医药生物 2025 年 08 月 24 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -12% 0% 12% 24% 36% 48% 2024-08 2024-12 2025-04 医药生物 沪深300 相关研究报告 《国谈药品初审名单公布，关注相关 公司的投资机会 — 行 业 周 报 》 -2025.8.17 《二代 IO 升级迭代，PD-1/VEGF 三抗 加速推进—行业周报》-2025.8.10 《设备更新政策持续深化，医疗设备 招采稳步复苏—行业周报》-2025.8.3 关注 PD-(L)1/VEGF 双抗海内外临床进展 ——行业周报 | 余汝意（分析师） | 余克清（分析师） | 聂媛媛（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | nieyuanyuan@kysc.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790124050002 | PD-(L)1/VEGF 双抗赛道第一梯队海外临床加速开展 依沃西单抗（康方生物/Summit ...

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].

Core Viewpoint - AstraZeneca is reportedly in deep negotiations with Summit for a global licensing deal for AK112, potentially worth up to $15 billion, which has stirred significant market interest [2][4]. Group 1: Market Reaction - Following the announcement, Summit's stock surged nearly 15% during trading, closing up 14.68%, while CanSino Biologics, the original developer of AK112, saw a 9.43% increase in its stock price the next day, marking a market capitalization exceeding HKD 100 billion [3]. Group 2: Product Overview - AK112 is a PD-1/VEGF bispecific antibody developed by CanSino Biologics. The rights for its development and commercialization in major markets were previously licensed to Summit for a total of up to $5 billion, with an initial payment of $500 million [4]. Group 3: Clinical Data and Challenges - In a Phase III clinical trial, AK112 demonstrated a significantly improved progression-free survival (PFS) of 11.1 months compared to 5.8 months for Keytruda, marking it as the first product to outperform Keytruda in a head-to-head trial [7]. - However, subsequent data from another Phase III study indicated that while PFS was statistically significant, overall survival (OS) did not reach statistical significance, raising concerns about its market viability [8]. Group 4: Competitive Landscape - The PD-(L)1/VEGF bispecific antibody market is becoming increasingly competitive, with multiple multinational corporations (MNCs) actively pursuing assets in this space. Pfizer, for instance, shifted its focus to another bispecific antibody, SSGJ-707, indicating a lack of confidence in AK112 [10][12]. - Major players like BMS and Merck are also making significant investments in this area, highlighting the strategic importance of PD-(L)1/VEGF products in the immuno-oncology (IO) market [14][15]. Group 5: Strategic Implications for AstraZeneca - AstraZeneca's potential acquisition of AK112 is seen as a move to enhance its competitive position in the tumor immunotherapy sector, especially given its relatively fewer commercialized products compared to established players like Merck and BMS [19]. - The timing of the acquisition is critical, as the recent decline in Summit's valuation following the mixed clinical data may provide AstraZeneca with a more favorable negotiation position [18][20]. Group 6: The Rise of Chinese Biotech - The emergence of PD-(L)1/VEGF bispecific antibodies is largely driven by the rapid growth of Chinese biotech companies, which are now seen as key players in the global market [25][26]. - The total transaction value in the PD-1/VEGF space has exceeded $17 billion in 2024 alone, reflecting the increasing global bargaining power of Chinese innovative drugs [27].

Group 1 - Junshi Biosciences (01877) saw its stock price increase by over 10%, currently trading at 26.2 HKD with a transaction volume of 4.52 billion HKD [1] - The preclinical research results of JS207, a recombinant humanized PD-1 and VEGF bispecific antibody developed by Junshi, were published in the journal "Frontiers in Immunology," detailing its molecular design, in vitro characteristics, functions, and anti-tumor efficacy [1] - According to Founder Securities, the preclinical data of JS207 demonstrates the potential of second-generation PD-1 antibodies in anti-tumor applications, indicating its business development (BD) potential [1] Group 2 - Reports indicate that AstraZeneca is in discussions with Summit regarding a collaboration on the AK112 drug, with a potential deal value of up to 15 billion USD [2] - PD-(L)1/VEGF bispecific antibodies are expected to be the next-generation cornerstone drugs in the immuno-oncology market, with ongoing combinations with ADC/TCE likely to expand market opportunities [2] - As of May 2025, only Pfizer and Merck have entered this market segment among multinational corporations, suggesting that other early-stage PD-(L)1/VEGF bispecific antibodies from China may have opportunities for business development abroad as data matures [2]