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 | | | | | | | | | --- | --- | --- | - ...

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 focus in the PD-(L)1/VEGF bispecific antibody market has shifted from business development amounts to development efficiency and indication differentiation [1] - The competition is intensifying as multiple PD-(L)1/VEGF bispecific antibodies are entering Phase III clinical trials, emphasizing the importance of research speed and strategic indication planning [1] Domestic Indication Layout - The PD-(L)1/VEGF bispecific antibody market in China is characterized by rapid development and strategic positioning, with 康方生物/Summit’s Ivonescimab leading the way [2] - Ivonescimab has received approval for two indications in China, with projected sales of approximately 9 billion CNY in 2024 and 7.2 billion CNY in the first half of 2025, and a forecasted total sales exceeding 15 billion CNY in 2025 [2][3] Clinical Development and Market Potential - The first indication for Ivonescimab was approved in May 2024 for treating advanced non-squamous non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI therapy [3] - The second indication was approved in April 2025 for first-line treatment of PD-L1 positive (TPS≥1%) EGFR mutation negative and ALK negative advanced NSCLC [3] - The third indication for Ivonescimab is under review for first-line treatment of advanced squamous NSCLC [3] - The potential of the advanced lung cancer market is significant, with non-small cell lung cancer accounting for approximately 85% of all lung cancer cases [3] Competitive Landscape - The competitive landscape includes other key players such as BioNTech/BMS with PM8002 and Pfizer with SSGJ-707, both of which are also in late-stage clinical trials [5][6] - PM8002 is focusing on triple-negative breast cancer (TNBC) and small cell lung cancer (SCLC), while SSGJ-707 has initiated a head-to-head comparison with Keytruda for treating PD-L1 positive NSCLC [6][8] Global Market Dynamics - The global PD-(L)1/VEGF bispecific antibody market is dominated by three main players: 康方生物/Summit, BioNTech/BMS, and Pfizer, all of which are conducting Phase III clinical trials [8] - The strategies of these companies vary, with 康方生物 focusing on building a strong clinical barrier in the lung cancer market, BioNTech/BMS creating differentiation in TNBC and SCLC, and Pfizer leveraging its ADC advantages in colorectal cancer [18]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The PD-(L)1/VEGF dual antibody track is seeing accelerated overseas clinical development, with significant advancements in multiple clinical trials [5][20] - The report emphasizes the importance of monitoring upcoming clinical data releases and business development (BD) opportunities in the second tier of products [6][26] - The pharmaceutical and biotechnology sector experienced a 1.05% increase in the fourth week of August, underperforming the CSI 300 index by 3.13 percentage points [10][12] Summary by Sections 1. PD-(L)1/VEGF Dual Antibody Track - The first tier of PD-(L)1/VEGF dual antibodies has initiated overseas clinical trials, with Ivosidenib (康方生物/Summit) leading with over ten registered Phase III trials and nearly twenty ongoing overseas trials [5][20] - SSGJ-707 (三生制药/辉瑞) has commenced a head-to-head Phase III clinical trial in China for PD-L1 positive NSCLC and is expected to accelerate overseas clinical development [24] - PM8002 (普米斯/BioNTech/BMS) is exploring combination therapies with dual antibodies and ADCs, showing promising early data in various tumor types [23] 2. Upcoming Clinical Data and BD Opportunities - The report highlights the significance of upcoming clinical data releases for products like JS207 (君实生物), RC148 (荣昌生物), and others, which are expected to mature in the second half of 2025 [6][26] - The inclusion of RC148 in the breakthrough therapy designation (BTD) list marks it as the fourth PD-1/VEGF dual antibody in China, indicating a growing pipeline in this segment [14][16] 3. Recommended and Benefiting Companies - Recommended companies in the pharmaceutical and biotechnology sector include 恒瑞医药, 华东医药, 三生制药, and others, with a focus on various sub-sectors such as CXO, research services, traditional Chinese medicine, and medical devices [7][10]

Core Viewpoint - The article discusses the emergence of bispecific antibodies targeting both PD-(L)1 and VEGF in cancer treatment, highlighting the approval of Ivoris monoclonal antibody as the first of its kind in China, which has sparked a wave of interest and competition in this field [2][3]. Group 1: Overview of Bispecific Antibodies - The combination of immune therapy and anti-angiogenesis drugs has shown significant clinical success, but traditional dual-drug regimens face challenges such as dosage control and side effects [2]. - Ivoris monoclonal antibody, developed by Kangfang Biopharma, is the first PD-1/VEGF bispecific antibody approved globally, marking a significant milestone in the industry [2][3]. Group 2: Competitive Landscape - Over 17 PD-(L)1/VEGF bispecific antibodies are currently in clinical trials globally, indicating a highly competitive environment with numerous companies entering the market [3]. - The competition is characterized by a diverse range of technical approaches and designs, leading to a "hundred flowers bloom" scenario in the industry [3][4]. Group 3: Key Technical Variables - Three critical variables differentiate the designs of PD-(L)1/VEGF bispecific antibodies: 1. Selection of immune targets (PD-1 vs. PD-L1), which affects the breadth of immune response and potential side effects [6]. 2. Choice of anti-angiogenesis targets (VEGF vs. VEGFR), influencing the mechanism of action and potential adverse effects [6]. 3. Antibody structure and fusion methods, which impact the drug's pharmacological properties and production processes [9]. Group 4: Representative Technical Designs - Kangfang Biopharma's Ivoris features a symmetrical tetravalent structure ("2+2 design") that enhances affinity for both PD-1 and VEGF targets, showcasing a promising design in the bispecific antibody landscape [13]. - Other companies are exploring different fusion strategies, such as C-terminal and N-terminal fusions with nanobodies, which may offer advantages in tissue penetration and efficacy [14]. Group 5: Clinical Relevance - The article emphasizes that despite theoretical advantages of various designs, the true measure of success will be clinical efficacy and safety data, as past experiences with PD-1 and PD-L1 antibodies have shown that theoretical differences do not always translate into clinical outcomes [16][17]. - The focus should remain on actual clinical results, production efficiency, and market competitiveness rather than solely on innovative structural designs [20].

Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the biopharmaceutical industry, indicating an expected price increase exceeding the benchmark index by over 10% [10]. Core Insights - The PD-1(L1)/VEGF dual antibody is highlighted as a potential cornerstone drug for tumor immunotherapy, showing significant efficacy in various cancers, including non-small cell lung cancer (NSCLC) and colorectal cancer [3][4]. - Multiple phase III clinical trials for PD-1(L1)/VEGF dual antibodies have achieved progression-free survival (PFS) endpoints, demonstrating clear benefits in first-line treatments for several tumor types [3][4]. - The report emphasizes the promising survival benefits of IBI363 in NSCLC, colorectal cancer, and melanoma, marking it as a breakthrough in clinical outcomes [3]. Summary by Sections Market Performance - The biopharmaceutical industry has shown strong market performance over the past year, with significant advancements in innovative drug development [1]. Drug Evaluation - The report discusses the efficacy of various drugs, including: - Ivoxi in first-line PD-L1 positive NSCLC achieving an overall response rate (ORR) of 50.0% and a disease control rate (DCR) of 89.9% [4]. - Ivoxi combined with chemotherapy in squamous NSCLC showing an ORR of 71.4% and a DCR of 90.5% [4]. - PM8002 demonstrating an ORR of 78.6% in first-line triple-negative breast cancer (TNBC) [6]. Clinical Trial Results - Ivoxi's combination therapies in various cancers have shown promising results: - In MSS colorectal cancer, the combination with FOLFOXIRI achieved an ORR of 81.8% [5]. - In head and neck squamous cell carcinoma, Ivoxi alone had an ORR of 30% [5]. - PM8002 in second-line small cell lung cancer (SCLC) showed a median overall survival (mOS) of 14.3 months [6]. Future Outlook - The report suggests that the ongoing clinical trials and the development of PD-1/VEGF dual antibodies could lead to significant advancements in cancer treatment, positioning the industry for continued growth [3][4].

Group 1 - The core viewpoint of the article highlights the dual effects of the business development (BD) wave in China's innovative pharmaceutical industry, questioning whether BD is a lifeline or a chronic poison for companies [2][3] - The surge in BD transactions is driven by multiple factors, including the patent cliff crisis faced by multinational pharmaceutical companies and the accumulation of potential first-in-class (FIC) and best-in-class (BIC) pipelines by Chinese firms [2] - The total amount of BD transactions in China's innovative drug sector reached $57.1 billion in 2024, with over $50 billion in transactions occurring from early 2025 to the present [2] Group 2 - The benefits of BD are evident, including rapid cash flow acquisition, leveraging multinational resources for global development, and enhancing international recognition of Chinese innovative drugs [3] - However, there are significant concerns, such as a high return rate of 40% in BD transactions, with 25 out of 62 transactions in 2020 being terminated [3] - Companies that rely heavily on BD, like Kangfang Biotech, may face severe financial challenges if BD revenues decline, as seen with a 95% drop in 2024 [3] Group 3 - Successful companies typically possess differentiated innovation capabilities, such as Kangfang Biotech's PD-1/CTLA-4 bispecific antibody [4] - Internationalization capabilities are crucial, exemplified by BeiGene's successful entry into the U.S. market while maintaining its R&D pace [5] - A reasonable pipeline structure is also important, as demonstrated by Ascentage Pharma's high revenue-sharing ratio of 15% for Olverembatinib, potentially generating $300 million in future revenue [6] Group 4 - Companies that are merely "bare swimming" exhibit characteristics such as product homogeneity and reliance on single BD transactions, which can lead to significant market value loss [6] - The CXO companies, particularly those in contract manufacturing organizations (CMO), are clear beneficiaries of the BD trend, as they provide essential production capabilities for innovative drug projects [7] - WuXi Biologics' "CRDMO+" model allows deep involvement in the entire lifecycle of innovative drugs, ensuring continuous orders and revenue regardless of the success of BD transactions [8] Group 5 - After the BD wave subsides, only companies that can consistently produce high-quality innovative drugs and effectively commercialize them will emerge as true winners [9] - Companies must possess strong R&D capabilities and clear commercialization paths, while those relying solely on BD for funding may struggle when the tide recedes [9] - BD should be viewed as a means rather than an end, with the marathon of innovative drug development just beginning [9]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology sector [5]. Core Insights - The PD-1 (PD-L1)/VEGF dual antibody concept is gaining significant attention, with Chinese innovative pharmaceutical companies leading the research and development efforts [2][20]. - The global market for dual antibodies is projected to exceed $80 billion by 2030, with PD-1 (PD-L1)/VEGF drugs expected to challenge the traditional PD-1/PD-L1 drugs in cancer treatment [20][21]. - The report highlights the importance of clinical data barriers and international expansion for companies in this sector, suggesting that these factors will create differentiated investment opportunities [3][26]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 2.21%, outperforming the CSI 300 index by 3.30 percentage points and the ChiNext index by 2.00 percentage points, ranking second among 31 sub-industries [11][12]. Clinical Progress - Notable advancements include the IND applications for BG-60366 by BeiGene and RFUS-949 by Renfu Pharmaceutical, as well as ongoing clinical trials for various drugs by companies like Hengrui Medicine and Stone Pharmaceutical [29][30]. Key Developments - The report notes that 14 PD-1 (PD-L1)/VEGF products are currently in clinical stages, all associated with Chinese companies, with the fastest progress seen in Ivonescimab by Kangfang Biotech, which has been approved in China [21][22]. Investment Strategy - The report emphasizes a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: hospital payments, out-of-pocket payments, and overseas payments [4][26]. - Recommended companies include Hengrui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical [4]. Company Announcements - Recent announcements include various companies receiving approvals for new drugs and medical devices, indicating ongoing innovation and regulatory progress within the sector [28][29].

Core Insights - Hainan Haiyao and Wanbangde have achieved two consecutive trading limit increases, while Huahai Pharmaceutical has reached the daily limit, indicating strong market performance in the pharmaceutical sector [1] - The announcement from Bristol-Myers Squibb regarding a licensing agreement with BioNTech for the next-generation cancer drug BNT327, with potential milestone payments up to $11.1 billion, highlights significant investment and collaboration in the biotech industry [1] - BNT327 was previously developed by Chinese pharmaceutical company Pumice as PM8002, showcasing the ongoing innovation and development within the Chinese pharmaceutical landscape [1] Company Performance - Hainan Haiyao and Wanbangde have shown notable stock performance with two consecutive limit increases [1] - Huahai Pharmaceutical has reached its daily trading limit, reflecting positive investor sentiment [1] - Other companies such as Qianhong Pharmaceutical, Weixin Bio, Huasen Pharmaceutical, Shutaishen, and Shenzhou Cell have also experienced stock price increases, indicating a broader positive trend in the sector [1] Industry Developments - The licensing agreement between Bristol-Myers Squibb and BioNTech for BNT327 represents a significant milestone in cancer treatment development, with potential payments reaching $11.1 billion [1] - The collaboration underscores the importance of partnerships in advancing pharmaceutical innovations and highlights the competitive landscape in the biotech industry [1] - The historical context of BNT327's development by Pumice emphasizes the role of Chinese companies in contributing to global pharmaceutical advancements [1]