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 Insights - The recent government policies aim to support innovative drugs, including "first launch price protection" for CAR-T therapies, which will not be included in centralized procurement for the first five years post-launch [1] - Despite these policies, the payment challenges for CAR-T therapies remain significant, with prices ranging from 999,000 to 1,290,000 RMB, far exceeding the implicit thresholds of 300,000 RMB for basic medical insurance [1][2] - The focus for the 2025 negotiations will be on the long-term competitiveness of companies, assessing their ability to manage price pressures, cost control, and commercialization efficiency [2] Group 1: CAR-T Products and Pricing - Six CAR-T products will participate in commercial health insurance negotiations in September 2025, but basic medical insurance access is unlikely [3] - The current pricing for the listed CAR-T products is as follows: - Axicabtagene ciloleucel (Fosun Kite): 1,200,000 RMB - Relmacabtagene autoleucel (WuXi AppTec): 1,290,000 RMB - Nanjing Biomedicine's product: 999,000 RMB - Others range from 1,280,000 to 1,290,000 RMB [4] Group 2: Economic Evaluation and Price Pressure - Only three of the six CAR-T products have published cost-effectiveness analysis reports for the Chinese market, which will influence their negotiation positions [5] - The incremental cost-effectiveness ratios (ICER) for these products are as follows: - Axicabtagene ciloleucel: 463,000 RMB/QALY - Relmacabtagene autoleucel: 203,000 RMB/QALY - Other products show varying ICERs, indicating different levels of price pressure [6] Group 3: Competitive Strategies and Market Dynamics - The negotiation dynamics will depend on the companies' ability to demonstrate cost control and effective commercialization strategies [2][14] - Companies like WuXi AppTec and Legend Biotech have competitive advantages due to their existing ICERs being closer to the expected thresholds, while others may need to prove the reliability of unpublished data or offer price concessions [14] Group 4: Future Market Potential and Insurance Access - The potential for CAR-T therapies to enter the insurance market hinges on their ability to lower costs and expand patient access, particularly in the context of solid tumors [16][22] - The expected patient population for blood cancers is approximately 26,000 to 48,000 annually, while solid tumors could see a much larger patient base, enhancing the long-term viability of CAR-T therapies [20][22] Group 5: Key Observations for Investors - The completeness of health economic data will determine the negotiation eligibility for insurance access, while the feasibility of price reductions and commercialization efficiency will influence the speed of market entry [14][15] - The ability to expand hospital coverage and partnerships with health insurance will be critical for companies to achieve rapid market penetration and revenue growth [15]

Summary of Conference Call Records Company Overview - The company is focused on innovative drug development and has successfully commercialized six self-developed innovative drugs since its establishment in 2012 [2][45]. - The company has a diverse pipeline with multiple candidates entering clinical stages, including ADCs and dual antibodies [3][6][42]. Key Industry Insights - The oncology market is highlighted as a significant area, with the global market for lung cancer treatments exceeding $25 billion in 2024 [12]. - The company has made substantial progress in clinical trials, with four major Phase III clinical positive results announced in 2024 [2][4]. Financial Performance - Total revenue for 2024 reached RMB 2.12 billion, with cash and short-term financial assets amounting to RMB 7.3 billion [3][46]. - The company reported a net loss of approximately RMB 500 million, a significant reduction from RMB 788 million in 2023, indicating improved financial stability [46]. - R&D expenses for 2024 were RMB 1.187 billion, reflecting a commitment to innovation despite a slight decrease in overall R&D spending [45][50]. Product Pipeline and Clinical Trials - The company has initiated 11 Phase III clinical trials in 2024, covering various indications including first-line treatments for bile duct cancer and triple-negative breast cancer [4][14]. - Two globally innovative dual antibodies have been successfully included in the national medical insurance directory, enhancing their market accessibility [4][6]. - The company is actively pursuing new indications for existing products, with five new indication applications submitted to regulatory authorities [2][4]. Strategic Partnerships and Collaborations - The company has established strategic collaborations with major pharmaceutical firms, including a significant partnership with Pfizer for ADC product development [15][12]. - A five-year strategic cooperation agreement was signed with MD Anderson Cancer Center, focusing on various oncology research projects [15][16]. Market Access and Commercialization Strategy - The company has achieved a hospital access rate of 80% for its core products, with a goal to reach over 2,000 hospitals by the end of 2025 [9][51]. - The commercial team has expanded to over 1,000 sales personnel, enhancing the company's market penetration capabilities [3][8]. Future Outlook - The company anticipates significant growth in 2025, driven by the successful commercialization of its dual antibodies and ongoing clinical trials [7][26]. - Expectations for 2025 include the approval of four NDA applications and the release of Phase III clinical data for key products [26][51]. - The company aims to maintain a strong focus on R&D, with plans to continue developing innovative therapies to meet clinical needs [23][49]. Additional Noteworthy Points - The company emphasizes a long-term commitment to innovation and sustainable growth, with a robust pipeline of over 50 innovative candidates in various stages of development [48][49]. - The management team is focused on enhancing operational efficiency and resource allocation to support ongoing clinical and commercial activities [24][47].