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创新药驶向“新航海时代”
Xin Lang Cai Jing· 2026-01-02 20:29
文 陈婷 赵毅 转自:中国经营网 一款国内售价2388元/支的中国创新药,以约14倍的价格4600美元/支在美国上市销售,这是亿帆医药 (002019.SZ)旗下创新药产品亿立舒的出海溢价叙事。 近日,亿帆医药执行总裁王峰在接受《中国经营报》记者采访时表示,从产业角度看,亿立舒在美国实 现的定价,说明中国创新药已经开始被纳入全球主流市场的价值定价体系,而不再只是成本或替代品定 价。"溢价的本质是'可复制性''确定性'。一次高价不是溢价,能够持续供货、持续被用、持续扩大适应 证,才是真正的溢价能力。" 那么,中国创新药凭什么获得远超国内价格的"全球溢价"? 在王峰看来,过去中国创新药更多是"性价比",但亿立舒这类产品,已经进入了欧美市场的主流价值定 价体系,这基于三个根本性突破。一是药物并非"便宜做出来",而是"在同一规则下被认可"。在美国市 场,定价不是看产品来自哪里,而是看有没有成熟的临床证据、能不能进入主流使用场景、有没有商业 化的可持续性。"亿立舒能做到这一点,说明它已经不再是'补充性产品'。"二是中国创新药正在提供"更 适合真实临床使用"的解决方案。不只是疗效指标,而是给药方式、稳定性、供应可靠性、整 ...
2025中国创新药出海一年狂揽1356亿美元,2026年能否持续?
Jing Ji Guan Cha Wang· 2026-01-01 02:55
Core Insights - The surge in BD (business development) transactions in China's innovative pharmaceutical sector is a reflection of the industry's maturation and increasing global recognition, with 2025 marking a significant year for License-out agreements [3][4][5] Group 1: BD Transactions Overview - In December 2025, several Chinese pharmaceutical companies, including Ganli Pharmaceutical and Heng Rui Medicine, announced significant BD agreements, indicating a trend towards increased collaboration and innovation in the sector [2] - The total value of BD transactions for Chinese innovative drugs reached $135.655 billion in 2025, with upfront payments totaling $7 billion, marking a historical high in both transaction volume and value [3] - The number of BD transactions involving Chinese companies and top multinational corporations (MNCs) increased from 3 in 2015 to 35 in 2025, highlighting the growing interest from global players [3] Group 2: Market Dynamics and Future Outlook - The BD transaction boom is expected to continue into 2026, with industry experts predicting sustained high activity levels, although the focus may shift from quantity to value [5][14] - The NewCo model, which allows for "technology equity + capital cooperation," is emerging as a new pathway for Chinese pharmaceutical companies to engage in international markets, although its prevalence may decrease in 2026 [14][15] - The overall trend indicates a shift from isolated transactions to a more collaborative ecosystem, where companies leverage partnerships to enhance their global market presence [16][20] Group 3: Transaction Structures and Strategies - The structure of BD transactions is evolving, with companies increasingly engaging in co-development and co-commercialization agreements, allowing for shared risks and benefits [10][11] - The pricing of BD transactions is becoming more rational, with companies focusing on the clinical value and market potential of their products, which influences upfront payment amounts [19][18] - Legal and advisory services are becoming integral to BD transactions, reflecting the increasing complexity and importance of these deals in the pharmaceutical landscape [17]
从“借船出海”到“造船远航”:2025药企出海十大关键词
Xi Niu Cai Jing· 2025-12-29 09:34
Core Insights - The article discusses the transformation of Chinese pharmaceutical companies from merely selling products to actively participating in global value chains, with a significant increase in outbound licensing deals reaching over $100 billion by November 2025, a 75% increase year-on-year [3][4]. Group 1: Major Transactions - In 2024, major deals like Hengrui's $5 billion GLP-1 product and a $12.5 billion upfront payment from Pfizer to 3SBio for a dual antibody drug highlight the trend of billion-dollar collaborations becoming standard [4][6]. - Hengrui's partnership with GSK for $12.5 billion includes not only current products but also options for 11 early-stage projects, indicating a shift towards long-term strategic partnerships [4][10]. Group 2: Licensing Strategies - Chinese companies are moving from "one-off sales" to retaining rights in core markets while sharing rights in other regions, allowing them to benefit from both local and global markets [5][6]. - The new strategy involves keeping rights for the Greater China region while sharing development costs and rights for other markets, enhancing long-term revenue potential [6][10]. Group 3: Innovative Drug Categories - Antibody-drug conjugates (ADCs) and dual antibodies are emerging as key areas for Chinese companies, with significant deals reflecting their growing importance in the global market [6][7]. - The shift from traditional cancer drugs to innovative metabolic drugs like GLP-1 is notable, with companies like FOSUN and Hansoh making substantial deals in this area [14][15]. Group 4: Independent Global Expansion - Companies are increasingly opting for "self-driven" global expansion rather than simply licensing out, as seen with Kangfang Biopharma's approach to leading its own global clinical trials [8][9]. - This strategy, while riskier, offers higher potential returns compared to traditional licensing agreements [9]. Group 5: Platform-Based Collaborations - The trend is shifting from selling individual products to offering entire R&D platforms, as demonstrated by Hengrui's collaboration with GSK, which includes options for future projects [10][11]. - This model allows companies to monetize their ongoing research capabilities, enhancing their value proposition to partners [10][11]. Group 6: Regulatory and Pricing Developments - The introduction of a drug pricing registration system by China's National Healthcare Security Administration is expected to alleviate concerns about domestic pricing affecting global pricing strategies [12][13]. - This regulatory change has led to increased foreign investment in Chinese R&D, with a 28% year-on-year growth in 2025 [13]. Group 7: Market Valuation Changes - The market's evaluation criteria for Chinese innovative drug companies have shifted from focusing on generic drug revenues to assessing the value of outbound pipelines and global clinical progress [19][21]. - The average price-to-earnings ratio for innovative drug companies in China has risen significantly, reflecting a revaluation of their market potential [21].
中国创新药“闯关”海外市场,如何实现全球价值兑现?
在百利天恒因临床试验到账2.5亿美元款项之时,全行业都在关注这笔资金所释放的信号:中国创新药高额BD交易正步入成果兑现阶段;三生 制药与辉瑞达成的60.5亿美元交易创下纪录,这不仅标志着中国创新药从快速追随者向全球首创者的转变,也反映了中国药企在全球医药版图 重构中的日益重要角色;由和誉医药研发的罕见病新药贝捷迈®,仅用九年七个月便完成从实验室到市场的跨越,这一"中国速度"正重塑全球 药物研发的效率标准。 近日,默克与和誉医药联合宣布,中国国家药品监督管理局(NMPA)已通过优先审评程序,批准贝捷迈®(盐酸匹米替尼胶囊)用于治疗手 术切除可能导致功能受限或引发严重并发症的症状性腱鞘巨细胞瘤(TGCT)成年患者。贝捷迈®是和誉医药自主研发的集落刺激因子-1受体 (CSF-1R)抑制剂,也是国内首个获批用于TGCT治疗的一类创新药。此次获批基于全球Ⅲ期MANEUVER研究数据,结果显示,在第25周 时,该药物的客观缓解率达54%。 这款药物的研发历程,恰是中国创新药企于全球医药创新版图中加速崛起的生动缩影。从靶点发现到全球同步开展临床试验,再到率先在中国 获批上市,中国Biotech(生物科技)公司已实现从技术跟 ...
平安基金周思聪:特朗普药价政策扰动有限,中国创新药出海韧性凸显
Quan Jing Wang· 2025-12-21 04:23
2、进一步剖析政策指向,特朗普的真正目标并非制药企业本身,而是瞄准美国药品流通环节中的保险 机构和药品福利管理机构(PBM)。美国药品标价与净价之间存在巨大价差(这部分利润属于PBM等 中间商的收入)。特朗普主张通过"消除中间商"模式来压缩流通环节利润空间,从而实质性降低终端药 价。这一思路与5月提出的行政命令一脉相承,但需要指出的是,目前该政策仍停留在言论层面,缺乏 具体实施细则,且面临重大执行障碍。历史经验表明,特朗普在2020年9月曾推出类似政策,最终因行 业强烈反对和司法干预而搁浅,后被拜登政府撤销。 特朗普近期对全球17家药企发出降价通牒,要求在60天内采取措施大幅削减美国药品价格,引发市场波 动。对此,平安基金基金经理周思聪表示: 1、特朗普的政策并非单纯打压药企,而是通过"最惠国待遇"机制,要求欧洲和其他国家提高药品支付 金额,而美国相应降低支付金额,以实现美国药品价格与其他发达国家一致。理论上,这一调整可维持 药企总收入稳定,不影响大药企继续引进新药。值得注意的是,该政策若落地可能倒逼美国药企提升研 发效率,进而增加其对中国创新药资产的收购需求,有望加速中国创新药的出海进程。 整体来看,当前国 ...
药闻 | 2025中国创新药“出海潮”透视
Xin Hua Cai Jing· 2025-11-25 14:46
Core Insights - Since 2025, China's innovative pharmaceuticals have experienced a "simultaneous leap in scale and quality" driven by policy benefits and industry accumulation, with total outbound licensing exceeding $90 billion by the end of October, nearly doubling from $51.9 billion in 2024 [1] - The third quarter saw a significant increase in the "value" of outbound transactions, with notable collaborations such as the global strategic partnership between Hengrui Medicine and GSK, involving 12 innovative drugs and potential milestone payments of up to $12 billion [2][3] - The overall trend indicates three structural changes in China's innovative pharmaceuticals' outbound efforts: an increase in high-value transactions, diversification of technology areas, and enhanced contributions from emerging markets [4] Group 1: Market Performance - The total amount of outbound licensing has surpassed $90 billion, indicating a robust growth trajectory [1] - Hengrui Medicine's collaboration with GSK includes a $500 million upfront payment and potential milestone payments of $12 billion, showcasing the shift from traditional licensing to collaborative development [2] - BeiGene's global sales of its core product, Zebrutinib, reached 7.423 billion yuan, marking a 51% year-on-year increase, with the U.S. market contributing significantly [2][3] Group 2: Structural Changes - High-value transactions are becoming mainstream, with large upfront payments and high-potential milestone clauses [4] - Collaborations are diversifying beyond oncology to include areas like autoimmune diseases and rare diseases [4] - There is a rising trend of local partnerships in countries along the Belt and Road Initiative, which helps reduce costs and expedite market entry [4] Group 3: Challenges and Opportunities - Despite the impressive growth, there are underlying issues such as insufficient internal capabilities and a lack of robust ecological support, which hinder the industry's collective advancement [5][6] - The phenomenon of "selling seedlings" reflects the financial pressures faced by many companies, leading to a reliance on licensing rather than developing their own capabilities [6][7] - The report suggests that targeting Belt and Road countries could provide a strategic opportunity for mid-sized and smaller companies to meet local demand for affordable innovative drugs [8][9] Group 4: Future Directions - The report emphasizes that Chinese pharmaceutical companies should not only focus on drug exports but also on promoting a comprehensive "going out" strategy that includes technology and supply chain integration [9] - The transition from merely "product output" to "technology output" represents a significant evolution in China's pharmaceutical industry, enhancing its global competitiveness [9]
从欧美到东南亚,中国创新药出海的下一个风口在哪
2025-11-24 01:46
Summary of Key Points from the Conference Call Industry Overview - The Chinese pharmaceutical sector is experiencing structural growth after a period of deep adjustment, with innovative drugs like Zebutinib and Furmetin achieving significant sales in North America, indicating a shift from generic to innovative drug development [1][2][6] - The global contribution rate of Chinese innovative drugs has been steadily increasing since 2015, expected to reach a transformative stage by 2025, with products like Zebutinib projected to become a $5 billion blockbuster [1][2][6] Core Insights and Arguments - The A-share pharmaceutical sector has shown a clear turning point in 2025, with the Shenwan Pharmaceutical Biotechnology Index rising by 21.1% year-to-date, reflecting a recovery and reversal trend [2] - The improvement in the policy environment, such as relaxed centralized procurement policies and enhanced dual payment systems for medical insurance, is fostering growth in the pharmaceutical industry [2][7] - The shift in strategy for Chinese innovative drugs has moved from "license out" to first-in-class drug development, entering a new phase of global collaboration and establishing overseas teams [1][8] Market Dynamics - Global market fluctuations have impacted the A-share market, with volatility in U.S. stocks affecting Asian tech stocks and subsequently the A-share market, although the underlying logic of the A-share market remains unchanged [5] - The medical industry is expected to benefit significantly from the current macroeconomic environment of interest rate cuts, which historically have favored the healthcare sector [7][22] Challenges and Opportunities - Chinese innovative drug companies face challenges in the U.S. market due to heightened FDA approval standards, necessitating improved communication with regulatory bodies and adherence to international clinical trial standards [3][9] - Emerging markets like Southeast Asia present growth opportunities despite challenges such as limited payment capabilities and high registration barriers; leveraging cost advantages and establishing local teams can facilitate market entry [11][8] Technological Advancements - AI technology is becoming a crucial enabler in the pharmaceutical industry, enhancing data processing and analysis capabilities, optimizing medical SOP processes, and potentially leading to breakthroughs in drug development [12][16] - AI applications in drug development can significantly improve efficiency and success rates, potentially increasing the success rate from 10% to 20% and reducing development time [16][13] Future Outlook - The outlook for the medical industry, particularly the innovative drug sector, is optimistic, with expectations of continued strong growth driven by supportive policies and market dynamics [6][7][22] - Key upcoming events, such as major conferences and clinical trial results, are critical for investment opportunities in the innovative drug sector [20][21] Investment Sentiment - Investors are encouraged to maintain confidence in the pharmaceutical sector, particularly in innovative drugs, as the market is expected to continue its upward trajectory despite short-term fluctuations [17][22] - The healthcare payment environment is improving, with expectations of increased funding and reduced cost control concerns, further supporting the industry's growth [18][22]
跨国药企中国两条腿走路:加速全球引进,与本土创新药一起出海
Di Yi Cai Jing· 2025-11-07 09:04
Core Insights - The rapid development of China's biopharmaceutical sector is prompting multinational pharmaceutical companies (MNCs) to adjust their strategies, focusing on increasing investment in the Chinese market and accelerating the introduction of global innovative products into China [1][2] - MNCs are adopting a dual strategy of enhancing local market engagement while leveraging Chinese innovations to expand globally, as highlighted by GSK and Kelsey Group's approaches [1][2][3] Group 1: Investment and Collaboration - The top 20 MNCs have steadily increased the number and value of assets introduced from China since 2021, with a total of $39.4 billion in innovative drug assets introduced in the first eight months of 2025, accounting for 37.4% of global transaction totals [2] - In the first three quarters of 2025, the total amount for Chinese license-out transactions reached $92.03 billion, indicating a vibrant BD transaction environment for domestic innovative drugs [2] - GSK's strategic partnership with Heng Rui Pharmaceutical involves the joint development of up to 12 innovative drugs, with GSK committing a total of $500 million in upfront payments and potential milestone payments of approximately $12 billion [2][3] Group 2: Market Dynamics and Growth - Kelsey Group's strategy includes three pillars: China to China, Global to China, and China to Global, emphasizing increased investment in the Chinese market and the integration of Chinese innovations into its global system [1][2] - Kelsey Group's recent collaboration with Haisco on the innovative drug HSK31858 represents a significant step in bringing Chinese innovations to global markets, particularly in treating chronic airway diseases [3] - The Chinese market is becoming a key growth engine for GSK, with expectations that approximately 18 new products and indications will be approved in China over the next three years [9] Group 3: Strategic Initiatives and Future Outlook - MNCs are increasingly focusing on enhancing their R&D presence in China, with Kelsey Group planning to increase its R&D personnel and strengthen its engagement with the local innovation ecosystem [4][6] - Boehringer Ingelheim's strategy includes a planned investment of over 5 billion RMB in R&D in China over the next five years, focusing on areas such as metabolism, inflammation, eye health, and oncology [8] - The China International Import Expo (CIIE) is recognized as a vital platform for MNCs to showcase innovations and deepen collaborations, with Boehringer Ingelheim highlighting its commitment to open innovation through this event [7][8]
20cm速递|科创创新药ETF国泰(589720)大涨超6%!辉瑞加码三生707三期临床
Mei Ri Jing Ji Xin Wen· 2025-10-31 05:00
Group 1 - Pfizer officially launched two global multi-center phase III clinical trials for the PD-1/VEGF dual antibody (code: 707) developed by 3SBio, targeting first-line treatment for non-small cell lung cancer and colorectal cancer, designed as a "head-to-head" challenge against current standard therapies (Keytruda and Bevacizumab) [1] - This event signifies a critical advancement in the model of Chinese innovative drugs going global, shifting from "license-out" to being led and heavily invested in by global multinational corporations (MNCs) for late-stage global development [1] - Pfizer's decision to rapidly advance clinical trials and design them as high-standard "head-to-head" tests serves as a strong endorsement of 3SBio's original innovation capabilities and the potential of the 707 molecule, indicating that the value of Chinese innovative drugs has progressed from "early potential" to being recognized as having "disruptive global market potential" [1] Group 2 - The Guotai Innovation Drug ETF (589720) focuses on innovative drug companies listed on the Sci-Tech Innovation Board, tracking a representative index of 30 high-quality companies, primarily in high-growth biotech, with a 20% limit on price fluctuations to better align with sector volatility [2] - Since the "924 market" rally, the Sci-Tech Innovation Drug Index has outperformed the Hang Seng Hong Kong Stock Connect Innovation Drug Index, with respective gains of 117.04% and 109.62% during the market rebound from September 24, 2024, to September 30, 2025 [2] - The Sci-Tech Innovation Drug Index may help capture the resilience of the Sci-Tech Innovation Board when market risk appetite rebounds [2]
十年维度看,CDMO的投资节奏是怎样演变的?
GOLDEN SUN SECURITIES· 2025-10-26 08:06
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [4]. Core Insights - The report discusses the evolution of investment rhythms in the CDMO sector over the past decade, highlighting significant changes from initial industry transfers from overseas to China, to shifts in focus from small molecules to larger molecules and new types like peptides and ADCs [17]. - The report emphasizes that the innovation drug sector is entering a new bull market, driven by the potential for significant breakthroughs and the need for companies to adapt to changing market dynamics [11][12]. Summary by Sections 1. Industry Performance - During the week of October 20-24, the Shenwan Pharmaceutical Index increased by 0.58%, underperforming compared to the ChiNext Index and the CSI 300 Index [10]. - The overall market showed an upward trend, with the Shanghai Composite Index reaching a ten-year high, led by technology stocks, while the pharmaceutical sector experienced volatility [10][11]. 2. Recent Review - The report notes that the innovation drug sector has seen limited performance despite recent business development (BD) activities and data releases, attributing this to the digestion of previous trading volumes rather than fundamental industry issues [11]. - The report anticipates that after a period of consolidation, the innovation drug sector may see a resurgence driven by significant catalysts, with a focus on disruptive innovations rather than mere revaluation [11][12]. 3. Future Outlook - The report outlines a two-pronged strategy for the pharmaceutical sector: focusing on companies with strong Q3 earnings and deepening investments in innovative drugs in preparation for potential rebounds in Q4 and Q1 [12]. - Key investment themes include overseas large pharmaceuticals, small and mid-cap technology revolutions, and the integration of new technologies such as AI in healthcare [12][13]. 4. Strategic Allocation - The report provides a detailed list of recommended companies across various segments, including innovative drugs, chronic disease treatments, and new technologies [13][15]. - Specific companies highlighted include Innovent Biologics, BeiGene, and WuXi AppTec, among others, indicating a diverse approach to investment within the pharmaceutical landscape [13][15]. 5. CDMO Market Insights - The report indicates that the CDMO market in China has grown significantly, with a compound annual growth rate (CAGR) of 39.9%, expanding from 16 billion RMB in 2018 to 85.9 billion RMB in 2023 [25]. - It projects that the market will continue to grow, reaching 208.4 billion RMB by 2028 and 536.9 billion RMB by 2033, highlighting China's increasing share of the global CDMO market [25]. 6. Investment Strategies in Sub-sectors - The report categorizes investment strategies into several areas, including innovative drugs, medical devices, and new technologies, emphasizing the importance of selecting companies that align with emerging trends and market demands [47][48]. - It also notes the significance of focusing on companies that have established strong partnerships with multinational corporations (MNCs) and have developed scalable production capabilities in high-demand areas like ADCs and peptides [45][46].