Core Viewpoint - The company Fuhong Hanlin (02696) has received acceptance for its New Drug Application (NDA) for Hansuzhuang (sulizumab injection) in combination with platinum-based chemotherapy for the treatment of PD-L1 positive, resectable gastric cancer patients, which has been prioritized for review by the National Medical Products Administration (NMPA) [1] Group 1 - The NDA acceptance is aimed at expediting the review process for the new indication of Hansuzhuang [1] - The application is based on a Phase 3 clinical study that compared Hansuzhuang combined with chemotherapy against placebo combined with chemotherapy for the neoadjuvant/adjuvant treatment of gastric cancer patients [1] - The study results demonstrated that Hansuzhuang combined with chemotherapy significantly extended the event-free survival (EFS) of patients, meeting the predefined superiority criteria, and showed better safety and tolerability compared to standard chemotherapy [1]

Core Viewpoint - The company has received acceptance for the New Drug Application (NDA) of its self-developed drug Hanshuan® (sulizumab injection) for a new indication in the treatment of PD-L1 positive, resectable gastric cancer patients, which is now prioritized for review by the National Medical Products Administration (NMPA) [1][2] Group 1 - The NDA acceptance is based on a Phase 3 clinical study that demonstrated the efficacy and safety of Hanshuan® combined with chemotherapy compared to placebo combined with chemotherapy, significantly extending the event-free survival (EFS) of patients [1] - The study met the predefined superiority criteria and showed better safety and tolerability compared to standard chemotherapy [1] Group 2 - Hanshuan® is an innovative anti-PD-1 monoclonal antibody that has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received orphan drug designation in several regions, including the US, EU, Switzerland, and South Korea, and is approved in multiple countries such as the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - The company is actively advancing multiple clinical trials for Hanshuan® and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [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） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療用 於胃癌新輔助/輔助治療的上市註冊申請(NDA) 獲國家藥品監督管理局(NMPA)受理，並已納入優先審評 A. 緒言 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，本公司自主開發的漢斯狀® （斯魯 利單抗注射液）（「漢斯狀®」）聯合含鉑化療新輔助，在手術後輔助治療，用於 PD-L1陽性的、可手術切除的胃癌患者的上市註冊申請(NDA)獲國家藥品監 督管理局(NMPA)藥品審評中心受理，並已納入優先審評審批程序，將加速 其上市審評進程。 B. 申報背景及依據 本次漢斯狀®新適應症的上市註冊 ...

Market Performance - The Hong Kong stock market continued to show weakness, with the Hang Seng Index down 0.43% to 25,324.75 points, the Hang Seng Tech Index down 0.68%, and the National Enterprises Index down 0.51% [1] - Major technology stocks exhibited mixed performance, with NetEase and Bilibili down over 1%, Tencent down 1%, while Meituan rose over 1% [1] - Precious metals performed strongly, with silver reaching a historical high and gold-related stocks rising, including Lingbao Gold which increased nearly 10% [1] - Shipping stocks declined, with Pacific Basin Shipping down 9.5% and Orient Overseas International down 5% [1] - The photovoltaic sector also fell, with China Metallurgical Group down 4.3% and other companies like Xinyi Solar and Flat Glass down over 3% [1] Company News - Datang New Energy reported a cumulative power generation of approximately 31.6521 million MWh in the first 11 months, an increase of 10.58% year-on-year [2] - Jiangshan Holdings reported a total solar power generation of approximately 279.78 thousand MWh in the first 11 months, a decrease of 5.61% year-on-year [3] - New City Development reported a cumulative contract sales amount of approximately 17.917 billion yuan in the first 11 months, a decrease of 51.53% year-on-year [4] - Longfor Group achieved a total contract sales amount of 59.39 billion yuan in the first 11 months [5] - CIFI Holdings reported a cumulative contract sales amount of approximately 15.1 billion yuan in the first 11 months [6] Institutional Insights - Dongwu Securities indicated that the Hong Kong stock market is still in a left-side phase, with a rebound needing to wait, but mid-term positioning appears attractive [12] - Huaxia Fund noted that the previous irrational panic in the tech sector has eased, and the future outlook for AI development is pragmatic with clear commercialization paths [12] - China International Capital Corporation highlighted that the recent weakness in the Hong Kong market is due to multiple factors including a declining credit cycle and liquidity pressure [13] - Everbright Securities mentioned that after a rebound in 2025, the current Hang Seng Index P/E ratio is above the past five-year average, indicating overall valuation repair but still within a reasonable range [13]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 in combination with HLX87 for HER2-positive breast cancer treatment in mainland China [1] Group 1 - The approved clinical trials will focus on the use of HLX22 as a novel targeted monoclonal antibody for first-line treatment and neoadjuvant therapy in HER2-positive breast cancer [1] - HLX87 is an innovative antibody-drug conjugate (ADC) that links a topoisomerase I inhibitor with an anti-HER2 monoclonal antibody through a stable cleavable linker [1]

Core Insights - The company Fuhong Hanlin (02696) has received approval from the National Medical Products Administration for clinical trial applications of HLX22 and HLX87 for the treatment of HER2-positive breast cancer [1][2] Group 1: HLX22 - HLX22 is a novel humanized anti-HER2 monoclonal antibody that has potential indications for solid tumors including gastric and breast cancer [1] - The drug has received orphan drug designation from the FDA and the European Commission for the treatment of gastric cancer, with approvals granted in March and May 2025 respectively [1] Group 2: HLX87 - HLX87 is an innovative antibody-drug conjugate (ADC) targeting HER2, currently in phase 3 clinical trials for HER2-positive breast cancer treatment [2] - The drug utilizes a high-permeability topoisomerase inhibitor as an effective payload, demonstrating a balance between efficacy and safety by reducing systemic toxicity [2] - Preclinical studies indicate that HLX87 shows comparable anti-tumor activity to Trastuzumab with significant safety advantages [2] - Phase 1 clinical data presented at the AACR 2024 conference shows HLX87 has good tolerability and safety across a dosage range of 2.0 mg/kg to 8.4 mg/kg, with excellent therapeutic effects in various solid tumors including breast, gastric, and lung cancers [2] - A phase 3 clinical trial for HLX87 as a second-line treatment for HER2-positive breast cancer is currently underway in China [2] - The company has established a strategic partnership with external collaborators regarding HLX87, with specific arrangements to be formalized in a licensing agreement [2]

智通财经APP讯，复宏汉霖(02696)发布公告，近日，HLX22(重组人源化抗HER2单克隆抗体注射液) (HLX22)联合注射用HLX87(靶向HER2抗体偶联药物)(HLX87)用于HER2阳性乳腺癌(BC)一线治疗，以 及用于HER2阳性乳腺癌新辅助治疗(BC neo)的2/3期临床试验申请，分别获国家药品监督管理局批准。 本公司拟于条件具备后于中国境内开展相关临床研究。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体，潜在适应症包括胃癌和乳腺 癌等实体瘤。HLX22用于治疗胃癌已分别于2025 年3月及2025年5月获美国食品药品监督管理局(FDA)及 欧盟委员会(EC)授予孤儿药资格认定(Orphan-drug Designation)。 HLX87是靶向HER2的创新抗体偶联药物(ADC)，通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成，目前正处于3期临床研究阶段，拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷，具有强效旁观者杀伤作用，同时结合独特、稳定的连接子设计 降低全身毒性，实现疗效与安全性的平衡。临床前研 ...

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received approval from the National Medical Products Administration for clinical trial applications of HLX22 and HLX87 for the treatment of HER2-positive breast cancer [1] Group 1 - HLX22, a humanized anti-HER2 monoclonal antibody injection, is approved for first-line treatment of HER2-positive breast cancer [1] - HLX87, a HER2-targeted antibody-drug conjugate, is approved for neoadjuvant treatment of HER2-positive breast cancer [1] - The company plans to conduct related clinical research in China once conditions are met [1]

自願公告 HLX22（重組人源化抗HER2單克隆抗體注射液）聯合 注射用HLX87（靶向HER2抗體偶聯藥物）分別用於 HER2陽性乳腺癌(BC)一線治療與HER2陽性乳腺癌新輔助治療 (BC neo)的2/3期臨床試驗申請獲國家藥品監督管理局批准 A. 緒言 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」）欣然宣布，近日，HLX22（重組人源化抗HER2單 克隆抗體注射液）（「HLX22」）聯合注射用HLX87（靶向HER2抗體偶聯藥物） （「HLX87」）(1)用於HER2陽性乳腺癌(BC)一線治療，以及(2)用於HER2陽性 乳腺癌新輔助治療(B ...

Summary of Conference Call on HLX43 and Industry Insights Company and Industry Overview - The conference call discusses the clinical trial results of HLX43 (43P 六 1 ADC) in the treatment of PD-L1 positive cervical cancer patients, highlighting its potential as a new therapeutic option in the oncology sector [2][3][4]. Key Points and Arguments Clinical Efficacy - HLX43 demonstrated preliminary efficacy in cervical cancer, with an objective response rate (ORR) of 70% in the 3.0 mg dosage group, although the sample size was small (n=10) and follow-up time was short (3.5 months) [2][5][11]. - The trial included three dosage groups (2.0 mg, 2.5 mg, and 3.0 mg), with each group initially planned to enroll 30 patients, but the analysis was based on 30 patients as of September 1, 2024 [3][4]. - The drug showed good efficacy in patients who had failed first-line chemotherapy, aligning with historical data [3]. Safety Profile - The overall safety of HLX43 was manageable, with hematological toxicities such as anemia and nausea being the primary adverse effects [6][9]. - Immune-related adverse events (IAE) occurred at a rate of 23.3%, primarily mild, with no severe adverse reactions reported [7][9]. - The company has ceased enrollment in the 2.0 mg group due to relatively poor efficacy and will focus on the 2.5 mg and 3.0 mg groups while monitoring long-term toxicity [8][12]. Future Development Plans - The company plans to expand patient enrollment and optimize dosing strategies, including exploring loading doses and combination therapies with other agents like SruLi monoclonal antibody [12][16]. - Upcoming clinical trials are set to start in 2026, with a potential fast-track approval strategy for indications showing very good OR [16]. Comparative Analysis - The adverse event (AE) and IAE levels in cervical cancer treatment with HLX43 are comparable to other indications, indicating a manageable safety profile [9]. - The drug's performance in cervical cancer is promising compared to other approved ADCs, suggesting it could be a viable treatment option [9]. Additional Important Insights - The proportion of PD-L1 positive patients in cervical cancer is relatively high, providing a basis for further stratified studies [4]. - The company is cautious about the potential for immune-related adverse reactions similar to those seen in lung cancer patients, although none have been observed in the cervical cancer cohort thus far [15]. - Future data releases are planned for gastrointestinal tumors at upcoming conferences, contingent on sufficient sample sizes [13]. This summary encapsulates the critical findings and strategic directions discussed in the conference call regarding HLX43 and its implications in the oncology market.