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PK流感“神药”的国产创新药来了
经济观察报· 2025-06-02 03:52
Core Viewpoint - The article discusses the successful development and market entry of the innovative flu drug, Olanidavir, by Zhongsheng Pharmaceutical, which has managed to outperform the established flu medication, Oseltamivir, in clinical trials [3][4][7]. Industry Progress - Since the initiation of drug regulation reforms in 2015, China's biopharmaceutical industry has made significant advancements in drug development, achieving breakthroughs in several areas previously dominated by multinational companies [3]. - The emergence of valuable drug molecules from both new and established pharmaceutical companies is expected to create substantial economic and social value for China [3]. Company Development - Zhongsheng Pharmaceutical's Olanidavir is the first flu RNA polymerase PB2 protein inhibitor approved in China, marking a significant milestone in the company's innovation journey [4][17]. - The drug was developed over a decade, with a focus on addressing the limitations of existing treatments, particularly the resistance and side effects associated with Oseltamivir [6][19]. Clinical Trial Success - In head-to-head clinical trials, Olanidavir demonstrated a median symptom relief time and fever relief time shorter than that of Oseltamivir, with nearly a 10% reduction in illness duration [7]. - Olanidavir showed superior efficacy against flu viruses, including those resistant to Oseltamivir and the newer drug, Marbofloxacin [7][8]. Market Potential - The Chinese flu medication market is projected to reach approximately 20 billion yuan, with Olanidavir expected to capture a significant share [19]. - The overall market for flu medications in China is nearing 20 billion yuan in 2023 and is anticipated to grow to 26.91 billion yuan by 2028 [18][19]. Future Plans - Zhongsheng Pharmaceutical aims to explore licensing opportunities for Olanidavir in international markets, particularly in the U.S. and Belt and Road countries, despite facing challenges in conducting large-scale clinical trials abroad [18]. - The company is also preparing for negotiations regarding national health insurance coverage for Olanidavir [18].
PK流感“神药”的国产创新药来了
Jing Ji Guan Cha Wang· 2025-05-30 14:30
Core Insights - The article discusses the approval of a new influenza drug, Anglatavir, by China's drug regulatory authority, which is the first innovative drug to outperform the widely used Oseltamivir in head-to-head trials [1][3] - The drug targets the PB2 protein of the influenza virus and has been in development for 10 years, with expectations of capturing a market share of 2 billion yuan [1][10] Company Overview - Zhongsheng Pharmaceutical's subsidiary, Zhongsheng Ruichuang, is responsible for the development of Anglatavir, which has been a significant shift from traditional pharmaceutical practices to innovative drug development [2][8] - The company faced challenges during the development process, particularly after Johnson & Johnson's failure in clinical trials for a similar drug, VX-787, which raised doubts among investors [6][9] Market Context - The influenza drug market in China has evolved significantly, with Oseltamivir and the newer drug, Marbofloxacin, dominating the market [2][3] - The market for antiviral drugs in China is approaching 20 billion yuan, with projections indicating growth to 26.91 billion yuan by 2028 [9][10] Clinical Trial Results - Phase III clinical trial results showed that Anglatavir significantly reduced the time to symptom relief and viral load compared to Oseltamivir, indicating its potential effectiveness [3][4] - Anglatavir demonstrated superior efficacy against strains resistant to both Oseltamivir and Marbofloxacin, suggesting a strong competitive advantage [3][4] Future Prospects - The company plans to explore licensing opportunities for Anglatavir in international markets, particularly in the U.S. and Belt and Road countries, despite facing challenges in conducting large-scale clinical trials abroad [9][10] - The drug is currently approved for adults with uncomplicated influenza, and a pediatric formulation is in the pipeline, which could further expand its market reach [10]
【A股收评】三大指数集体反弹,软件板块狂涨!
Sou Hu Cai Jing· 2025-05-29 08:10
Group 1: Market Performance - Major indices experienced a strong rebound, with the Shanghai Composite Index rising by 0.7%, Shenzhen Component Index by 1.24%, and ChiNext Index by 1.37% [2] - Over 4,200 stocks in the two markets saw gains, with a total trading volume of approximately 1.19 trillion yuan [2] Group 2: Digital Currency and Software Sector - The digital currency and software sectors led the market rally, with notable stocks like Lakala (300773.SZ) and Sifang Jingchuang (300468.SZ) hitting the daily limit with a 20% surge [2] - New Guodu (300130.SZ) rose over 14%, while Feitian Chengxin (300386.SZ) and Shenzhou Information (000555.SZ) also saw significant increases of 12.84% and 10%, respectively [2] Group 3: Autonomous Driving and Intelligent Connected Vehicles - Stocks related to autonomous driving and intelligent connected vehicles surged, with companies like Fulongma (603686.SH) and Jintour Environment (001230.SZ) hitting the daily limit [3] - A strategic cooperation agreement was signed between Xiaoma Zhixing and Guangzhou Public Transport Group, focusing on autonomous vehicle services [3] Group 4: Innovative Pharmaceuticals - The innovative pharmaceutical sector remains active, with companies like Sanofi Guojian (688336.SH) rising over 12% [4][3] - The sector is supported by policy backing, global competitiveness, and improving fundamentals, with a focus on "innovation + internationalization" [4] Group 5: Automotive Sector - The automotive sector showed strong performance, with Jinlong Automobile (600686.SH) and Dongfeng Co. (600006.SH) both increasing by 10% [5] - The launch of new models by XPeng and supportive government policies in Fujian province are contributing factors to the sector's growth [5] Group 6: Weak Sectors - The precious metals and food processing sectors experienced declines, with companies like Western Gold (601069.SH) and Laiyifen (603777.SH) seeing significant drops [5]
基金5月26日参与20家公司的调研活动
Group 1 - A total of 26 companies were investigated by institutions on May 26, with 20 companies specifically targeted by funds [1] - The most popular company among funds was Cankin Technology, which had 13 participating funds, followed by Greebo and Hars, each with 12 funds [1] - The companies investigated belong to various sectors, including electronics, machinery, basic chemicals, and pharmaceutical biology, with three stocks from each of these sectors being highlighted [1] Group 2 - Among the companies investigated, four had a total market capitalization exceeding 50 billion yuan, with BOE Technology Group being one of them, while ten companies had a market cap below 10 billion yuan [1] - In terms of market performance, eight stocks among the investigated companies saw an increase in the last five days, with Kailer Co., Zhongsheng Pharmaceutical, and Zhongchumei leading with increases of 21.62%, 7.52%, and 5.76% respectively [1] - Conversely, twelve stocks experienced declines, with Jiangnan Yifan, Tangyuan Electric, and Greebo showing the largest drops of 5.68%, 4.34%, and 3.89% respectively [1] Group 3 - The funds that participated in the investigations included significant net inflows, with Zhongsheng Pharmaceutical receiving a net inflow of 122 million yuan, the highest among the stocks [2] - Other companies with notable net inflows included Haida Group and Kailer Co., with net inflows of 36.68 million yuan and 11.77 million yuan respectively [2] - The table of companies investigated includes various details such as stock codes, latest closing prices, five-day price changes, and industry classifications [2][3]
众生药业(002317) - 2025年5月26日投资者关系活动记录表
2025-05-26 11:24
Group 1: Product Development and Clinical Trials - The innovative drug Anglavei (brand name: Anruiwei®) has been approved for market release, showing significant efficacy in clinical trials compared to placebo, with a median symptom relief time of 38.83 hours versus 63.35 hours for the placebo group (P<0.001) [5] - Anglavei has demonstrated superior antiviral activity against various strains of influenza, outperforming existing treatments like Oseltamivir and Baloxavir, particularly against resistant strains [4] - The Phase II clinical trial for Anglavei granules in children aged 2-17 showed a median symptom relief time of 31.72 hours, with high-dose and low-dose groups showing times of 28.63 hours and 33.65 hours, respectively [4] Group 2: Safety and Efficacy - No serious adverse events were reported during the clinical trials of Anglavei granules, indicating good safety and tolerability in children and adolescents [7] - The Phase II trial results for Anglavei granules indicated that most adverse reactions were mild and resolved without treatment, confirming the drug's favorable safety profile [7] Group 3: Financial and Asset Management - In 2024, the company recorded an asset impairment loss of CNY 546.68 million, impacting the net profit attributable to shareholders by CNY 484.10 million [10] - The company has taken a cautious approach to asset management, including impairment provisions for inventory and goodwill, totaling CNY 201.68 million for goodwill impairment [10] Group 4: Strategic Initiatives and Market Positioning - The company plans to enhance its marketing strategy for Anglavei by building an academic ecosystem and integrating digital services to improve healthcare solutions [7] - The company has increased its stake in its subsidiary, Zhongsheng Ruichuang, from 61.11% to 74.26% by redeeming shares for CNY 546 million, strengthening control over its innovative drug development [29] Group 5: Research and Development Pipeline - The company has established a robust R&D ecosystem focusing on metabolic and respiratory diseases, with multiple innovative drug projects in various stages of clinical trials [13] - The innovative drug ZSP1601 for treating non-alcoholic steatohepatitis (NASH) has shown promising results in Phase II trials, significantly reducing liver inflammation markers [17] Group 6: New Drug Approvals and Market Impact - The oral antiviral drug Liratewei (brand name: Leruoling®) received conditional approval in March 2023 and is included in the national medical insurance directory, expanding access for patients [14] - RAY1225, a GLP-1 receptor agonist, has shown significant weight loss and glycemic control in Phase II trials, with a notable reduction in HbA1c levels [20]
众生药业创新药获批 专家称市场进入收获期
Jing Ji Guan Cha Wang· 2025-05-26 06:10
众生药业表示,本次RAY1225注射液两项降糖III期临床试验组长单位伦理批件的获得,标志着以下两 项III期临床试验将全面启动:(1)RAY1225注射液单药治疗T2DM患者的安全性和有效性的III期临床试验 (SHINING-2);(2)RAY1225注射液与口服降糖药物联合治疗T2DM患者的获益和风险的III期临床试验 (SHINING-3)。 经观新科技 众生药业(002317)26日发布公告,控股子公司广东众生睿创生物科技有限公司(以下简称"众生睿创") 自主研发的一类创新多肽药物RAY1225注射液用于2型糖尿病(T2DM)患者的两项III期临床试验 (SHINING-2和SHINING-3)获批开展。 据了解,RAY1225注射液是众生睿创研发的,具有全球自主知识产权的创新结构多肽药物,具有GLP-1 受体和GIP受体双重激动活性,得益于优异的药代动力学特性,具备每两周注射一次的长效药物潜力。 目前,RAY1225注射液治疗肥胖/超重患者的III期临床试验(REBUILDING2),已获得北京大学人民医院 和中山大学孙逸仙纪念医院伦理审查批件,批准项目开展。此前,公司公告称,RAY1225注射液 ...
5月26日早间重要公告一览
Xi Niu Cai Jing· 2025-05-26 05:40
Group 1 - Northern Long Dragon is planning to acquire the controlling stake of Henan Zhongsheng and raise matching funds, leading to a stock suspension [1] - The company specializes in the research, design, production, and sales of non-metal composite materials for military vehicle equipment [1] - Koyuan Pharmaceutical's major shareholder plans to reduce their stake by up to 3%, amounting to 324.87 million shares [2] Group 2 - Jiaste Technology's shareholder intends to reduce their stake by up to 3%, totaling 1,428.75 million shares [2] - Chengdi Xiangjiang's subsidiary has won a bid for a data center project with China Mobile, valued at 492 million yuan [3] - Zhongchao Holdings' actual controller sold 223 million shares during a period of stock price fluctuation, representing 0.16% of total shares [4] Group 3 - ST Yushun's stock will resume trading after confirming no significant changes in its operational environment [6] - Xing Shuai Er's shareholder plans to reduce their stake by up to 0.37%, equating to 130 million shares [7] - Weiguang Co. intends to reduce its stake by up to 1.32%, totaling 300 million shares [8] Group 4 - Zhongsheng Pharmaceutical's subsidiary has received ethical approval for two Phase III clinical trials for its innovative peptide drug RAY1225 [9][10] - Nongxin Technology's major shareholder plans to reduce their stake by up to 1.35%, amounting to 135 million shares [12] - Mintai Aluminum has signed a strategic cooperation agreement with Penghui Energy for collaboration in battery technology [14] Group 5 - Youyan Powder's controlling shareholder plans to reduce their stake by up to 1%, totaling 103 million shares [16] - Runjian Co. has been shortlisted for a procurement project with China Mobile, valued at 374 million yuan [17] - Bangyan Technology has terminated its plan to issue shares and raise funds for asset acquisition [18] Group 6 - Xianggang Technology's controlling shareholder intends to reduce their stake by up to 3%, equating to 648.42 million shares [19] - Zhongke Shuguang is undergoing a stock suspension due to a planned share swap merger with Haiguang Information [20]
新进展不断 多家A股公司创新药业务迈向“收获季”
Zheng Quan Ri Bao· 2025-05-25 15:49
Group 1 - The core viewpoint of the articles highlights the rapid development of China's innovative drug industry, supported by government policies, leading to a significant increase in the number of approved innovative drugs [1][2] - Guangdong Zhongsheng Pharmaceutical Co., Ltd. announced the approval of its innovative drug, Anladiwei Tablets, marking a major breakthrough in respiratory system treatment and enhancing the company's market competitiveness [2][3] - The approval of Anladiwei Tablets is expected to contribute positively to the company's future performance, as it expands the product line and strengthens its leading position in the respiratory drug market [2][3] Group 2 - Health元药业集团 announced the approval of its long-acting injectable Aripiprazole Microspheres, which is the first of its kind globally, targeting adult schizophrenia [3] - Sichuan Kelun Pharmaceutical Co., Ltd. made progress in international collaboration by entering into an exclusive licensing agreement for the development of SKB378/HBM9378/WIN378, indicating a strategic move in the innovative drug sector [3] - The overall demand for innovative drugs is expected to grow due to aging populations, changing disease patterns, and increased health awareness, suggesting a significant market opportunity for domestic companies [3]
实控人减持股票用于江苏精铸设备采购等!15天9板机器人概念股发布股价异动公告|盘后公告集锦
Sou Hu Cai Jing· 2025-05-25 13:15
Company Focus - Zhongchao Holdings' actual controller Yang Fei sold 2.23 million shares, accounting for 0.16% of the total share capital, during the stock's abnormal fluctuation period, with proceeds primarily used for purchasing precision casting equipment in Jiangsu [2] - Chengdi Xiangjiang is part of a consortium that is pre-qualified for the construction project of the power system for China Mobile's data center in Zhejiang [3] - Wangzi New Materials' involvement in controllable nuclear fusion is minimal, and the sustainability of this business is uncertain, as it only provides capacitor products for a component of the nuclear fusion magnetic power supply project [3] - Beifang Changlong is planning to acquire controlling stakes in Henan Zhongsheng and is undergoing related financing, resulting in a stock suspension [4] - ST Yushun's stock will resume trading on May 26, 2025, after confirming no significant changes in its recent operational situation and external environment [5] Investment & Contracts - Mingtai Aluminum signed a strategic cooperation framework agreement with Penghui Energy [6] - Runjian Co. is a candidate for a project with a total value of 374 million yuan for China Mobile's household access construction services from 2025 to 2026 [6] Shareholding Changes - Bangyan Technology has terminated its plan to issue shares and pay cash for asset purchases and related fundraising [6] - Jiashe Technology's shareholder Qianxin Heng plans to reduce its stake by no more than 3% [6] - Xianggang Technology's actual controller intends to reduce its stake by no more than 3% [6] Other Developments - Zhongsheng Pharmaceutical's subsidiary has received ethical approval for two Phase III clinical trials of its innovative drug RAY1225 injection for type 2 diabetes patients [7]
众生药业(002317) - 关于控股子公司获得一类创新药RAY1225注射液两项降糖III期临床试验伦理批件的公告
2025-05-25 07:45
本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,广东众生药业股份有限公司(以下简称"公司")控股子公司广东众 生睿创生物科技有限公司(以下简称"众生睿创")自主研发的一类创新多肽药 物 RAY1225 注射液用于 2 型糖尿病(T2DM)患者的两项 III 期临床试验 (SHINING-2 和 SHINING-3)获得组长单位北京大学人民医院伦理审查批件, 批准项目开展。具体情况如下: 一、RAY1225 注射液临床试验进展情况 证券代码:002317 公告编号:2025-055 广东众生药业股份有限公司 关于控股子公司获得一类创新药 RAY1225 注射液 两项降糖 III 期临床试验伦理批件的公告 RAY1225 注射液是众生睿创研发的、具有全球自主知识产权的创新结构多 肽药物,具有 GLP-1 受体和 GIP 受体双重激动活性,得益于优异的药代动力学 特性,具备每两周注射一次的长效药物潜力。 目前,RAY1225 注射液治疗肥胖/超重患者的 III 期临床试验(REBUILDING- 2)已获得组长单位北京大学人民医院和共同组长单位中山大学孙逸仙纪 ...