华福证券 ADC 药物迎来快速发展期，市场规模广阔 团队成员 投资要点： 政策红利加速释放：国家密集出台多项抗体偶联药物专项政策，推动 ADC 药物研发标准化。同时，2024 年医保目录新增 5 款 ADC 药物，国产 药物借政策东风抢占市场先机。 百亿蓝海爆发在即：全球 ADC 市场已突破 140 亿美元，有望在 2030 年突破 660 亿美元（CAGR 30.3%），中国市场发展同样极为迅猛，作为 全球 ADC 市场核心增长极，有望在 2030 年突破 600 亿元人民币。 临床需求刚性凸显：乳腺癌、淋巴瘤等核心适应症全球年新增病例超 240 万，ADC 药物凭借"抗体靶向+毒素杀伤"的特性替代传统化疗趋势 明确，Enhertu® 2024 年销售额达 37.5 亿美元印证临床价值。 风险提示 产业链价值逐渐凸显：中国国内已形成完整 ADC 产业链，上中游企 业受益最为显著。 分析师： 赵月(S0210524050016) zy30563@hfzq.com.cn 相关报告 技术研发不及预期；宏观需求变化；医疗事件风险 华福证券 华福证券 策略点评 正文目录 | 1 | 政策指导促进 ADC 药物发展，多 ...

Core Viewpoint - The article highlights a significant shift in the pharmaceutical market in China, where the market share of imported original research cancer drugs in top-tier hospitals is projected to drop from 68% in 2021 to 34% in 2024, while the combined share of domestic generic and innovative drugs is expected to rise to 66% [5][10]. Group 1: Market Dynamics - The transition from imported original drugs to domestic alternatives reflects deeper changes in the pharmaceutical market, driven by cost advantages of domestic generics and innovations [1][6]. - In the first half of 2025, over 30 original research drugs from multinational companies are expected to withdraw from the market, including those from Takeda, Pfizer, and GlaxoSmithKline [1]. - The declining market share of imported drugs is attributed to multinational companies' pricing strategies and the competitive pricing of domestic generics [6][10]. Group 2: Patient Perspectives - Many patients are initially hesitant to switch from imported to domestic drugs due to concerns about efficacy and safety, as illustrated by the experiences of patients like Ms. Zhou and an elderly male patient [3][4]. - However, some patients have reported positive outcomes after switching to domestic drugs, noting both cost savings and effective treatment [4][12]. Group 3: Policy and Regulatory Environment - The article discusses the impact of national drug procurement policies, which have significantly reduced the market presence of imported original drugs, with a low winning rate of 3.7% in recent procurement rounds [6][10]. - The ongoing reforms in the healthcare payment system, including DRG and DIP models, are pushing hospitals to prioritize lower-cost drugs, further squeezing the space for imported original drugs [10][12]. Group 4: Industry Adjustments - Multinational pharmaceutical companies are adapting by localizing their operations, including expanding production bases and upgrading research centers in China [13][14]. - Companies like Sanofi and Roche are shifting their focus towards innovative drugs and adjusting their product portfolios in response to market changes [8][14]. Group 5: Future Outlook - The article emphasizes the need for a transparent and competitive market environment to foster the development of high-quality, reasonably priced drugs, whether domestic or imported [16]. - The ongoing evolution in the pharmaceutical landscape suggests that both multinational and domestic companies will continue to adapt their strategies to meet changing patient needs and regulatory requirements [9][16].

Core Insights - The China National Medical Products Administration (NMPA) has announced that the injection of Trastuzumab Deruxtecan (T-DXd, DS-8201a) developed by Daiichi Sankyo is proposed for priority review for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received one treatment regimen [1][2] - Trastuzumab Deruxtecan is a targeted HER2 antibody-drug conjugate (ADC) that has already received approval for four indications in China, including HER2-positive advanced breast cancer and HER2 (ERBB2) activating mutation non-small cell lung cancer [1] - The DESTINY-Gastric04 study, the first Phase 3 trial for Trastuzumab Deruxtecan in HER2-positive advanced gastric cancer, demonstrated significant overall survival (OS) improvement compared to standard treatments [2] Summary by Sections Drug Approval and Indications - Trastuzumab Deruxtecan is under priority review for treating HER2-positive gastric cancer in patients who have received prior treatment [1] - The drug has previously been approved for multiple indications in China, including advanced breast cancer and non-small cell lung cancer [1] Clinical Study Results - The DESTINY-Gastric04 study showed that Trastuzumab Deruxtecan significantly improved median overall survival to 14.7 months, extending it by 3.3 months compared to the standard treatment of 11.4 months [2] - The study indicated a 30% reduction in the risk of death for patients treated with Trastuzumab Deruxtecan compared to standard therapies [2] - The safety profile of Trastuzumab Deruxtecan was deemed manageable, with low-grade adverse events, although attention is needed for the risk of interstitial lung disease [2]

Core Viewpoint - Breast cancer treatment is evolving towards more precise subtyping and mechanisms, with various innovative treatment options being introduced. However, to truly benefit patients, challenges related to education, accessibility, and standardized guidelines need to be addressed [1]. Group 1: Research and Development - AstraZeneca has showcased its commitment to breast cancer research at the ASCO conference, presenting significant studies such as SERENA-6 and DESTINY-Breast09, focusing on key molecular subtypes like HR-positive/HER2-negative and HER2-positive [3][4]. - The DESTINY-Breast09 trial demonstrated the benefits of trastuzumab deruxtecan combined with pertuzumab over traditional therapies for HER2-positive metastatic breast cancer, potentially offering new treatment options for patients [4]. - The SERENA-6 study highlighted the potential of Camizestrant in treating HR-positive, HER2-negative advanced breast cancer with ESR1 mutations, marking it as a significant finding at ASCO [5]. Group 2: Treatment Framework - AstraZeneca has developed a comprehensive treatment framework for the three major breast cancer subtypes: HER2-positive, HR-positive/HER2-negative, and triple-negative, covering all treatment stages from early to late [4]. - The company is actively exploring new mechanisms and treatment options for triple-negative breast cancer, aiming to introduce innovative ADC therapies to the Chinese market [5]. Group 3: Implementation and Accessibility - The BCCE project, led by the National Cancer Center with AstraZeneca's support, aims to bridge the gap between guidelines and clinical practice, enhancing breast cancer diagnosis and treatment across various healthcare levels [7][8]. - AstraZeneca is focused on improving drug accessibility by facilitating the registration and inclusion of innovative breast cancer drugs in China's national insurance directory, thereby reducing patient financial burdens [10]. - The company emphasizes the importance of patient education and multi-disciplinary collaboration to enhance the standardization of breast cancer treatment in China [8][10]. Group 4: Future Goals - AstraZeneca aims to contribute to the "Healthy China 2030" initiative by enhancing cancer survival rates through systematic approaches that promote standardized, precise, and sustainable breast cancer treatment [11].

Group 1: Global Gold Demand - In Q1 2025, global gold demand reached 1206 tons, a year-on-year increase of 1% despite gold prices exceeding $3000 per ounce [1] - Gold ETF demand surged, leading to a more than doubling of gold investment demand to 552 tons, a 170% year-on-year increase, marking the highest quarterly level since Q1 2022 [1] - Retail investment in gold bars and coins in China increased by 3% to 325 tons, the second-highest quarterly demand on record [1] Group 2: Securities Firms Performance - In Q1 2025, 49 securities firms reported a total revenue of 132.4 billion yuan, a year-on-year increase of 27.1% [1] - The net profit attributable to shareholders reached 55.39 billion yuan, up 75.55% year-on-year; excluding special impacts, the growth rate was 49.26% [1] - Proprietary trading accounted for 39% of total net income, making it the largest revenue source, followed by brokerage business at 26% [1] Group 3: Television Market Forecast - TrendForce predicts a 0.7% year-on-year decline in global TV shipments in 2025 due to the impact of U.S. tariffs and reduced consumer demand [2] Group 4: Public Cloud Market Growth - IDC reports that the public cloud IaaS market in China is expected to grow to 94.82 billion yuan in H2 2024, a 13.8% year-on-year increase, driven by AI [2] - Alibaba Cloud ranks first in market share, with a continuous recovery over three consecutive quarters [2] Group 5: Instant Retail Development - Taobao's "Hour Delivery" service has been upgraded to "Taobao Flash Purchase," launching in 50 cities with plans for nationwide expansion [2] Group 6: Seafood Market Trends - The price of crayfish has dropped significantly, with medium-sized crayfish prices falling from 40 yuan per jin to 17 yuan per jin, a decline of over 50% [3] - Companies like Guolian Aquatic and Anjijin Food reported declines in revenue and net profit, attributed to market conditions and reduced demand for crayfish [3] Group 7: AstraZeneca's Tax Issues - AstraZeneca faces potential fines exceeding $800,000 due to allegations of tax evasion related to the import of a specific drug in China [3] Group 8: Chengdu Rural Commercial Bank Performance - Chengdu Rural Commercial Bank reported a total asset size of 914.26 billion yuan, marking a significant growth trend [5] Group 9: Investment Strategy Insights - Notable investor Mark Mobius stated that 95% of his fund's position is in cash, reflecting a cautious approach amid upcoming trade negotiations [5] Group 10: Corporate Governance Changes - Several executives at Xiaogoods City have resigned due to organizational changes [8] Group 11: Financial Regulatory Updates - The China Securities Regulatory Commission approved the IPO registration of Shandong Xintong Electronics [6] Group 12: Legal and Compliance Issues - Tianjin Pharmaceutical was fined 69.19 million yuan for engaging in monopolistic practices [6] - Jiangwei New Energy received a warning from the Shenzhen Securities Regulatory Bureau for failing to fulfill a shareholding commitment [7]

Core Insights - The Chinese pharmaceutical industry has made significant advancements in innovative drug development over the past decade, driven by supportive policies and reforms [1] - Currently, domestic pharmaceutical companies are reassessing strategies and exploring new business models due to challenges such as declining drug prices, financing difficulties, and geopolitical risks [1] - Global pharmaceutical giants are experiencing a performance divide, with companies like Merck, AstraZeneca, and Novartis showing resilience through innovative products, while others like Bristol-Myers Squibb and Roche face short-term challenges due to declining revenues from mature products [1][4] Industry Trends - The first quarter of 2025 is referred to as the "patent cliff year," where major drugs face generic competition, prompting companies to adopt diversification strategies to mitigate impacts [2][5] - Innovation in oncology, autoimmune, and neurological disease sectors remains crucial for growth, with companies needing to maintain rapid innovation and flexible localization strategies [2] - The global pharmaceutical market is projected to grow significantly, with spending expected to reach approximately $2.2 trillion by 2028, driven by increased drug usage, new product launches, and the rise of biosimilars [12] Company Performance - Bristol-Myers Squibb reported total revenue of $11.2 billion in Q1 2025, a 6% decline year-over-year, with growth products contributing $5.6 billion, while mature products saw a 20% revenue drop [4] - Roche's total revenue for Q1 2025 was approximately $18.5 billion, with a 6% year-over-year increase, driven by strong sales of innovative drugs, although the Chinese market faced a 23% decline [6][7] - Johnson & Johnson's Q1 2025 revenue reached $21.89 billion, a 2.4% increase, with significant contributions from CAR-T therapy Carvykti, which saw a 135% increase in sales [8] Strategic Adjustments - Companies are increasingly focusing on innovation and strategic partnerships to navigate market challenges, with many adopting dual strategies that combine internal R&D with external collaborations [15][16] - The need for cost control and operational optimization is evident, as companies like Roche and Bristol-Myers Squibb implement restructuring measures to adapt to market pressures [7][4] - The pharmaceutical industry is witnessing a shift towards differentiated value propositions and breakthrough innovations, with companies leveraging acquisitions and partnerships to enhance their market positions [11][15]

Core Insights - AstraZeneca reported Q1 2025 revenue of $13.588 billion, a 10% year-over-year increase, with product sales reaching $12.875 billion, up 9% [1] - The company’s R&D investment was $3.159 billion, reflecting a 15% increase [1] - The U.S. market contributed $5.646 billion, a 10% increase, while China contributed $1.805 billion, a 5% increase, making China the third-largest market for AstraZeneca [1] Financial Performance - Revenue by disease area: Oncology contributed $5.643 billion (up 13%), CVRM (Cardiovascular, Renal, and Metabolic diseases) contributed $3.322 billion (up 13%), R&I (Respiratory and Immunology) contributed $2.084 billion (up 13%), V&I (Vaccines and Immune Therapies) contributed $0.225 billion, and Rare Diseases contributed $2.042 billion [3] - Top-selling products: Farxiga (Dapagliflozin) generated $2.057 billion, Tagrisso (Osimertinib) generated $1.679 billion (up 8%), and ADC drug, Trastuzumab deruxtecan, generated $1.086 billion [3] Market Dynamics - The ADC market in China is highly competitive, with significant growth expected; the HER2 ADC market is projected to grow from $0.6 billion in 2022 to $8.4 billion by 2030, with a CAGR of 39% [5] - Trastuzumab deruxtecan has rapidly expanded its indications since its approval in China in February 2023, benefiting from policy support for innovative drugs [4][5] Strategic Initiatives - AstraZeneca is focusing on innovation and local partnerships to navigate the challenges in the Chinese pharmaceutical market, including collaborations with local companies for clinical research [7][8] - The company is diversifying its pipeline to mitigate risks associated with single products, particularly in the ADC space [6][9] Future Outlook - AstraZeneca's ability to convert its clinical pipeline into sustainable revenue will be crucial for its growth in the coming years, especially in light of increasing competition and market pressures [9]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，一項HLX22（重組人源化抗 HER2單克隆抗體注射液）（「HLX22」）聯合德曲妥珠單抗治療HER2低表達 HR陽性的局部晚期或轉移性乳腺癌的2期臨床研究於中國境內（不包括港澳 台地區，下同）完成首例患者給藥。 B. 臨床試驗設計及目的 本研究是一項多中心的2期臨床研究，旨在評估HLX22聯合德曲妥珠單抗治 療經標準治療後疾病進展或不可耐受毒性反應的，HER2低表達HR陽性的 局部晚期或轉移性乳腺癌患者的療效和安全性。符合條件的受試者將接受 HLX22（15mg/kg，靜脈注 ...