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百克生物: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
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。 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。 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》。 ...
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。 ...
百克生物: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得批准
Xin Lang Cai Jing· 2025-10-09 07:38
百克生物(688276.SH)公告称,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》。该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。若该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。但该疫苗后 续临床试验的开展具有一定的不确定性,能否最终实现商业目的也存在一定的不确定性。 ...
百克生物回应半年报问询函 详解带状疱疹疫苗销量下滑原因
Xin Jing Bao· 2025-09-29 16:13
Core Viewpoint - The company reported a significant decline in revenue and profit for the first half of 2025, primarily due to a drop in sales of the shingles vaccine, which has been attributed to various factors affecting consumer demand and awareness [1][2]. Financial Performance - The company's revenue for the first half of 2025 was 285 million yuan, a year-on-year decrease of 53.93% [1]. - The net profit for the same period was -73.57 million yuan, marking a shift from profit to loss compared to the previous year [1]. Vaccine Sales Analysis - The sales volume of the shingles vaccine during the reporting period was -17,300 doses, resulting in a sales revenue of -65.23 million yuan [1]. - The company sold 86,500 doses of the shingles vaccine at a price of 1,369 yuan per dose, generating approximately 115 million yuan in revenue [2]. - The company also conducted a welfare project, selling 43,900 doses at a discounted price (30-80% of the normal price), which contributed 29.49 million yuan to revenue [2]. Revenue Adjustments - Revenue was further impacted by returns of previously recognized sales, with 147,700 doses returned, leading to a revenue reduction of 196 million yuan [2]. - The company noted that factors such as low disease awareness and consumer willingness to receive the vaccine contributed to the decline in sales and revenue [1][2].
百克生物(688276) - 长春百克生物科技股份公司关于2025年半年度报告的信息披露监管问询函的回复公告
2025-09-29 09:15
证券代码:688276 证券简称:百克生物 公告编号:2025-036 长春百克生物科技股份公司 关于 2025 年半年度报告的信息披露监管问询函的回复公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 长春百克生物科技股份公司(以下简称"公司")于近日收到上海证券交易所 科创板公司管理部下发的《关于长春百克生物科技股份公司 2025 年半年度报告的 信息披露监管问询函》(上证科创公函【2025】0375 号)(以下简称"半年报问询 函")。公司收到半年报问询函后高度重视,根据半年报问询函的要求,公司对半 年报问询函所列事项进行了认真核查、逐项落实,现就有关事项回复如下: 说明:本公告中部分合计数与各加数直接相加之和在尾数上如有差异,差异是 由四舍五入造成。 1、关于业绩亏损 (1)报告期内公司营业收入 2.85 亿元,同比下滑 53.93%;净利润-0.74 亿元, 同比由盈转亏,公司披露业绩下滑主要系带状疱疹疫苗销量下滑。(2)报告期末, 公司应付退货款、应收退货成本均为 0 元,分别同比减少 7075.46 万元、 ...
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]
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|创新药观察
Hua Xia Shi Bao· 2025-09-27 14:37
Core Insights - Changchun Baike Biotechnology Co., Ltd. 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 [2][3] Financial Performance - In the first half of 2025, the company reported a 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 the shingles vaccine in 2023 [2][3] - The 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 [3][5] Market Dynamics - The domestic birth rate has decreased from 18.83 million in 2016 to 9.02 million in 2023, leading to a shrinking market for children's vaccines [5] - The number of competitors in the varicella vaccine market has increased from three to five, with companies like Hualan Biological and Sinovac adopting low-price strategies, resulting in a 12% drop in the average bidding price for varicella vaccines from 2021 to 2024 [5][6] Product Performance - The varicella vaccine still contributes nearly 70% of the company's revenue, indicating a continued reliance on this product despite its declining performance [3] - The shingles vaccine, which initially showed promise with sales of 668,000 doses and revenue of 883 million yuan in its first year, saw a dramatic drop in 2024, with sales plummeting to 200,400 doses, a year-on-year decline of 69.8% [6][8] R&D Investment - The company has increased its R&D investment in the first half of 2025 to 98.2 million yuan, accounting for 34.47% of its revenue, a 14.81% increase from the previous year [8][9] - Baike has established five major platforms, with 16 projects in the pipeline, including 11 that are in clinical trial or registration stages [9][10] Marketing and Education Efforts - The company is focusing on innovative marketing strategies and public education to enhance awareness of diseases and stimulate demand for vaccines [2][10] - Efforts include academic promotion activities and community outreach to correct public misconceptions and improve the recognition of the shingles vaccine [10]
百克生物:重组人源抗呼吸道合胞病毒单克隆抗体注射液项目处于临床前研究阶段
Zheng Quan Ri Bao Wang· 2025-09-26 12:13
证券日报网讯百克生物9月26日在互动平台回答投资者提问时表示,公司在研项目中包含重组人源抗呼 吸道合胞病毒单克隆抗体注射液项目,目前处于临床前研究阶段。 ...
百克生物:关于股东部分股份解除冻结的公告
Zheng Quan Ri Bao· 2025-09-24 10:13
(文章来源:证券日报) 证券日报网讯 9月24日晚间,百克生物发布公告称,公司股东魏学宁先生持有公司13,302,076股股 份,占公司总股本的比例为3.22%。公司于近日收到股东魏学宁先生的通知,其所持有的公司1,166, 680股股份已由上海市闵行区人民法院全部解除冻结,占公司总股本比例为0.28%。本次股份解除冻结 后,魏学宁先生持有的公司股份无被冻结的情形。 ...
百克生物:股东魏学宁解除冻结约117万股
Mei Ri Jing Ji Xin Wen· 2025-09-24 09:12
每经头条(nbdtoutiao)——"9·24"一周年,A股总市值破116万亿元!四大变革重塑中国资本市场新生 态 (记者 王晓波) 2024年1至12月份,百克生物的营业收入构成为:生物医药占比100.0%。 截至发稿,百克生物市值为90亿元。 每经AI快讯,百克生物(SH 688276,收盘价:21.83元)9月24日晚间发布公告称,公司股东魏学宁先 生持有公司约1330万股股份,占公司总股本的比例为3.22%,全部为无限售流通股。魏学宁先生不属于 公司的控股股东、实际控制人。 本次魏学宁先生持有的公司股份解除冻结数量约为117万股,占公司总股本的比例为0.28%,本次股份 解除冻结后,魏学宁先生持有的公司股份无被冻结的情形。 ...