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。临床前研究显示，HLX87在多个肿瘤细胞系异种移植模型 中展现出与德曲妥珠单抗相当的抗肿瘤活性，且安全性优势明显。根据2024年美国癌症研究协会年会 (AACR2024)公布的HLX87治疗HER2表达或突变晚期实体瘤的1期临床数据，结果显示，HLX87在 2.0mg/kg~8.4mg/kg剂量范围内均表现出良好的耐受性和安全性，同时在乳腺癌、胃癌、肺癌等多种实 体肿瘤患者中表现出优异的治疗效果。目前，一项HLX87用于HER2阳性乳腺癌二线治疗的3期临床试 验正于中国境内开展。此前，本公司与外部合作伙伴就本公司引进HLX87达成战略合作，具体合作安 排及执行将以双方后续拟签订的正式许可协议中的交易安排为准。 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 ...

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 ...

格隆汇12月9日丨复宏汉霖(02696.HK)宣布，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")(1)用于HER2阳性乳腺癌(BC)一线治 疗，以及(2)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。公司拟于条件具备后于中国境内开展相关临床研究。 ...

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 ...

摘要 HLX43（43P 六 1 ADC）在 PD-L1 阳性宫颈癌患者中显示出初步疗效， 尤其是在 3.0 毫克剂量组中，客观缓解率（ORR）达到 70%，但样本量 小（n=10），随访时间短（3.5 个月），需扩大样本验证。 HLX43 在不同剂量下安全性总体可控，主要毒性为血液学毒性，如贫血、 恶心呕吐，免疫相关不良事件（IAE）发生率为 23.3%，程度轻微，未 见严重级别不良反应，血液学毒性与剂量相关。 公司已停止 2.0 毫克剂量组的入组，后续研究将重点放在 2.5 毫克和 3.0 毫克两个高剂量组上，并密切监测长期毒性的累积效应，优化给药 方案。 8,201 药物（HLX43）在不同瘤种中的疗效存在差异，宫颈癌初步数据 显示 3 毫克剂量组的 ORR 达到 70%，但数据尚不完全可靠，需扩大样 本量并优化剂量方案。 公司计划继续扩大患者入组数量，优化给药方案，研究加载剂量，并进 行斯鲁利单抗与 8,201 联合用药的安全性研究，未来将根据适应症优先 级推进不同组合治疗策略。 Q&A 请介绍一下此次在 ESMO Asia 大会上披露的 HLX43 在宫颈癌二期临床试验 中的具体数据和结果。 在此次 ...

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]

复妥宁®系公司许可引进的创新型CDK4/6小分子抑制剂。2025年5月，于中国境内获批上市，首次获批 适应症为联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因 子受体2(HER2)阴性的复发或转移性成年乳腺癌患者;2025年9月，复妥宁®于中国境内新增获批一项适 应症，用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者： 与芳香化酶抑制剂联合使用作为初始内分泌治疗。 复宏汉霖(02696)发布公告，近日，复妥宁®(枸橼酸伏维西利胶囊)获纳入《国家基本医疗保险、生育保 险和工伤保险药品目录(2025年 )》乙类范围，获纳入的适应症为联合氟维司群用于既往接受内分泌治疗 后出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的复发或转移性成年乳腺癌患 者。新版国家医保药品目录将于2026年1月1日起正式实施。 ...

复宏汉霖(02696)发布公告，近日，复妥宁(枸橼酸伏维西利胶囊)获纳入《国家基本医疗保险、生育保险 和工伤保险药品目录(2025年)》乙类范围，获纳入的适应症为联合氟维司群用于既往接受内分泌治疗后 出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的复发或转移性成年乳腺癌患 者。新版国家医保药品目录将于2026年1月1日起正式实施。 复妥宁系公司许可引进的创新型CDK4/6小分子抑制剂。2025年5月，于中国境内获批上市，首次获批适 应症为联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子 受体2(HER2)阴性的复发或转移性成年乳腺癌患者;2025年9月，复妥宁于中国境内新增获批一项适应 症，用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者：与 芳香化酶抑制剂联合使用作为初始内分泌治疗。 ...

本次复妥宁获纳入国家医保目录，体现了国家医疗保障局对其临床价值、患者获益、创新程度等方面的 认可，提升了HR阳性、HER2阴性乳腺癌患者可及性，亦有利于复妥宁的市场推广和销售布局。 复妥宁系公司许可引进的创新型CDK4/6小分子抑制剂。2025年5月，于中国境内获批上市，首次获批适 应症为联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子 受体2(HER2)阴性的复发或转移性成年乳腺癌患者；2025年9月，复妥宁®于中国境内新增获批一项适应 症，用于激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性局部晚期或转移性乳腺癌成人患者：与 芳香化酶抑制剂联合使用作为初始内分泌治疗。 格隆汇12月7日丨复宏汉霖(02696.HK)公告，近日，复妥宁(枸橼酸伏维西利胶囊)获纳入《国家基本医 疗保险、生育保险和工伤保险药品目录(2025年)》("国家医保药品目录")乙类范围，获纳入的适应症为 联合氟维司群用于既往接受内分泌治疗后出现疾病进展的激素受体(HR)阳性、人表皮生长因子受体 2(HER2)阴性的复发或转移性成年乳腺癌患者。新版国家医保药品目录将于2026年1月1日起正式 ...