机构：中信建投证券 研究员：贺菊颖/袁清慧 核心观点 康方生物作为全球双抗引领者，其核心产品依沃西（AK112 ，PD-1/VEGF 双抗）成为全球首个在1L 肺 癌治疗中mPFS 超越K 药的双抗，海外HARMONi 数据延续国内获益趋势，验证了依沃西在跨区域研究 中具有一致性的临床疗效。本篇报告是2.0 版本深度，主要更新（1）AK112 国内外临床数据，论证其 为什么是重磅品种（2）AK104 与AK112 如何差异化定位（3）后续值得关注的双抗新靶点在研产品。 后续建议关注1）2025 ESMO HARMONi-6 临床数据公布，2）AK112、AK104 海外临床进展,3)国内 2025 年医保谈判，4)潜在BD。 报告背景及亮点 我们于2023 年12 月发布康方生物第一篇深度报告《深耕创新的综合性平台，出海合作拥抱机遇》，主 要分析了AK104 其临床优势与市场空间，AK112 前期临床数据展现出的潜力以及公司其他肿瘤和自免/ 代谢管线的临床布局和潜力。2024 年以来随着AK112 多项重磅III 期数据的披露，其潜力不断凸显，第 二篇深度在第一篇的基础上（1）结合过往PD-1+VEGF 单抗 ...

Core Insights - The FDA has publicly released 202 drug approval rejection letters (CRLs), exposing the failure records of global pharmaceutical companies, including four Chinese firms [1][2] - The transparency brought by the CRL publication is expected to reshape industry standards and compel companies to improve compliance and clinical design [4] Group 1: Chinese Pharmaceutical Companies' Rejections - Zhejiang Innovation Biotech faced three rejections for its Vancomycin injection due to non-compliance in production facilities and significant safety report omissions [3] - Luye Pharma's Risperidone injection was rejected twice due to severe safety concerns, including unexplained spikes in blood drug concentration during key clinical trials [3] - Baiji Shenzhou's Bevacizumab biosimilar failed due to flaws in analytical methods, leading to the dismissal of key efficacy data and multiple quality control issues [3] - Kangfang Biotech's Pembrolizumab was blocked due to insufficient clinical data and unstable production cell lines, although it later received approval for two indications after addressing the FDA's concerns [3] Group 2: Industry Implications - The cases highlight common weaknesses among Chinese pharmaceutical companies, such as clinical design flaws, quality control lapses, and insufficient bioequivalence evidence [4] - The experience of Kangfang Biotech demonstrates that CRLs are not the end; companies can successfully reverse decisions by providing additional data [4] - The shift from a "black box" to a "glass house" in the approval process necessitates that Chinese firms integrate compliance awareness throughout the entire R&D chain to gain lasting trust in global markets [4]

Core Insights - Guangdong Province has approved a list of 107 innovative drug and medical device products, including 46 innovative drugs, to enhance the application of these products in public medical institutions [1][5] - Among the approved innovative drugs, 10 are anti-cancer drugs, representing 22% of the total, showcasing Guangdong's strength in cancer treatment research and manufacturing [3][5] Summary by Category Innovative Drug List - The list includes 107 innovative products, with 46 classified as innovative drugs [1] - The anti-cancer drugs cover various prevalent malignant tumors, indicating significant research capabilities in this area [3] Anti-Cancer Drugs - The 10 anti-cancer drugs listed include: - Aorebatinib for chronic myeloid leukemia - Sapalizumab for cervical cancer and Hodgkin lymphoma - Socazolimab for cervical cancer - Sidabenzamide for diffuse large B-cell lymphoma - Cardunilimab for cervical cancer and gastric adenocarcinoma - Acetate injection for prostate cancer - Trelizumab for multiple cancers including Hodgkin lymphoma and non-small cell lung cancer - Panitumumab for multiple cancers including non-small cell lung cancer - Obinutuzumab for adult lymphomas - Ivorilumab for lung cancer [4] Industry Development - Guangdong pharmaceutical companies are accelerating their internationalization, exemplified by the approval of Panitumumab for the U.S. market [5] - The integration of industry, academia, and research has been pivotal in the development of these innovative drugs, with local scholars leading significant research efforts [5] - The comprehensive innovation capability from research to clinical application is being established, enhancing Guangdong's competitive edge in the global biopharmaceutical industry [5]

Group 1: Marine Economy - The Central Financial Committee emphasized high-quality development of the marine economy, focusing on top-level design, policy support, and encouraging social capital participation [1] - Guangdong Province has implemented new regulations for high-quality marine economic development, while Shandong Province aims for marine specialty industries to grow significantly faster than GDP by 2027 [1] - The pharmaceutical value of marine biological resources is substantial, with new drug development opportunities expected to drive rapid growth in the marine biomedicine industry, particularly for new drugs based on marine active substances [1] Group 2: Photovoltaic Industry - Prices for silicon materials, silicon wafers, battery cells, and TopCon components are projected to decrease by 11.42%, 9.28%, 10.52%, and 4.22% respectively by 2025 [2] - BC batteries (bifacial batteries) gained attention at the SNEC exhibition and are seen as having the potential to challenge TopCon technology, although large-scale production has not yet been achieved [2] - TCL Photovoltaic Technology is exploring new growth points in the domestic market through an integrated solution of "photovoltaics + energy storage + charging piles + heat pumps," especially as costs decline [2] Group 3: Embodied Intelligence - The application of embodied intelligence has shown initial results, but experts indicate it is still in the exploratory stage and not yet at a mature industrial level [3] - Traditional industrial robots rely on manual programming, requiring long adjustments for product model changes, while embodied intelligence can significantly shorten this process and enhance production efficiency [3] - The lack of uniform hardware among different manufacturers complicates data sharing and interoperability, increasing the difficulty of industry standardization [3] Group 4: Semiconductor Industry - Despite short-term pressure on tech stocks, long-term investment in the semiconductor and chip sectors remains strong, with notable declines in stocks like Hengxuan Technology and Cambricon [4][5] - The semiconductor industry is experiencing consolidation, with increased support for mergers and acquisitions from national policies, exemplified by several high-profile acquisitions [4] - AI technology is expected to drive demand growth in AI servers, AI phones, and AIPC devices, forming a smart ecosystem centered around AI servers [4] Group 5: Innovative Pharmaceuticals - Guangdong Province has released its first batch of approved innovative drug and medical device products, including 107 items, with 10 cancer drugs making up about 22% of the total [5] - The approval of innovative drugs like Cardunilumab for cervical cancer treatment highlights the advancements in tumor immunotherapy and the capabilities of local companies [5] - Research teams from Sun Yat-sen University have successfully developed and commercialized innovative drugs, contributing to the international success of local pharmaceutical products [5]

创业最前线 . 创业有道·创新中国｜长期关注中国科技创新经济市场，提供更有价值的创投科技报道。 作者 | 孟祥娜 来源 | 创业最前线 导 语： 康方生物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。 近日，重庆巫山县肿瘤患者李某美求医购药的经历，将创新药企康方生物推向舆论的风口浪尖。 以下文章来源于创业最前线 ，作者孟祥娜 据大象新闻6月2日报道，李某美经医生推荐，耗费79320元购入卡度尼利单抗注射液，在使用的约 70支药物中，仅有6支为正规上市药品、5支标注"慈善基金会捐赠"，其余竟均为严禁流入市场的临 床研究用药。 面对质疑，康方生物迅速回应，坚称从未向患者收取临床研究药物费用，强调销售人员也未从中获 利，直指"花钱购买临床研究用药"是子虚乌有。 戏剧性的是，就在争议持续发酵之时，康方生物6月5日宣布重大喜讯：卡度尼利联合含铂化疗（联 合 或不联合贝伐珠 单抗）一线治疗宫颈癌的新适应症获批，填补国内该领域免疫治疗空白，标志 着这款药物拿下第三项全人群适应症。 实际上，早在2022年6月，卡度尼利便获批用于既往接受含铂化疗治疗失败的 ...

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 中国创新药在 ASCO 表现超预期，关注信达 生物、科伦博泰等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 环码生物 RNA 创新药获 FDA IND 默示许可；PROTAC 雌激素受体降 解剂向 FDA 递交 NDA；国产九价 HPV 疫苗获批上市，填补高端疫苗 空白 6 月 6 日，环码生物宣布，其自研的环形 RNA 新药 HM2002 获 FDA 新药临床试验申请（IND）默示许可。该药为全球首款完成患者给 药的环形 RNA 类药物，曾于 1 月获中国 NMPA IND 批准。6 月 7 日， Arvinas 与辉瑞联合宣布，已向 FDA 递交 Vepdegestrant 的新药申请 （NDA），该药为全球首个口服 PROTAC 雌激素受体降解剂，适用于 ER+/HER2-乳腺癌患者。6 月 4 日，由翔安实验室与厦门大学等联合研 制的国产九价 HPV 疫苗获国家药监局批准上市，成为我国首个自主供 应的九价 HPV 疫苗，标志中国正式成为继美国后第二个具备高价 HPV 疫苗自主可控能力的国家。 ◼ 具体配 ...

[Table_IndustryInfo] 2025 年 05 月 18 日 强于大市(维持) 证券研究报告•行业研究•医药生物 医药行业创新药周报（5.12-5.16） 2025 年 5 月第三周创新药周报 A 股和港股创新药板块及 XBI 指数本周走势 西南证券研究院 2025[Table_Summary] 年 5月第三周，陆港两地创新药板块共计 39个股上涨，67个股下跌。其中 涨幅前三为德琪医药-B（18.34%）、思路迪（14.57%）、嘉和生物-B（14.48%）。 跌幅前三为歌礼制药-B（-17.10%）、康宁杰瑞制药-B（-8.72%）、云顶新耀-B （-7.77%）。 本周 A 股创新药板块上涨 1.75%，跑赢沪深 300 指数 0.63pp，生物医药上涨 1.19%。近 6 个月 A 股创新药累计上涨 12.20%，跑赢沪深 300 指数 13.49pp， 生物医药累计下跌 8.18%。 本周港股创新药板块上涨 2.77%，跑赢恒生指数 0.68pp，恒生医疗保健上涨 0.57%。近 6 个月港股创新药累计上涨 25.74%，跑赢恒生指数 5.95pp，恒生医 疗保健累计上涨 18.27% ...

Market Overview - Recent improvement in US stock market sentiment attributed to Trump's successful Middle East visit [1] - Hong Kong stock market remains sluggish with average trading volume around 220 billion, failing to exceed 300 billion for a breakthrough [1] - Both markets are experiencing weakness due to lack of new stimuli following US-China talks, with a focus on stability in policy adjustments [1] Company Developments - BYD announced the establishment of its European headquarters in Budapest, Hungary, with a total investment of 100 billion HUF (approximately 24.8 million euros), creating 2,000 jobs [3] - The new headquarters will focus on sales, after-sales, vehicle certification, and local design, marking a significant step for BYD in the European market [3] - Netease reported strong financial results, maintaining growth despite the absence of new hits, indicating a healthy industry environment [5] Regulatory Changes - A new mandatory national standard for light vehicle automatic emergency braking systems has been drafted, expanding its applicability to N1 class commercial vehicles [4] - This change is expected to significantly benefit companies like Nanchang Special Vehicle Co., which has been a leader in this technology since 2017 [4] Financial Performance - Tencent and Alibaba reported stable earnings with approximately 10% revenue growth, while JD.com faced a decline of over 4% due to potential losses in local services [4] - China Biopharmaceutical is projected to achieve a revenue of 28.87 billion yuan (+10.2%) in 2024, with a notable increase in innovative drug approvals [11][12] - The company has received FDA approval for its first innovative drug in the US, marking a significant milestone [11] Market Trends - The gaming industry shows resilience with increased engagement despite economic downturns, as evidenced by Netease's stock surge of over 13% [5] - The restaurant sector is also performing well, with companies like Zhou Hei Ya and Guoquan showing positive trends [6] - The stock market is witnessing varied attitudes towards technology stocks, with notable movements from major investors like Buffett and Soros [6]

Policy Developments - The National Medical Products Administration (NMPA) emphasizes the need for comprehensive drug regulation reform to enhance drug safety and support high-quality development in the pharmaceutical industry [2] Drug and Device Approvals - Zai Lab's new drug application for JAK inhibitor, Tofacitinib, for treating severe alopecia areata has been accepted by the NMPA, marking its second indication for this drug [4] - Tonghua Dongbao's insulin injection has received marketing approval in Nicaragua, expanding its overseas sales potential [5] - BeiGene's new indication application for its BCL2 inhibitor, Sotorasib, for treating mantle cell lymphoma has been accepted by the NMPA [6] - Yilian Biopharma's antibody-drug conjugate targeting VEGF has received clinical trial approval in the U.S. [7] - Zhengda Tianqing's combination therapy for advanced hepatocellular carcinoma has shown positive results in a Phase III trial, with plans for a market application in November 2024 [8] - Rongchang Biopharma's clinical trial application for its ADC molecule RC278 has been accepted by the NMPA [9][10] Capital Markets - Easternova Biotechnology has submitted its IPO application to the Hong Kong Stock Exchange, focusing on regenerative medical materials [12] - China National Pharmaceutical Group plans to acquire 100% of Jinsui Technology for 302 million yuan, enhancing its e-commerce operations in health products [13] Industry Developments - Suzhou Industrial Park has launched a plan to accelerate the development of the biopharmaceutical and health industry, focusing on innovation and enterprise growth [15] - Ganli Pharmaceutical has signed a cooperation agreement with the Brazilian Ministry of Health, becoming the first Chinese pharmaceutical company to enter Brazil's PDP program [16]

[Table_IndustryInfo] 2025 年 05 月 11 日 强于大市(维持) 证券研究报告•行业研究•医药生物 医药行业创新药周报（5.5-5.9） 2025 年 5 月第二周创新药周报 A 股和港股创新药板块及 XBI 指数本周走势 西南证券研究院 [Table_Summary] 2025 年 5月第二周，陆港两地创新药板块共计 39个股上涨，67个股下跌。其中 涨幅前三为海创药业-U（22.76%）、长春高新（8.99%)、众生药业（8.98%）。 跌幅前三为复宏汉霖（-12.64%）、康诺亚-B（-12.40%）、博安生物（-11.77%）。 本周 A 股创新药板块上涨 2.33%，跑赢沪深 300 指数 0.33pp，生物医药上涨 0.75%。近 6 个月 A 股创新药累计上涨 5.43%，跑赢沪深 300 指数 9.13pp， 生物医药累计下跌 10.55%。 本周港股创新药板块下跌 2.14%，跑输恒生指数 3.75pp，恒生医疗保健下跌 3.75%。近 6 个月港股创新药累计上涨 22.08%，跑赢恒生指数 4.47pp，恒生医 疗保健累计上涨 18.10%。 本周 XBI 指数 ...