized, active-controlled, and non-inferiority trial that recruited 301 healthy adults aged 50 and above, with at least 291 receiving two doses of either LZ901 or HZ/su vaccine [1] - Results indicated that LZ901 induced superior cellular immunogenicity and demonstrated better safety compared to the HZ/su vaccine in the target age group [1] Group 2: Product Information - LZ901 is a recombinant shingles vaccine developed by the company, aimed at preventing shingles and related complications, including postherpetic neuralgia, in adults aged 40 and above [1] - As of the announcement date, the biological product license application for LZ901 has been accepted by the National Medical Products Administration of the People's Republic of China and is currently under review [1]
绿竹生物-B(02480.HK):LZ901头对头比较研究的积极临床数据
Ge Long Hui· 2025-08-17 23:43
Core Insights - The company, Green Bamboo Bio-B (02480.HK), announced positive immunogenicity and safety data for its core product LZ901 in a head-to-head comparison with the HZ/su vaccine (Shingrix®) in adults aged 50 and above [1] Group 1: Clinical Trial Results - A randomized, active-controlled, non-inferiority trial was conducted, enrolling 301 healthy adults aged 50 and above, with at least 291 receiving two doses of either LZ901 or HZ/su vaccine [1] - LZ901 demonstrated superior cellular immunogenicity and better safety profile compared to the HZ/su vaccine in the target demographic [1] Group 2: Product Development - LZ901 is a recombinant shingles vaccine developed by the company, aimed at preventing shingles and related complications, including postherpetic neuralgia, in adults aged 40 and above [1] - As of the announcement date, the biological product license application for LZ901 has been accepted by the National Medical Products Administration of China and is currently under review [1]
绿竹生物(02480) - 自愿性公告 - LZ901头对头比较研究的积极临床数据
2025-08-17 23:36
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,概不會就因本公告全部或任何部分內容而產生或因 依賴該等內容而引致的任何損失承擔任何責任。 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2480) 自願性公告 LZ901頭對頭比較研究的積極臨床數據 本公告乃由北京綠竹生物技術股份有限公司(「本公司」,連同其附屬公司統稱為 「本集團」)自願作出,以告知本公司股東及潛在投資者本集團的最新業務發展。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本集團核心產品LZ901與重組糖 蛋白E(gE)亞單位疫苗HZ/su疫苗(Shingrix®)進行頭對頭比較的一項隨機、主動對 照及非劣效性試驗,在50歲及以上成人中獲得了積極的免疫原性和安全性數據。 該研究招募了301名50歲或以上健康成人,其中至少291名健康成人接種了兩劑 LZ901或HZ/su疫苗。研究結果顯示,與HZ/su疫苗相比,LZ901在50歲或以上成 人中誘導出更優的細胞免疫原性和表現出更佳的安全性。 LZ901頭對頭比較研究的關鍵結果概述如下: 免疫原性結果 安全性及反應 ...