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康希诺PCV24肺炎疫苗获批临床试验
深耕肺炎疫苗领域多年,康希诺已积累扎实的技术积淀。2025年9月,公司自主研发的13价肺炎球菌多 糖结合疫苗优佩欣®(PCV13i)正式上市供应,该产品是我国首款采用CRM197与破伤风类毒素(TT) 双载体技术的肺炎球菌结合疫苗。通过创新双载体设计,优佩欣®有效规避了单一载体过量引发的不良 反应风险,减少与其他疫苗共注射时的免疫干扰,显著提升免疫原性,尤其对我国儿童疾病负担最重的 19F、19A、7F、3型等血清型实现精准防护。 在优佩欣®成功上市的基础上,康希诺加速推进高价次疫苗研发进程。此次获批的PCV24疫苗实现关键 技术突破,不仅覆盖当前肺炎球菌主要流行血清型,更延续了双载体技术优势,采用多糖抗原与蛋白载 体共价结合工艺,完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺及成品处方的开发与确 认。该疫苗拟适用于2月龄(最小6周)及以上全人群接种,可有效预防24种肺炎球菌血清型引发的感染 性疾病,有望进一步填补高价次肺炎疫苗的市场空白。 2026年新年伊始,康希诺生物(688185)传来研发进展:公司自主研发的24价肺炎球菌多糖结合疫苗 (CRM197/破伤风类毒素,简称"PCV24")正式获得国 ...
默沙东欣瑞来在华获批;亿帆医药子公司与尚德药缘达成合作
Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is seeking public opinions on the draft guidelines for the real-world comprehensive value assessment of medical services, aiming to establish a unified evaluation system across the country [1] - CanSino Biologics has received approval for clinical trials of its 24-valent pneumococcal polysaccharide conjugate vaccine, which targets major circulating serotypes and is intended for individuals aged 2 months and older [2] - Merck has announced that its breakthrough therapy, Sotatercept, has been approved in China for treating adult patients with pulmonary arterial hypertension (PAH), based on data from the STELLAR Phase III clinical trial [3] - ST. Renfu has received approval for clinical trials of HW221043 tablets, intended for the treatment of advanced solid tumors, with no similar drugs currently approved in the market [4] - Heng Rui Medicine has received approval for clinical trials of HRS-4357 injection and HRS-5041 tablets, aimed at treating PSMA-positive prostate cancer [5] Group 2: Market Activities - Shenzhou Cell has received approval from the China Securities Regulatory Commission for its application to issue stocks to specific investors [6] - Tianchen Medical has signed a strategic cooperation agreement with Inspur Digital Technology to promote innovation in medical intelligent manufacturing and robotics [7] - Zhonghong Medical's subsidiary has participated in a bidding project for centralized procurement of medical consumables, with some products expected to be selected, enhancing market presence [8] - Yifan Pharmaceutical's subsidiary has signed an exclusive agreement with Shangde Yaoyuan for the ACT001 drug, involving a total payment of 1 billion yuan [9] - Yijiahe is exploring the application of "brain-computer interface + embodied intelligent robots" technology in smart healthcare scenarios, having signed a strategic cooperation agreement with Mairande [10]
1月5日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-05 10:18
Group 1 - Ugreen Technology expects a net profit of 653 million to 733 million yuan for 2025, representing a year-on-year growth of 41.26% to 58.56% [1] - SenTai Co. plans to invest no more than 140 million yuan to establish a production base in Vietnam [2] - Muyuan Foods reported a December 2025 sales revenue of 9.667 billion yuan from commodity pigs, a year-on-year decline of 36.06% [3] Group 2 - Pumen Technology has received a medical device registration certificate for a quality control product used in various cancer markers [4] - Heng Rui Medicine's subsidiary has received approval for clinical trials of two injection drugs targeting obesity [5] - Quartz Co. was fined 2.7 million yuan for commercial secret infringement by its subsidiary [6] Group 3 - Chifeng Gold expects a net profit of 3 billion to 3.2 billion yuan for 2025, an increase of approximately 70% to 81% year-on-year [7] - Fulong Technology has terminated the transfer of 82.0969 million shares [8] - Senba Sensor's actual controller has released the pledge of 16.48 million shares [9] Group 4 - Hanma Technology reported a cumulative truck sales increase of 58.45% for 2025 [12] - Guankang Clean won a bid for a special procurement project worth 157 million yuan [14] - Defu Technology signed a cooperation agreement for high-end copper foil supply with a leading CCL company [15] Group 5 - Tianchen Medical signed a strategic cooperation agreement with Inspur Digital Technology [16] - CanSino received approval for clinical trials of a 24-valent pneumococcal polysaccharide conjugate vaccine [17] - Yipin Hong's subsidiary received approval for a supplementary application for oseltamivir phosphate capsules [19] Group 6 - Taotao Vehicle expects a net profit of 800 million to 850 million yuan for 2025, a year-on-year increase of 85.50% to 97.10% [20] - Yutong Bus reported a cumulative sales increase of 5.54% for 2025 [21] - Kingoo Co. received a notification from VinFast to supply automotive wheel products [22] Group 7 - ST Renfu's subsidiary received approval for clinical trials of a new drug for late-stage solid tumors [23] - Nanxing Co. expects a net profit of 90 million to 120 million yuan for 2025, reversing a loss from the previous year [24] - Jinrui Mining's subsidiaries will undergo routine maintenance starting January 5, 2026 [25] Group 8 - Changjiang Power reported a 3.82% increase in total power generation for its six hydropower stations in 2025 [26] - David Medical's subsidiary received a medical device registration certificate for an electronic endoscope image processor [28] - Guiguan Power reported a 26.68% increase in cumulative power generation for 2025 [29] Group 9 - ShenNan Electric's subsidiary won a project worth 208 million USD for a power plant operation service [30] - ST Kaiyuan's major shareholder's shares will be auctioned [31] - Jiecheng Co.'s major shareholder's shares have been auctioned [32] Group 10 - Tongbao Energy's wind power project has begun generating electricity [33] - Xusheng Group received an order worth 7.8 billion yuan from a North American EV manufacturer [34] - Qianli Technology reported a 154.08% increase in December 2025 electric vehicle production [35] Group 11 - Chint Electric plans to issue H-shares and list on the Hong Kong Stock Exchange [36][37] - Whirlpool expects a net profit increase of approximately 150% for 2025 [38] - Yongjie New Materials signed a 2 billion yuan aluminum alloy procurement contract [39]
康希诺24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)临床试验获批
Bei Jing Shang Bao· 2026-01-05 09:28
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) [1][2] Group 1 - The clinical trial approval indicates that PCV24 meets the requirements for drug registration and is set to prevent infections caused by 24 serotypes of pneumococcus [1] - As of the announcement date, there are no marketed products for the 24-valent pneumococcal polysaccharide conjugate vaccine in both domestic and international markets [2]
康希诺(688185) - 康希诺H股公告
2026-01-05 09:15
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 康希諾生物股份公司 本月底法定/註冊股本總額: RMB 247,043,801 FF301 II. 已發行股份及/或庫存股份變動 呈交日期: 2026年1月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06185 | 說明 | H 股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 132,670,900 | RMB | | 1 RMB | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 132,670,900 | R ...
康希诺:24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)获批临床试验
智通财经网· 2026-01-05 09:09
公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。截止公告披 露日,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 智通财经APP讯,康希诺(688185.SH)发布公告,公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》, 同意开展预防由本品所含24种肺炎球菌血清型引起的感染性疾病的临床试验。 ...
康希诺(688185.SH):24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)获批临床试验
智通财经网· 2026-01-05 09:04
智通财经APP讯,康希诺(688185.SH)发布公告,公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》, 同意开展预防由本品所含24种肺炎球菌血清型引起的感染性疾病的临床试验。 公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。截止公告披 露日,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...
康希诺生物(06185):24价肺炎球菌多糖结合疫苗(CRM197╱破伤风类毒素)在中国获临床试验批准
智通财经网· 2026-01-05 09:04
智通财经APP讯,康希诺生物(06185)发布公告,公司研发的24价肺炎球菌多糖结合疫苗(CRM197╱破 伤风类毒素)(PCV24)已获得中国国家药品监督管理局批准,可以开展相关临床试验。 公司PCV24覆盖当前肺炎球菌主要流行血清型,採用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。于本公告日 期,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...
康希诺生物:24价肺炎球菌多糖结合疫苗(CRM197╱破伤风类毒素)在中国获临床试验批准
Zhi Tong Cai Jing· 2026-01-05 09:01
康希诺生物(06185)发布公告,公司研发的24价肺炎球菌多糖结合疫苗(CRM197╱破伤风类毒素) (PCV24)已获得中国国家药品监督管理局批准,可以开展相关临床试验。 公司PCV24覆盖当前肺炎球菌主要流行血清型,採用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。于本公告日 期,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...
康希诺生物(06185.HK):PCV24在中国获临床试验批准
Ge Long Hui· 2026-01-05 08:58
公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。于本公告日 期,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 格隆汇1月5日丨康希诺生物(06185.HK)发布公告,公司研发的24价肺炎球菌多糖结合疫苗(CRM197╱破 伤风类毒素)("PCV24")已获得中国国家药品监督管理局批准,可以开展相关临床试验。 ...