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创纪录!远大医药(00512)易甘泰®钇[90Y]15项研究成果入选顶级肝癌会议APPLE ,40万肝癌患者迎新希望
智通财经网· 2025-07-13 09:33
智通财经APP获悉,易甘泰®钇[90Y]微球注射液自2022年在中国大陆上市以来,至今已惠及超3000例肝部肿瘤患者。2025 年7月11日至13日,第十五届亚太原发性肝癌专家联盟(APPLE)年会于日本神户盛大召开,15篇中国大陆钇-90树脂微球 研究成果重磅入选,充分展现出易甘泰®在肝癌治疗领域的"中国方案"获国际学术界的关注与认可。 2025年7月7日,钇[90Y]微球注射液更获美国FDA提前正式批准新适应症用于不可切除肝细胞癌(HCC),且未限制肿瘤直 径大小,由此易甘泰®成为全球首个且唯一获FDA批准用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治 疗产品。这一里程碑式的突破,或将加速易甘泰®的国内商业化,并全面重塑中国肝癌的治疗格局。 第十五届APPLE年会,中国专家展现易甘泰®的本土化临床适用性 APPLE联盟创建于2010年,官方期刊《Liver Cancer》位列JCR Q1区,影响因子高达13.8。APPLE大会自首届在韩国举办以 来,十余年间已发展成为备受瞩目的亚太地区肝癌领域顶级学术盛会。本次为第十五届年会,以"肝癌多学科治疗新时 代"为主题,汇聚全球顶尖专家,围绕"精准诊 ...
海外消费周报:港股医药中报前瞻:子行业分化明显,创新药持续销售放量-20250711
行 业 及 产 业 海外消费服务 行 业 研 究 / 行 业 点 评 2025 年 07 月 11 日 港股医药中报前瞻—子行业分化明显,创新药 持续销售放量 看好 ——海外消费周报(20250704-20250710) 相关研究 证 券 研 究 报 告 证券分析师 黄哲 A0230513030001 huangzhe@swsresearch.com 周文远 A0230518110003 zhouwy@swsresearch.com 贾梦迪 A0230520010002 jiamd@swsresearch.com 胡梦婷 A0230524060004 humt@swsresearch.com 研究支持 胡梦婷 A0230524060004 humt@swsresearch.com 联系人 胡梦婷 (8621)23297818× humt@swsresearch.com 本研究报告仅通过邮件提供给 中庚基金 使用。1 本期投资提示: ⚫ 海外医药:港股医药中报前瞻—子行业分化明显,创新药持续销售放量 港股医药中报前瞻:创新药:商业化持续放量,部分公司有望迎来盈利拐点。创新药板块,我们预计 1H25 收入同比增速 ...
远大医药20250710
2025-07-11 01:05
Q&A 远大医药的历史和发展历程是怎样的? 远大医药 20250710 摘要 远大医药 2024 年总资产达 249 亿港币,收入 116.4 亿港币,归母净利 润 24.7 亿港币,合药板块收益显著,同比增长 17.7%。分红 9.1 亿港 币,不考虑泰利斯公允价值变动情况下录得 17.6 亿港币,同比增长 4.6%。 公司业务分为核药抗肿瘤、心脑血管疾病介入诊疗科技和制剂科技三大 领域。核药抗肿瘤及心脑血管疾病介入诊疗科技板块收入同比增长 148.3%,制剂科技领域收入同比增长 9.6%。 核药板块形成全球产销研一体化布局,肝泰维球注射液全年收入近 5 亿 港币。成都合药生产基地落成,覆盖所有研发管线合作产品生产,加强 医院合作与医生培训,探索多元化支付手段。 公司拥有国际一流肿瘤介入平台和 RDC 研发平台,15 款创新产品处于 注册阶段,覆盖 5 个合作项目和 7 个癌种,另有十余款储备产品。三款 处于临床三期,一款国际多中心三期临床已提交申请。 呼吸及危重症方面,核心产品切诺持续领导口服圈市场,布局多种吸入 性制剂。针对过敏性鼻炎的复方鼻喷剂 Raltex 即将上市,未来将朝着复 杂粉雾剂与软雾剂方 ...
基石药业与Gentili达成欧洲商业化合作;润达医疗回复上交所问询函丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-08 23:22
Group 1 - Tong Ren Tang's Executive Vice President Zhang Chunyou submitted a resignation letter, effective July 8, 2025, due to work adjustments, while remaining as General Manager of Tong Ren Tang Technology [1] - The company stated that Zhang Chunyou's departure will not adversely affect daily operations, indicating limited market impact from this internal personnel adjustment [1] Group 2 - Basestone Pharmaceuticals announced an exclusive strategic partnership with Istituto Gentili for the commercialization of Sugliant in Western Europe and the UK, granting Gentili exclusive rights in 23 countries [2] - Basestone will receive up to $192.5 million in payments, including upfront, registration, and sales milestone payments, along with nearly 50% revenue sharing from net sales in the authorized region [2] - This collaboration enhances Basestone's international market recognition and strengthens investor confidence in future growth [2] Group 3 - Fosun Pharma announced guarantees for its subsidiaries, providing a maximum joint liability guarantee for a financing application not exceeding 500 million yuan with Bank of China [3] - Additionally, a guarantee was provided for a financing contract not exceeding 150 million yuan with China Construction Bank for its subsidiary Hanlin Pharmaceutical [3] - This move supports subsidiaries in obtaining funds for business expansion or R&D, although it introduces certain financial risks [3] Group 4 - Run Da Medical responded to the Shanghai Stock Exchange's inquiry regarding its 2024 annual report, addressing issues related to operating performance, goodwill, short-term solvency, and prepayments [4] - The response aims to alleviate market concerns and stabilize investor confidence, although ongoing monitoring of the company's performance improvement measures is necessary [4] Group 5 - Yuan Da Pharmaceutical announced that its joint venture Sirtex Medical Pty Ltd received FDA approval for SIR-Spheres Yttrium-90 microspheres for treating unresectable hepatocellular carcinoma (HCC) [5] - This product is the first and only FDA-approved selective internal radiation therapy for both unresectable HCC and colorectal cancer liver metastases [5] - This breakthrough enhances Yuan Da's market position in oncology and boosts investor confidence in future growth [5]
滚动更新丨沪指小幅高开0.04%,钢铁、多元金融等板块回调
Di Yi Cai Jing· 2025-07-08 01:39
盘面上,先进封装、半导体、电力题材走强,退税商店、重组蛋白、CPO概念低开。 09:32 航运港口概念开盘走强,宁波远洋、宁波海运均涨超3%,国航远洋、连云港等个股跟涨;消息面上,胡塞武装 自去年12月以来首次袭击红海商船。 盘面上,存储芯片、页岩气等板块走强,钢铁、多元金融、光伏玻璃等板块回调。 09:21 港股开盘丨恒生科技指数涨0.28% 恒生指数开盘涨0.17%,恒生科技指数涨0.28%。远大医药涨5.5%,易甘泰®获FDA提前正式批准新增HCC适应症。基 石药业涨近15%,与Istituto Gentili就舒格利单抗在西欧和英国达成独家战略合作。海隆控股复牌大涨50%。 09:21 央行公开市场开展690亿元7天期逆回购操作,操作利率1.40%。Wind数据显示,今日1310亿元逆回购到期。 09:15 人民币对美元中间价调贬28个基点 09:30 存储芯片概念涨幅居前,精智达涨超7%,科翔股份、深科技、古鳌科技等个股跟涨;消息面上,国产DRAM内 存芯片大厂长鑫存储启动上市辅导。 09:25 A股开盘丨上证指数涨0.04% 三大股指开盘涨跌不一,上证指数报3474.63点,涨0.04%,深成指报 ...
港股开盘,恒生指数开涨0.17%,恒生科技指数开涨0.28%;创新药概念反弹,远大医药(00512.HK)涨超5%;芯片股回升,上海复旦(01385.HK)涨1.5%。
news flash· 2025-07-08 01:26
港股开盘,恒生指数开涨0.17%,恒生科技指数开涨0.28%;创新药概念反弹,远大医药(00512.HK)涨 超5%;芯片股回升,上海复旦(01385.HK)涨1.5%。 ...
恒生指数开盘涨0.17%,恒生科技指数涨0.28%。创新药概念反弹,远大医药涨超5%。
news flash· 2025-07-08 01:24
恒生指数开盘涨0.17%,恒生科技指数涨0.28%。创新药概念反弹,远大医药涨超5%。 ...
远大医药(00512)易甘泰®海外临床取得突破性中期数据,获FDA提前正式批准拓展HCC适应症,或重塑肝癌治疗格局
智通财经网· 2025-07-07 13:26
Core Insights - The article highlights the significant milestone achieved by YuanDa Pharmaceutical with its innovative nuclear medicine product, SIR-Spheres Yttrium-90 microsphere injection, which has received FDA approval for dual indications in treating unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases [1][2][3] Product Development and Approval - SIR-Spheres Yttrium-90 microsphere injection is the first and only selective internal radiation therapy (SIRT) product globally approved by the FDA for both unresectable HCC and colorectal cancer liver metastases, showcasing its clinical value [1][2] - The product achieved a remarkable objective response rate of 98.5% and a local tumor control rate of 100% in the DOORwaY90 clinical trial, with a median duration of response exceeding 300 days [2][3] - The FDA's early approval for the new indication of unresectable HCC, without restrictions on tumor diameter, reflects the product's significant advantages over competitors [2][3] Market Potential and Clinical Impact - The global liver cancer treatment market is projected to reach USD 9.81 billion by 2030, indicating a substantial opportunity for innovative therapies like SIR-Spheres [7] - With liver cancer being the sixth most common and the third deadliest cancer globally, and China accounting for a significant portion of new cases and deaths, the product is positioned to address a critical healthcare need [4][7] Company Positioning and Strategy - YuanDa Pharmaceutical has established a comprehensive nuclear medicine ecosystem, encompassing research, production, sales, and regulatory compliance, positioning itself as a leader in the nuclear medicine field [8][15] - The company has a robust pipeline of 15 innovative products targeting various cancers, supported by a state-of-the-art production facility that meets international standards [8][13][15] - The successful operation of the Chengdu Wenjiang nuclear medicine R&D and production base marks a strategic leap for the company, enabling it to meet global demand for therapeutic and diagnostic nuclear medicines [13][15]
远大医药(00512.HK):核药增速快 脓毒症STC3141有望成为全球大药
Ge Long Hui· 2025-06-27 02:24
Core Viewpoint - The company is experiencing stable growth in traditional business while new sectors are contributing significantly to high growth, particularly in nuclear medicine, cardiovascular precision intervention, pharmaceutical technology, and biotechnology [1] Group 1: Nuclear Medicine Development - The demand for nuclear medicine is increasing due to aging populations and rising cancer incidence, leading to market expansion for diagnostic and therapeutic applications [1] - The core commercial product, Yttrium-90 microspheres, is expected to grow over 140% in 2024, supported by training of over 1,100 doctors across more than 70 hospitals and inclusion in 45 health insurance plans [1] - The company has 12 innovative RDC products in its pipeline, with 4 approved for clinical research and 3 in Phase III trials, including TLX591-CDx for prostate cancer and TLX250-CDx for renal cell carcinoma [1] Group 2: New Product Opportunities - The company has a diverse range of existing products, but the inclusion of Lishuan in the 10th batch of national procurement is expected to exert short-term pressure on performance [2] - New products in sepsis (STC3141) and ophthalmology are anticipated to have significant market potential, with STC3141 projected to reach peak sales of 10 billion yuan based on a 20% market share and a unit price of 8,000 yuan [3] - The company is also advancing in the ENT field with multiple products in development, including a nasal spray expected to be approved by the end of 2024 [3] Group 3: Financial Projections - Revenue projections for 2025-2027 are estimated at 12.203 billion, 13.292 billion, and 14.663 billion HKD, with net profits of 2.076 billion, 2.422 billion, and 2.764 billion HKD respectively, indicating a low valuation compared to peers [4] - The current price-to-earnings (PE) ratios are projected at 15, 13, and 11 times for the respective years, compared to an average of 25, 23, and 20 times for comparable companies, suggesting the company is undervalued [4]
远大医药(00512):核药增速快,脓毒症STC3141有望成为全球大药
Soochow Securities· 2025-06-25 05:38
Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1][10]. Core Insights - The company is expected to experience significant growth in its nuclear medicine sector, with the STC3141 sepsis product projected to become a major global drug. The report emphasizes the potential of new products in various therapeutic areas, including respiratory, critical care, and ophthalmology [3][9]. - The company has a diversified product portfolio and a robust pipeline, with a focus on innovative therapies and strategic acquisitions to enhance its market position [9][18]. Summary by Sections 1. Company Overview - The company operates in three main segments: nuclear medicine, pharmaceutical technology, and biotechnology, with a strong emphasis on innovation and market expansion through acquisitions [9][18]. 2. Nuclear Medicine Sector - The nuclear medicine segment is rapidly growing, with a focus on the core product Yttrium-90 (Y[90]) and a pipeline of 12 innovative products targeting various cancers. The company has established partnerships with leading international firms to enhance its research and development capabilities [9][35][37]. 3. Pharmaceutical Technology - The pharmaceutical technology segment is expected to see growth from new products in the respiratory and critical care fields, as well as in ophthalmology. The company is well-positioned to capitalize on the market opportunities presented by these new therapies [3][9]. 4. Financial Projections - The company forecasts revenue growth from 116.45 billion HKD in 2024 to 146.63 billion HKD by 2027, with net profit expected to rise from 24.68 billion HKD to 27.64 billion HKD in the same period. The projected P/E ratios indicate that the company is undervalued compared to its peers [1][10][24]. 5. Market Potential - The global nuclear medicine market is projected to grow significantly, with estimates suggesting a rise from 10.7 billion USD in 2023 to 22.8 billion USD by 2030. The Chinese market for radiopharmaceuticals is also expected to expand rapidly, driven by increasing demand and regulatory support [36][38].