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康希诺:重组三价脊髓灰质炎疫苗(Sf-RVN细胞)获得药物临床试验批准通知书
news flash· 2025-07-16 08:41
Core Viewpoint - CanSino Biologics has received approval from the National Medical Products Administration for the clinical trial of its trivalent inactivated poliovirus vaccine (Sf-RVN cells), indicating progress in vaccine development and potential market entry [1] Group 1: Company Developments - CanSino Biologics announced the receipt of the clinical trial approval notice for its trivalent inactivated poliovirus vaccine [1] - The vaccine is developed using protein structure design and VLP assembly technology, ensuring it does not contain viral genetic material, which contributes to its safety and immunogenicity [1] - The vaccine is currently undergoing Phase I/II clinical trials in Indonesia [1] Group 2: Regulatory and Clinical Trial Information - The approval from the National Medical Products Administration allows CanSino to proceed with clinical trials in accordance with national drug registration regulations and requirements [1]
康希诺接待17家机构调研,包括Indus Capital Partners、My Alpha Management HK Advisors、SCHP等
Jin Rong Jie· 2025-07-03 11:53
Core Viewpoint - 康希诺 is actively advancing its vaccine development pipeline, focusing on innovative products and expanding its market presence both domestically and internationally [1][2][3] Group 1: Vaccine Development and Commercialization - 康希诺's 13-valent pneumonia conjugate vaccine PCV13i has significant advantages in product characteristics and production processes, showing excellent clinical results and safety profiles [3][4] - The company is targeting the commercialization of PCV13i, which overlaps with its existing product MCV4, enhancing marketing efficiency [4] - The four-valent meningococcal conjugate vaccine MCV4 has received acceptance for age expansion applications for 4-6 years and plans to submit for 18-59 years within the year [5] Group 2: Research and Development Progress - 康希诺 has established five major R&D platforms, with multiple products at various stages of development, including Tdcp for adolescents and adults, which has completed Phase III clinical trials [2][7] - The company is exploring therapeutic vaccine development and has a positive attitude towards expanding into innovative fields [8] - The infant DTcP vaccine's application for market approval has been accepted and is undergoing priority review, with plans for clinical trials for a combination vaccine [6][9] Group 3: Financial Position and Future Plans - As of March 2025, 康希诺 has approximately 34 billion RMB in funds, sufficient for current development needs, with no large-scale investment plans outside of its vaccine industrial park project [2][10] - Future financing plans will be considered based on market conditions and company development stages, with timely announcements to be made if necessary [10]
康希诺(688185) - 康希诺H股公告
2025-07-03 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 | 2025年6月30日 | | --- | | 狀態: | | 截至月份: 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 呈交日期: 2025年7月3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 | RMB | | 1 | RMB | | 1 ...
康希诺(688185) - 2024年年度股东大会决议公告
2025-06-04 12:15
证券代码:688185 证券简称:康希诺 公告编号:2025-016 康希诺生物股份公司 2024年年度股东大会决议公告 本公司董事会及全体董事保证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。 重要内容提示: 本次会议是否有被否决议案:无 一、 会议召开和出席情况 (一) 股东大会召开的时间:2025 年 6 月 4 日 (二) 股东大会召开的地点:天津市河东区卫国道 126 号天津东凯悦酒店二层 悦宾厅 1 (三) 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况: | 1、出席会议的股东和代理人人数 | 275 | | --- | --- | | 其中:A 股股东人数 | 274 | | H 股股东人数 | 1 | | 2、出席会议的股东所持有的表决权数量 | 89,499,039 | | 股股东所持有表决权数量 其中:A | 46,684,269 | | 股股东所持有表决权数量 H | 42,814,770 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比 | 36.23 | | 例(%) ...
康希诺(688185) - 康希诺H股公告
2025-06-04 10:45
FF301 截至月份: 2025年5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 呈交日期: 2025年6月4日 I. 法定/註冊股本變動 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 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 | 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 | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | 已發行股份總數 | | | 上月底結存 | | | 132,670,900 | 0 | | 132,670,900 | | 增加 / 減少 (-) | | | 0 | 0 | | | | 本月底結存 | | | 132,670,900 | 0 | | 132,670,900 | | 1. 股份分類 | 普通股 | 股份類別 | ...
连涨4天,涨幅超10%。港股创新药ETF(159567)今日盘中强势涨幅超1.5%,逼近上市以来新高。康希诺生物,君实生物,凯莱英领涨
Xin Lang Cai Jing· 2025-05-21 02:11
Group 1 - The Hong Kong Innovation Drug Index (987018) has seen a strong increase of 2.33% as of May 21, 2025, with notable gains in constituent stocks such as CanSino Biologics (06185) up 8.87%, Junshi Biosciences (01877) up 8.16%, and Kelun Pharmaceutical (06821) up 7.02% [1] - The Hong Kong Innovation Drug ETF (159567) has risen by 1.56%, marking its fourth consecutive increase, with the latest price reported at 1.3 HKD. Over the past week, the ETF has accumulated an increase of 8.63% [1] - The trading activity for the Hong Kong Innovation Drug ETF has been robust, with an intraday turnover of 10.03% and a transaction volume of 171 million HKD, indicating active market participation. The average daily trading volume over the past month reached 736 million HKD, with the ETF's latest scale reaching 1.667 billion HKD, a new high in nearly a year [1] Group 2 - The CDMO sector is expected to see rapid growth driven by the increasing demand for chemical macromolecules and XDC CDMO production, particularly in polypeptides and oligonucleotides, presenting investment opportunities in the related industry chain [1] - The CRO sector is anticipated to benefit from improving overseas financing conditions and a gradual shift towards a rate-cutting environment, with expectations of revenue recovery for integrated CRO/CDMO and domestic preclinical CROs, suggesting potential valuation recovery opportunities [2] - The CRO sector has been significantly impacted by domestic and international financing challenges, but with supportive domestic policies, there is an expectation for gradual recovery, highlighting investment opportunities in clinical CROs [2]
港股医药股延续强势,康希诺生物(06185.HK)涨超10%,君实生物(01877.HK)涨超9%,三叶草生物(02197.HK)、康方生物(09926.HK)等跟涨。
news flash· 2025-05-21 01:54
港股医药股延续强势,康希诺生物(06185.HK)涨超10%,君实生物(01877.HK)涨超9%,三叶草生物 (02197.HK)、康方生物(09926.HK)等跟涨。 ...
异动盘点0516|网易高开超10%,正大企业国际早盘涨超32%,部门药品股早盘走高;比特币概念股走低
贝塔投资智库· 2025-05-16 04:15
Group 1: Company Performance - NetEase-S (09999) saw a significant increase of 10.89% in stock price after reporting Q1 2025 net revenue of RMB 28.8285 billion, a year-on-year increase of 7.4%, and gross profit of RMB 18.5 billion, up 8.6% [1] - H&H International Holdings (01112) rose over 8% as the market speculated on the ergotamine concept, with its Swisse brand showing strong performance in high-growth segments [2] - China Gold International (02099) experienced a stock price increase of over 5% after reporting a 351% rise in Q1 revenue to USD 273 million [2] Group 2: Clinical and Pharmaceutical Developments - Shandong Xinhua Pharmaceutical (00719) surged over 14% as COVID-19 infections showed an upward trend, with the company preparing for Phase II clinical trials of OAB-14 [1] - Innovent Biologics (01801) rose nearly 3% after announcing the completion of the first patient dosing in the Phase III clinical study of Ma Shidu peptide for obesity [1] - Kangxi Biologics (06185) increased over 3% after receiving approval from the Indonesian drug regulatory authority for its inhaled tuberculosis vaccine clinical trial [1] Group 3: Market Trends and Reactions - The Nasdaq Golden Dragon China Index fell over 2%, with notable declines in popular Chinese stocks such as Tiger Brokers (TIGR.US) down over 8% and Beike (BEKE.US) down over 5% [3] - UnitedHealth Group (UNH.US) experienced a significant drop of over 15% following reports of a U.S. Department of Justice investigation into potential insurance fraud [3] - Bitcoin-related stocks declined, with CleanSpark (CLSK.US) down nearly 6% and Coinbase (COIN.US) down over 7%, as Bitcoin itself fell over 1.5% [3]
科创医药ETF(588860)盘中翻红,迈威生物-U涨超5%,机构:看好有全球竞争力的优质创新药公司
Group 1 - The A-share market saw a collective decline on May 16, while the Sci-Tech Innovation Pharmaceutical sector rebounded, with the Sci-Tech Innovation Pharmaceutical ETF (588860) rising by 0.16% [1] - Notable stocks in the sector included Maiwei Biotech-U, which increased by over 5%, along with Shouyao Holdings-U, KQ Biotech, Innotec, CanSino, and Baotai, all of which experienced gains [1] - The Sci-Tech Innovation Pharmaceutical ETF closely tracks the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which selects 50 large-cap companies in biopharmaceuticals and related fields to reflect the overall performance of representative companies in the sector [1] Group 2 - According to CMB International, the optimization of centralized procurement policies in mainland China provides hospitals and enterprises with more flexibility and autonomy, benefiting leading prescription drug companies [2] - The anticipated implementation of favorable policies, such as the 2025H2 medical insurance category, is expected to accelerate industry consolidation, with the sector's valuations remaining at historical lows [2] - The recommendation is to focus on innovative drug targets with high growth potential or clear breakeven timelines after short-term sentiment stabilizes [2]
CRO行业一季度业绩集体回暖,港股创新药ETF(159567)涨超1%,机构:看好国产创新药的出海前景
中邮证券表示,受益于海外投融资市场的率先复苏,需求端逐步恢复,CXO&上游公司订单增速提升, 行业拐点已过。CXO板块收入端恢复良好增长态势,盈利能力持续修复,利润端改善趋势更为显著, 基本面已呈现向上趋势。优质、高效、低成本的产品及服务为核心壁垒,我国制药业优势持续巩固,有 望在全球市场占据更高市场份额。中国创新药经过数十年发展,正在进入收获期,叠加政策友好性和市 场流动性提升,国内创新药市场前景光明。建议重点关注肿瘤、自免、减重、阿尔兹海默症、NASH、 脱发、乙肝等领域。 甬兴证券表示,百济神州凭借泽布替尼在欧美市场份额的提升保持收入规模的增长、恒瑞医药也多次实 现创新药的对外授权,我们认为国产创新药的竞争力正在持续提升,看好国产创新药的出海前景。 (本文机构观点来自持牌证券机构,不构成任何投资建议,亦不代表平台观点,请投资人独立判断和决 策。) 5月14日港股低开低走,医药生物板块逆市走强。热门ETF方面,港股创新药ETF(159567)盘中震荡 走高,截至发稿涨1.01%。换手率超7%,成交额快速突破1亿元,交投活跃。 成分股方面,三生制药涨超4%,康希诺生物、凯莱英涨超3%,晶泰控股、再鼎医药、科 ...