Core Insights - The PD-1/VEGF dual antibody is currently a hot topic in innovative drug development, with significant collaborations and financial transactions highlighting its potential [1][2][3] Group 1: Industry Dynamics - Chinese biotech companies are emerging as key players in the global PD-(L)1/VEGF dual antibody development race, demonstrating advanced research progress and achieving international recognition through high-value business development (BD) deals [2][3] - Major collaborations include 12.5 billion USD upfront payment and 60.5 billion USD total deal value between 3SBio and Pfizer for SSGJ-707, and BioNTech's 15 billion USD upfront payment for BNT327 licensed to BMS, totaling over 90 billion USD [1][2] Group 2: Clinical Developments - The PD-(L)1/VEGF target gained traction after Kangfang Biotech's AK112 outperformed the benchmark drug, Pembrolizumab (K drug), in head-to-head trials, leading to increased interest from multinational corporations (MNCs) [3][4] - AK112 demonstrated a higher objective response rate (ORR) of 50% compared to K drug's 38.5% and a disease control rate (DCR) of 89.9% versus 70.5% in late-stage non-small cell lung cancer (NSCLC) trials [4][6] Group 3: Competitive Landscape - The success of AK112 has intensified competition among MNCs, with companies eager to capitalize on the potential of PD-(L)1/VEGF dual antibodies, as evidenced by Pfizer's strategic investments [9][10] - As of May 2025, there are 14 PD-(L)1/VEGF dual antibodies in clinical stages globally, with half originating from Chinese biotech firms, indicating a robust pipeline and potential for further BD opportunities [15][24] Group 4: Future Prospects - Companies like Junshi Biosciences, I-Mab, and Hualan Biological Engineering are actively pursuing PD-(L)1/VEGF dual antibodies, with significant investments and clinical trials underway [15][20][22] - The shift from merely imitating existing drugs to innovating new targets and technologies marks a significant evolution in the Chinese pharmaceutical industry, enhancing its international competitiveness [24][25]

J P M O R G A N Asia Pacific Equity Research 05 June 2025 Akeso AK104 approval in 1L CC with catalysts ahead Akeso announced today that AK104, a PD-1/CTLA-4 bispecific antibody, has received approval in China for the first-line treatment of persistent, recurrent, or metastatic cervical cancer (CC). This treatment is to be used in combination with platinum-based chemotherapy, with or without bevacizumab, marking the third approved indication of AK104. Despite the market's focus on AK112, we believe AK104 is ...

2025ASCO：中国创新，闪耀全球 20250606 摘要 中国创新药在 ASCO 会议上的数据占比创新高，口头报告 73 项，LBA 报告 11 项，表明中国药企创新能力显著提升，尤其在双抗、ADC 和小 分子疗法领域。 信达生物的二代 IO 产品 IBI363 通过增强 IL-2 功能并降低毒性，在黑色 素瘤、结直肠癌和肺癌中显示出潜力，尤其在非小细胞肺癌后线治疗中， 低剂量组总生存期超过 15 个月。 IBI363 在结直肠癌四线治疗中，1 毫克剂量组 OS 达 17.5 个月，接近 一线治疗水平，联合贝伐珠单抗后 ORR 接近 20%，DCR 超过 60%， 显著延长患者总生存期。 康方生物卡度尼利单抗一线治疗宫颈癌亚组分析显示，PD-L1 低表达患 者 PFS 达 12 个月，CPS>10%患者 PFS 达 11.1 个月，验证了其在宫 颈癌治疗中的优势。 博泰公司的 ADC 药物 264 在 HER2 突变耐药及 TNBC 中表现突出， HER2 突变耐药患者 ORR 达 45.1%，PFS 达 6.9 个月；一线 TNBC 患 者 ORR 达 71%，PFS 达 13.4 个月。 Q&A 近年 ...

Core Viewpoint - The incident involving a cervical cancer patient purchasing a clinical trial drug from a representative of Kangfang Biopharma raises serious concerns about the distribution and management of clinical trial medications in China [1][2][4]. Company Summary - Kangfang Biopharma's drug, Cardunilumab, was conditionally approved by the National Medical Products Administration in June 2022 for treating recurrent or metastatic cervical cancer after platinum-based chemotherapy failure [3]. - The company stated that the sales personnel had forged research documents to obtain the drug under the guise of clinical research, and the patient was given the drug without charge [4]. - Kangfang Biopharma has committed to cooperating with regulatory authorities in the investigation and ensuring the protection of patient rights [5][8]. Industry Summary - The incident highlights the regulatory challenges in the management of clinical trial drugs, emphasizing the responsibility of drug manufacturers for the safety and efficacy of their products throughout the entire lifecycle [9]. - The ongoing investigation by the Chongqing Drug Administration indicates a proactive approach to addressing potential violations in drug distribution practices [7][8].

Company Update - The company announced the results of the global multicenter Phase III clinical trial HARMONi for AK112 in 2L EGFRm NSCLC, achieving a PFS HR of 0.52 and an OS HR of 0.79, indicating a successful primary endpoint for PFS and a significant trend in OS benefit [1] - The results from the international HARMONi trial are consistent with the domestic HARMONi-A trial, which reported a PFS HR of 0.46 and an OS HR of 0.80 (52% data maturity) [1] - The HARMONi clinical program enrolled 420 patients, with 38% from Europe and the US, supporting the extrapolation of domestic clinical data to global data [1] Market Context - Currently, no FDA-approved drugs have achieved statistically significant OS in 2L EGFRm NSCLC, with the OS p-value for HARMONi being 0.057 [2] - The lack of statistically significant OS data in the market indicates a substantial unmet clinical need for 2L+ EGFRm NSCLC treatments [2] - AK112 shows promise based on positive PFS and OS data, potentially addressing the needs of 2L+ EGFRm NSCLC patients [2] Financial Forecast and Valuation - The company maintains its profit forecasts for 2025 and 2026 unchanged [2] - The target price is set at HKD 120.0, indicating a 60% upside potential from the current stock price [2]

Market Performance - Jinli Permanent Magnet (06680) rose over 17% due to significant increases in overseas medium and heavy rare earth prices, which are expected to gradually transmit to the domestic market [1] - Zhixing Technology (01274) increased over 3% after securing a platform-based logistics vehicle contract with a leading domestic brand [1] - Weimeng Group (02013) surged over 9% as its upgraded Weimeng Guide Agent product is anticipated to benefit from the growth of WeChat e-commerce [1] - Zhaoke Ophthalmology-B (06622) gained over 8% following FDA approval for a new drug trial application for cyclosporine eye gel [1] - Zai Ding Pharmaceutical (09688) rose over 5% after reporting excellent data from the low-dose group of ZL-1310 [1] - Lianlian Digital (02598) saw a mid-session increase of over 5% as it partnered with BVNK to provide stablecoin payment solutions for its merchants [1] - Reading Group (00772) increased over 7% after acquiring a 26.67% stake in Yihua Kaitian, with its IP+AI strategy expected to unlock more value [1] - NIO opened nearly 4% higher, projecting a year-on-year revenue growth of 11.8%-15% for Q2 [1] - Kuaishou-W (01024) rose over 6% as its Kecing AI recently launched a new 2.1 series model, with institutions optimistic about its profitability [1] - Meituan (03690) surged over 3%, reaching a nearly two-month high, with southbound funds continuing to accumulate for 13 consecutive days [1] US Market Highlights - Applied Digital (APLD.US), a stock related to Nvidia, surged nearly 30%, with a 94% increase over three trading days, as long-term contracts are expected to generate $7 billion in revenue [2] - Tesla (TSLA.US) fell 3.55% due to declines in both the Chinese and European automotive markets, with a 15% year-on-year drop in China's May wholesale sales of new energy passenger vehicles [2] - MongoDB (MDB.US) saw a nearly 15% increase in after-hours trading following better-than-expected Q1 results and an $800 million stock buyback plan [2] - Broadcom (AVGO.US) rose over 3% before earnings, reaching a new historical high, with Morgan Stanley stating that AI is operating at full speed, expecting strong Q2 results [3] - Meta increased over 3% as it was reported to be accelerating the development of ultra-lightweight open-headset projects [3] - Guidewire Software (GWRE.US) surged over 16% after exceeding Q3 earnings expectations and raising its guidance [3] - Dollar Tree (DLTR.US) fell over 8% after warning of potential 50% declines in adjusted earnings due to tariffs and weak consumer spending [3] - STMicroelectronics (STM.US) rose nearly 11% amid reports that Italy and France are considering splitting its joint management rights [3]

Group 1 - The Hong Kong stock market showed strong performance on June 5, with the Hang Seng Index rising by 0.93% and the Hang Seng Tech Index increasing by 1.5% [1] - The Hang Seng Medical Index ETF (159557) rose by 0.81% with a turnover rate of 7.52%, indicating active trading [1] - Notable performers among the constituent stocks included Four Seasons Medicine and Hutchison China MediTech, both rising over 7%, while Zai Lab increased by over 6% and CanSino Biologics rose by over 5% [1] Group 2 - According to industrial analysts, demand in the domestic market is expected to recover by 2025, with a positive outlook for the consumption medical sector, including medical services, OTC traditional Chinese medicine, and chain pharmacies [2] - The medical device sector is also anticipated to improve by 2025, with AI in healthcare expected to bring significant changes to the pharmaceutical industry [2] - China's innovative drugs have gained recognition from large overseas pharmaceutical companies, indicating that the country's R&D capabilities are now internationally competitive, which is expected to drive performance growth [2]

Policy Developments - Shandong Province's health commission has introduced a plan to provide free care services in all public tertiary hospitals by the end of 2025, aiming to enhance patient experience and satisfaction [2] Drug and Device Approvals - The first domestically produced nine-valent HPV vaccine, named Xinkening 9, has been approved for women aged 9-45, with a two-dose regimen for ages 9-17 and a three-dose regimen for ages 18-45. This vaccine is the second nine-valent HPV vaccine globally, breaking a long-standing market monopoly held by Merck [4] - Huayu Pharmaceutical has received a drug registration certificate for injectable polymyxin B sulfate, effective against nearly all Gram-negative bacteria except for a specific strain [5] - AstraZeneca's drug, Imfinzi (durvalumab), has been approved for the treatment of limited-stage small cell lung cancer in adults, based on positive results from the ADRIATIC Phase III clinical trial [6] Capital Markets - Tianchen Biopharmaceuticals has completed over 200 million yuan in Series C financing, which will be used for the clinical development and commercialization of its core pipeline products [8] Industry Events - Kangfang Biotech has denied allegations of selling clinical research drugs, stating that a sales representative misappropriated drugs for a patient without charging any fees [10][11] - Eli Lilly has signed a licensing and development agreement with Camurus to jointly develop long-acting insulin drugs for obesity and diabetes treatment, with potential milestone payments of up to $870 million [12] - Xinghao Pharmaceutical announced that major shareholder Shuanglu Pharmaceutical plans to reduce its stake by up to 1.51% through various trading methods [14]

每经记者｜金喆 林姿辰 每经编辑｜陈俊杰 6月4日，康方生物方面向《每日经济新闻》记者表示，经调查核实，对于患者李某美使用的临床研究药 物，公司重庆销售人员通过伪造研究立项文件及医院伦理批件等材料，以研究者发起的药品上市后临床 研究的名义，从公司骗取了若干药物，并无偿给予患者李某美使用。公司从未向患者李某美收取任何费 用，公司经办销售人员亦未收取患者李某美的任何费用。 记者了解到，为规范临床试验，国家药品监督管理局和国家卫生健康委员会对临床试验药物有非常严格 的管理要求。国内某顶级肿瘤医院负责临床试验的医务人员告诉记者，他们有专人管理和记录用于临床 试验的药物，临床研究助理会负责清点药品数量、进行回收登记和双人核对。 康方生物否认向患者销售临床研究用药 卡度尼利单抗注射液是康方生物的PD-1单抗，在2022年6月获得国家药品监督管理局批准上市，用于治 疗复发或转移性宫颈癌。 从去年4月到今年2月，李某美每隔21天注射一次卡度尼利单抗注射液，每次5支，共计用药十四五次， 约有70瓶。 康方生物方面对记者表示，经公司内部自查，并向相关DTP（直接面向患者）药房以及患者李某美本人 核实：2024年4至5月期间，患者 ...

Core Viewpoint - The recent controversy surrounding the clinical trial drug Cardunilumab from Kangfang Biopharma has raised significant industry attention due to issues of compliance and clinical trial results [2][6]. Compliance Issues - A patient purchased 70 doses of Cardunilumab for 79,320 yuan, most of which were labeled for "clinical research use only" [3][4]. - Kangfang Biopharma stated that the sales representative forged documents to obtain the drugs and provided them to the patient without charge, emphasizing that no fees were collected from the patient [4][5]. Clinical Trial Results - The Phase III trial HARMONi showed significant improvement in progression-free survival (PFS) with a risk ratio of 0.52, but did not achieve statistical significance in overall survival (OS) with a risk ratio of 0.79 [6][8]. - Despite the OS results, both Kangfang and its partner Summit Therapeutics expressed confidence in the drug's potential, noting that no FDA-approved treatments have significantly improved OS in this patient group [7][8]. Financial Performance - In 2024, sales revenue for Cardunilumab reached 1.713 billion yuan, a year-on-year increase of 16.53%, while the newly launched Ivosidenib generated 289 million yuan in just seven months, accounting for 14.44% of total revenue [8][9]. - The company's R&D expenditure decreased by 5.29% to 1.188 billion yuan, while sales and marketing expenses increased by 12.51% to 1.002 billion yuan, indicating a strategic shift [9]. Future Outlook - Kangfang Biopharma plans to continue advancing clinical research for Ivosidenib and other products, with a focus on global development in the oncology immunotherapy field [10]. - The recent licensing agreement between 3SBio and Pfizer for a competing PD-1/VEGF dual antibody adds competitive pressure in the market, necessitating careful global strategy planning by Kangfang [10].