肿瘤锚定下一代IO基石疗法，早研FIC分子进入临床验证期;自免管线进展迅速，即将进入收获期 智通财经APP获悉，招商证券发布研报称，首次覆盖给予三生制药（01530）"强烈推荐"评级，PD- (L)1/VEGF双抗是下一代IO治疗的核心药物，SSGJ-707分子设计独特、早期临床数据具备BIC潜力。辉 瑞14亿美元前端付款+最高48亿美元里程碑付款+1亿美元股份认购获得全球权益，充分认可707分子潜 力和公司研发实力，并且随着辉瑞多项全球临床的快速推进、后续更多ADC联用的临床开启，公司估 值空间有望持续打开。公司业绩基本盘稳健，产品管线衔接有序，中长期成长动力充沛。 招商证券主要观点如下： 公司背景 基本盘扎实，创新周期再加速。三生制药成立于1993年，是国内领先的生物药物公司，在研发/生产/销 售生物药方面具有丰富的经验。经过30多年发展，公司在肾科、血液及肿瘤、自免、毛发皮肤等治疗领 域布局了丰富的产品和在研管线。同时公司具备强大的国内商业化能力，核心产品特比澳、EPO、益赛 普、蔓迪在所处赛道占据高市占率，驱动业绩持续增长。 升板产品：主力大单品竞争格局佳，拓展适应症挖掘增长空间。特比澳为公司核心大单 ...

Investment Rating - The report gives a "Strong Buy" rating for the company [2]. Core Views - The PD-(L)1/VEGF dual antibody is positioned as a core drug for next-generation immuno-oncology treatments, with the SSGJ-707 molecule showing unique design and early clinical data indicating its potential as a best-in-class (BIC) candidate. The collaboration with Pfizer, involving an upfront payment of $1.4 billion and potential milestone payments of up to $4.8 billion, reflects the recognition of SSGJ-707's potential and the company's R&D capabilities [1][8][48]. - The company's financial performance is stable, with a well-structured product pipeline and strong long-term growth drivers [1][8]. Summary by Sections Company Overview - Established in 1993, the company is a leading biopharmaceutical firm in China, focusing on R&D, production, and sales of biological drugs. It has developed a rich product and pipeline portfolio across various therapeutic areas, including nephrology, oncology, autoimmune diseases, and dermatology [13][16]. Oncology Pipeline - The SSGJ-707 is expected to become a cornerstone in global cancer immunotherapy, with multiple first-in-class (FIC) molecules entering clinical stages. The collaboration with Pfizer is a significant milestone, with substantial financial backing and a strategic focus on expanding clinical trials [1][8][37]. - Clinical data for SSGJ-707 shows promising efficacy and safety profiles, with high overall response rates (ORR) in various cancer types, indicating its potential to address unmet medical needs in oncology [1][8][37][38]. Autoimmune Pipeline - The company has several pipelines nearing commercialization, with notable advancements in clinical trials for various autoimmune treatments. The IL-17A monoclonal antibody SSGJ-608 and IL-1β monoclonal antibody SSGJ-613 have received NDA acceptance, indicating progress towards market entry [8][19]. Commercialization Capability - The company demonstrates strong commercialization capabilities, with core products maintaining high market shares. The flagship product, TPIAO, is expected to generate significant revenue, supported by new indications and stable pricing strategies [8][19][30]. - The company is also expanding its product portfolio in the erythropoiesis-stimulating agent market, maintaining a leading position despite competitive pressures [8][19]. Financial Projections - Revenue projections for 2025-2027 are estimated at 185.2 billion, 115.5 billion, and 117.8 billion CNY, respectively, with corresponding net profits of 97.7 billion, 37.2 billion, and 32.8 billion CNY. The report anticipates a significant increase in revenue in 2025, followed by a decline in subsequent years [7][8].

Core Viewpoint - Summit Therapeutics plans to submit a Biologics License Application (BLA) to the FDA in Q4 2025 for evorpacept in combination with chemotherapy for EGFR mutation non-squamous non-small cell lung cancer (NSCLC) patients who have progressed after third-generation EGFR-TKI treatment, marking a significant step in the drug's overseas commercialization efforts [1][2]. Group 1: Clinical Trial Results - The decision to submit the BLA is based on the positive results from the global Phase III clinical trial HARMONi, which achieved its primary endpoint of progression-free survival (PFS) [1]. - Updated data from the HARMONi study showed an improvement in overall survival (OS) with a hazard ratio (HR) of 0.78 (p=0.0332) for the intention-to-treat (ITT) population, particularly notable in the North American cohort with an HR of 0.70 [2]. - The median overall survival (mOS) for the evorpacept group was reported at 16.8 months compared to 14 months for the control group, with a HR of 0.79 [1]. Group 2: Commercialization and Partnerships - In December 2022, a collaboration agreement worth up to $5 billion was established between Kangfang Biopharma and Summit Therapeutics for the development and commercialization of evorpacept in key markets including the US, Canada, Europe, and Japan [3]. - A supplemental licensing agreement was signed in June 2024, expanding Summit's rights to develop and commercialize evorpacept in additional markets including China, South America, the Middle East, and Africa, with Kangfang receiving a $70 million upfront payment [3]. Group 3: Industry Context and Future Prospects - The development of PD-(L)1/VEGF dual-targeted therapies is seen as a critical advancement in cancer treatment, addressing limitations of existing therapies [7][8]. - The success of evorpacept in clinical trials has sparked renewed interest and investment in the PD-(L)1/VEGF space, with significant cross-border transactions indicating the global market's recognition of the drug's potential [8][9]. - The ongoing clinical exploration of evorpacept is expected to accelerate, with Summit planning to initiate new Phase III trials targeting additional indications [6].

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].

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]