证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 中国创新药在 ASCO 表现超预期，关注信达 生物、科伦博泰等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 环码生物 RNA 创新药获 FDA IND 默示许可；PROTAC 雌激素受体降 解剂向 FDA 递交 NDA；国产九价 HPV 疫苗获批上市，填补高端疫苗 空白 6 月 6 日，环码生物宣布，其自研的环形 RNA 新药 HM2002 获 FDA 新药临床试验申请（IND）默示许可。该药为全球首款完成患者给 药的环形 RNA 类药物，曾于 1 月获中国 NMPA IND 批准。6 月 7 日， Arvinas 与辉瑞联合宣布，已向 FDA 递交 Vepdegestrant 的新药申请 （NDA），该药为全球首个口服 PROTAC 雌激素受体降解剂，适用于 ER+/HER2-乳腺癌患者。6 月 4 日，由翔安实验室与厦门大学等联合研 制的国产九价 HPV 疫苗获国家药监局批准上市，成为我国首个自主供 应的九价 HPV 疫苗，标志中国正式成为继美国后第二个具备高价 HPV 疫苗自主可控能力的国家。 ◼ 具体配 ...

中国的创新药，最近腰杆很硬。 五月下旬，辉瑞用约12.5亿美元的代价换取了三生制药一款抗癌药非中国内地区域的权益，如果顺利的 话，未来三生制药还能收获最高约48亿美元的里程碑付款收益外加1亿美金的股份认购。 石药集团也迫不及待于近期宣布其即将完成50亿美元的BD交易。 今年的ASCO（美国临床肿瘤学会）年会中国有73项研究入选了口头报告环节，创亚洲国家新的记录。 这一切，距离2024年锐格医药与罗氏的8.5亿美元首付款交易还不到一年，距离康方生物与Summit Therapeutics达成的最高50亿美元的BD协议，以及百利天恒与百时美施贵宝最高84亿美元的BD协议，也 仅短短两年时间。 泼天富贵从天而降，中国创新药出海交易的爆发式增长引人侧目。 相关统计数据显示，2024年中国创新药对外授权交易总金额高达519亿美元，同比增长26%；2025年仅 第一季度，出海交易额已达369.29亿美元，再创同期历史新高。 股市从来不亏待好消息，创新药相关概念股票在端午节后迎来一波暴涨。 恒瑞医药、石药集团等传统巨头与新兴Biotech企业，正将自主研发的ADC（抗体偶联药物）、双抗等 管线推向欧美市场，辉瑞、默克、BM ...

证券研究报告/行业研究 生物医药行业企稳复苏，创新成为驱动行业增长新动能 ——创新药行业动态追踪 投资要点 ➢ 生物医药产业结构性升级，创新成为发展新动能 中国在研管线数量2014年来持续增加，据Pharmaprojects统计，2014年中 国在研管线数量为701个，至2024年已增至6,119个，复合增速高达24%，在 研管线数量的全球占比由2014年的6%增至2024年的27%，得益于中国医药 企业持续的研发投入，管线的深度和广度不断扩展，中国药物出海（license- out）及在海外成立New-co势头迅猛，创新逐渐转变为支撑中国生物医药产 业发展的新动能。 据医药魔方相关数据显示，中国医药市场结构仍以仿制药为主，2023年仿制 药占中国医药市场结构的65%左右，创新药占比较低，有极大的提升空间。 从创新药上市数量来看，2019年来中国创新药上市数量整体而言不断增加， 且国产创新药占比呈上升趋势，反映出中国医药生物企业创新能力不断增强， 处于行业新旧动能切换，由仿制到创新的过渡阶段，创新驱动特征逐渐显现。 ➢ 出海进程提速，海外市场带来业绩增量 中国创新药出海取得了重大成果，交易数量和交易金额呈现爆 ...

Group 1: Industry Overview - In May, at least six domestic innovative pharmaceutical companies announced BD transaction orders, primarily involving cross-border collaborations between Chinese and foreign pharmaceutical companies [1] - The total amount of license-out transactions by Chinese innovative pharmaceutical companies reached $45.5 billion from January to May 2025, indicating a significant surge in outbound transactions compared to $51.9 billion for the entire year of 2024 [1] - The Chinese innovative drug market is projected to exceed 2 trillion yuan by 2030, with a compound annual growth rate of 24.1% [2] Group 2: Company Highlights - 3SBio and its subsidiary, 3SBio Guojian, entered into a global exclusive development rights agreement with Pfizer, featuring a $1.25 billion upfront payment and a potential total transaction value exceeding $6 billion, setting new records for Chinese innovative drugs [1] - Following the announcement, 3SBio's stock surged over 32%, with its subsidiary's stock hitting multiple daily limit-ups, effectively doubling in value [1] - CSPC Pharmaceutical Group is in discussions regarding three potential transactions related to drug development, production, and commercialization, with a total potential transaction value of approximately $5 billion, leading to a stock price increase of over 12% in a single day [1][2] Group 3: Market Performance - Innovative drug-related ETFs have shown strong performance, with year-to-date increases of 48.53%, 47.97%, and 47.23% for three major ETFs [2] - The ASCO annual meeting showcased a record number of 73 oral presentations from Chinese companies, highlighting the growing recognition of Chinese innovative drugs on the global stage [2][3] - The performance of various indices, such as the Xinhua Manufacturing Outbound 50 and Xinhua TMT Outbound 50, has been notably positive, with significant increases driven by supportive policies and industry benefits [3][4]

Group 1 - The Hong Kong stock market for innovative drugs has seen significant gains, with notable increases in shares of companies such as CSPC Pharmaceutical Group rising over 13%, Lepu Biopharma increasing by 9%, and King’s Ray Biotechnology up over 5% [1] - Various Hong Kong innovative drug ETFs have also performed well, with several funds, including GF Hong Kong Innovative Drug ETF and Huatai-PineBridge Hong Kong Innovative Drug ETF, rising over 2% [1][2] - The approval of CSPC's adenosylcobalamin capsules by the National Medical Products Administration of China is expected to enhance the company's product line in the blood and nervous system treatment areas [4] Group 2 - Lepu Biopharma announced that its candidate drug MRG003, an innovative antibody-drug conjugate for treating recurrent or metastatic nasopharyngeal carcinoma, will present key clinical research results at the 2025 American Society of Clinical Oncology annual meeting [4] - King’s Ray Biotechnology reported that its affiliate Legend Biotech submitted a 6-K form to the SEC, revealing long-term results from the CARTITUDE-1 study, indicating that one-third of patients did not experience disease progression for five years or more after a single CARVYKTI infusion [5] - According to research reports, the pharmaceutical sector is expected to experience a turning point this year, with strong growth in profitability anticipated over the next two years, driven by favorable policies and macroeconomic recovery [5][6]

Q&A 创新药出海的必要条件是什么？临床数据在其中扮演什么角色？ 创新药出海的必要条件是高质量创新或差异化创新。临床数据的读出是支持差 异化创新出海的关键因素。通过高质量、差异化的临床数据，能够证明创新药 在全球市场中的独特价值和竞争力。 科伦博泰 SKB264（TROP2 ADC）联合 PD-1 单抗一线治疗非小细胞 肺癌，整体 ORR 约 60%，PFS 达 15 个月，PD-L1≥1%患者 PFS 达 17.8 个月，有望挑战一线标准治疗。赛斯替尼针对 EGFR 突变非小细胞 肺癌三线治疗 PFS 为 6.9 个月，HR 值为 0.30，OS 调整后差异显著， 有望成为二线标准治疗。 信达生物 PDL-1 抗体 ADC 43 公布 2mg/kg 剂量组非小细胞肺癌患者 数据，ORR 达 38%，DCR 超 80%，不良反应可控，显示初步有效性。 丰翰林 ADC 药物 ORR 为 38%，优于辉瑞同类药物，且进度领先。 泽璟 006 在小细胞肺癌三线以上治疗中表现出最高的 ORR，具有显著 优势，有望成为该类型药物中的最佳选择。Engie 公司的 taletrectinib 在二线治疗中击败了化疗，有望很 ...

Group 1 - The Hong Kong stock market saw a high opening but closed lower, with the innovative drug sector initially weakening before rebounding. Notable stocks included Green Leaf Pharmaceutical rising over 5%, and others like Kangnuo Pharmaceutical-B, United Pharmaceutical, and CSPC Pharmaceutical rising over 2% [1] - The Hong Kong innovative drug ETF (159567) experienced a net inflow of over 80 million yuan in the past 20 trading days, indicating high market interest [1] - Leading domestic innovative pharmaceutical companies showcased their achievements at the ASCO annual meeting, with Heng Rui Pharmaceutical presenting four studies as oral reports and five as rapid oral reports, highlighting their academic and clinical significance [1] Group 2 - The innovative drug ETF (159567) tracks the Guozheng Hong Kong Stock Connect Innovative Drug Index, with 90% of its weight in innovative drug companies, making it the highest among all medical theme indices, poised to benefit from trends like AI-enabled drug development and the international expansion of domestic innovative drugs [2] - The innovative drug ETF (159992) tracks the innovative drug index, which includes leading companies in the innovative drug industry chain, benefiting from AI advancements and the introduction of a new insurance category for high-priced innovative drugs [2] - East Wu Securities noted that China's innovative drug licensing transactions are entering a booming phase, driven by improved internal R&D capabilities and increased international trust in Chinese drug pipelines [2]

昨日，创新药ETF天弘(517380)回调却获资金逆势净流入。 爱建证券指出，看好中国创新药出海的产业趋势。虽然近期2025ASCO大会上中国研究成果的催化剂集 中释放，部分投资者难免对后续行情有所担忧，但我们认为本轮创新药行情反映了未来3-5年维度，中 国创新药出海的产业趋势。目前中国医药产业在ADC、双抗、细胞治疗等领域处于全球创新第一梯 队，在研发和生产端的成本优势、技术平台优势明显；在与全球MNC不断达成重磅BD交易的背书效应 下，中国创新药在全球市场的认可度和影响力快速提升，进一步推动创新出海加速，形成"正反馈"的良 性循环。 Wind数据显示，6月5日，创新药ETF天弘(517380)收跌1.68%，但该ETF却获资金净流入645万元，已连 续2日获资金净流入，累计"吸金"超1820万元。截至最新收盘，基金份额达6.68亿份，创历史新高。 （本文机构观点来自持牌证券机构，不构成任何投资建议，亦不代表平台观点，请投资人独立判断和决 策。） 中泰证券指出，展望6月，拥抱创新大时代，积极围绕Q2业绩布局。三生制药破纪录的BD交易金额、 中国药企在ASCO的亮眼表现，都说明国产创新药在全球范围内的竞争力越 ...

Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]

Group 1 - The Hong Kong innovative drug sector is undergoing an unprecedented wave of value reassessment, with around 12 innovative drug concept stocks rising over 50% year-to-date, including Rongchang Biopharma and Sanofi Biotech, which have surged over 200% [1] - The ASCO annual meeting served as a key catalyst, showcasing over 70 research results from Chinese pharmaceutical companies, with Innovent Biologics' IBI363 clinical data generating significant attention due to its breakthrough efficacy in treating advanced non-small cell lung cancer [2] - License-out transactions have become a core engine for valuation reshaping, with 41 outbound transactions totaling $36.93 billion in Q1 2025, nearing the total for the entire year of 2023 [3] Group 2 - Domestic drug approvals are accelerating, with the National Medical Products Administration approving 11 innovative drugs from 8 companies, including 9 domestically developed drugs, indicating a robust pipeline for commercialization [4] - The policy environment is favorable, with the National Healthcare Security Administration constructing a multi-tiered payment system to support innovative drugs throughout their lifecycle, enhancing the attractiveness of the sector [5] - The pharmaceutical sector is expected to see strong performance in H1 2025, driven by favorable external conditions and the ongoing trend of self-sufficiency in drug development [6]