Core Viewpoint - XinNuoWei (300765) announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SYS6023, an antibody-drug conjugate targeting HER3, aimed at treating unresectable locally advanced or metastatic breast cancer [1] Group 1 - The SYS6023 drug is designed to utilize a self-developed topoisomerase I inhibitor payload, which is expected to avoid drug resistance through efflux mechanisms [1]

Core Viewpoint - The company XinNuoWei (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SYS6023, a HER3-targeted antibody-drug conjugate [1] Group 1 - SYS6023 is designed to target specific receptors on tumor surfaces and utilizes a topoisomerase I inhibitor developed by the company as its payload [1] - The mechanism of SYS6023 involves binding to tumor cells, entering them through endocytosis, and releasing toxins to kill cancer cells [1] - The payload of SYS6023 is not a substrate for efflux pumps, which is expected to help avoid resistance issues commonly seen with DXd class ADCs [1]

Core Viewpoint - The announcement highlights that New Horizon (新诺威) has received approval from the National Medical Products Administration for clinical trials of SYS6023, a HER3-targeted antibody-drug conjugate [2] Group 1: Product Development - SYS6023 is designed as a HER3-targeted antibody-drug conjugate that utilizes a self-developed topoisomerase I inhibitor as its payload [2] - The drug is intended to bind to specific receptors on tumor surfaces, allowing for internalization and subsequent release of toxins to kill tumor cells [2] - The payload of SYS6023 is not a substrate for efflux pumps, which is expected to help avoid resistance issues commonly seen with DXd class ADCs [2]

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary, Suzhou Merdia Biopharmaceutical Co., Ltd., has received inclusion of its injectable SHR-A1811 (Rocatinib) in the list of breakthrough therapies by the National Medical Products Administration (NMPA), marking the 10th indication for which it has received breakthrough therapy certification [1] Group 1: Drug Information - Drug Name: Injectable Rocatinib (SHR-A1811) [1] - Acceptance Number: CXSL2000087 [1] - Drug Type: Therapeutic biological product [1] - Registration Category: Class 1 [1] - Application Date: December 2, 2025 [1] - Proposed Indication: First-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations [1] Group 2: Approved Indications - The injectable Rocatinib was approved for domestic market launch in May 2025, indicated for adult patients with unresectable locally advanced or metastatic NSCLC who have previously received at least one systemic therapy and have HER2 (ERBB2) activating mutations [2] Group 3: Market Context - Primary lung cancer is the most common malignant tumor globally, with GLOBOCAN 2022 data indicating approximately 2.48 million new cases and 1.82 million deaths annually, making it the leading cause of cancer mortality [3] - In 2022, China reported 1.06 million new lung cancer cases, accounting for 22.0% of all malignant tumors, and 733,300 deaths, representing 28.5% of all cancer deaths [3] - NSCLC accounts for about 85% of lung cancer cases, with approximately 2%-4% of NSCLC patients experiencing HER2 mutations, which are associated with high tumor invasiveness and poor prognosis [3] - Recent advancements in antibody-drug conjugates and highly selective HER2-TKIs have provided new treatment options for patients with advanced NSCLC harboring HER2 mutations [3] Group 4: Drug Mechanism and Competition - Injectable Rocatinib binds to HER2-expressing tumor cells, inducing cell cycle arrest and apoptosis through the release of toxins in the tumor cell lysosome [4] - Competing intravenous products in the domestic market include Roche's Ado-trastuzumab emtansine, AstraZeneca and Daiichi Sankyo's Fam-trastuzumab deruxtecan, Rongchang Biopharmaceutical's Vidisichu monoclonal antibody, and Kelun-Biotech's Bodo-trastuzumab [4] - According to EvaluatePharma, the global sales of similar products are projected to reach approximately $6.557 billion by 2024 [4] - Cumulative R&D investment for injectable Rocatinib is approximately 1.7725 billion yuan (unaudited) [4]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 注射用HLX43（靶向PD-L1抗體偶聯藥物） 聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） 或漢斯狀® （斯魯利單抗注射液） 在晚期或轉移性結直腸癌患者中開展的1b/2期臨床研究 於中國境內完成首例患者給藥 A. 緒言 1 料，暫定HLX43的劑量水準為2.5 mg/kg和3.0 mg/kg，該階段主要目的是研究不 同劑量HLX43聯合固定劑量HLX07在轉移性結直腸癌(mCRC)患者中的有效性， 次要目的包括評價其安全性和耐受性、HLX43的PK特徵和免疫原性、並研究潛在 預測性或耐藥性生物標誌物。第二部分為一項隨機、多中心、開放標籤研究，評 估HLX43 2.0 mg/kg或2.5 mg/kg聯合固定劑量漢斯狀®(30 ...

评级：中性(维持) 曹泽运(证券分析师) 李畅(证券分析师) S0350525110001 S0350524010004 caozy@ghzq.com.cn lic05@ghzq.com.cn 证券研究报告 2026年01月30日 医药生物 生物医药深度报告：国产ADC药物即将迎来高光时刻 ——ADC子行业专题研究 最近一年走势 相关报告 《医药生物行业动态研究：中国独立医学实验室行业的先行者（中性）*医药生 物*曹泽运，林羽茜》——2026-01-27 《医药生物行业动态研究：AI药研或引产业革命，JPM大会再推行业新峰（中 性）*医药生物*曹泽运，林羽茜》——2026-01-20 相对沪深300表现 | 表现 | 1M | 3M | 12M | | --- | --- | --- | --- | | 医药生物 | 2.0% | -2.7% | 21.1% | | 沪深300 | 2.1% | 1.3% | 24.5% | 请务必阅读报告附注中的风险提示和免责声明 2 -9% 0% 9% 19% 28% 37% 2025/02/05 2025/05/06 2025/08/04 2025/11/02 医药生物 ...

HLX43研发进展： 复宏汉霖HLX43三联疗法获批临床试验 核心要点： 获批情况：HLX43（靶向PD-L1抗体偶联药物）联合HLX07（抗EGFR单抗）及汉斯状（斯鲁利单抗） 用于晚期实体瘤治疗的临床试验申请获NMPA批准，拟在中国境内开展。 临床数据显示：既往治疗失败的NSCLC患者ORR达37.0%，DCR达87.0%；宫颈癌患者ORR达 41.4%（3.0mg/kg剂量组达70%） 市场地位：全球范围内尚无同类联合用药方案获批上市。 风险提示：公司无法确保能成功开发及商业化HLX43及HLX07。 在中国、美国、日本等多地开展1期/2期临床试验 覆盖NSCLC、结直肠癌、宫颈癌、食管鳞癌等多个适应症 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，注射用HLX43（靶向PD-L1抗體 偶聯藥物）（「HLX43」）聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） （「HLX07」）及漢斯狀® （斯魯利單抗注射液）（「漢斯狀®」）用於晚期實體瘤治 療的臨床試驗申請獲國家藥品監督管理局（「NMPA」）批准。本公司擬於條件 具備後於中國境內開展相關臨床試驗。 1 B. 關於HLX43、HLX07及漢斯狀® HLX43是由本公司利用許可引進的新型DNA拓撲異構酶I抑制劑小分子毒 素－肽鏈連接符與本公司自主研發的靶向PD-L1的抗體進行偶 ...

Core Viewpoint - The approval of trastuzumab deruxtecan for a new indication in China marks a significant milestone for Daiichi Sankyo and AstraZeneca, expanding its use in treating HER2-positive gastric cancer patients [1] Group 1: Drug Approval and Indication - Trastuzumab deruxtecan has received approval from the National Medical Products Administration of China for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a treatment regimen containing trastuzumab [1] - This new indication is the sixth approved use of trastuzumab deruxtecan in China and the second indication related to HER2-positive gastric cancer [1] Group 2: Clinical Trial Results - The approval is based on results from the international, multicenter, randomized, open-label phase 3 study DESTINY-Gastric04, which demonstrated statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) [1] - The safety profile of trastuzumab deruxtecan was found to be acceptable and manageable, consistent with known safety characteristics, with no new safety issues identified [1] - Results from the DESTINY-Gastric04 study were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine [1]

Group 1 - The core viewpoint of the article is that the Chinese CRO industry is transitioning from being mere service providers to becoming innovative ecosystem builders, as highlighted by Dr. Duan Maosheng at the ACCESS ASIA forum [1] - The forum discussed cutting-edge topics such as antibody-drug conjugates (ADC), cell and gene therapy (CGT), and AI-driven drug discovery, reflecting global capital's interest in innovation [1] - China is increasingly important in the global pharmaceutical innovation landscape due to its regulatory alignment with international standards, talent return, and technological accumulation [1] Group 2 - Mediso, a leading one-stop drug R&D service platform, has invested approximately 2,000 square meters in a research office in Boston to support its globalization strategy and meet the growing demands of overseas clients [2] - The company emphasizes its role as a partner alongside clients, not just a service provider, and aims to help clients navigate asset valuation, development planning, and international negotiations [2] - Mediso has supported the successful internationalization of multiple innovative drugs and is focused on aiding emerging pharmaceutical companies in their global strategies [3] Group 3 - As of now, Mediso has participated in the development of 588 new drug projects that have received clinical trial approvals from regulatory bodies such as China's NMPA, the US FDA, and Australia's TGA from 2015 to June 2025 [3] - The company has averaged about 100 IND approvals annually in the past three years, accelerating the drug development process [3] Group 4 - Huaxi Securities has raised its earnings forecast for Mediso, anticipating that the company will benefit from improving domestic market conditions and has maintained a "buy" rating [5]