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 自願公告 帕妥珠單抗生物類似藥HLX11 （重組抗HER2結構域II人源化單克隆抗體注射液） 獲歐洲藥品管理局(EMA)人用醫藥產品 委員會(CHMP)積極審評意見 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 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。 茲提述本公司於2025年3月28日刊發的公告，內容有關本公司自主研發的 Perjeta® （帕妥珠單抗）生物類似藥候選藥HLX11（重組抗HER2結構域II人源 化單克隆抗體注射液）（「HLX11」）適用於：(1)與曲妥珠單抗和化療聯合(i)用 於HER2陽性、局部晚期、炎性或早期乳腺癌且具有高復發風險成人患者的 新輔助治療；以及(ii)用於具有高復發風險 ...

2月26日，甘李药业及其欧洲全资子公司甘李药业欧洲有限责任公司（简称"甘李欧洲"）联合发布公告 称，公司旗下赖脯胰岛素注射液（商品名：Bysumlog®）、门冬胰岛素注射液（商品名：Dazparda®） 的上市许可申请（MAA），已获得欧洲药品管理局（EMA）人用药品委员会（CHMP）的积极意见， 这标志着上述产品在欧洲市场上市进程取得突破性进展。 据悉，CHMP作为EMA下属核心审评机构，其积极意见是药品获得欧盟上市许可的重要前提。根据此 次意见，CHMP建议欧盟委员会（EC）批准赖脯胰岛素作为Humalog®的生物类似药上市，用于治疗成 人和儿童的糖尿病；同时建议批准门冬胰岛素作为NovoRapid®的生物类似药上市，用于治疗成人、青 少年及1岁及以上儿童的糖尿病治疗。若EC最终审核通过，两款产品将正式获准在欧盟所有成员国，以 及挪威、冰岛、列支敦士登上市销售，全面切入欧洲糖尿病治疗市场。 公开信息显示，两款产品均为临床常用的速效胰岛素类似物，核心优势在于起效快、达峰迅速、作用持 续时间短，能够精准模拟人体生理性餐后胰岛素分泌，有效控制餐后血糖波动，同时降低餐前低血糖的 发生风险，为糖尿病患者提供更安全、 ...

格隆汇2月25日｜华兰生物(002007.SZ)公告称，公司参股公司华兰安康收到国家药品监督管理局《药物 临床试验批准通知书》，同意帕博利珠单抗注射液按生物类似药开展临床试验。帕博利珠单抗注射液为 生物类似药，由默沙东公司开发，是全球首个获批上市的PD-1抑制剂之一。目前国内除原研外，暂未 有类似药获批上市。本次临床试验获批，标志着药物可正式开展对应临床研究，进一步验证安全性与有 效性，为后续注册上市奠定基础，同时丰富公司产品管线，优化产品结构。但药品研发具有周期长、环 节多、风险高的特点，后续尚需完成全部临床试验、生产申报、国家药监局审批等环节，各环节结果均 存在不确定性；同时面临临床数据与进度不及预期、市场竞争激烈、行业政策及技术迭代变化等风险。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688177 证券简称：百奥泰 公告编号：2026-010 百奥泰生物制药股份有限公司 关于GotenfiaR（戈利木单抗注射液）获欧洲EMA上市批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）于近日收到欧洲药品管理局（以下简 称"EMA"）签发的关于GotenfiaR（BAT2506，戈利木单抗注射液）上市批准通知。 GotenfiaR作为百奥泰又一个获得EMA上市批准的产品，将进一步拓展公司国际化市场，提升公司产品 的国际影响力，有望对公司长期经营业绩产生积极影响。已上市竞品和其他潜在竞品可能会拥有先行者 优势，GotenfiaR可能在未来面临激烈的市场竞争。 考虑到医药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及产品从研制、临床试验报 批到投产的周期长，易受到技术、审批、政策等多方面因素的影响，未来产品市场竞争形势均存在诸多 不确定性，敬请广大投资者谨慎决策，注意投资风险，公 ...

根据IQVIA MIDASTM的资料(IQVIA是全球医药健康产业专业信息和战略谘询服务提供商)，2024年 度，达雷妥尤单抗于全球范围内的销售额约为128.8亿美元。 据悉，HLX15(重组抗CD38全人单克隆抗体)是公司自主研发的达雷妥尤单抗生物类似药，拟用于多发 性骨髓瘤(MM)等治疗。达雷妥尤单抗是一种人源化的抗CD38的IgG1κ单克隆抗体，其可与肿瘤细胞表 面表达的CD38结合，通过补体依赖的细胞毒作用(CDC)、抗体依赖的细胞毒作用(ADCC)和抗体依赖的 细胞吞噬作用(ADCP)、以及Fcγ受体等多种免疫相关机制诱导肿瘤细胞凋亡。除此之外，达雷妥尤单抗 还可通过降低髓源性抑制细胞和消耗CD38表达阳性的免疫调节性T、B细胞来达到减少MM细胞的作 用。2024年6月，HLX15-IV(静脉注射制剂)在中国男性健康受试者中开展的1期临床研究已成功完成。 复宏汉霖(02696)公布，近日，公司自主研发的HLX15-SC(重组抗CD38全人单克隆抗体注射液-皮下注 射)(HLX15-SC)用于多发性骨髓瘤治疗的1期临床试验申请(IND)获国家药品监督管理局(NMPA)批准。 ...

Group 1 - The core point of the article is that Baiotai (688177.SH) has signed a licensing and commercialization agreement with Avalon Pharma for its BAT3306 (pembrolizumab) injection in the Saudi and MENA markets, with potential total payments up to $7 million [1][2] - The agreement includes an upfront payment of $2 million, milestone payments not exceeding $5 million, and a percentage of net sales as revenue sharing [1] - BAT3306 is developed based on guidelines from NMPA, FDA, and EMA for biosimilars and is an immuno-oncology drug classified as a humanized monoclonal antibody [1] Group 2 - The purpose of the agreement is to quickly convert the company's R&D achievements into economic benefits through commercial cooperation and licensing [2] - The collaboration with Avalon is expected to integrate advantages in R&D, production quality control, technology enhancement, clinical application, and commercial promotion, creating favorable conditions for the company's future development [2] - The successful implementation of the agreement is anticipated to have a positive impact on the company's future operating performance [2]

Group 1 - The core point of the article is that Baiotai (688177.SH) has signed a licensing and commercialization agreement with Avalon Pharma for its BAT3306 (Pabrolizumab) injection in the Saudi and Middle East and North Africa markets, with potential total payments up to $7 million [1][2] - The agreement includes an upfront payment of $2 million, milestone payments not exceeding $5 million, and a two-digit percentage of net sales as revenue sharing [1] - BAT3306 (Pabrolizumab) is developed based on guidelines for biosimilars from the National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) [1] Group 2 - The purpose of the agreement is to quickly transform the company's research and development achievements into economic benefits through commercial cooperation and licensing [2] - The collaboration with Avalon is expected to integrate advantages in research, production quality control, technology enhancement, clinical application, and commercial promotion, creating favorable conditions for the company's future development [2] - The successful implementation of the agreement is anticipated to have a positive impact on the company's future operating performance [2]

格隆汇2月3日丨百奥泰(688177.SH)公布，百奥泰于北京时间2026年2月3日与Avalon签署授权许可与商 业化协议。根据协议，百奥泰将公司的BAT3306（帕博利珠单抗）注射液在沙特与中东及北非地区市场 的独占的产品商业化权益有偿许可给Avalon，并可获得总金额最高至700万美元的首付款及里程碑款， 其中包括200万美元首付款、累计不超过500万美元里程碑付款，以及净销售额的两位数百分比作为收入 分成。 BAT3306（帕博利珠单抗）是百奥泰根据国家药监局（NMPA）、美国食品药品监督管理局（FDA）、 欧洲药品管理局（EMA）生物类似药相关指导原则开发的帕博利珠单抗注射液。帕博利珠单抗是一种 人源化单克隆抗体药物，属于免疫检查点抑制剂。它能够特异性地结合位于淋巴细胞上的PD-1受体， 通过阻断PD-1与其配体PD-L1和PD-L2的结合，从而解除肿瘤对T细胞的免疫抑制，重新激活T细胞对肿 瘤细胞的免疫应答，进而实现对多种类型癌症的治疗效果。公司目前正在开展一项评价BAT3306对比 US-可瑞达®在IB-IIIA期非小细胞肺癌受试者中的药代动力学、免疫原性、安全性和有效性的多中心、 随机、双盲、 ...

Core Viewpoint - The company focuses on innovative treatments for mature targets, aiming to differentiate itself in the competitive PD-(L)1 market, particularly with its PD-1 monoclonal antibody, which is set to be the first and only approved treatment for ES-SCLC in the EU by February 2025 [1] Group 1: Innovative Drug Pipeline - The PD-1 monoclonal antibody is targeting small cell lung cancer as a core differentiation track while also expanding into new indications, potentially becoming the first immunotherapy approved for perioperative gastric cancer and first-line colorectal cancer [1] - HLX07, an engineered EGFR monoclonal antibody, has an extended half-life allowing for a three-week dosing schedule alongside H drug, showing excellent efficacy and safety in treating refractory squamous non-small cell lung cancer [1] - HLX43, a PD-L1 ADC with a dual toxin release mechanism, has shown superior anti-tumor efficacy and manageable safety in Phase I trials, with multiple Phase II trials for mainstream cancers like non-small cell lung cancer and liver cancer poised to start [1] Group 2: Biosimilar Drug Pipeline - The company has a long-standing commitment to the biosimilar drug sector and is advancing its global strategy, with HLX14 (dexamethasone) already approved in Europe and the US, and HLX11 (pertuzumab) approved in the US with applications pending in China and Europe [2] - The pipeline also includes targets like CTLA-4 and CD38, with ongoing overseas clinical studies to support global market expansion [2] Group 3: Financial Forecast - The company anticipates continued revenue contributions from its biosimilar drugs and accelerated innovation drug development, projecting revenues of 6.009 billion, 5.999 billion, and 6.438 billion yuan for 2025-2027, with net profits of 798 million, 804 million, and 839 million yuan respectively, corresponding to PE ratios of 47, 46, and 45 times [2]

Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Chengdu Kanghong Biotechnology Co., has received approval from the National Medical Products Administration for the clinical trial of KH816 injection, a biosimilar of Dupilumab [1] Group 1: Product Development - KH816 injection is developed as a biosimilar to Dupilumab, which is a fully human monoclonal antibody (IgG4 type) [1] - The mechanism of action involves specific binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes, inhibiting the signaling pathways of IL-4 and IL-13 [1] Group 2: Therapeutic Indications - IL-4 and IL-13 mediated inflammation plays a crucial role in the pathogenesis of asthma, atopic dermatitis, nodular prurigo, and chronic obstructive pulmonary disease [1] - The inflammatory response involves various cell types expressing IL-4Rα, including mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, and goblet cells, as well as inflammatory mediators such as histamine, leukotrienes, cytokines, and chemokines [1] Group 3: Mechanism of Action - By blocking IL-4Rα, Dupilumab can inhibit the inflammatory responses induced by IL-4 and IL-13 cytokines, including the release of pro-inflammatory cytokines, chemokines, nitric oxide, and IgE [1]