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科伦博泰生物(06990) - 自愿公告SKB575新药临床试验申请获国家药品监督管理局批准
2026-03-09 08:31
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 不對因本公告全部或任何部份內容而產生或因倚賴該等內容而引致的 任 何 損 失 承 擔 任 何 責 任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 (於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司) (股 份 代 號:6990) 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司(「本公司」)董 事(「董 事」)董 事 會(「董 事 會」)欣 然 宣 佈,本 公 司 與 和 鉑 醫 藥 控 股 有 限 公 司(「和鉑醫藥」)合 作 研 發 的靶向胸腺基質淋巴細胞生成素(TSLP)及一個未公開靶點的長效雙特異 性抗體(bsAb)SKB575(亦 稱HBM7575)的 新 藥 臨 床 試 驗(IND)申請已獲中國 國家藥品監督管理局(NMPA)批 准,用 於 治 療 特 應 性 皮 炎。 關 於SKB575(亦 稱 ...
和铂医药(02142) - 自愿公告 - HBM7575用於治疗特应性皮炎的新药临床试验申请获NMP...
2026-03-09 08:30
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分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 本公告由和鉑醫藥控股有限公司(「本公司」,連同其附屬公司統稱「本集團」)自願 作出,以告知本公司股東及潛在投資者有關本集團的最新業務更新。 本公司董事會(「董事會」)欣然宣佈,用於治療特應性皮炎的靶向胸腺基質淋巴 細胞生成素(「TSLP」)及一個未公開靶點的長效雙特異性抗體HBM7575(亦稱 SKB575)的新藥臨床試驗(「IND」)申請已獲中國國家藥品監督管理局(「NMPA」) 批准。 關於HBM7575/SKB575 HBM7575/SKB575是一款靶向TSLP及一個未公開靶點的長效雙特異性抗體,具 有雙重作用機制。一方面,通過阻斷TSLP與其受體的相互作用,其可抑制TSLP 介導的信號通路以及Th2免疫細胞的啟動;另一方面,其針對另一未公開靶點 的結合與阻斷可產生協同效應,克服TSLP單靶點抗體的耐藥問題。HBM7575/ SKB575經過工程化設計,具有延長的半衰期以及良好的可開發性,可實現 ...
小核酸药物方兴未艾,海外创新与国内崛起共振
Xinda Securities· 2026-03-09 08:25
Investment Rating - The report rates the industry as "Positive" [2][7] Core Insights - Small nucleic acid drugs represent the third major paradigm in modern pharmaceuticals, following small molecules and antibody drugs, with advantages such as broad target range, lasting efficacy, and direct research pathways [2][21] - The global small nucleic acid drug market is expected to grow from USD 7.1 billion in 2025 to USD 54.9 billion by 2034, with ASO and siRNA currently holding equal market shares [3][62] - Key players in the overseas market include Ionis, Sarepta, Alnylam, and Arrowhead, each leading in different therapeutic areas and technologies [4][62] Summary by Sections 1. Small Nucleic Acids: A New Era in Modern Pharmaceuticals - Small nucleic acid drugs intervene at the RNA level, offering a new approach to disease treatment with significant advantages over traditional therapies [21][24] - The main technical paths for sequence design are ASO and siRNA, with clinical trials for these types significantly outpacing others [42][62] 2. Acceleration of Global Commercialization in the Small Nucleic Acid Industry - The global small nucleic acid drug industry is characterized by a clear value distribution across the supply chain, with solid-phase synthesis as the preferred production method [3][62] - The number of clinical pipelines globally totals 327, with siRNA leading in quantity and a wide distribution of targets [3][62] 3. Overseas Giants Leading Technological Frontiers - Ionis is a pioneer in ASO technology, with a strong pipeline and successful product sales [4][62] - Alnylam is recognized as the global leader in siRNA, achieving profitability in 2025 with its top-selling drug Amvuttra [4][62] 4. Recommended Domestic Companies - The report suggests focusing on domestic companies such as Rebio, Bowang Pharmaceutical, Saint Gene, Frontier Biotech, Hengrui Medicine, China Biopharmaceutical, and CSPC [5][62]
在男性主导的生物医药圈,女性掌门人闯出了一片天地
第一财经· 2026-03-08 02:19
Core Viewpoint - The article highlights the transformation of China's biopharmaceutical industry into a mature sector and a pillar of innovation, with a notable increase in female leadership within the industry [3][5]. Group 1: Industry Overview - The Chinese biopharmaceutical sector is characterized as technology-intensive, capital-intensive, and high-barrier, with a long development cycle [3]. - The government has elevated biopharmaceuticals from an emerging industry to a pillar industry, indicating its growing importance in global pharmaceutical innovation [3]. - In 2025, China approved 76 innovative drugs, significantly surpassing the 48 approved in 2024, reflecting a robust growth in the sector [7]. Group 2: Female Leadership in Biopharmaceuticals - Among the 163 biopharmaceutical companies listed in Hong Kong, only about 16 are led by women, representing less than 10% [5]. - Notable female leaders include Zhong Huijuan of Hansoh Pharmaceutical, whose wealth increased to 160 billion RMB, making her one of the wealthiest female entrepreneurs in China [6]. - Female leaders are recognized for their resilience and meticulousness, which are seen as advantages in a challenging environment [15][16]. Group 3: Company Performance and Innovations - Hansoh Pharmaceutical achieved sales revenue of 6.145 billion RMB from innovative drugs and collaborations in the first half of 2025, accounting for approximately 82.7% of the company's total revenue [7]. - Innovative drugs developed by domestic companies are showing potential comparable to international blockbuster drugs, particularly in the PD-1/VEGF dual antibody space [7]. - In 2025, Innovent Biologics completed two external licensing transactions, with one exceeding 2 billion USD, showcasing the financial viability of innovative drug companies [8]. Group 4: Challenges and Future Directions - The article discusses the challenges faced by innovative drug companies, including high investment costs and significant failure risks, which require careful financial management [12]. - The need for a shift from product internationalization to comprehensive corporate globalization is emphasized, necessitating strong innovation capabilities and effective global integration [16]. - The leadership in biopharmaceutical companies must balance innovation with market needs, leveraging unique insights to enhance research and development efficiency [16].
数千万元!外泌体诊疗公司完成Pre-A轮融资
思宇MedTech· 2026-03-07 01:10
2025年,苏州中科易微科技发展有限公司完成千万级Pre-A轮融资,由长春长兴基金独家战略投资。此 前,公司曾获国科创投投资。本轮募集资金将用于先进外泌体抗衰系统性产品研发及产业化落地,以及外 泌体制备的批量化、标准化技术提升。 # 公司介绍 成立日期: 2022年12月 # 产品与技术简介 核心产品类型: 应用科室或手术场景: 总部所在地: 苏州(拟在长春建设GMP厂房) 企业定位: 外泌体诊疗与大健康技术研发企业 主要业务领域: 外泌体诊断、外泌体药物、医美抗衰原料及制剂 创始人背景: 杨延莲,国家纳米科学中心研究员 1. 诊断产品: 基于iMAF™技术平台的外泌体检测产品,用于脑胶质瘤、肺癌、阿尔茨海默症等疾病的生 物标志物检测 2. 医美原料: 基于SuperEV™技术平台的外泌体制备产品,包括EVPlus(易微佳)等医美产品原材料及 制剂配方 肿瘤科(脑胶质瘤、肺癌诊断) 神经内科(阿尔茨海默症诊断) 医美抗衰、皮肤修复 技术方向或解决的问题: # 融资历程 据思宇MedTech查询爱企查网站,该公司融资历程如下表: | 序号 | 发布日期 | 融资轮次 | 融资金额 | 投资方 | | --- | ...
派格生物医药(02565) - 自愿性公告 派格生物新一代GLP-1(CR059)首次人体试验 取得...
2026-03-06 09:00
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分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 PegBio Co., Ltd. 派格生物醫藥(杭州)股份有限公司 CR059採用脂質納米顆粒(LNP)遞送系統,通過體內持續表達GLP-1受體激動劑以 實現長效代謝干預,預期有助於延長給藥間隔並提升患者治療依從性。 臨床前研究結果 1 - 在db/db小鼠模型中,於以司美格魯肽作為對照的頭對頭研究條件下,CR059 呈現更強的代謝干預效應並顯示明確的劑量-反應關係,支持其基於體內表 達機制實現穩定GLP-1受體激動效應。 - 在自發性2型糖尿病恒河猴模型中,CR059每月一次皮下注射(D1、D32)給藥 後可顯著降低空腹血糖,且代謝改善效應可跨越給藥間隔持續存在;至D88 糖化血紅蛋白(HbA1c)較基線持續改善,顯示基於環狀RNA的體內蛋白持續 表達策略有潛力支持延長給藥間隔的治療模式。 - 在健康恒河猴模型中,CR059單次皮下注射後可在數週內維持代謝干預效應 (單次給藥後5週體重下降約11.8%) ...
维立志博-B(09887) - 自愿公告 - 维利信TM(PD-L1/4-1BB双特异性抗体奥帕替...
2026-03-06 08:30
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 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Nanjing Leads Biolabs Co., Ltd. (於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司) (股 份 代 號:9887) 自願公告 維 利 信™(PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗,LBL-024) 於一線食管鱗狀細胞癌II期試驗的首例患者入組 本公告由南京 維 立志博生物科技股份有限公司(「本公司」,連 同 其 附 屬 公 司 統 稱「本集團」)自 願 作 出,以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布,評 價 維 利 信™(PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗, LBL-024)用於治療一線食管鱗狀細胞癌的II期 臨 床 研 究 首 ...
港股异动 | 荣昌生物(09995)涨超6% 25年股东应占利润7.09亿元 机构料其现金储备显著增加
Zhi Tong Cai Jing· 2026-03-06 02:32
Core Viewpoint - Rongchang Biopharma (09995) reported a significant increase in revenue and profitability for the fiscal year 2025, driven by higher sales of its injectable products and a substantial rise in technology licensing income [1] Financial Performance - The company achieved total revenue of RMB 3.251 billion, representing a year-on-year increase of 89.36% [1] - Net profit attributable to the parent company was RMB 709 million, marking a turnaround from a loss to profitability [1] - Basic earnings per share were RMB 1.29 [1] Revenue Drivers - The increase in revenue was primarily due to higher sales of injectable drugs, specifically Tai Tasi Pi and Vidi Si Tuo Monoclonal Antibody [1] - The company granted Vor Biopharma Inc. exclusive global development and commercialization rights for Tai Tasi Pi outside Greater China, leading to a significant increase in technology licensing income [1] Margin and Expenditure Outlook - Nomura's research report predicts that the company's gross margin will increase by 5.4 percentage points year-on-year to 94.4%, benefiting from improved drug margins and a higher proportion of high-margin collaborative income [1] - Operating expenses are expected to rise by 28% year-on-year to RMB 3.5 billion due to a significant increase in cash reserves, reversing last year's cost-saving trend [1] - Research and development expenses and sales costs are projected to be RMB 1.6 billion each, aimed at sponsoring new molecular research and clinical trials, as well as enhancing drug sales [1]
荣昌生物涨超6% 25年股东应占利润7.09亿元 机构料其现金储备显著增加
Zhi Tong Cai Jing· 2026-03-06 02:25
Core Viewpoint - Rongchang Biopharma (09995) reported a significant increase in revenue and profit for the fiscal year 2025, driven by strong sales of its injectable products and a notable rise in technology licensing income [1] Financial Performance - The company achieved total revenue of RMB 3.251 billion, representing a year-on-year increase of 89.36% [1] - Net profit attributable to the parent company was RMB 709 million, marking a turnaround from a loss to profitability [1] - Basic earnings per share reached RMB 1.29 [1] Revenue Drivers - The increase in revenue was primarily due to higher sales of injectable products, specifically Tai Taisip and Vidisitamab [1] - The company granted Vor Biopharma Inc. exclusive global development and commercialization rights for Tai Taisip outside Greater China, leading to a substantial increase in technology licensing income [1] Margin and Expenses Outlook - Nomura's report predicts that the company's gross margin will rise by 5.4 percentage points year-on-year to 94.4%, benefiting from improved drug margins and a higher proportion of high-margin collaborative income [1] - Operating expenses are expected to increase by 28% year-on-year to RMB 3.5 billion due to a significant rise in cash reserves, reversing last year's cost-saving trend [1] - Research and development expenses and sales costs are projected to be RMB 1.6 billion each, aimed at sponsoring new molecular research and clinical trials, as well as enhancing drug sales [1]
信达生物获摩根大通增持约40.86万股 每股作价约84.94港元
Xin Lang Cai Jing· 2026-03-06 00:12
Group 1 - Morgan Stanley increased its stake in Innovent Biologics (01801) by 408,630 shares at a price of HKD 84.9352 per share, totaling approximately HKD 34.7071 million [1] - After the increase, Morgan Stanley's total shareholding in Innovent Biologics reached approximately 86,908,100 shares, representing a 5% ownership stake [1]