本集团已于2023年在中国开始CBT-199的药物发现过程。CBT-199已自2023年6月起于临床前动物研究中 进行安全性和耐受性评估，有关研究预期将有助于未来的临床试验。 本公司认为，由于CBT-199的临床试验现被认为可安全推进，标志着CBT-199临床开发的关键里程碑， 且本集团已正式获授权启动第2阶段临床试验。本集团将持续密切关注审评进度，并适时另行刊发公 告，以知会本公司股东及潜在投资者有关本集团业务的最新发展。 智通财经APP讯，拨康视云-B(02592)发布公告，本公司于美利坚合众国(美国)特拉华州注册成立的全资 附属公司 ADS Therapeutics LLC (ADS USA)，已完成有关于2025年12月12日向美国食品及药物管理局 (美国药管局)提交的CBT-199(一种由本集团开发的潜在同类最佳眼科候选药物)新药临床试验申请(新药 临床试验申请)的审查期。由于美国药管局未发出任何临床试验暂停令，新药临床试验申请现已生效， 临床试验被认定为可安全推进。 CBT-199是一种新型局部眼用乳液，适用于治疗老花眼，而老花眼为常见的年龄相关性病症，患者眼内 晶状体逐渐增厚且失去弹性，导致聚焦 ...

智通财经APP讯，长风药业(02652)发布公告，根据恒生指数有限公司于2026年2月13日公布的截至2025 年12月31日止期间的恒生指数系列季度检讨结果，公司已获选并将获纳入为恒生综合指数的成份股，有 关变动将于2026年3月9日起生效。 董事会认为，公司获纳入恒生综合指数成份股，反映资本市场对本集团于呼吸系统疾病治疗市场的领先 地位及其于综合吸入给药平台方面能力的认可。董事会预期，有关纳入将有助扩大公司的股东基础及增 加公司股份的买卖流动性，从而进一步提升公司于资本市场的声誉及投资价值。 恒生综合指数提供一项全面的香港市场指标，涵盖在香港联合交易所有限公司主板上市的公司总市值约 95%。 ...

复宏汉霖(02696)发布公告，近日，本公司自主研发的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)获美国食品药品管理局(FDA)批 准。 HLX15(重组抗CD38全人单克隆抗体)(HLX15)是本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。 2026年2月，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。2025年2月，本公司与Dr.Reddy's Laborat ...

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依 賴該等內容而引致的任何損失承擔任何責任。 CF PharmTech, Inc. 長風藥業股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2652） 自願公告 本公司獲納入恒生綜合指數成份股 本公告乃由長風藥業股份有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，以知會股東及潛在投資者有關本集團之最新業務發展。 作為全球吸入給藥技術的創新者，長風藥業致力於構建連接複雜製劑與臨床未滿 足需求的跨學科橋樑。本公司深耕高壁壘複雜吸入製劑，是一家集裝置工程、精 準給藥、全球法規註冊與商業化落地於一體的平台型創新藥企。 1 依託完全自主構建的全球化全產業鏈能力－從呼氣驅動鼻噴遞送系統、脂質體吸 入技術到siRNA核酸遞送平台等，本公司正系統性地推進面向中國、美國及歐洲 市場的創新管線。治療領域深度佈局呼吸系統疾病（包括哮喘、慢性阻塞性肺病 及支氣管擴張症）及鼻科疾病（包括過敏性鼻炎及慢性鼻竇炎），並戰略性拓展至 肺纖維化 ...

依托完全自主构建的全球化全产业链能力——从呼气驱动鼻喷递送系统、脂质体吸入技术到siRNA核酸 递送平台等，本公司正系统性地推进面向中国、美国及欧洲市场的创新管线。治疗领域深度布局呼吸系 统疾病(哮喘、慢性阻塞性肺病及支气管扩张症)及鼻科疾病(过敏性鼻炎及慢性鼻窦炎)，并战略性拓展 至肺纤维化、肺动脉高压、罕见肺部感染及中枢神经系统疾病，率先探索「鼻—脑通路」精准给药的全 新前沿领域。 目前，本公司已在中国建立了广泛覆盖的立体式商业化网络，并通过全球合规的制造体系与日益深化的 海外布局，稳步迈向全球化创新药企的发展目标。 智通财经APP获悉，2026年2月13日，恒生指数公司公布截至 2025 年 12月31日的恒生指数系列季度检 讨结果，长风药业(02652)成功获纳入恒生综合指数成份股名单，相关调整将于 2026 年 3 月 6 日(星期 五)收市后实施，并于2026年3 月 9 日(星期一)起正式生效。此次获纳入恒生综合指数，标志着公司满足 了包括市值、流动性和上市时间等在内的一系列标准，反映了资本市场对公司在吸入制剂细分领域可持 续创新潜力和投资价值的高度认可。 作为全球吸入给药技术的创新者，长风药业 ...

Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug, Bemosituzumab (brand name: Andevate®), for a new indication in treating patients with unresectable stage III non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) sensitive mutations or anaplastic lymphoma kinase (ALK) rearrangements after platinum-based chemoradiotherapy without disease progression [1]. Group 1 - The drug Bemosituzumab has been approved for a specific patient population, which includes those with unresectable stage III NSCLC [1]. - The approval is significant as it addresses a critical need for treatment options in patients who have not progressed after receiving platinum-based therapies [1]. - The indication specifically targets patients without known EGFR sensitive mutations or ALK rearrangements, highlighting a niche market for the drug [1].

Core Viewpoint - AstraZeneca expects a double-digit percentage growth in core earnings per share by 2026, with total revenue projected to grow in the mid-to-high single digits at constant exchange rates [1] Group 1: Clinical Trials and Product Development - The company plans to announce results from up to 20 advanced clinical trials by 2026, focusing on oncology, respiratory diseases, and rare diseases [1] - Key trials include AVANZAR and TROPION-Lung07 [1] - The oral GLP-1 drug elecoglipron has entered late-stage clinical trials, and the company has partnered with CSPC Pharmaceutical Group to accelerate its entry into the weight loss drug market [1] Group 2: Financial Outlook and Shareholder Returns - AstraZeneca has increased its annual dividend by approximately 3% to $3.30 [1] - The company reaffirms its long-term goal of achieving $80 billion in revenue by 2030 [1]

Group 1 - The article highlights the ongoing efforts of the local market regulatory authorities in Huzhou to enhance drug safety governance and protect public health, with a focus on rigorous inspections of pharmacies and clinics as the Spring Festival approaches [1] - Huzhou has achieved a public satisfaction rate of 92% regarding drug safety, ranking second in the province for three consecutive years, reflecting the effectiveness of its regulatory measures [1] - The regulatory framework includes a comprehensive mechanism for monitoring, early warning, and feedback, emphasizing proactive problem-solving rather than reactive penalties [1] Group 2 - A portable eye pressure meter developed in Huzhou received certification in just 43 days, setting a record for the fastest approval in the province, thanks to improved collaboration between local regulatory bodies and higher authorities [2] - The market regulatory department plans to enhance risk prevention mechanisms and focus on the governance of small businesses while prioritizing key industries like biomedicine to optimize the business environment [2] - Continuous efforts will be made to solidify the foundation for drug safety and high-quality industrial development in the region [2]

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not progressed after platinum-based chemotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who had not progressed after synchronous/sequential chemoradiotherapy, comparing Bemosituzumab to a placebo [1] Group 2 - The median follow-up time was 19.4 months, with a median progression-free survival (PFS) of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation therapy after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]