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 ...

Investment Rating - The report maintains a neutral rating for the biopharmaceutical industry, specifically focusing on the ADC (Antibody-Drug Conjugate) sector [1]. Core Insights - The global ADC market is experiencing rapid growth, with the total market size reaching approximately $10.4 billion in 2023 and projected to grow to $66.2 billion by 2030, reflecting a compound annual growth rate (CAGR) of over 30% [11]. - Domestic Chinese companies are catching up in ADC drug development, with the number of research pipelines expected to surpass that of the United States by 2024, positioning China as the leader in ADC research pipelines [11][16]. - Several domestic companies are optimizing ADC drugs by leveraging existing technologies and platforms developed by international firms, leading to the development of more effective and stable ADC products [7][9]. - Key targets for ADC drugs include HER2, TROP2, EGFR, and HER3, with multiple domestic companies showing promising clinical data for their pipelines in these areas [7][9]. Summary by Sections Section 1: Introduction to ADC Drugs - ADCs are a class of targeted cancer therapies that combine monoclonal antibodies with cytotoxic drugs, allowing for precise delivery of treatment to cancer cells while minimizing damage to normal cells [19]. Section 2: Domestic and International ADC Platforms - The report highlights the advancements made by domestic companies in establishing ADC platforms, with firms like Hengrui Medicine and Kolon Biotech leading the way in developing innovative ADC technologies [70][62]. Section 3: Popular Targets and Key Pipelines for ADC Drugs - Notable companies such as Hengrui Medicine and Kolon Biotech have developed ADCs targeting HER2 and TROP2, showing strong clinical efficacy in treating breast and lung cancers [7][9]. Section 4: Business Development (BD) Situations for Domestic ADC Drugs - The report notes an increasing trend of domestic ADC drugs being sought after by international firms, with the number of BD transactions for ADCs accounting for 12%-13% of total drug transactions from 2022 to 2024 [9]. Section 5: Related Companies and Investment Opportunities - The report suggests focusing on companies with established ADC platforms and promising product pipelines, including Hengrui Medicine, Kolon Biotech, BaiLi Tianheng, and China National Pharmaceutical Group [9].

Group 1 - Approval Status: HLX43 (a PD-L1 targeted antibody-drug conjugate) in combination with HLX07 (an anti-EGFR monoclonal antibody) and Hansizhuang (Sruvelizumab) has received approval from NMPA for clinical trials aimed at treating advanced solid tumors in China [1] Group 2 - R&D Progress: Phase 1/2 clinical trials for HLX43 are being conducted in multiple regions including China, the United States, and Japan, covering indications such as NSCLC, colorectal cancer, cervical cancer, and esophageal squamous cell carcinoma [2] - Clinical Data: In patients with previously treated NSCLC, the overall response rate (ORR) reached 37.0% and the disease control rate (DCR) was 87.0%; for cervical cancer patients, the ORR was 41.4% (with the 3.0 mg/kg dosage group achieving 70%) [2] - Market Position: There are currently no similar combination therapies approved for marketing globally [2]

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]