1月6日，药物临床试验登记与信息公示平台官网显示，华海药业子公司华奥泰登记了一项评估 HB0025 联合化疗一线治疗晚期鳞状非小细胞肺癌的III期临床 研究。根据公开资料，这是该药启动的首个III期临床研究。 | 登记号 CTR20260016 | | | --- | --- | | 相关登记号 CTR20232184,CTR20251978,CTR20254814 | | | 药物名称 HB0025注射液 曾用名: | | | 药物类型 生物制品 | | | 临床申请受理号 企业选择不公示 | | | 适应症 鳞状非小细胞肺癌 | | | 试验专业题目 评估HB0025联合化疗过比帕博利珠单抗联合化疗一线治疗局部晚期或转移性鳞状非小细胞师瘟有效性的随机对照、双盲、多中心川期 | | | 试验通俗题目 评估HB0025联合化疗对比帕博利珠单抗联合化疗一线治疗晚期鳞状非小细胞肺癌川期临床研究 | | | 试验方案编号 HB0025-C-0302 | 方案最新版 | | 版本日期: 2025-08-19 | 方案是否为联合 | 据摩熵医药数据库显示，HB0025 是由华奥泰自主研发的一款创新型抗PD-L1/VEG ...

来源：龙谈价值2023 大家好，我是龙哥。 2025年的创新药大行情，总体围绕创新药海外BD交易展开，市场对BD交易的预期从一个极端走向另一 个极端——从已经BD出去的要看到比较明确的临床推进才愿意给部分估值，到大多创新药公司的管线 都被拉出来用放大镜看一圈、只要有潜力BD出去的就炒一把。经过自10月份以来的多个BD交易落地或 海外资产被并购后反而股价暴跌的市场表现，3个月的行情、情绪、关注度的退潮，很多A股和H股的小 公司股价腰斩，市场情绪趋于理性，创新药行业2026年的驱动逻辑被市场重新理解和认知。 2026年行业靠什么驱动？我们此前文章已经多次讲过，淡化一过性的BD交易，后续要靠实实在在的海 外临床推进、海外商业化确定性的提升来驱动，到现在市场对该认知已经逐渐理解，创新药行业β也再 次显现，行业龙头和优质二线公司以及此前讲过的持仓比较纯粹的520880港股通创新药ETF都陆续企稳 向上。 本文我们来讨论一下2026年海外注册临床会有明确进展的公司，所谓的进展既包括新开全球多中心注册 临床，也包括临床数据的读出，我们在此抛砖引玉的列举一部分公司，也欢迎大家的补充。 1、行业影响巨大的两个肿瘤药 首先我们要 ...

Investment Rating - The report assigns an "Outperform" rating to multiple stocks in the Hong Kong healthcare sector, including Hansoh Pharma, 3SBio, Kelun-Biotech, Innovent Biologics, Akeso, JD Health, WuXi AppTec, and BeiGene [1][4][37]. Core Insights - The rollout of the "dual formulary" system, which includes the National Reimbursement Drug List (NRDL) and the inaugural Commercial Innovation Drug List, is expected to significantly benefit the innovative drug value chain. The NRDL added 114 drugs with an 88% success rate, up from 76% in 2024, while the commercial list includes 19 innovative drugs [7][40]. - The report highlights three key features of the new drug lists: a focus on innovation, addressing the needs of the elderly and children, and reinforcing the distinction between basic and commercial insurance coverage [7][40]. - The report expresses a long-term positive outlook on the innovative drug value chain, driven by state support for novel drugs and the inclusion of high-innovation therapies in the commercial insurance list [7][40]. Summary by Sections Stock Recommendations - The report lists several top picks for January 2026, including Hansoh Pharma, 3SBio, Kelun-Biotech, Innovent Biologics, Akeso, JD Health, WuXi AppTec, and BeiGene, all rated as "Outperform" [1][4][37]. Market Performance - The December 2025 portfolio of Hong Kong "Golden Picks" saw an average decline of 12.4%, underperforming the Hang Seng Healthcare Index, which fell by 9.5% [5][38]. - Notable performers in December included WuXi AppTec, Akeso, and JD Health, which experienced smaller declines compared to the overall portfolio [5][38]. Industry Trends - The healthcare services sector is noted as undervalued, with companies like Hygeia and Jinxin Fertility showing strong performance due to ongoing market buy-backs [8][41]. - The report suggests monitoring the recovery opportunities in the consumer healthcare sector for 2026, particularly in light of low base effects [8][41]. Recent Developments - A series of business development (BD) deals in December 2025 indicates sustained interest from multinational corporations (MNCs) in the biotech and pharmaceutical sectors, with significant upfront payments and milestone agreements [10][43][44]. - The report emphasizes the attractiveness of the biotech sector following recent valuation resets, suggesting potential for pre-earnings catch-up trades [10][42].

12月26日，据华海药业发布公告，其下属子公司上海华奥泰生物的 HB0025 联合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审 评中心Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司将正式启动 HB0025注射液 的III期临床试验。 截图来源：企业公告 据摩熵医药数据库显示（https://vip.pharnexcloud.com/?zmt-mhwz），目前康方生物研发的 依沃西单抗（PD-1/VEGF双抗）已在中国获批上市，BMS的 PM8002（PD-L1/VEGF双抗）、辉瑞的 SSGJ-707（PD-1/VEGF双抗）已进入临床III期。 华奥泰在2025年ESMO会议（欧洲肿瘤内科学会）公布的 HB0025 联合化疗一线治疗晚期肺鳞癌和肺腺癌II期临床数据，具有较好的客观缓解率和疾病控制 率，尤其在PD-L1阴性人群中ORR的响应率高，3级以上免疫相关不良事件（irAEs）发生率低。 HB0025国内研发状态（部分） | 研发现状 8 | active研发详情 0 | inactive研发详情 0 | | | | | | | | | --- | --- | --- | - ...

2025年，是中国创新药在技术、市场、国际化领域破釜沉舟的一年，药企"走出去"迈出了关键一 步。对外授权交易（BD）爆发是最佳证明，全年对外授权总金额突破1000亿美元，首付款达81亿美 元，超九成跨国药企已经与中国药企达成合作，模式已不再局限于单纯技术转让，而是向"授权+联合 开发+商业化参与"多层次合作迈进。总体看，中国正加速从医药大国向医药强国转型。 "十四五"收官，我国生物医药市场规模稳居全球第二，在研创新药约占全球的30%，标志着我国医 药产业实现了从跟跑到并跑的关键跨越。"十四五"期间，我国共批准上市创新药220个、创新医疗器械 282个，分别达到"十三五"期间的6.2倍、3.1倍。批准415个儿童药品、155个罕见病药品上市，批准上市 中药创新药28个，新批准注册和备案公示化妆品新原料344件，医药产业创新发展活力不断增强。 国际化：从跟跑到领跑 医药行业国际化势头在2025年彻底爆发，一方面表现在BD交易激增，另一方面是"A+H"布局火 热。 数据显示，2025年中国创新药对外授权出海总金额已突破1000亿美元，较2024年同期飙升约75%， 从"卖产品"到"卖技术"，从"被动授权"到"主动布 ...

格隆汇12月26日丨华海药业(600521.SH)公布，近日，公司的下属子公司上海华奥泰生物药业股份有限 公司就HB0025联合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审评中心 Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司将正式启动 HB0025 注射液的 III 期临床试 验。 综上，HB0025 有望为多类肿瘤患者带来更具协同机制的治疗选择，成为"免疫+血管"双靶抗体治疗策 略的重要突破口。 截至目前，公司在 HB0025 项目上已合计投入研发费用约人民币32,597万元。 HB0025 是由华奥泰自主研发的一款创新型抗 PD-L1/VEGF 双特异性融合蛋白，同时靶向肿瘤免疫逃逸 通路 PD-L1 和肿瘤血管生成通路VEGF。该药物设计实现了两个靶点的高亲和力结合，协同调控肿瘤免 疫微环境与血管生成，具备"免疫增强+抗血管"双重抗肿瘤机制。根据和 CDE 的会议沟通，公司将启动 两项确证性 III 期临床试验。 目前，康方生物研发的依沃西单抗(PD-1/VEGF 双抗)已在中国获批上市，BMS 的 PM8002(PD-L1/VEGF 双抗)、辉瑞的 SSGJ-707(PD ...

格隆汇12月26日丨华海药业(600521.SH)公布，近日，公司的下属子公司上海华奥泰生物药业股份有限 公司就HB0025联合化疗一线治疗鳞状和非鳞状非小细胞肺癌经过与国家药品监督管理局药品审评中心 Ⅱ期临床试验结束/Ⅲ期临床试验启动前的会议沟通，公司将正式启动 HB0025 注射液的 III 期临床试 验。 HB0025 是由华奥泰自主研发的一款创新型抗 PD-L1/VEGF 双特异性融合蛋白，同时靶向肿瘤免疫逃逸 通路 PD-L1 和肿瘤血管生成通路VEGF。该药物设计实现了两个靶点的高亲和力结合，协同调控肿瘤免 疫微环境与血管生成，具备"免疫增强+抗血管"双重抗肿瘤机制。根据和 CDE 的会议沟通，公司将启动 两项确证性 III 期临床试验。 目前，康方生物研发的依沃西单抗(PD-1/VEGF 双抗)已在中国获批上市，BMS 的 PM8002(PD-L1/VEGF 双抗)、辉瑞的 SSGJ-707(PD-1/VEGF 双抗)已进入临床 III 期。华奥泰在 2025 年 ESMO 会议(欧洲肿瘤 内科学会)公布的HB0025(PD-L1/VEGF 双抗)联合化疗一线治疗晚期肺鳞癌和肺腺癌II 期临床数 ...

Core Insights - The year 2025 is viewed as the "globalization year" for China's biotech sector, with BD transaction volumes and values expected to significantly exceed those of 2024, prompting a reevaluation of innovative drug assets [1] Group 1: Industry Dynamics - Global recognition of asset quality: Multinational pharmaceutical companies are increasingly viewing China not just as a sales market but as a core source for R&D pipelines [1] - Reconstruction of cash flow models: Large upfront payments are improving the balance sheets of biotech companies, allowing them to maintain high R&D investments without relying on equity financing during capital downturns [1] - Establishment of differentiated competitive advantages: Chinese innovative pharmaceutical companies have formed a "group army" advantage in cutting-edge fields like bispecific antibodies and ADCs, demonstrating global Best-in-Class R&D capabilities [1] Group 2: Market Outlook - The understanding of BD transactions is shifting from "one-time income" to "long-term revenue sharing expectations," with industry valuation logic expected to transition from PS (Price-to-Sales) to PE (Price-to-Earnings) [1] - The current state of the innovative drug sector shows improving fundamentals due to the onset of the Fed's interest rate cut cycle, the confirmation of moderate domestic medical insurance negotiations, and the ongoing international expansion of innovative drugs [2] - Despite a significant rebound, the valuation of the innovative drug sector remains at historical low levels [3] Group 3: Future Catalysts - The market is expected to enter a stable upward channel characterized by dual increases in performance and valuation in 2026, with key catalytic phases identified [3] - The sentiment recovery phase (late December 2025 - January 2026) is anticipated to be marked by the J.P. Morgan Healthcare Conference, where numerous Chinese pharmaceutical companies are expected to disclose new clinical data and BD cooperation intentions [3] - The performance verification phase (Q1 - Q2 2026) will focus on two key indicators: whether BD upfront payments are recognized as revenue and the sales growth of core innovative drugs [3] - The valuation reshaping phase (second half of 2026) will see the first overseas Phase III clinical results from Chinese innovative drugs, potentially marking the emergence of China's first overseas marketed innovative drugs [4] Group 4: Investment Focus - The current adjustment in China's A-share and H-share innovative drug markets is nearly complete, with the industry at a historic turning point from "following innovation" to "global leadership" [4] - Future investment focus will be on leading innovative pharmaceutical companies with global intellectual property, differentiated clinical value, and strong cash flow, seizing historical opportunities for industrial upgrades and value reassessment [4]

Group 1 - The core point of the news is that Kangfang Biopharma's stock rose over 3% following the announcement of promising clinical trial results for its PD-1/VEGF bispecific antibody, Ivosidenib, in treating locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) [1] - Ivosidenib has shown significant clinical potential in first-line treatment for TNBC, as evidenced by updated efficacy data presented at the ESMO IO conference [1] - The drug has been included in the Breakthrough Therapy Designation (BTD) list by the National Medical Products Administration (NMPA) in China, indicating its promising efficacy and safety [1] Group 2 - Ivosidenib is the world's first PD-1/VEGF bispecific antibody developed by Kangfang Biopharma, with its first indication expected to receive approval from the NMPA in May 2024 for treating locally advanced or metastatic non-small cell lung cancer (nsq-NSCLC) [2] - The drug represents a novel combination of tumor immunotherapy and anti-angiogenesis mechanisms, marking a significant advancement in cancer treatment [2] - In November 2024, Ivosidenib was included in the national medical insurance catalog, enhancing its accessibility for patients [2]

Core Viewpoint - Kangfang Biotech's PD-1/VEGF bispecific antibody, Ivosidenib, shows promising efficacy in treating locally advanced unresectable or metastatic triple-negative breast cancer (TNBC) in a phase II clinical study, highlighting its potential in first-line therapy [1] Group 1: Clinical Development - Ivosidenib has been included in the Breakthrough Therapy Designation (BTD) list by the National Medical Products Administration (NMPA) for its excellent efficacy and safety in treating TNBC [1] - A multicenter, randomized, double-blind phase III clinical study (HARMONi-BC1/AK112-308) for Ivosidenib in this indication is currently progressing efficiently [1] Group 2: Product Approval and Market Position - Ivosidenib is the world's first PD-1/VEGF bispecific antibody for tumor immunotherapy, with its first indication expected to receive approval from the NMPA in May 2024 for locally advanced or metastatic non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI treatment [2] - In November 2024, Ivosidenib was included in the national medical insurance catalog, enhancing its market accessibility [2]