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创新产品四连击,远大医药(00512)产品生态进入收获期,全球布局开启发展新篇章
智通财经网· 2026-01-05 01:54
智通财经APP获悉,2025年末,远大医药(00512)接连亮出多款创新产品新进展,覆盖核药、中药抗抑郁以及急救等前沿治疗领域,全面展现了公司"自研 +引进"创新战略布局成效。 12月初,公司抗抑郁症创新中药在国内的II期临床研究告捷;其后,公司又接连披露了两款创新RDC药物的临床新进展,包括自研的FAP靶向实体瘤诊断核 药获FDA批准进入临床研究阶段,以及引进的前列腺癌诊断核药已成功达到国内III期临床研究终点,商业化兑现在即;近日,公司心脑血管急救板块再添重 磅管线,全球首款治疗I型过敏肾上腺素鼻喷雾剂的落地中国。 短短30天内的四大创新产品里程碑进展,是公司管线势能的集中释放,印证了这家老牌药企在产品布局上的独到眼光以及技术转化能力的深厚积淀。同时, 基于创新药物海内外双线并进的临床研究策略,远大也已勾勒出中国创新药企全球化突围的清晰路径,有望在后续书写中国创新药支撑可持续发展的新篇 章。 核药进展锐不可当,两款差异化产品拓宽增长空间 作为远大医药全球化布局的核心引擎,核药抗肿瘤板块迎来了现象级突破,不仅有GPN01530印证了公司在核药领域的技术突破,更有TLX591-CDx即将实 现商业化落地,彰显 ...
远大医药前列腺癌诊断创新核药TLX591-CDx国内Ⅲ期达到主要临床终点
Zheng Quan Ri Bao Wang· 2025-12-21 13:47
TLX591-CDx在中国Ⅲ期临床试验的成功,也意味着远大医药在构建"诊疗一体化"的前列腺癌核药产品组合上迈出了关键 一步。在前列腺癌治疗方面,公司另一创新RDC产品TLX591已在中国获批加入国际多中心Ⅲ期临床研究。未来,两款产品组 合,有望为中国前列腺癌患者带来更为精准、高效的诊疗方案,并将在商业上形成强大的协同效应,释放巨大的市场价值,巩 固远大医药在核药领域的综合优势。 据悉,前列腺癌是我国男性群体中常见的癌症类型,且随着人口老龄化加剧等原因,我国前列腺癌患者的发病率和病死率 呈明显上升趋势。据弗若斯特沙利文数据,到2030年我国前列腺癌发病率或将超过16.5万例,同期我国前列腺癌药物市场规模 有望达到约376亿元。 本报讯 (记者张敏)12月21日,港股上市公司远大医药集团有限公司(以下简称"远大医药")发布的公告显示,公司用于 诊断前列腺癌的创新RDC药物TLX591-CDx(Illuccix®,gallium Ga68 PSMA-11)在中国进行的Ⅲ期临床试验已取得积极的顶 线结果,并成功达到了主要临床终点。 根据公告,TLX591-CDx是一款全球创新、基于放射性核素-小分子偶联技术的靶向前列 ...
Go Global战略再突破 远大医药(00512)自研创新FAP靶点核药美国临床获批 撬动超千亿市场空间
智通财经网· 2025-12-19 00:36
智通财经APP获悉,近日,中国医药创新领域迎来一项具有标杆意义的进展——远大医药(00512)自主研发的全球创新放射 性核素偶联药物(RDC)GPN01530正式获得FDA批准在美国开展用于诊断实体瘤的I/II期临床研究。 此举不仅意味着远大医药在成纤维细胞活化蛋白(FAP)这一明星靶点上的布局取得国际认可,更体现了公司在国际化临床开 发与注册申报上的综合实力,这也将成为公司后续推进其他创新药全球化布局的重要里程碑。未来若GPN01530开发顺利, 该产品有望成为破解实体瘤诊疗困境的重要突破口,凭借显著的产品优势重塑实体瘤诊疗格局,抢占全球领先的市场地 位,并为全球患者带来新的希望。 布局十亿美元级靶点,BIC惠及全球超千万患者 远大医药GPN01530并非寻常意义上的又一款创新核药,其特殊性源于产品靶点背后的泛实体瘤应用前景、所突破的技术瓶 颈以及所承载的"诊疗一体化"愿景,这也使得该产品成为企业在核药领域差异化竞争的核心抓手,更有望成为中国创新核 药出海的标杆范例。 公告显示,GPN01530优化了FAP配体的结构,提高了其在肿瘤组织中的摄取,同时降低其在正常组织中的摄取。临床前研 究结果显示,与其它FA ...
创新药商业模式有望整体改善
● 本报记者 李梦扬 近日,西安市人民政府办公厅发布《促进生物医药产业能力提升实施方案(2025—2027年)》。其中提 到,在干细胞药物、多肽药物、肝靶向创新药物、麻醉制品等领域突破一批药物研发关键核心技术。支 持企业开展Ⅰ类创新药、临床紧缺药研发及成果转化,推动企业研发立项Ⅱ类创新药,提升企业在创新 药领域的研发能力和竞争力。 值得关注的是,今年以来,北京、上海、重庆、四川等多地出台相关政策,促进医药健康产业创新,推 动创新药行业高质量发展。业内人士表示,医药行业尤其是创新药已经步入新一轮的政策支持发展新周 期。全链条鼓励创新有望带动创新药商业模式整体改善。 突破药物研发关键核心技术 具体来看,《实施方案》提出三大主要目标。产业规模方面,根据《实施方案》,到2027年,西安市生 物医药产业规模达到400亿元,其中中药、化药生物药、医疗器械、消费医疗产业链群分别达到90亿 元、120亿元、60亿元、130亿元。 在免疫细胞治疗领域,《实施方案》表示,支持企业与西安交大一附院、唐都医院等医疗机构围绕胃 癌、肝癌等领域,合作开展"CAR-T实体瘤"技术突破和临床研究,推动免疫细胞产业化。 在细胞衍生物治疗领域, ...
突破FAP靶点技术瓶颈!远大医药(00512)自研创新RDC美国临床获FDA批准 剑指千亿肿瘤药物市场
智通财经网· 2025-12-17 11:04
Core Viewpoint - The approval of GPN01530 by the FDA marks a significant milestone for the company, enhancing its global strategy and showcasing its capabilities in nuclear medicine technology and international clinical development [1][16]. Group 1: Product Development and Clinical Research - GPN01530 is the first self-developed radioactive drug conjugate (RDC) by the company to receive FDA approval for clinical research, specifically for diagnosing solid tumors [1]. - The drug targets fibroblast activation protein (FAP), which is highly expressed in 90% of epithelial tumors, offering a promising diagnostic tool with higher sensitivity compared to traditional imaging agents like 18F-FDG [1][2]. - Preclinical studies indicate that GPN01530 shows rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties compared to other FAP ligands [2][4]. Group 2: Market Potential and Growth - The global cancer drug market is projected to grow from $150.3 billion in 2020 to $452.5 billion by 2030, with a compound annual growth rate (CAGR) of 10.2% [4]. - The radioactive drug market is expected to reach approximately $9.7 billion by 2024 and $57.3 billion by 2035, with a CAGR of about 17.5% [8]. - The company has a robust pipeline with 16 innovative products in the registration phase, covering various cancers and utilizing multiple radioactive isotopes [9]. Group 3: Strategic Positioning and Global Expansion - The successful development of GPN01530 aligns with the company's "Go Global" strategy, which aims to enhance its competitiveness in the global nuclear medicine market [8][16]. - The company has established a comprehensive global nuclear medicine supply chain, including R&D, production, and sales, with bases in Boston and Chengdu [8][13]. - The company is positioned as a leader in the nuclear medicine sector, with a focus on integrating diagnosis and treatment, thereby reshaping the landscape of solid tumor therapy [7][9].
国元国际:维持远大医药“买入”评级 目标价格为11.88港元
Zhi Tong Cai Jing· 2025-12-15 09:26
盈利预测 25年中期实现总营业收入61.1亿港元,人民币口径同比增长2.0%;正常化溢利10.2亿港元,人民币口径 同比下降5.0%。主要业务板块中,制药科技产品贡献最大,收入为港币38.45亿元,人民币口径同比上 涨2.9%。核药抗肿瘤诊疗收入为港币4.2亿元,人民币口径同比增长105.5%,增长主要源于易甘泰钇 [90Y]微球。FDA基于突破性中期临床数据,提前正式批准了SIR-Spheres钇[90Y]微球注射液用于不可切 除HCC的适应症,且未限制肿瘤直径大小。成为全球首个且目前唯一获FDA批准用于治疗不可切除 HCC和结直肠癌肝转移双重适应症的选择性内放射治疗"SIRT"产品。 创新药管线丰富,重点布局核药 公司拥有5大技术平台和8大研发中心,25年上半年研发及项目投入为10.2亿港元。公司重点布局创新核 药,拥有全球领先的核药管线,涵盖放射性核素偶联药物(RDC)及肿瘤介入产品,如TLX591、 TLX250、GPN02006等,均处于III期临床或获批新增适应症阶段。创新核药管线当前已达到27条,其中 自研产品占比50%,注册研发阶段储备15款创新产品,涵盖5种核素,覆盖7个癌种。创新药STC3 ...
国元国际:维持远大医药(00512)“买入”评级 目标价格为11.88港元
智通财经网· 2025-12-15 09:25
Core Viewpoint - Yuan Da Pharmaceutical (00512) is experiencing continuous revenue growth driven by the gradual launch of innovative products and efficient management, with a target price of HKD 11.88, indicating a potential upside of 45.23% from the current price, maintaining a buy rating [1] Group 1: Revenue Growth - The company achieved total revenue of HKD 6.11 billion in the first half of 2025, representing a year-on-year increase of 2.0% in RMB terms; normalized profit was HKD 1.02 billion, down 5.0% year-on-year in RMB terms [2] - The pharmaceutical technology segment contributed the most to revenue, generating HKD 3.845 billion, with a year-on-year increase of 2.9% in RMB terms [2] - Revenue from nuclear medicine for tumor diagnosis and treatment reached HKD 420 million, showing a significant year-on-year growth of 105.5%, primarily driven by the approval of SIR-Spheres Yttrium-90 microspheres for unresectable HCC [2] Group 2: Innovative Drug Pipeline - The company has five major technology platforms and eight R&D centers, with R&D and project investment of HKD 1.02 billion in the first half of 2025 [3] - The focus is on innovative nuclear medicine, with a leading global pipeline that includes radiolabeled drug conjugates (RDC) and interventional oncology products, with 27 innovative drug candidates currently in development [3] - The innovative drug STC3141 for treating sepsis has reached clinical endpoints in Phase II trials in China, showing significant improvement in SOFA scores compared to the placebo group [3] Group 3: Profit Forecast - Future revenue growth is expected, with projected revenues of HKD 12.35 billion, HKD 13.39 billion, and HKD 14.79 billion for 2024 to 2026, respectively; EPS is forecasted to be HKD 0.59, HKD 0.66, and HKD 0.77 for the same period [4]
云南白药(000538) - 2025年12月10日调研活动附件之投资者调研会议记录(二)
2025-12-12 10:44
Group 1: Health Products Business Performance - In the first half of 2025, the health products segment achieved revenue of 3.442 billion CNY, a year-on-year growth of 9.46% [2] - The segment focuses on a full-channel operation strategy, enhancing offline distribution and increasing online promotion efforts [2] - Key products include oral care toothpaste, which maintains a leading position, and hair care brand Yangyuanqing, which continues to grow driven by online sales [2][4] Group 2: Pharmaceutical Business Performance - The pharmaceutical segment reported a main business revenue of 4.751 billion CNY in the first half of 2025, with a year-on-year increase of 10.8% [5] - Sales of Yunnan Baiyao aerosol exceeded 1.453 billion CNY, showing a significant growth of over 20.9% [5] - Other traditional Chinese medicine products also saw notable growth, with sales of Qianling Jianpi Granules surpassing 100 million CNY and Pudilan Anti-inflammatory Tablets nearing 100 million CNY [5] Group 3: Traditional Chinese Medicine Resource Business - The traditional Chinese medicine resource segment generated external revenue of 914 million CNY in the first half of 2025, reflecting a year-on-year growth of approximately 6.3% [6] - The segment implements a "six unifications" operational model to enhance the traditional Chinese medicine industry chain [7] Group 4: R&D and Innovation Progress - The company emphasizes innovation-driven development, focusing on both traditional Chinese medicine and innovative drugs [8] - In the first half of 2025, the company initiated phase III clinical trials for the prostate cancer diagnostic nuclear drug project INR101, with 60 subjects enrolled [9] - The innovative drug project INR102 for prostate cancer treatment received clinical trial approval, and phase I trials have commenced [9] Group 5: Dividend Distribution - For the 2024 fiscal year, the company distributed a cash dividend of 11.85 CNY per 10 shares, totaling approximately 2.164 billion CNY [10] - The total cash dividend for 2024, including special dividends, amounted to 4.279 billion CNY, representing 90.09% of the net profit attributable to shareholders [10] - In the first half of 2025, the company distributed a cash dividend of 10.19 CNY per 10 shares, totaling 1.818 billion CNY, which accounted for 50.05% of the net profit for that period [10]
核药的“火”烧得更旺了
3 6 Ke· 2025-11-27 01:00
Group 1: Market Overview - Pluvicto has become a major topic in the nuclear medicine field, with sales projected to reach $1.392 billion in 2024, a 42% increase year-over-year [1] - The sales of Pluvicto for the first three quarters of this year reached $1.389 billion, reflecting a 33% year-over-year growth [1] - Novartis predicts that Pluvicto's peak sales will exceed $5 billion [1] Group 2: Competitive Landscape - Major pharmaceutical companies such as Eli Lilly, BMS, AstraZeneca, and Roche are actively entering the nuclear medicine market [2][5] - Domestic companies like Heng Rui and Chengdu Nuyret are also making significant strides in nuclear medicine research and development [2][6] - The market is experiencing a new wave of growth, particularly in radiolabeled drug conjugates (RDC) [2][5] Group 3: Clinical Developments - Novartis leads the nuclear medicine sector with multiple products, including Lutathera and Pluvicto, and is developing additional candidates like 177Lu-NeoB and 225Ac-PSMA-617 [5][6] - Several domestic companies have products in late-stage clinical trials, such as ITM-11 and NRT6003, targeting various cancers [6][11] - The clinical pipeline for 177Lu-based products is expanding, with 17 innovative drug products currently in clinical stages in China [9] Group 4: Supply Chain and Production - The supply chain for Lu-177 has seen significant improvements, with domestic production capabilities being established to meet market demand [13][14] - The launch of the core product Lu-177 by Hefu One on June 25, 2025, marks a major breakthrough in the domestic production of medical isotopes [13] - The integration of nuclear medicine production and supply chains is becoming more evident, particularly in regions like Sichuan and Haiyan [23] Group 5: Future Trends - Research is expanding into new alpha-emitting isotopes, with a focus on Ac-225, which has shown promise in treating various cancers [15][17] - The supply chain challenges for Ac-225 are more severe than those for Lu-177, with a significant gap between production and clinical demand [22] - The nuclear medicine sector is entering a new phase of rapid growth, driven by advancements in both research and production capabilities [24]
9点1氪:泡泡玛特回应“卖79有点贵”直播事故;微信被曝测试“多台手机登录同一账号”,客服回应;陈睿卸任上海哔哩哔哩科技总经理
36氪· 2025-11-08 01:19
Group 1 - Bubble Mart confirmed a live streaming incident occurred and is under investigation, but no employees involved will be dismissed [2] - The company reported a gross margin of 70.3% in the first half of 2025, comparable to Hermes and significantly higher than major competitors like Apple and LVMH [18] Group 2 - WeChat is exploring the possibility of allowing the same account to be logged in on multiple devices, currently in a testing phase [3] - Bilibili announced a change in management with Chen Rui stepping down as general manager, but his core management role remains unchanged [3] Group 3 - Forbes released the 2025 China Rich List, with notable wealth increases among billionaires, including Lei Jun ranking seventh, surpassing Jack Ma [4] - The Chinese government provided 1.1 trillion yuan in subsidies to support pension payments in the first half of the year [4] Group 4 - China Life Insurance has become the largest life insurance company globally, with reserves of $798.07 billion [5] - Xiaomi is set to open end-to-end assisted driving experiences for its vehicles, enhancing user experience [6] Group 5 - Ant Group has restructured its organization, establishing a new health business group to accelerate its healthcare initiatives [8] - The first domestic nuclear drug has been approved for market release, providing new treatment options for advanced prostate cancer patients [11] Group 6 - The Chinese central bank has increased its gold reserves for the 12th consecutive month, reaching approximately 2304.457 tons [12] - Honda is recalling over 400,000 vehicles in the U.S. due to a manufacturing defect that could cause wheels to detach [12]