Workflow
贺普拉肽
icon
Search documents
国内乙肝创新药迎来重要突破,创新药景气度或将延续?
Xin Lang Ji Jin· 2025-11-18 08:37
Core Viewpoint - The 76th AASLD conference showcased significant advancements in China's innovative drug sector, particularly in hepatitis B treatment, indicating a positive outlook for the industry moving forward [1][4][5]. Group 1: Performance of Chinese Innovative Drug Companies - Chinese research teams made notable contributions at the AASLD 2025 conference, presenting findings on hepatitis B and other liver diseases, with several experts receiving prestigious awards [4]. - Breakthrough drugs and clinical data were highlighted, including HepaPrax combined with interferon achieving "sterilizing cure" for hepatitis B, and AHB-137 showing a 39% sustained clearance rate post-treatment [4][5]. Group 2: Future Outlook for the Innovative Drug Sector - The innovative drug sector is benefiting from several positive industry trends, including a sustained "going global" momentum, with overseas licensing deals reaching $104.2 billion and upfront payments totaling $8.1 billion by October 2025 [8]. - The pharmaceutical sector reported a net profit of 40.51 billion yuan in Q3 2025, a 7.67% year-on-year increase, with expectations for continued growth in innovative drug commercialization and overseas deals [8]. - Ongoing policy support is anticipated, with upcoming insurance negotiations expected to enhance the accessibility and affordability of high-priced innovative drugs [8]. - The innovative drug sector has experienced a three-month adjustment period, which is viewed as healthy, with expectations for a new round of growth as market dynamics shift [8].
国内乙肝创新药物获突破性进展,港股创新药精选ETF(520690)最新份额超6亿份,创成立以来新高
Xin Lang Cai Jing· 2025-11-11 06:24
流动性方面,港股创新药精选ETF盘中换手7.74%,成交4223.87万元。拉长时间看,截至11月10日,港股创新药精选ETF近1年日均成交1.20亿元。 据报道,11月10日,华润三九公告,与琅钰集团、Bioproject 达成重磅合作,拿下发作性睡病创新药铧可思(替洛利生片)在中国大陆开发与商业化权益。华 润三九这款创新药的获得,不仅将为患者带来安全治疗新选择,更标志着华润三九在罕见病赛道的布局迈出关键一步。 消息方面,近日,第76届美国肝病研究协会(AASLD)年会在美国华盛顿开幕。由上海贺普药业研发的乙肝创新药贺普拉肽临床研究取得突破性进展,以 大会报告形式公布了治疗慢性乙肝II期随机双盲临床试验结果。据介绍,该创新药通过独特的病毒进入阻断独特机制,在II期临床试验中显示可逆转"大三 阳"乙肝患者对干扰素治疗的耐药性,在部分患者实现cccDNA清除,达到国际公认乙肝治愈最高标准-灭菌性治愈(sterilising cure)。 截至2025年11月11日 14:02,恒生港股通创新药精选指数下跌0.94%。成分股方面涨跌互现,联邦制药领涨1.92%,MIRXES-B上涨1.74%,三生制药上涨 0.9 ...
【财闻联播】中际旭创拟赴港股上市!山东黄金子公司需补税7.38亿元
券商中国· 2025-11-10 13:14
Macro Dynamics - The State Council issued measures to guide private capital's orderly participation in low-altitude economy infrastructure construction, optimizing satellite communication business access policies and supporting capable private enterprises in major national technology tasks [2] Pharmaceutical Innovations - Shanghai Hepu Pharmaceutical's innovative hepatitis B drug Hepulapta achieved breakthrough results in a Phase II clinical trial, showing the ability to reverse drug resistance in chronic hepatitis B patients and achieve sterilizing cure [3] Automotive Market - In October, the retail sales of new energy passenger vehicles reached 1.282 million units, a year-on-year increase of 7.3%, while the cumulative sales from January to October reached 10.151 million units, growing by 21.9% [4][5] Oil Price Adjustments - Domestic gasoline and diesel prices will increase by 125 and 120 yuan per ton respectively starting from November 10, with an average increase of 0.10 yuan per liter for 92, 95 gasoline, and 0 diesel [6] Monetary Policy - The Bank of Japan's October meeting minutes suggest a possible interest rate hike in December, aligning with market expectations for an increase in borrowing costs by early next year [7] Financial Institutions - Zhejiang Securities announced the retirement of Chairman Wu Chenggen and the appointment of Qian Wenhai as the new chairman and president [9] Market Data - The Shanghai Composite Index rose by 0.53% on November 10, with significant gains in the consumer goods sector, particularly in food and beverage stocks [11] - The total margin financing balance decreased by 50.19 billion yuan as of November 7, with the Shanghai Stock Exchange reporting a balance of 12,567.49 billion yuan [12] Company Developments - Purun Co. announced a share transfer at 106.66 yuan per share, which is a 38% discount compared to the closing price [14] - Zhongji Xuchuang plans to issue H-shares and list on the Hong Kong Stock Exchange [15] - Mindray Medical submitted an application for H-share listing on the Hong Kong Stock Exchange [16] - Shandong Gold's subsidiary needs to pay 738 million yuan in taxes, which is expected to impact the company's net profit for 2025 by 230 million yuan [17] - Lingzhi Software plans to acquire 100% of Kaimiride's equity, with stock resuming trading on November 11 [18] - *ST Yuancheng's stock will be suspended from trading due to falling below the mandatory delisting threshold [19]
我国乙肝创新药物临床研究取得突破性进展
Zheng Quan Ri Bao Wang· 2025-11-10 12:26
Core Insights - The 76th American Association for the Study of Liver Diseases (AASLD) annual meeting opened in Washington, D.C., showcasing significant advancements in liver disease research and treatment [1] - Chinese research teams presented multiple reports at the AASLD 2025 conference, highlighting breakthroughs in hepatitis B research, clinical diagnosis, new drug development, liver cancer mechanisms, cirrhosis, and fatty liver disease [1] - Hepu Pharmaceutical's innovative hepatitis B drug, Hepulapta, demonstrated breakthrough results in a Phase II randomized double-blind clinical trial, addressing the global challenge of interferon resistance in hepatitis B treatment [1][2] Drug Development - Hepulapta, developed by Hepu Pharmaceutical, utilizes a unique mechanism to block HBV virus entry into liver cells, significantly enhancing the clinical efficacy of interferon treatment [2] - The drug showed potential in reversing interferon resistance in "big three positive" hepatitis B patients during Phase II clinical trials, achieving international standards for viral clearance [2] Public Health Impact - The advancements in hepatitis B treatment from China are expected to contribute to the World Health Organization's (WHO) goal of eliminating viral hepatitis as a major public health threat by 2030 [2] - These developments align with the objectives of the "Healthy China 2030" initiative, providing strong support for public health goals in China [2]
国内乙肝创新药物获突破性进展
人民财讯11月10日电,近日,第76届美国肝病研究协会(AASLD)年会在美国华盛顿开幕。由上海贺普药 业研发的乙肝创新药贺普拉肽临床研究取得突破性进展,以大会报告形式公布了治疗慢性乙肝II期随机 双盲临床试验结果。据介绍,该创新药通过独特的病毒进入阻断独特机制,在II期临床试验中显示可逆 转"大三阳"乙肝患者对干扰素治疗的耐药性,在部分患者实现cccDNA清除,达到国际公认乙肝治愈最 高标准-灭菌性治愈(sterilising cure)。 ...
乙肝治愈再现新的曙光?这款药物二期临床研究可实现乙肝灭菌性治愈
Di Yi Cai Jing· 2025-05-11 08:53
Group 1 - Hepatitis B virus (HBV) infection is a significant global public health issue, with chronic HBV potentially leading to cirrhosis and liver cancer if not controlled [1][2] - Current treatments for chronic HBV do not achieve a complete cure, with existing drugs unable to eliminate the virus entirely [2][4] - HepaPlus, a drug developed by Shanghai HepaPlus Pharmaceutical, is one of the few candidates aiming for sterilizing cure in hepatitis B treatment [1][4] Group 2 - The recent Phase II clinical trial results presented at the 2025 European Association for the Study of the Liver (EASL) conference showed that HepaPlus significantly improved the response rate of HBV DNA when combined with PEG interferon [1][5] - The trial included 96 patients, with an average age of 35.3 years, and demonstrated response rates of 78.3%, 87.5%, and 70.8% for different doses of HepaPlus compared to 58.3% for the placebo group [5][6] - The study indicated that a portion of participants achieved cccDNA clearance after 24 weeks of treatment, meeting the criteria for sterilizing cure [1][6] Group 3 - HepaPlus works by blocking HBV infection through the NTCP receptor and preventing rcDNA from forming cccDNA, while PEG interferon enhances immune response to deplete cccDNA [5][6] - The trial showed good tolerability for HepaPlus, with most adverse effects attributed to interferon, and serious adverse events not exceeding grade 2 [6] - The company plans to initiate a global Phase III clinical trial with over 500 participants to further validate the sterilizing cure potential by the end of 2027 [7]
从EASL2025看中国创新药的全球影响力
Huan Qiu Wang· 2025-05-10 04:49
Core Insights - The Chinese innovative drug industry is undergoing a significant transformation, moving from a catch-up phase to a leading position in certain areas, particularly in liver disease research [1][2] - At the recent EASL Congress 2025, 13 research teams from China presented findings on various aspects of liver disease, showcasing the country's advancements in this field [1] - The clinical trial results for the hepatitis B drug Hepalapide have shown promising outcomes, achieving sterilizing cure standards, which has garnered significant attention from experts [2] Industry Overview - The global transaction value involving Chinese innovative drug companies reached $51.9 billion in 2024, with upfront payments totaling $4.1 billion, indicating increasing international interest [4] - The proportion of molecules introduced by global pharmaceutical companies from Chinese innovative drug firms rose from 0% in 2019 to 31% in 2024, highlighting the growing importance of Chinese innovation in the global pharmaceutical landscape [4] - Hepalapide is expected to enter Phase III clinical trials, potentially becoming the first drug capable of clearing cccDNA, offering new hope for chronic hepatitis B patients [4] Government Support - The rapid development of Chinese innovative drugs is supported by a series of government policies since 2015, facilitating a shift from generic to innovative drug development [5] - Reforms in drug review and approval processes have accelerated the market entry of innovative drugs, while the establishment of various stock exchanges has provided crucial financing channels for unprofitable innovative drug companies [5] - The successful development of drugs like Hepalapide aligns with the goals set out in the "Healthy China 2030" initiative, indicating a strong market outlook for these innovations [5]
贺普药业:公司在研新药的二期临床试验结果披露 达到行业乙肝治愈最高标准
Zheng Quan Ri Bao· 2025-05-10 02:39
Core Viewpoint - The phase II clinical trial results of Hepu Pharmaceutical's innovative drug Hepulapide combined with PEG interferon for chronic hepatitis B treatment have shown significant efficacy, meeting the sterilizing cure standards set by AASLD and EASL [1][5]. Company Summary - Hepu Pharmaceutical is preparing to initiate phase III clinical trials for Hepulapide in treating chronic hepatitis B, aiming for market registration to benefit patients globally [3]. - The company has developed Hepulapide, a class 1 innovative drug that blocks HBV from entering the cell nucleus, addressing a critical gap in current hepatitis B treatments [4]. Industry Summary - Chronic hepatitis B, caused by HBV, is a highly prevalent infectious disease, with approximately 296 million people infected globally as of 2022, including about 89 million in China [3]. - Current treatments for hepatitis B, such as nucleos(t)ide analogs and interferons, do not cure the disease due to the persistence of cccDNA in the cell nucleus, which can reactivate HBV replication [4].