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一款创新药如何少走弯路?每经记者走访药监局、药检院 还和药企、三甲医院聊了这些……
Mei Ri Jing Ji Xin Wen· 2025-10-21 14:24
Core Viewpoint - The article discusses the recent advancements in the approval process for innovative drugs in Beijing, highlighting the efforts made to optimize clinical trial reviews and approvals, thereby accelerating the availability of new medications to patients. Group 1: Clinical Trial Approval Process - The approval time for clinical trials in Beijing has been reduced from 60 working days to 30 working days, with some projects receiving approval in as little as 18 working days [1][4][5] - In the first half of this year, the overall pre-approval rate for clinical trials was 34.8%, with a parallel review rate of 23.5% for ethical and project approvals [1] - The average review time for clinical trial applications during the pilot program was 24.6 working days, with the fastest approval taking only 18 working days [5] Group 2: Innovative Drug Fast-Track Approval - A "dual-channel" mechanism has been implemented for drug approvals, allowing certain innovative drugs to enter a 30-day fast-track approval process based on clinical need [6] - The focus is on drugs for rare diseases, pediatric use, and those requiring global synchronized development [6] - The approval speed for innovative drugs has improved significantly, with some applications being processed in as little as 21 days [5] Group 3: Import Drug Inspection and Approval - Since the beginning of 2024, Beijing has attracted 67 new imported drug varieties, with a total value of $7.9 billion, and has implemented measures to expedite the inspection process [11] - The inspection time for certain targeted drugs has been reduced to as little as 7 to 19 days, significantly speeding up the time from approval to patient access [12] - The introduction of segmented production for imported drugs allows for more flexible resource allocation and faster market entry [13]
公募把脉四季度:A股具备长期投资价值,投资主线聚焦AI、创新药等
Bei Jing Shang Bao· 2025-10-21 13:16
Core Viewpoint - The A-share market shows a positive long-term outlook, with significant interest in sectors such as technology, robotics, and innovative pharmaceuticals, despite some short-term caution from certain institutions [4][6]. Market Performance - As of October 21, the Shanghai Composite Index returned to 3900 points, with the three major A-share indices closing up by 1.36%, 2.06%, and 3.02% respectively. Year-to-date, these indices have increased by 16.84%, 25.57%, and 43.99% [3][4]. - New account openings in the A-share market reached 2.9372 million in September, a year-on-year increase of 60.73% and a month-on-month increase of 10.83%, marking the second-highest monthly figure of the year [3][4]. Institutional Strategies - Multiple public funds have released their strategies for the fourth quarter, indicating a generally optimistic view on the long-term performance of the Chinese stock market, while some express caution regarding short-term valuations [4][6]. - Specific sectors highlighted for investment include AI, human-shaped robots, innovative pharmaceuticals, solid-state batteries/storage, and cyclical manufacturing benefiting from economic recovery [6][8]. Sector Performance - The AI, innovative pharmaceuticals, and technology sectors have shown remarkable performance this year, with the STAR Market Index and STAR 50 Index rising by 44.65% and 42.21% respectively [5][6]. - Funds focusing on these sectors have also reported impressive returns, with some achieving annual yields exceeding 175% [5]. Bond Market Outlook - The bond market is currently experiencing fluctuations, with the ten-year government bond yield rising to 1.8552% as of October 21, up nearly 20 basis points since June 30 [7]. - Institutions suggest that the bond market will not enter a prolonged bearish phase, but caution that credit bonds may lack a clear trend due to market adjustments [7][8].
BD密集落地,持续关注创新药械产业链
Investment Rating - The report maintains a positive outlook on the innovative drug and medical device industry, highlighting key targets for investment [5][24]. Core Insights - The innovative drug sector is experiencing high growth, with a focus on companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. The report emphasizes the potential for value re-evaluation in these firms [5][24]. - Recent business development (BD) deals in the innovative drug sector are expected to catalyze market activity, with notable transactions including Jiangsu Heng Rui Medicine's agreement with Kite for a $1.20 billion upfront payment, potentially reaching $15.20 billion in total [5][24]. - The A-share pharmaceutical sector underperformed the broader market in the third week of October 2025, with the Shanghai Composite Index falling by 1.5% and the SW Biopharma index declining by 2.5% [7][18]. Summary by Sections 1. Continuous Focus on Innovative Drugs and Medical Devices - The report emphasizes the high growth potential in innovative drugs, with key investment targets including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. Related targets include CSPC Innovation Pharmaceutical [5][24]. 2. A-Share Pharmaceutical Sector Performance - In the third week of October 2025, the A-share pharmaceutical sector saw a decline of 2.5%, underperforming the Shanghai Composite Index, which fell by 1.5%. The report notes that the sector's premium relative to all A-shares is currently at a normal level, with a relative premium rate of 74.5% [7][14][21]. 3. Hong Kong and U.S. Pharmaceutical Sector Performance - The report indicates that the Hong Kong and U.S. pharmaceutical sectors also underperformed, with the Hang Seng Healthcare index dropping by 5.8% and the S&P 500 Healthcare index increasing by only 0.7% during the same period [18][24].
港股通创新药回暖
Xin Lang Cai Jing· 2025-10-21 11:45
来源:新浪基金 10月21日,港股通创新药板块震荡回暖,100%创新药研发标的——港股通创新药ETF(520880)午后 稳定涨势,场内收涨1.21%终结两连跌。成份股荣昌生物、云顶新耀涨超4%,权重股石药集团、翰森制 药跌1%有所拖累。 【创新药"新势力"——港股通创新药ETF(520880):纯正创新药,聚焦真龙头,港股高弹性】 港股通创新药ETF(520880)被动跟踪恒生港股通创新药精选指数,该指数完全不含CXO,100%布局 创新药研发类公司,超7成仓位押注大市值创新药龙头,是精准表征创新药硬核力量的纯正创新药指 数。场外投资者可关注其联接基金:025221。 | | | 港股通创新药ETF (520880)标的指数 前十成份股权重高达71.63%,龙头优势显著 | | | --- | --- | --- | --- | | 代码 | 简称 | 权重(%) | 总市值(亿港元) | | 6160.HK | 三济神州 | 10.47 | 3.304 | | 1177.HK | 中国生物制药 | 10.01 | 1,527 | | 1093.HK | 石药集团 | 9.58 | 1,080 | | 18 ...
港股通创新药回暖,520880涨1.21%溢价飙升!基金经理:创新药行情或将重回“质量”驱动,龙头有望胜出
Xin Lang Ji Jin· 2025-10-21 11:40
10月21日,港股通创新药板块震荡回暖,100%创新药研发标的——港股通创新药ETF(520880)午后 稳定涨势,场内收涨1.21%终结两连跌。成份股荣昌生物、云顶新耀涨超4%,权重股石药集团、翰森制 药跌1%有所拖累。 值得关注的是,520880早尾盘震荡区间均涌现溢价,收盘溢价率更是超过1%,显示买盘尤为强劲。资 金面上,昨日3945万元逢跌净申购,近10日维度,累计超1.58亿元进场。 9月中旬以来,港股通创新药震荡走低,而创新药产业的态度和动作,成为波动行情中的"定心丸"。一 方面,美国第一药企辉瑞公司首席执行官直言,中国的生物医药生态系统"令人瞩目",美国应少关注如 何拖慢中国,而更多思考如何适应新的竞争。另一方面,上周行业出现久违的BD"小高潮",一天内三 个中国药企BD落地。 当下创新药怎么投?港股通创新药ETF(520880)基金经理丰晨成认为,创新药行情已经从"鸡犬升 天"的普涨行情,逐步过渡到关注"质量因子"的第二阶段。只有真正能落地、临床数据优异并具有商业 化能力的创新药龙头,才能取得财务的成功,并实现对于海外业务的"戴维斯双击"。 【创新药"新势力"——港股通创新药ETF(52088 ...
华人健康涨1.24%,成交额5412.97万元,近5日主力净流入-258.19万
Xin Lang Cai Jing· 2025-10-21 11:13
Core Viewpoint - The company, Anhui Huaren Health Pharmaceutical Co., Ltd., is actively expanding its presence in the health sector for the elderly, focusing on chronic disease management and product development tailored to the needs of older adults [2][3]. Group 1: Company Overview - Anhui Huaren Health Pharmaceutical Co., Ltd. was established on June 29, 2001, and is located in Hefei, Anhui Province. The company was listed on March 1, 2023, and primarily engages in pharmaceutical agency, retail, and terminal procurement [7]. - The main business revenue composition includes 97.60% from traditional Chinese and Western medicine, with the remaining 2.40% from other sources [7]. - The company is categorized under the pharmaceutical and biological industry, specifically in the pharmaceutical commercial sector, with concepts including e-pharmacy, innovative drugs, retail pharmacies, and Alibaba-related ventures [7]. Group 2: Financial Performance - For the first half of 2025, the company achieved a revenue of 2.504 billion yuan, representing a year-on-year growth of 15.52%. The net profit attributable to shareholders was 104 million yuan, showing a year-on-year increase of 42.17% [8]. - As of June 30, 2023, the number of shareholders increased by 45.15% to 26,100, while the average circulating shares per person decreased by 31.10% to 5,725 shares [8]. - The company has distributed a total of 80.02 million yuan in dividends since its A-share listing [8]. Group 3: Market Activity - On October 21, the company's stock rose by 1.24%, with a trading volume of 54.1297 million yuan and a turnover rate of 2.79%, leading to a total market capitalization of 5.236 billion yuan [1]. - The stock has seen a net outflow of 2.2021 million yuan from major investors today, with a ranking of 17 out of 32 in its industry [4][5]. - The average trading cost of the stock is 13.72 yuan, with the current price approaching a resistance level of 13.44 yuan, indicating potential for upward movement if this level is surpassed [6].
海普瑞涨2.14%,成交额3977.35万元,后市是否有机会?
Xin Lang Cai Jing· 2025-10-21 10:08
Core Viewpoint - Haiprime's stock increased by 2.14% with a trading volume of 39.77 million yuan and a total market capitalization of 17.52 billion yuan, indicating positive market sentiment towards the company [1] Group 1: Company Overview - Haiprime, established in 1998 in Shenzhen, is a leading multinational pharmaceutical company with A+H dual financing platforms, focusing on the heparin industry chain, biopharmaceutical CDMO, and innovative drug investment, development, and commercialization [2] - The company's main business segments include 63.06% from formulations, 18.59% from CDMO, 16.05% from heparin sodium and low molecular weight heparin raw materials, and 2.30% from other sources [7] - As of June 30, 2025, Haiprime reported a revenue of 2.817 billion yuan, a year-on-year decrease of 0.71%, and a net profit attributable to shareholders of 422 million yuan, down 36.44% year-on-year [7] Group 2: Financial Performance - The company benefits from a high overseas revenue ratio of 93.04%, positively impacted by the depreciation of the yuan [3] - Haiprime has distributed a total of 4.21 billion yuan in dividends since its A-share listing, with 514 million yuan distributed over the past three years [8] Group 3: Market Position and Trends - The stock's average trading cost is 11.56 yuan, with recent trading activity showing a decrease in holdings but at a slowing rate; the current stock price is between resistance at 12.33 yuan and support at 11.16 yuan, suggesting potential for range trading [6] - The main capital inflow today was 3.48 million yuan, accounting for 0.09% of the total, with the stock showing no clear trend in major capital movements [4][5]
资金周报|资金布局低位稀缺品种,中药ETF(159647)获连续22天净流入(10/13-10/17)
Sou Hu Cai Jing· 2025-10-21 07:16
Market Overview - The total scale of equity ETFs in the market reached 46,918.32 billion yuan, with a decrease of 761.24 billion yuan in total scale over the past week and a net inflow of 700.48 billion yuan [1] - Industry and thematic ETFs saw a net inflow of 465.43 billion yuan, primarily driven by inflows into the non-bank financial sector, while broad-based and strategic ETFs experienced a net outflow of 142.98 billion yuan [1] Fund Positioning - In the broad-based and strategic ETF segment, the top three inflow sectors were strategy-dividend, Sci-Tech 200, and Sci-Tech 50, while the top three outflow sectors were CSI A500, ChiNext, and CSI 500 [2] - For industry and thematic ETFs, the top five inflow sectors were non-bank financial, banking, semiconductor chips, rare earths, and non-ferrous metals, while the top five outflow sectors were telecommunications, chemicals, pan-pharmaceuticals, consumer electronics, and financial technology [2] Key Focus Areas 1. The leading securities ETF (159993) received a net inflow of 95 million yuan, indicating investor interest despite market conditions. The Shanghai Stock Exchange aims to enhance the quality of listed companies and attract long-term capital [4] 2. The Chinese herbal medicine ETF (159647) has seen continuous net inflows for 22 days, reflecting investor confidence in the sector, particularly following the announcement of a new drug entering clinical trials [5] 3. Institutional funds are at historically low equity positions, suggesting significant potential for future market entry, supported by ongoing capital market reforms and positive signals from US-China negotiations [4]
20cm速递|科创创新药ETF国泰(589720)盘中涨超2.1%,创新主线或迎来催化 要闻
Mei Ri Jing Ji Xin Wen· 2025-10-21 07:06
华福证券指出,创新药板块自8月调整至今已较为充分,10月下旬或是布局重要时点,看好强兑现 能力的优质创新药龙头。中长期建议关注创新药、医疗器械及业绩向好标的,创新药主要聚焦有商业化 能力且管线丰富的BioPharma、潜在BD标的及前沿技术方向。 (资料图片仅供参考) 10月21日,科创创新药ETF国泰(589720)盘中涨超2.1%。 科创创新药ETF国泰(589720)聚焦科创板创新药企业,跟踪汇聚30家代表性优质公司的上证科创 板创新药指数,以高成长biotech为主,产品20%涨跌幅限制使其更贴合板块波动。从业绩表现来 看,"924行情"以来,科创新药指数跑赢恒生港股通创新药指数!2024年9月24日至2025年9月30日市场 反弹期间,科创新药/恒生港股通创新药指数涨幅分别为117.04%/109.62%,科创新药指数或有助于在市 场风险偏好回升时更好地分享科创板的弹性。 标签: 创新药 港股通 ETF 中国 市场 科创创新 ...
20cm速递|科创创新药ETF国泰(589720)盘中涨超2.1%,创新主线或迎来催化
Mei Ri Jing Ji Xin Wen· 2025-10-21 07:00
Core Insights - The article highlights a significant increase in the performance of the Guotai Innovation Drug ETF (589720), which rose over 2.1% on October 21, indicating a positive market sentiment towards innovative drug stocks [1] - Huafu Securities suggests that the innovative drug sector has undergone sufficient adjustment since August, and October is seen as a crucial time for investment, particularly in high-quality innovative drug leaders with strong execution capabilities [1] - The article emphasizes the importance of focusing on innovative drugs, medical devices, and companies with improving performance, particularly those with commercial capabilities and rich pipelines in the BioPharma sector [1] Performance Metrics - The Guotai Innovation Drug ETF tracks 30 representative companies in the Shanghai Stock Exchange Science and Technology Innovation Board, primarily focusing on high-growth biotech firms [1] - Since the "924 market" period, the Science and Technology Innovation Drug Index has outperformed the Hang Seng Hong Kong Stock Connect Innovation Drug Index, with respective gains of 117.04% and 109.62% from September 24, 2024, to September 30, 2025 [1] - The article suggests that the Science and Technology Innovation Drug Index may provide better exposure to the resilience of the Science and Technology Innovation Board during periods of market risk appetite recovery [1]