【文/王力 编辑/周毅】 9月26日，美国总统特朗普在社交媒体平台宣布，自10月1日起对所有品牌或专利药品进口征收100%关 税，除非相关企业正在美国建设制药工厂。 这一政策标志着特朗普关税大棒首次直接瞄准全球医药核心领域，引发国际医药股集体下跌。受冲击最 大的包括欧洲制药巨头诺和诺德、葛兰素史克等，以及日本住友制药、韩国三星生物等亚洲药企。 截图来自Truth Social 然而，中国创新药企因其独特的出海模式可能受影响有限。当前中国药企对美出口主要以仿制药和原料 药为主，均不在此次关税征收范围内。而已进入美国市场的少数国产创新药，大多采用授权许可 （License-out）模式或已在美国本土建立生产能力，因此具备较强的政策免疫力。 这一"因祸得福"的局面可能为中国医药行业带来新的发展机遇，特别是在全球医药产业链重构的大背景 下，中国药企有望通过差异化策略实现更好的国际化布局。 关税政策细节解析：精准打击与豁免条件 从时间线来看，这一政策并非突然出台。今年4月，美国商务部就已启动对所有药品进口影响国家安全 的调查。7月，特朗普曾威胁征收高达200%的药品关税。相比之下，最终落地的100%税率虽然仍属严 厉， ...

Core Viewpoint - The significant stock price increases of Kangfang Biopharma and Pop Mart, which rose over 150% and 450% respectively, reflect the accurate predictions of the "Phoenix Star Listed Company Awards" regarding high-quality investment targets [1][4][18]. Group 1: Performance and Growth - Kangfang Biopharma achieved a revenue of 1.412 billion yuan in the first half of 2025, marking a year-on-year growth of 33.7%, driven by the commercialization of core products [5]. - Pop Mart reported a revenue of 13.88 billion yuan during the same period, with a remarkable year-on-year growth of 204.4%, showcasing the strong monetization capability of cultural IP operations [8]. - Both companies' growth is attributed to stable revenue contributions from their core businesses, with Kangfang Biopharma focusing on dual-antibody drug matrices and Pop Mart leveraging its leading IP series [8]. Group 2: Globalization Strategy - Kangfang Biopharma is actively pursuing a global strategy, with key products like Cardunili and Yivosi being central to its international expansion. The company has authorized Summit to commercialize Yivosi globally under a deal worth up to $5 billion [9]. - Pop Mart adopts a localized international strategy, signing artists globally to cater to diverse consumer needs and launching region-specific products, such as Thai-themed LABUBU products and collaborations with famous artworks in Paris [9]. Group 3: Industry Trends - The innovative pharmaceutical sector, where Kangfang Biopharma operates, is experiencing structural changes, with improved healthcare systems and accelerated drug approvals driving the growth of Chinese innovative drugs [12]. - Pop Mart is capitalizing on the rise of the IP economy, fueled by the increasing demand for emotional value consumption among Generation Z and the global popularity of "Guzi" culture [12]. Group 4: Evaluation Criteria - The "Phoenix Star Listed Company Awards" emphasizes long-term growth potential over short-term financial metrics, utilizing data analysis, expert reviews, and public voting to identify companies with sustainable value [13][14]. - The awards recognize Kangfang Biopharma's comprehensive layout from R&D to industrialization and Pop Mart's innovative capabilities in IP operations and global expansion potential [14].

自去年获得"2024凤凰之星上市公司评选"的"港股最具成长性上市公司"以来，康方生物和泡泡玛特备受资本市场青睐，截至9月21日，股价已分别涨超 150%、450%。 这两家分属不同赛道的企业，用持续攀升的股价，诠释了"凤凰之星上市公司评选"对优质标的的精准预判。这份前瞻性背后，究竟藏着怎样的逻辑？ 标普全球中国区主席、标普信评首席执行官黄直（中）为"2024凤凰之星上市公司评选"获奖企业颁奖 1、"凤凰之星"最具成长性上市公司为什么能股价大涨？ 两家企业分属不同的行业，却走出了相似的股价曲线，这背后并非偶然的市场炒作，而是多重优势共振的结果。 首先，扎实的业绩是两家企业获得资本市场认可的前提。 2025年上半年，康方生物实现营业收入14.12亿元，同比增长33.7%，这一增长源于其持续推进核心产品的商业化进程，如推动卡度尼利、依沃西两款产品被 纳入医保目录。 康方生物管线分布情况 积极推进全球化战略，充分挖掘海外市场潜力，也是两家企业实现规模跃升的重要因素。 具体来看，卡度尼利与依沃西是目前康方生物的出海核心。2022年，康方生物将依沃西以"5亿美元首付款+50亿美元总交易额+低双位数销售分成"交易模式 授权 ...

Core Viewpoint - Kangfang Biopharma/Summit presented updated data from the HARMONi study at the 2025 WCLC, showing improved overall survival (OS) with a hazard ratio (HR) of 0.78 (P=0.0332), indicating a significant trend of survival benefit compared to previous analyses [1][2] Group 1: Study Overview - The HARMONi study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III trial assessing the efficacy and safety of Ivonescimab in patients with disease progression after third-generation EGFR-TKI treatment [2] - A total of 438 patients were randomized (219 per group), with a median follow-up of 22.3 months, showing a significant improvement in progression-free survival (PFS) for the Ivonescimab group (HR=0.52, P<0.001) [3] Group 2: Efficacy Results - The median OS for the Ivonescimab group was 16.8 months compared to 14.0 months for the placebo group (HR 0.79, P=0.0570) [3] - Objective response rates were 44.7% for the Ivonescimab group versus 34.2% for the placebo group, with intracranial PFS also showing improvement [3] Group 3: Safety Profile - The Ivonescimab group demonstrated good safety and tolerability, with treatment-related adverse events (TRAEs) of grade ≥3 occurring in 50.0% of patients compared to 42.2% in the placebo group [4] - The most common TRAEs were laboratory abnormalities, with no new safety signals identified [4] Group 4: Follow-Up and Trends - Extended follow-up showed further improvement in OS, particularly in North American patients, with a median OS of 17 months compared to 14 months for the control group (HR=0.84) [5] - The study indicated that patients with brain metastases had better PFS outcomes compared to those without [5] Group 5: Comparative Analysis - The HARMONi study results align with the HARMONi-A study, demonstrating consistent efficacy trends across different regions, highlighting the global market potential of Ivonescimab [6] - Both studies achieved significant clinical endpoints, confirming the drug's rapid efficacy and favorable safety profile [6] Group 6: Future Outlook - Future focus will be on the results of ongoing Phase III trials, particularly HARMONi-3 and HARMONi-7, which will be critical for the drug's commercialization prospects [7] - The company has initiated multiple Phase III studies across various cancer types, indicating a robust pipeline and potential for sustained growth [7] Group 7: Financial Projections - The company projects revenues of 34.42 billion, 51.49 billion, and 76.28 billion for 2025, 2026, and 2027, respectively, with corresponding growth rates of 62.04%, 49.62%, and 48.14% [8] - The company is expected to achieve profitability by 2026, supported by a rich pipeline of products nearing approval [8]

Core Viewpoint - Kangfang Biopharma reported a revenue of 1.412 billion yuan for the first half of 2025, marking a year-on-year increase of 37.75%, while the loss expanded to 588 million yuan from 249 million yuan in the same period last year [1][3] Financial Performance - Revenue for the period was 1.412 billion yuan, a 37.75% increase year-on-year [1] - Commercial sales revenue reached 1.402 billion yuan, up 49.20% year-on-year [1] - The company incurred a loss of 588 million yuan, which is an increase from the previous year's loss of 249 million yuan [1][3] Revenue Drivers - The growth in commercial sales revenue was primarily driven by the inclusion of AK104 and AK112 in the national medical insurance since January, leading to increased sales volume [1] - The increase in losses was attributed to a rise in equity investment losses from a partnership with Summit, which increased from 32.6 million yuan to 192 million yuan, as well as higher R&D expenses and stock incentive costs [3] Product Pipeline and Market Position - Kangfang Biopharma has received approval for seven products, including AK104 and AK112, which are key dual antibodies, and has expanded its commercial product range to include metabolic and autoimmune areas [4] - The sales team has grown from over 800 to 1,200 members, covering oncology and specialty drug sectors [4] - The company is focusing on AK112, which has shown promising results in clinical trials for non-small cell lung cancer [5][8] Clinical Development and Strategy - AK112 has achieved significant clinical endpoints in trials, including a statistically significant improvement in progression-free survival (PFS) [8][9] - The company is pursuing a strategy termed "IO2.0+ADC2.0," which aims to integrate dual antibodies with antibody-drug conjugates (ADCs) [12][13] - Kangfang Biopharma's pipeline includes ongoing clinical trials for various indications, with a focus on enhancing the efficacy of existing treatments [12][16]

Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of HKD 9.40, indicating a potential upside of 24.9% from the current price of HKD 7.52 [1][3][23]. Core Insights - The report highlights the significant achievements of the company in its transformation from generic to innovative pharmaceuticals, focusing on key therapeutic areas such as oncology, liver disease/metabolism, respiratory, and surgical/pain management [1][9][26]. - The company has increased its R&D investment, with R&D expenses projected to reach RMB 5.09 billion in 2024, accounting for 17.6% of revenue, up from 9.9% in 2019 [10][40]. - The innovative product pipeline has expanded significantly, with 17 approved innovative drugs by the end of 2024, and the revenue contribution from innovative products is expected to reach 50% by 2025 and 60% by 2027 [10][47]. Financial Summary - For FY23A, the company reported sales revenue of RMB 26.199 billion, with a projected growth of 10.2% in FY24A [2]. - Adjusted net profit for FY23A was RMB 2.589 billion, with an expected increase of 33.5% in FY24A [2]. - The adjusted earnings per share (EPS) is forecasted to grow from RMB 0.14 in FY23A to RMB 0.19 in FY24A [2]. Market Performance - The company's market capitalization is approximately HKD 141.08 billion, with an average trading volume of HKD 860.8 million in March [3]. - The stock has shown strong performance, with a 166.7% increase over the past six months [5]. Product Pipeline and Innovation - The company has a robust pipeline with multiple products showing potential for overseas licensing, including TQC3721, 罗伐昔替尼, and TQB2102 [12][27]. - The oncology segment is highlighted as a key growth area, with 安罗替尼 being a cornerstone product that has received multiple indications and is expected to generate significant sales [13][14]. Business Strategy - The company is focusing on enhancing its supply chain and production efficiency, achieving a procurement coverage rate of 95% by 2024 [28]. - A strategic shift towards a more specialized sales structure has been implemented to improve marketing effectiveness and operational efficiency [33]. Growth Projections - Revenue is expected to grow at a compound annual growth rate (CAGR) of 10.5% from 2024 to 2027, driven by innovative product sales and a strong pipeline [23][24]. - Adjusted net profit is projected to increase at a CAGR of 11.4% during the same period [24].

Core Insights - The FDA has publicly released 202 drug approval rejection letters (CRLs), exposing the failure records of global pharmaceutical companies, including four Chinese firms [1][2] - The transparency brought by the CRL publication is expected to reshape industry standards and compel companies to improve compliance and clinical design [4] Group 1: Chinese Pharmaceutical Companies' Rejections - Zhejiang Innovation Biotech faced three rejections for its Vancomycin injection due to non-compliance in production facilities and significant safety report omissions [3] - Luye Pharma's Risperidone injection was rejected twice due to severe safety concerns, including unexplained spikes in blood drug concentration during key clinical trials [3] - Baiji Shenzhou's Bevacizumab biosimilar failed due to flaws in analytical methods, leading to the dismissal of key efficacy data and multiple quality control issues [3] - Kangfang Biotech's Pembrolizumab was blocked due to insufficient clinical data and unstable production cell lines, although it later received approval for two indications after addressing the FDA's concerns [3] Group 2: Industry Implications - The cases highlight common weaknesses among Chinese pharmaceutical companies, such as clinical design flaws, quality control lapses, and insufficient bioequivalence evidence [4] - The experience of Kangfang Biotech demonstrates that CRLs are not the end; companies can successfully reverse decisions by providing additional data [4] - The shift from a "black box" to a "glass house" in the approval process necessitates that Chinese firms integrate compliance awareness throughout the entire R&D chain to gain lasting trust in global markets [4]

Group 1: Marine Economy - The Central Financial Committee emphasized high-quality development of the marine economy, focusing on top-level design, policy support, and encouraging social capital participation [1] - Guangdong Province has implemented new regulations for high-quality marine economic development, while Shandong Province aims for marine specialty industries to grow significantly faster than GDP by 2027 [1] - The pharmaceutical value of marine biological resources is substantial, with new drug development opportunities expected to drive rapid growth in the marine biomedicine industry, particularly for new drugs based on marine active substances [1] Group 2: Photovoltaic Industry - Prices for silicon materials, silicon wafers, battery cells, and TopCon components are projected to decrease by 11.42%, 9.28%, 10.52%, and 4.22% respectively by 2025 [2] - BC batteries (bifacial batteries) gained attention at the SNEC exhibition and are seen as having the potential to challenge TopCon technology, although large-scale production has not yet been achieved [2] - TCL Photovoltaic Technology is exploring new growth points in the domestic market through an integrated solution of "photovoltaics + energy storage + charging piles + heat pumps," especially as costs decline [2] Group 3: Embodied Intelligence - The application of embodied intelligence has shown initial results, but experts indicate it is still in the exploratory stage and not yet at a mature industrial level [3] - Traditional industrial robots rely on manual programming, requiring long adjustments for product model changes, while embodied intelligence can significantly shorten this process and enhance production efficiency [3] - The lack of uniform hardware among different manufacturers complicates data sharing and interoperability, increasing the difficulty of industry standardization [3] Group 4: Semiconductor Industry - Despite short-term pressure on tech stocks, long-term investment in the semiconductor and chip sectors remains strong, with notable declines in stocks like Hengxuan Technology and Cambricon [4][5] - The semiconductor industry is experiencing consolidation, with increased support for mergers and acquisitions from national policies, exemplified by several high-profile acquisitions [4] - AI technology is expected to drive demand growth in AI servers, AI phones, and AIPC devices, forming a smart ecosystem centered around AI servers [4] Group 5: Innovative Pharmaceuticals - Guangdong Province has released its first batch of approved innovative drug and medical device products, including 107 items, with 10 cancer drugs making up about 22% of the total [5] - The approval of innovative drugs like Cardunilumab for cervical cancer treatment highlights the advancements in tumor immunotherapy and the capabilities of local companies [5] - Research teams from Sun Yat-sen University have successfully developed and commercialized innovative drugs, contributing to the international success of local pharmaceutical products [5]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - Chinese innovative drugs performed beyond expectations at the ASCO conference, highlighting companies such as Innovent Biologics and Kelun-Biotech as key players [1][2] - The report emphasizes the growth potential in the innovative drug sector, with specific recommendations for stock selection based on growth, valuation, and dividend yield [11][12] Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.1% this week and 7.8% year-to-date, outperforming the CSI 300 by 0.3% and 9.4% respectively [10] - The Hong Kong biotechnology index rose by 4.5% this week and 47.8% year-to-date, also outperforming the Hang Seng Technology Index [10] Innovative Drug Developments - The ASCO conference showcased 73 oral presentations from China, marking a historical high, with significant contributions in ADC and dual-antibody research [5][16] - Notable advancements include the FDA IND approval for the first circular RNA drug by Huanma Biotech and the NDA submission for the first oral PROTAC estrogen receptor degrader by Arvinas and Pfizer [2] Stock Selection Strategy - Recommended sub-industry rankings for investment are: Innovative Drugs > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies > Pharmaceutical Commerce [11] - Growth-oriented stock picks include Innovent Biologics, Zai Lab, BeiGene, Kelun-Biotech, and others in the innovative drug space [11] - For undervalued stocks, focus on traditional Chinese medicine companies such as Zhaoli Pharmaceutical and Tianshili [11] Market Trends - The report notes a significant increase in licensing deals for Chinese innovative drugs, with 94 transactions totaling $51.9 billion in 2024, reflecting a 26% year-on-year growth [17] - The report highlights the strong performance of specific stocks, including Yiming Pharmaceutical and Wanbangde, which saw increases of 33% this week [10]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 18, 2025 [1]. Core Insights - The report highlights that the A-share innovative drug sector outperformed the CSI 300 index by 0.63 percentage points, with a weekly increase of 1.75% [3][22]. - The Hong Kong innovative drug sector also showed strong performance, rising 2.77% and outperforming the Hang Seng Index by 0.68 percentage points [24]. - The report notes a significant increase in the number of innovative drug transactions globally, with notable deals including Rznomics and Eli Lilly for $1.3 billion, and Septerna and Novo Nordisk for $2.2 billion [7]. Summary by Sections 1. Market Performance - In the week of May 12-16, 2025, 39 stocks in the innovative drug sector rose while 67 fell, with the top gainers being Deki Medicine-B (up 18.34%), Sillodide (up 14.57%), and Jiahe Biology-B (up 14.48%) [3][19]. - Over the past six months, the A-share innovative drug sector has increased by 12.20%, outperforming the CSI 300 index by 13.49 percentage points [22]. - The Hong Kong innovative drug sector has seen a cumulative increase of 25.74% over the last six months, outperforming the Hang Seng Index by 5.95 percentage points [24]. 2. Drug Approvals and Clinical Trials - In May, one new drug was approved in China, with no new indications approved [5][30]. - The report indicates that in the U.S., one NDA was approved in May, but no new BLA approvals occurred during the week [6][34]. - Japan saw one innovative drug approved in May, with the same occurring in the week of the report [39]. 3. Key Transactions - The report details 11 significant global transactions, with four disclosing amounts, including a $1.3 billion deal between Rznomics and Eli Lilly, and a $2.0 billion agreement between Boston Pharmaceuticals and GSK [7]. 4. Innovative Drug Development - The report outlines the progress of GLP-1RA drugs for diabetes, noting 11 approved drugs globally, with three in NDA stage and nine in Phase III clinical trials [13]. - For obesity-related GLP-1RA drugs, three are approved, with one in NDA stage and six in Phase III clinical trials [15]. 5. Company-Specific Developments - The report mentions that several companies are advancing their innovative drugs, including Heng Rui Medicine's JAK1 inhibitor for atopic dermatitis and the approval of a new opioid analgesic by Haisco [43][44].