疫苗研发
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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+ ...
百克生物:三价流感病毒裂解疫苗临床试验申请获批
Zheng Quan Shi Bao Wang· 2025-10-13 10:40
Core Viewpoint - 百克生物 has received approval for its trivalent influenza virus split vaccine (BK-01 adjuvant) from the National Medical Products Administration, which is expected to enhance immune response in the elderly population, marking a significant step in flu prevention for this vulnerable group [1][2]. Group 1: Vaccine Development - The trivalent influenza virus split vaccine (BK-01 adjuvant) is specifically designed for individuals aged 60 and above, aiming to stimulate a stronger immune response compared to traditional vaccines [2]. - The company has developed a product matrix for adjuvanted influenza vaccines, including both trivalent and quadrivalent options, with the quadrivalent vaccine already receiving clinical trial approval [1][2]. - The World Health Organization has recommended the removal of the B/Yamagata strain from the Northern Hemisphere flu vaccine components, highlighting the importance of the trivalent vaccine in flu epidemic control [1]. Group 2: Impact on Company - If the trivalent vaccine successfully completes clinical trials and receives market approval, it will enhance the company's vaccine development pipeline and provide new vaccination options for the elderly, thereby expanding its market reach [2]. - The company reported a significant increase in R&D investment, amounting to 98.2 million yuan, which represents 34.47% of its revenue, compared to 85.5 million yuan and 13.83% in the same period last year [4]. - The company is focusing on a diverse pipeline of 13 vaccine products and 3 monoclonal antibodies for infectious disease prevention, with strategies including upgrades, filling domestic gaps, and technological breakthroughs [4].
绿竹生物-B于美国成功完成LZ901的I期临床试验
Zhi Tong Cai Jing· 2025-10-09 11:17
Core Viewpoint - The Phase I clinical trial of LZ901 vaccine conducted in the United States has been successfully completed, demonstrating good safety and immunogenicity in both high-dose and low-dose groups compared to the placebo group, laying the foundation for subsequent clinical research [1] Group 1: Clinical Trial Results - The Phase I clinical trial primarily aimed to verify the safety of the vaccine, with only the low-dose group showing mild adverse reactions related to the vaccine at a rate of 4.35%, while no adverse reactions were reported in the high-dose and placebo groups [1] - Both high-dose and low-dose groups of the LZ901 vaccine exhibited good safety and immunogenicity compared to the placebo group [1] Group 2: Product Development - LZ901 is a self-developed recombinant shingles vaccine by the company, targeting the prevention of shingles and related complications in adults aged 40 and above [1] - The Phase III clinical trial of LZ901 in China has met its clinical preset goals and achieved expected clinical results [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 evaluation [1]
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
Group 1 - The core product LZ901 is a recombinant vaccine developed by the company to prevent shingles and related complications in adults aged 40 and above [2] - The Phase I clinical trial of LZ901 in the United States was successfully completed in September 2025, demonstrating good safety and immunogenicity in both high-dose and low-dose groups compared to the placebo group [1] - The Phase I clinical trial began in February 2023, involving 66 healthy participants aged 50 to 70, and was designed as a randomized, double-blind, placebo-controlled, and dose-escalation study [1] Group 2 - The primary objective of the Phase I clinical trial was to verify the vaccine's safety, with only the low-dose group showing mild adverse reactions (4.35%), while no adverse reactions were reported in the high-dose and placebo groups [1] - LZ901 has achieved its clinical preset goals in the Phase III clinical trial in China and has received acceptance for its biological product license application from the National Medical Products Administration of China, which is currently under evaluation [2]
绿竹生物(02480) - 自愿性公告 - 於美国成功完成LZ901的I期临床试验
2025-10-09 11:03
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。 Beijing Luzhu Biotechnology Co., Ltd. 北京綠竹生物技術股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:2480) 香港聯合交易所有限公司證券上市規則第18A.05條規定的警示聲明:本公司無法 保證LZ901最終將成功開發及營銷。本公司股東及有意投資者於買賣本公司股份 時務請審慎行事。 關於於美國進行的I期臨床試驗 於美國進行的LZ901的I期臨床試驗於2023年2月開始,為一項隨機、雙盲、安慰 劑對照及劑量遞增研究,旨在評估LZ901在50至70歲健康受試者中的安全性及耐 受性。於美國進行的LZ901的I期臨床試驗合共招募66名受試者。 根據於美國進行的LZ901的I期臨床試驗結果,LZ901疫苗高劑量組和低劑量組較 安慰劑組而言,均表現出良好的安全性和免疫原性。本次臨床試驗主要研究目標 為驗證疫苗的安全性,其中僅LZ901疫苗低劑量組出現與 ...
康乐卫士跌5.54% 2023上市募资2.94亿中信证券保荐
Zhong Guo Jing Ji Wang· 2025-10-09 09:03
Group 1 - The core point of the article is that Kang Le Wei Zhi (康乐卫士) has experienced a significant decline in its stock price since its listing on the Beijing Stock Exchange, indicating a lack of investor confidence [1] - The stock was listed on March 15, 2023, with an initial price of 42.00 yuan, but it opened lower on the first day and closed at 35.52 yuan, reflecting a drop of 15.43% [1] - As of October 9, 2023, the stock price is reported at 12.27 yuan, with a further decline of 5.54%, indicating ongoing challenges for the company [1] Group 2 - Kang Le Wei Zhi issued a total of 7,000,000 shares, with an option for an additional 8,050,000 shares if the over-allotment option is fully exercised [1] - The total funds raised before the exercise of the over-allotment option amounted to 29,400,000 yuan, with a net amount of 26,662,410 yuan after deducting issuance costs of 2,737,590 yuan [1] - The company planned to raise 30,000,000 yuan for HPV vaccine research and a construction repurchase project for its Kunming production base [1] Group 3 - The total issuance costs for Kang Le Wei Zhi were 2,737,590 yuan before the exercise of the over-allotment option, and 3,008,020 yuan if the option was fully exercised [2] - The underwriting fees for the lead underwriters, CITIC Securities and Guosen Securities, were 1,902,830 yuan before the over-allotment option and 2,173,250 yuan if the option was fully exercised [2] Group 4 - On May 17, 2023, Kang Le Wei Zhi announced a dividend plan, proposing a stock bonus of 10 shares for every 10 shares held, with the ex-dividend date set for May 26, 2023 [3]
百克生物(688276.SH):吸附无细胞百白破b型流感嗜血杆菌联合疫苗临床试验申请获批
智通财经网· 2025-10-09 07:49
智通财经APP讯,百克生物(688276.SH)发布公告,公司近日收到国家药品监督管理局下发的吸附无细 胞百白破b型流感嗜血杆菌联合疫苗的《药物临床试验批准通知书》。 本次公司获批临床的吸附无细胞百白破b型流感嗜血杆菌联合疫苗(以下简称"百白破-Hib联合疫苗")是一 种可以同时预防百日咳、白喉、破伤风以及b型流感嗜血杆菌的疫苗。接种对象为2月龄及以上婴幼儿, 接种后可刺激机体产生免疫应答,用于预防百日咳、白喉、破伤风和b型流感嗜血杆菌引起的侵袭性感 染。 若本次获批的百白破-Hib联合疫苗顺利完成临床试验,并获批上市,将进一步完善公司联合疫苗研发管 线,有助于公司优化产品结构和主营业务的全面发展,为公众提供更为高质量的疫苗接种选择,同时助 力公司联合疫苗迎来新突破,为公司业绩创造新的增长点。 ...
智飞生物(300122.SZ):自主产品流感病毒裂解疫苗获得药品注册证书
Ge Long Hui A P P· 2025-09-29 12:28
Core Viewpoint - The company has successfully obtained the Drug Registration Certificate for its trivalent influenza virus split vaccine, marking a significant achievement in its commitment to dual-driven technology and market strategies [1] Group 1: Product Development - The trivalent influenza vaccine was developed by the company's wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] - This vaccine adds to the company's existing portfolio, which includes a quadrivalent influenza vaccine already approved for market and other vaccines in various stages of clinical trials and approval [1] Group 2: Market Strategy - The successful registration of the trivalent influenza vaccine demonstrates the company's innovative research and development capabilities [1] - The company aims to enhance its comprehensive competitiveness and promote sustainable and steady growth by offering a diverse range of high-quality products to meet public health needs [1]
智飞生物:自主产品流感病毒裂解疫苗获得药品注册证书
Ge Long Hui· 2025-09-29 12:25
Core Viewpoint - The company, Zhifei Biological Products (300122.SZ), has successfully obtained a drug registration certificate for its trivalent influenza virus split vaccine from the National Medical Products Administration, showcasing its innovation and research capabilities [1] Group 1: Product Development - The trivalent influenza vaccine is developed by the company's wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] - This achievement reflects the company's commitment to a dual-driven strategy of "technology & market," laying a solid foundation for further market expansion [1] Group 2: Product Portfolio - The newly registered trivalent influenza vaccine complements the company's existing product lineup, which includes a quadrivalent influenza virus split vaccine already approved for market, a quadrivalent/trivalent influenza vaccine (for children) currently under review, and a quadrivalent influenza vaccine (ZFA02 adjuvant) in Phase I/II clinical trials [1] - The comprehensive range of influenza vaccines covers all age groups and enhances the variety of products offered by the company [1] Group 3: Strategic Goals - The company aims to provide more high-quality products to meet public health needs, strengthen its overall competitiveness, and promote sustainable and steady development [1]
水痘疫苗遇价格战,带状疱疹疫苗销量“腰斩”!百克生物押注研发能否破转型困局
Hua Xia Shi Bao· 2025-09-28 10:06
Core Insights - Changchun Baike Biological Technology Co., Ltd. (Baike Bio) is facing significant challenges as it transitions from children's vaccines to adult vaccines, reflecting common issues in product iteration, market expansion, and R&D transformation within traditional vaccine companies [1][2] Financial Performance - In the first half of 2025, Baike Bio reported its most severe financial results since its IPO, with revenue of 285 million yuan, a year-on-year decline of 53.93%, and a net loss attributable to shareholders of 73.57 million yuan, marking a significant downturn following a brief growth period after the launch of its shingles vaccine in 2023 [1][2] - The company's revenue from the varicella vaccine decreased from 1.02 billion yuan in 2021 to 820 million yuan in 2023, with sales volume dropping from 8.11 million doses to 6.71 million doses, a decline of 17.3% over three years [2][4] Market Challenges - The varicella vaccine faces dual pressures: a declining birth rate in China, which fell from 18.83 million in 2016 to 9.02 million in 2023, and increased competition, with the number of competitors rising from three to five, leading to a 12% drop in the average bidding price for the vaccine [4][5] - The average bidding price for Baike Bio's varicella vaccine decreased from 65 yuan per dose in 2021 to 58 yuan in 2024, with further price reductions expected as competitors enter the market with lower pricing strategies [4][5] Product Performance - The shingles vaccine, initially a strong performer with 663,500 doses sold in its first year and revenue of 883 million yuan, saw a dramatic decline in 2024, with sales plummeting by 69.8% to 200,400 doses, leading to a significant inventory buildup [5][6] - The company’s only growth in 2024 came from its nasal spray influenza vaccine, which generated 141 million yuan in revenue, accounting for only 11.39% of total revenue, insufficient to offset overall declines [6] R&D and Future Prospects - Baike Bio has increased its R&D investment significantly in the first half of 2025, with expenditures reaching 98.2 million yuan, accounting for 34.47% of revenue, compared to 14.81% growth in the previous year [7][8] - The company has developed five major platforms, with 16 projects in the pipeline, including several that have received clinical trial approval, indicating a focus on innovation despite current market challenges [8][9] - However, concerns remain regarding the efficiency of R&D conversion and the high-risk nature of certain projects, such as the Alzheimer's vaccine, which has a failure rate exceeding 90% [9]