从海外映射寻找下半年创新药新赛道 20250706 摘要 PD-1 plus 资产表现亮眼，康方生物伊沃西单抗研究提升市场确定性， 带动相关公司出海交易，如李新医药与默沙东、百安泰克收购钴锂斯生 物。 海外大药企加速布局 PD-1 plus 类资产，三生制药授权辉瑞 PD-1 v j 双 抗海外权益，百安泰克与 BMS 合作开发 PDL one V E G F 双抗，预计 类似交易将持续。 下半年创新药热点包括自免领域双抗（如 TSLP 白介 13 双抗，关注康诺 亚、信达生物），蛋白降解剂（Protac，关注百济神州），新一代 TCE 双抗（实体瘤领域，关注百济神州），以及 ADC 迭代开发（关注百利天 恒 EGFR ADC 进展）。 HER3 ADC 进入三期研究，是双抗 ADC 中领先靶点组合。信达生物披 露 EGFR 和 B7H3 ADC 初步临床前数据，双毒素双配体 ADC 有望克服 耐药性，关注恒瑞医药、科伦博泰等公司。 核药领域，诺华 Provelto 拓展适应症，国内相关公司包括科伦博泰、百 利天恒等。心血管领域，礼来脂蛋白 a 小干扰 RNA 疗法二期结果积极， 关注悦康药业、成都先导等映射 ...

近日，一则关于康方生物临床试验抗癌药物卡度尼利单抗流入市场的消息引发行业关注。根据大象新闻 报道，李某美以79320元购买了70支药物，其中大部分为"仅供临床研究使用"的药品。 对此，康方生物向21世纪经济报道回应道：系医药代表伪造材料，将全面排查并优化业务流程，配合监 管部门调查，维护患者和公司的合法权益。 这或是一波未平一波又起。数日前，康方生物与合作伙伴Summit Therapeutics公布的III期临床试验 HARMONi顶线结果又将企业推向另一争议焦点。研究虽在PFS上取得显著获益，但OS未达统计学显著 性，引发业内对临床价值的讨论。 就在舆论聚焦用药合规问题之际，康方生物与合作伙伴Summit Therapeutics近期公布的III期临床试验 HARMONi顶线结果，又将其推向另一个争议漩涡。 有接近康方生物方面的人士亦对21世纪经济报道坦言："虽然数据解读存在复杂性，但在该治疗领域， 这个结果已经算是全球最佳水平。" 对于这一结果，业内不乏感慨新药不易。有业内人士表示，该治疗领域在美国等西方地区仍存在高度未 满足的临床需求，且获批治疗方案有限。 合规用药如何保障？ 此次卡度尼利单抗注射液的 ...

端午节期间，PD(L)1*VEGF双抗及GLP1领域重磅事件频出： 1）康方生物&summit公布伊沃西单抗针对2L EGFRm的全球临床HARMONI的顶线数据，我们认为核心结论如下： a）PD(L)1*VEGF双抗在EGFRm突变后线具有一定有效性，且中位随访时间较短，需要更长时间随访评估； 【国泰海通医药】热门领域重磅交易再起，继续推荐创新药板块 端午节期间，PD(L)1*VEGF双抗及GLP1领域重磅事件频出： 1）康方生物&summit公布伊沃西单抗针对2L EGFRm的全球临床HARMONI的顶线数据，我们认为核心结论如下： a）PD(L)1*VEGF双抗在EGFRm突变后线具有一定有效性，且中位随访时间较短，需要更长时间随访评估； b）HARMONI研究验证了中美临床的一致性；c）FDA指出 【国泰海通医药】热门领域重磅交易再起，继续推荐创新药板块 连续的PD(L)1*VEGF资产对外授权反应了MNC对于相关类型药物的看好，凭借MNC的临床和资金壁垒，我们认为 其有望找到更多优势的细分人群做出临床获益。 我们也看好ROG、ABBV等其他MNC的需求，国内荣昌生物、宜明昂科、华海药业、华兰生物、神 ...

今日港股创新药板块大爆发，三生制药大涨36%，石药集团涨超8%，荣昌生物涨超7%，先声药业涨超5%，信达生物、康哲药业、联邦制药、德琪医药-B、 中国生物制药超4%。 ETF方面，港股通创新药ETF工银、广发港股创新药ETF、景顺长城基金港股创新药50ETF、万家基金港股创新药ETF基金、汇添富基金港股通创新药ETF分 别涨5.23%、5.05%、4.89%、4.89%、4.81% ，易方达基金恒生创新药ETF涨4.72%。 | 序号 | 证券代码 | 证券简称 | 今日涨幅% | 年涨跌幅% | 基金管理人 | | --- | --- | --- | --- | --- | --- | | 1 | 159217 | 港股通创新药ETF工银 | 5.23 | 1.26 | 工银瑞信基金 | | 2 | 513120 | 港股创新药ETF | 5.05 | 32.00 | 广发基金 | | 3 | 513780 | 港股创新药50ETF | 4.89 | 29.86 | 景顺长城基金 | | 4 | 520700 | 港股创新药ETF基金 | 4.89 | 32.58 | 万家县金 | | 5 | 159570 ...

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].