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和誉-B:匹米替尼顺利获批,“十亿美元分子”价值加速兑现成配置关键
Zhi Tong Cai Jing· 2025-12-23 01:17
今年以来,在港股创新药牛市的推动下,恒生医疗保健指数(800804)从年初开盘的2331.02点一路拉升至9月的年内最高点4726.41点,区间累涨幅度达到 102.76%。随后在技术面驱动以及外部多重因素影响下,指数开启一轮向下震荡的行情,截至12月22日,已较前期高点下跌19.06%。 期间,不少前期股价涨幅出众,且拥有硬核创新实力、基本面稳健的公司标的同样受到一定波及,和誉-B(02256)便是其中之一。 智通财经APP观察到,在今年的港股创新药牛市中,和誉作为港股创新药板块内股价拉升的第一梯队,年内股价最大涨幅高达370.95%。虽然公司股价受板 块阶段性震荡下行影响出现一定回落,但随着核心品种匹米替尼(Pimicotinib)在国内顺利获批上市,和誉近期迎来重磅价值催化剂。 重磅"十亿美元分子"顺利商业化 12月22日,和誉发布一则重磅公告:基于全球III期MANEUVER研究的积极数据,中国国家药品监督管理局(NMPA)批准了贝捷迈(盐酸匹米替尼胶囊)的全球 首个新药上市申请。 智通财经APP了解到,贝捷迈是和誉自主研发的的1类新药,也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。作 ...
流感创新药亮“中国方案”!创新药替代进口加速?
Xin Lang Cai Jing· 2025-12-15 09:07
百亿市场待重构,替代空间广阔 今年,多款国产抗流感创新药密集获批上市,引发市场高度关注,2025年甚至被称为"国产流感创新药 元年"。有业内人士表示,国产流感创新药密集取得进展,是我国医药创新能力持续提升的必然结果。 这背后蕴藏着什么投资机遇?(资料参考:证券日报《国产创新药破局 为应对流感提供"中国方 案"》,2025.11.12) 国产流感创新药商业化提速 2025年3月至7月,我国有三款抗流感创新药(玛舒拉沙韦片、昂拉地韦片、玛硒洛沙韦片)获批上市, 另有两款药物(玛氘诺沙韦、玛帕西沙韦)完成临床试验,已经提出了上市申请,预计不久将加入市场 竞争。专业人士分析称,目前国产创新药上市以后,销量在稳步提升,反映出这些产品在疗效、安全性 方面获得了认可。(资料参考:央广网《全国整体进入流感流行季 多款国产流感创新药密集上市》, 2025.11.21;36氪《围剿"流感神药"奥司他韦,药厂卷起"一次治疗"新战场》,2025.11.14) 突破进口药局限,实现多重优化 国产新药与进口流感药玛巴洛沙韦作用机制相同,都是通过抑制流感病毒的CAP帽子结构依赖性内切 酶,从而阻断病毒复制。值得关注的是,这批国产新药并非简 ...
机构:看好创新药产业链
Xin Lang Cai Jing· 2025-12-14 12:50
天风证券认为,以BD为突破口(包括传统BD、NewCo、Co-Co),中国创新药将系统参与到全球创新 药市场中,而当前全球药品市场规模是中国药品市场规模的6倍左右,这将显著打开中国创新药的商业 化价值,整体生态体系也将愈发健康成熟,中国正加速迈入产品研发与商业销售的双轮驱动阶段。12月 7日,国家医保局、人力资源社会保障部发布《国家基本医疗保险、工伤保险和生育保险药品目录 (2025 年)》以及首版《商业健康保险创新药品目录(2025 年)》,要求进一步推动商业健康保险与 基本医保的有效衔接。东方证券指出,首版商保目录落地,开启中国创新药"新黄金十年"。总体来看, 首版商保目录具有3个看点:1)激烈角逐谨慎落地,121个通过形式审查的新药最终只有19个进入目 录,远低于惠民保特药平均41款的体量;2)5款国产CAR-T全部入场,2款AD新药同时入选,显示出商 保谈判对高临床疗效和高价值创新的认可信号;3)肿瘤仍是主战场,19款中有14款入选,占比达 74%。本次商保目录价格谈判只是一个开始,后续商保目录制定和价格谈判规则会在探索中趋于成熟, 商保作为医保补充背后是国家治理的决心,相关配套政策有望逐步落地。上述 ...
医药行业2025年三季报总结:业绩逐步筑底
Southwest Securities· 2025-11-27 09:04
Investment Rating - The report does not explicitly state an investment rating for the pharmaceutical industry Core Insights - The pharmaceutical industry is gradually stabilizing, with a total revenue of 16,766.9 billion yuan in the first three quarters of 2025, reflecting a slight decline of 0.7% year-on-year. The net profit attributable to shareholders decreased by 1.1% to 1,427.5 billion yuan, while the net profit excluding non-recurring items fell by 8.5% to 1,219.9 billion yuan [3][13][37] - Among the 388 selected pharmaceutical companies, 197 companies achieved revenue growth, accounting for 51%, while 189 companies reported positive net profit growth, representing 49% [3][13] - The third quarter of 2025 saw a positive revenue growth rate of 1.9% year-on-year, with net profit showing stable growth [14] Summary by Sections Overall Industry Performance - The pharmaceutical industry experienced a revenue decline of 0.7% in the first three quarters of 2025, with a total revenue of 16,766.9 billion yuan. The net profit attributable to shareholders decreased by 1.1% to 1,427.5 billion yuan [3][37] - The first three quarters showed a quarterly revenue of 5,586 billion yuan in Q1, 5,593 billion yuan in Q2, and 5,588 billion yuan in Q3, with Q3 marking a return to positive growth [14][16] Sector Performance - **Innovative Drugs and Formulations**: Revenue of 3,437.8 billion yuan (+0.6%) and net profit of 342.8 billion yuan (+5.0%) [4] - **Medical Devices**: Revenue of 1,457 billion yuan (-2.4%) and net profit of 265 billion yuan (-14.4%) [5] - **CXO**: Revenue of 695.7 billion yuan (+13.0%) and net profit of 165.4 billion yuan (+60.0%) [5][30] - **Active Pharmaceutical Ingredients**: Revenue of 782.1 billion yuan (-1.5%) and net profit of 114.2 billion yuan (+6.6%) [5] - **Life Sciences Upstream**: Revenue of 60.2 billion yuan (+0.1%) and net profit of 4.4 billion yuan (+15.6%) [5] - **Medical Services**: Revenue of 436 billion yuan (+0.4%) and net profit of 57.3 billion yuan (-13.8%) [5] - **Blood Products**: Revenue of approximately 176 billion yuan (+0.5%) and net profit of approximately 37.7 billion yuan (-20.0%) [5] - **Retail Pharmacies**: Revenue of 859 billion yuan (+0.7%) and net profit of 35.2 billion yuan (+8.9%) [6] - **Pharmaceutical Distribution**: Revenue of 6,087.3 billion yuan (+1.4%) and net profit of 116.8 billion yuan (+5.5%) [6] - **Traditional Chinese Medicine**: Revenue of 2,506 billion yuan (-3.6%) and net profit of 292.7 billion yuan (-0.5%) [6] - **Vaccine Sector**: Revenue of 174 billion yuan (-49.2%) and net profit of -9 billion yuan (-121.6%) [6] Profitability Analysis - The overall industry saw a decline in gross profit margin and net profit margin, with the gross profit margin at 33.7% and net profit margin at 8.5% [37][40] - The CXO sector exhibited the highest growth in net profit, increasing by 60% [31][35] - The medical device sector faced significant profit pressure, with a net profit decline of 14.4% [5][30]
创新药崛起!院内用药占比持续增长,中国医药行业结构性拐点已至
第一财经· 2025-11-26 13:49
Core Viewpoint - The Chinese innovative drug market is experiencing a "structural turning point," which is expected to reverse the downward trend in the pharmaceutical industry [3][11]. Industry Overview - The domestic pharmaceutical terminal sales have shown negative growth since 2024, with over 30% of regulated pharmaceutical companies reporting losses in the first half of this year [3][7]. - The low concentration in several sub-sectors, particularly in the generic drug industry, has led to "price internalization," which is a key constraint on the development of the Chinese pharmaceutical industry [3][7]. Innovative Drug Market Potential - Despite the challenges, there has been a significant emergence of innovative drug achievements in China this year, with innovative drugs rapidly increasing their market share and frequent external licensing deals [3][5]. - The market share of innovative drugs in China is currently only 8.6%, compared to over 70% in the US and European countries, indicating substantial growth potential [5][17]. Financial Performance - The overall revenue of pharmaceutical companies in China decreased by 5.5% year-on-year, but innovative transformation companies and some emerging innovative drug firms have maintained good growth and profitability [3][7]. - In the first half of 2025, 34.3% of the surveyed companies reported losses, highlighting the financial strain within the industry [7][10]. Market Dynamics - The average price level of generic drugs has been further reduced due to policies on price governance and drug price control, leading to intensified competition and downward pressure on prices [8][9]. - The Chinese pharmaceutical industry is still primarily driven by domestic circulation, with exports contributing only 10% to 15% of industrial revenue over the past four years [7][10]. Future Outlook - The commercialization of innovative drugs is expected to become the core driving force for industry growth during the downturn [11][12]. - The market for innovative drugs (including biosimilars) reached 120 billion yuan in 2023, with a growth rate of 27%, indicating a robust pipeline of new products [12][17]. Export Performance - From January to October 2025, China's pharmaceutical product exports reached 91.17 billion USD, a year-on-year increase of 3.5%, with a significant growth in formulation exports [15][16]. - The proportion of formulation exports in total pharmaceutical exports reached a historical high of 16.1%, indicating a shift in the export landscape [16]. Challenges and Opportunities - The domestic innovative drug market is still not large enough, and the pricing support system needs improvement to sustain growth [17][21]. - The industry faces challenges from funding shortages and low accessibility of innovative drugs, with about 88% of respondents in a survey indicating insufficient funding for innovative drug development [17][21]. Strategic Recommendations - To enhance the commercialization efficiency of innovative drugs, the industry should focus on reducing competition among numerous players and fostering a healthier market structure [23][24]. - Building an international innovation platform is crucial for Chinese pharmaceutical companies to capture a larger share of the global innovation dividend [24].
创新药崛起!院内用药占比持续增长,中国医药行业结构性拐点已至
Di Yi Cai Jing· 2025-11-26 12:35
Group 1: Market Overview - In the US and five European countries, innovative drugs account for 70%-80% of the local market, while in China, the market share of innovative drugs is only 8.6% [1][10] - The Chinese innovative drug market is experiencing a "structural turning point," which is expected to reverse the downward trend in the pharmaceutical industry [1] - The domestic pharmaceutical terminal sales are projected to show negative growth starting in 2024, with over 30% of regulated pharmaceutical companies reporting losses in the first half of this year [1][3] Group 2: Industry Challenges - The pharmaceutical industry is facing a survival crisis due to external growth factors diminishing, and the capital market's enthusiasm for business development (BD) transactions cooling down [3] - The low concentration in several sub-sectors, particularly in the generic drug industry, has led to price competition, which is a key constraint on the development of the Chinese pharmaceutical industry [3][4] - The average price level of generic drugs has been further reduced due to policies on price governance and drug price comparison [4] Group 3: Innovative Drug Growth - Despite the overall revenue decline in the pharmaceutical industry, innovative drug companies have maintained good growth and profitability, with some achieving record high revenues [1][7] - The market size of innovative drugs (including biosimilars) reached 120 billion yuan in 2023, with a growth rate of 27% [7] - The revenue growth rate for biological products was 2.2%, with profit growth at 10.6%, indicating a strong performance in the innovative drug sector [8][7] Group 4: Regulatory and Policy Developments - The National Healthcare Security Administration has announced reforms to improve the immediate settlement of medical insurance funds, which is expected to alleviate the financial pressure on hospitals and improve drug payment timelines [5][6] - The implementation of policies to expand the scope of drug procurement and price control is expected to further impact the market dynamics [4][10] Group 5: Future Opportunities - The commercial potential of innovative drugs is anticipated to become the core driver of industry growth during the downturn [7] - The increasing number of innovative drug approvals and the shift in hospital medication structure are expected to enhance the market share of innovative products [7] - The industry is encouraged to build international innovation platforms to capture a larger share of the global market [2][18]
多家创新药企业迎来内外资机构密集调研,港股创新药ETF(513120)盘中涨超2%,盘中成交额超47亿元居全市场医药类ETF之首!
Xin Lang Cai Jing· 2025-11-24 06:37
Group 1: Industry Insights - Multiple innovative pharmaceutical companies have received significant attention from both domestic and foreign institutional investors, with BeiGene receiving inquiries from 88 institutions and Zai Lab from 36 institutions [1] - The Chinese pharmaceutical industry is entering a critical phase characterized by "innovation realization + global layout," supported by population and domestic demand, as well as comprehensive manufacturing capabilities [1] - By 2026, opportunities in innovative commercialization, global breakthroughs, policy optimization, and industry mergers and acquisitions are expected to emerge [1] Group 2: Market Performance - As of November 24, 2025, the CSI Hong Kong Innovative Drug Index rose by 3.05%, with the Hong Kong Innovative Drug ETF (513120) increasing by 2.23% and achieving a trading volume exceeding 4.7 billion [2] - Over the past six months, the Hong Kong Innovative Drug ETF has accumulated a return of 33.71% [2] - The latest scale of the Hong Kong Innovative Drug ETF reached 24.102 billion, with continuous net inflows over the past six days totaling 170 million [2] Group 3: Company Developments - Traditional pharmaceutical companies like Heng Rui Medicine and Hansoh Pharmaceutical have successfully completed their innovation transformations, while companies like Bai Li Tianheng have emerged with globally innovative products [1] - Chinese pharmaceutical companies are becoming significant sources of innovation for multinational pharmaceutical firms, with improvements in their global competitiveness [1]
港股医药板块早盘走强,港股创新药ETF(159567)一度涨逾2%
Mei Ri Jing Ji Xin Wen· 2025-11-24 02:14
Group 1 - The Hong Kong pharmaceutical sector showed strength on November 24, with companies like 3SBio rising over 7% and Hengrui Medicine and Innovent Biologics increasing by more than 4% [1] - The Hong Kong Innovative Drug ETF (159567) rose approximately 2.2% by 9:51 AM, with a trading volume exceeding 300 million yuan [1] - As of last Friday, the product's shares increased by 1.105 billion shares this month, reaching a total of 9.922 billion shares, nearing the 10 billion mark [1] Group 2 - Institutions believe that the Chinese pharmaceutical industry has entered a critical phase of "innovation realization + global layout," supported by population and domestic demand, as well as comprehensive manufacturing capabilities [1] - Companies are actively exploring diversified overseas paths, with a focus on opportunities arising from innovation commercialization, global breakthroughs, policy optimization, and industry mergers and acquisitions by 2026 [1] - The Hong Kong Innovative Drug ETF (159567) tracks the CSI Hong Kong Stock Connect Innovative Drug Index, reflecting the performance characteristics of listed companies in the innovative drug sector within the Stock Connect framework [1]
内外资机构密集调研创新药企业
Core Viewpoint - The Chinese innovative drug sector is at a critical turning point, transitioning from a "research investment phase" to a "commercial harvest phase," indicating significant long-term growth potential [1][2][3] Group 1: Market Performance - The Dongcai Innovative Drug Index has increased by over 32% year-to-date as of November 20 [1] - The sector experienced a strong rally in the first half of the year, followed by a notable decline [1] Group 2: Institutional Interest - Numerous innovative drug companies, including BeiGene, have attracted intensive research from both domestic and foreign institutions, signaling heightened market interest [1] - BeiGene was researched by 88 public and foreign institutions, while Zai Lab received attention from 36 institutions [1] Group 3: Growth Potential - The sales revenue of domestic innovative drugs is growing rapidly but currently accounts for only about 10% of the overall domestic pharmaceutical market, suggesting over three times potential growth [2] - The next three years are expected to see a significant commercial breakthrough for Chinese innovative drugs in overseas markets, positively impacting the performance of these companies [2] Group 4: R&D and Policy Support - Chinese innovative drug companies have significantly improved their R&D capabilities and gained international recognition, now ranking among the top tier globally in terms of R&D pipeline [2] - Continuous policy support and improvements in commercial insurance payment methods are anticipated to provide additional support for the innovative drug sector [2] Group 5: Investment Opportunities - The Chinese innovative drug industry is perceived to be entering a "historic" investment opportunity phase, with a clear logic chain from scientific breakthroughs to commercialization [3] - As the industry transitions to the "commercial harvest phase," the commercial value of the innovative drug sector is expected to continue to be released, enhancing its growth logic and investment value [3]
创新药板块延续涨势,关注恒生创新药ETF(159316)、创新药ETF易方达(516080)等配置机遇
Mei Ri Jing Ji Xin Wen· 2025-11-13 02:50
Group 1 - The innovative drug sector continues to rise, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index up by 3.7% and the CSI Innovative Drug Industry Index up by 1.1% as of 10:18 AM [1] - The Hang Seng Innovative Drug ETF (159316) has attracted a total of 1.4 billion yuan in the past month, indicating strong investor interest in related products [1] - The introduction of a "commercial insurance innovative drug catalog" in the 2025 national medical insurance negotiations is expected to create new payment channels for high-priced innovative drugs, significantly improving cash flow for pharmaceutical companies [1] Group 2 - In the first ten months of 2025, the total value of outbound licensing transactions for Chinese innovative drugs exceeded 100 billion USD, highlighting the global competitiveness of Chinese pharmaceutical companies [1] - Major leading pharmaceutical companies are expected to report strong performance in their Q3 2025 results, indicating a shift from the "R&D investment phase" to the "commercialization harvest phase" [1] - The trend of innovative drugs going global is clear, with ongoing benefits from drug review reforms and supportive policies, marking the entry of the Chinese innovative drug industry into its 2.0 era [1] Group 3 - The Hang Seng Hong Kong Stock Connect Innovative Drug Index consists of leading companies in the Hong Kong innovative drug sector, being the first ETF-tracked index with a "purity" of 100% in innovative drugs [2] - The CSI Innovative Drug Industry Index focuses on leading companies in the A-share innovative drug sector, comprising no more than 50 companies primarily engaged in innovative drug R&D [2] - The Hang Seng Innovative Drug ETF (159316) and the E Fund Innovative Drug ETF (516080) track the aforementioned indices, providing investors with convenient access to opportunities in the innovative drug industry [2]