Core Insights - Henlius is a leading Chinese biopharmaceutical company focused on R&D with six products approved for marketing in China and four products successfully entering international markets [1][4] - The company's pipeline emphasizes oncology and autoimmune diseases, featuring innovative candidates like HLX43 (PD-L1 ADC) and HLX22 (anti-HER2 monoclonal antibody) [1][2] Product Development - HLX43 is the first PD-L1 ADC globally to enter Phase II clinical trials, showing promising efficacy with an objective response rate (ORR) of 75% in thymic squamous cell carcinoma (TSCC) patients and 40% in squamous non-small cell lung cancer (sqNSCLC) patients [1] - HLX22, a novel anti-HER2 monoclonal antibody, is expected to redefine the standard of care for first-line HER2-positive gastric cancer, with ongoing Phase III trials in combination with trastuzumab and chemotherapy [2] Market Performance - Hansizhuang (Serplulimab) has achieved rapid domestic sales growth, reaching Rmb1.31 billion in 2024, and has been approved in multiple international markets [3] - The company has successfully entered global markets with four products, including Hanlikang and Hanquyou, and has established collaborations for the commercialization of various biosimilars [4] Financial Projections - Revenue forecasts indicate growth to Rmb5.96 billion in 2025, Rmb6.36 billion in 2026, and Rmb7.02 billion in 2027, with net profits projected at Rmb790 million, Rmb900 million, and Rmb1.14 billion respectively [5]

招银国际一举升复宏汉霖目标价至61.98港元 料创新药研发有庞大潜力 金十数据6月25日讯，招银国际发表研究报告指，复宏汉霖(02696.HK)有能力从一家正在盈利的生物类 似药公司，发展成为生物制剂领域的领先企业，包括HLX43、HLX22、斯鲁利单抗（Serplulimab）等多 款正在研发的创新药临床数据均表现良好，相信发展潜力庞大，因此目标价从20.33港元一举上调至 61.98港元，维持买入评级。招银国际认为，复宏汉霖正积极通过与药企合作，拓展全球生物类似药业 务，旗下汉曲优（曲妥珠单抗）及斯鲁利单抗商业化表现强劲，而HLX14和HLX11的上市许可申请目 前正获FDA审查当中，相信可开招海外收入来源。 ...

Core Insights - The innovative drug sector is experiencing a significant uptrend driven by new drug launches, reduced losses in biotech, and major business development (BD) activities, with a positive outlook for continued growth in the industry [1] - Fosun International's health sector is gaining market attention due to its innovative transformation in the pharmaceutical industry, showcasing unique value in "innovation," "technology," and "globalization" [1] Group 1: Company Developments - Fosun Pharma and its subsidiary, Hualan Biological Engineering, are entering a critical phase of pipeline realization, with a focus on differentiated and internationalized R&D strategies [1][4] - The PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), has become the first globally approved first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) [1] - Hualan's HLX43, a PD-L1 antibody-drug conjugate (ADC), is positioned to address unmet clinical needs in advanced/metastatic solid tumors, showing promising initial efficacy in non-small cell lung cancer (NSCLC) and thymic squamous cell carcinoma (TSCC) [2][3] Group 2: Market Expansion and Collaborations - Fosun is actively promoting its innovative products internationally, having established deep collaborations with over 20 leading biopharmaceutical companies to expand into global markets [5] - The approval of Sru Li Single Antibody in the EU and its coverage across over 30 countries demonstrates Fosun's capabilities in overseas registration and market access [5] - Ongoing clinical trials for innovative therapies targeting gastric cancer and breast cancer further indicate Fosun's commitment to expanding its global clinical capabilities [5] Group 3: Future Growth Potential - The combination of self-research, licensing, and globalization strategies positions Fosun for sustainable and high-value growth, with a strong pipeline and innovative technology platforms [6] - The recent approval of multiple new drugs by the National Medical Products Administration (NMPA) is expected to boost Fosun's performance, especially with the upcoming medical insurance negotiations [6] - The Chinese biotechnology sector has seen a significant revaluation, with a 72% increase year-to-date, indicating a robust outlook for the innovative drug market [6][7]

2025ASCO 大会国内重点研究总结报告 | [Tabl 分析师： | 罗佳荣 | 分析师： | 李安飞 | | --- | --- | --- | --- | | e_Author] | SAC 执证号：S0260516090004 | | SAC 执证号：S0260520100005 | | | SFC CE.no: BOR756 | | | | | 021-38003671 | | 021-38003669 | | | luojiarong@gf.com.cn | | lianfei@gf.com.cn | | | 请注意，李安飞并非香港证券及期货事务监察委员会的注册持牌人，不可在香港从事受监管活动。 | | | [Table_Summary] 核心观点： 相关研究 [Table_Report ： ] 医药生物非药行业 2024 年报及 2025 年 1 季报总结:蓄势待发，看好国内创新优势与制造优势 2025-05-05 识别风险，发现价值 请务必阅读末页的免责声明 [本报告联系人： Table_C ontacter] 龙雪芳 021-38003558 longxuefang@gf.com.cn 王 ...

该公司还在2025美国临床肿瘤学会(ASCO)年会上首次公布了HLX43(PD-L1 ADC)治疗晚期/转移性实体 瘤患者的I期临床试验数据，该研究由中国医学科学院肿瘤医院王洁教授担任牵头主要研究者。目前， 全球范围内尚无PD-L1 ADC获批上市，HLX43有望解决PD-1/L1免疫疗法不响应或耐药问题，为更多晚 期/转移性实体瘤患者带来新的治疗选择。 复宏汉霖已有6款产品在中国获批上市，4款产品在国际获批上市，触达50多个国家和地区，累计惠及全 球超80万患者。自2025年初至今，复宏汉霖股价已涨逾100%。近期该公司已获纳入MSCI全球小型股指 数成分股，有望进一步吸引更多国际资本关注。 智通财经APP获悉，复宏汉霖(02696)6月9日发布公告，H股全流通备案申请获中国证监会受理。今日(6 月10日)公司股价依旧维持强势，收涨2.17%，报49.40港元。市场可期待该公司未来完成H股全流通后， 除增加公司股份流动性外，也将进一步提升公司治理和市场竞争力，进而推进公司业务高速发展，为股 东创造价值。 此外，复宏汉霖研究成果也积极在美国临床肿瘤学会(ASCO)年会亮相。公司近日宣布，创新型抗HER2 单抗 ...

2015年药品审评审批制度改革被视为中国创新药行业的起点，2025年正好是中国创新药发展了十年 的节点，我国创新药行业交上了一份怎样的答卷？且看今年ASCO年会上他们如何冲击全球第一梯队。 一年一度的美国临床肿瘤学会（ASCO）年会于5月30日至6月3日在芝加哥盛大召开。作为全球肿 瘤学领域规模最大、学术影响力最高和最具权威性的盛会，这里不仅汇聚了全球肿瘤学领域的医生、工 业界代表、患者倡导者和媒体等，每年还有诸多最前沿的数据与成果发布。 在本届年会上，中国专家的发言数量再创新高，共有73项原创性研究成果入选口头发言环节（Oral Abstract Session），数量创下历史新高。其中，有11项以最新突破摘要（Late-Breaking Abstracts， LBA）形式公布。在2015年的ASCO年会上，我国仅有1项新药研究入选口头报告，最新突破摘要为 零。今年中国创新药可谓"研"值拉满，医药巨头中国生物制药以12项口头报告创下中国药企在ASCO的 最高纪录，且其有4项研究被列为LBA，加上壁报和摘要收录，共有40余项研究亮相。 1 国产ADC管线占据半壁江山 编者按： 从现场看，国产抗体偶联药物（AD ...

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 ...

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 ...

Core Insights - The 2025 ASCO Annual Meeting will showcase significant research results from domestic innovative drugs, highlighting their potential in oncology treatments [1] Group 1: Clinical Data and Drug Performance - The TROP2 ADC SKB264 from Kelun-Biotech reported a 59.3% overall response rate (ORR) and a 91.4% disease control rate (DCR) in a Phase II trial for non-small cell lung cancer (NSCLC) [2] - The median progression-free survival (mPFS) for the same patient group was 15.0 months, with ORR varying by PD-L1 expression levels: 47.1% for TPS<1%, 68.1% for TPS≥1%, and 77.8% for TPS≥50% [2] - Compared to previous data, the ORR decreased from 72.7% to 59.3% in a larger sample size [2] - SKB264 demonstrated superior efficacy over other PD-1/VEGF dual antibodies, with ORR of 54.5% for SSGJ-707 and 47% for Ivosidenib [3] Group 2: Safety and Adverse Effects - The incidence of grade 3 or higher adverse reactions for SKB264 was 40%, higher than SSGJ-707's 24.1% and Ivosidenib's 29% [3] - However, the discontinuation rate due to adverse effects for SKB264 was 0%, lower than Ivosidenib's 2% and SSGJ-707's 6% [3] Group 3: Comparative Efficacy in EGFR Mutant NSCLC - In a separate study for EGFR mutant NSCLC, SKB264 showed a 45.1% ORR and mPFS of 6.9 months, statistically significant compared to Docetaxel [4] - Despite a decrease in ORR and mPFS in larger sample sizes, SKB264 still outperformed Dato-DXd (43%) and HER3-DXd (35.2%) in efficacy [4] - Other domestic competitors also showed promising results, with Ivosidenib achieving an ORR of 50.6% and BL-B01D1 reaching 52.5% in their respective trials [4][5]

今日港股多数飘红，T+0交易的港股通创新药ETF（159570）盘中进一步上涨近1%，成交额轻松突破12亿元！资金积极 涌入，盘中狂揽净流入7700万元，近60日更是大举"吸金"超18亿元！ | 日 周 月 更多 | 综合屏 F9 前复权 超级叠加 画线 工具 © 2 | | 港股通创新药ETF | | 159570 | | --- | --- | --- | --- | --- | --- | | 收 1.380 幅0.73%(0.010) 开 1.367 高 1.387 低 1.364 均 1.376 量827万 换 | 160 1.2101 MA120 1.1021 MA250 0.9901 2024/09/30-2025/06/03(160日) ▼ | | 380 | | +0.010 +0.73% | | | | | | SZSE CNY 13:25:33 交易中 T+0 間 / Q 4 | | | 1.40 | 1.393 | | 净值走势 | | 汇添富国证港股通创新药ETF | | | | | रोस 43.60% 120日 | | 39.82% | | 1.30 | | | R | 9.18 ...