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.

Core Insights - The National Healthcare Security Administration (NHSA) has officially announced the latest version of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, which includes 114 new drugs and 19 drugs in the first version of the Commercial Health Insurance Innovative Drug Catalog, effective from January 1, 2026 [1][2][3] Industry Summary - The NHSA has adjusted the drug catalog for the eighth time since its establishment, with a total of 949 new drugs added over the years, and the medical insurance fund has spent over 4.6 trillion RMB on negotiated drugs, driving sales exceeding 6 trillion RMB [1][2] - The new catalog includes 50 first-class innovative drugs, with an overall success rate of 88%, significantly higher than the 76% in 2024 [3] - The inclusion of drugs for major diseases such as triple-negative breast cancer, pancreatic cancer, and lung cancer, as well as rare diseases and chronic conditions, addresses gaps in basic medical insurance coverage [2][3] Company-Specific Updates - Green Leaf Pharmaceutical has successfully included five new products in the NHSA's drug catalog, including MiMeiXin® and ZhanBiJia® [4] - Fuhong Hanlin announced that its product Fuzhuoning® has been included in the NHSA's drug catalog for specific indications [5] - Junshi Biosciences reported that its products Tuoyi® and Junshida® have been successfully included in the NHSA's drug catalog [6] - Innovent Biologics has successfully added seven innovative products to the new NHSA drug catalog, including Daboru® and Xindimian® [6]

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]