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百奥赛图今日申购 专利技术构筑坚实护城河 海外扩张赋能公司估值
Ge Long Hui· 2025-12-09 23:22
在持续较高且可控研发投入的同时,公司盈利能力不断增强。2025年上半年营收6.21亿元,同比增长 51.5%,净利润4,800万元,已超过去年全年水平,经营现金流全面转正,展现出强劲的自我造血能力。 其中,靶点人源化小鼠业务收入2.74亿元,同比增长56.1%,毛利率高达79%。抗体分子转让开发业务 收入达1.63亿元,同比增长38%。公司仍然保持较高的研发投入,2025年上半年公司研发费用达2.09亿 元,同比增长29%。 国际化生物技术公司百奥赛图(688796.SH)今日(11月28日)启动申购,该股于上交所科创板上市,发行价 每股26.68元(人民币,下同),发行4750万股新A股,占公司总股本10.63%,料净集资约11.44亿元。公司 以创新技术驱动新药研发,依托"源头抗体分子库 + 靶点人源化小鼠库"双核心平台,加速全球合作伙伴 新靶点、新机制与新疗法的研发进程,推动行业从探索式研发迈向更高确定性的成药时代。 百奥赛图成立于2009年,总部位于北京,在中国(江苏海门、上海)、美国(波士顿、旧金山、圣地亚哥) 及德国海德堡等地设有分支机构,全球扩张能力强,具备重构估值逻辑。截至2025年上半年,公 ...
康缘药业多款药品纳入医保目录 将推动新药市场推广与销售增长
Zheng Quan Shi Bao Wang· 2025-12-09 13:06
Core Viewpoint - Kangyuan Pharmaceutical has successfully included its unique products, including Wenyang Jiedu Granules and Yunu Decoction Granules, as well as the first generic drug Sumatriptan Naproxen Sodium Tablets, in the National Medical Insurance Directory (2025 edition) [1] Group 1 - Wenyang Jiedu Granules, as a unique product, is recognized for its clinical efficacy in improving symptoms such as cough, fever, fatigue, and loss of appetite, along with good safety [1] - Yunu Decoction Granules, also a unique product, is classified as a Category 3.1 new traditional Chinese medicine, aimed at treating dental pain, periodontal disease, oral ulcers, diabetes, and early-stage diabetes [1] - Sumatriptan Naproxen Sodium Tablets are expected to provide a new treatment option for acute migraine [1] Group 2 - The inclusion of these new drug varieties in the National Medical Insurance Directory is anticipated to drive the company's market promotion and sales growth, enhance its R&D innovation and brand influence, and benefit a wide range of patients [1] - The company has established a rich product portfolio in the respiratory and infectious disease sector, including products like Heat Toxicity Ning Injection and Jinzhen Oral Liquid, which have shown significant clinical efficacy [2] - Despite a decline in sales due to weakened terminal demand in the first three quarters of 2025, the company is ramping up production to meet the recovering market demand in the fourth quarter [2] Group 3 - The company is advancing its pipeline of innovative biological drugs for treating obesity or overweight and type 2 diabetes, with the first subject enrollment for the innovative drug ZX2021 Injection completed in June 2025, showing weight loss effects [3] - The innovative drug ZX2010 Injection for type 2 diabetes and obesity has also commenced its second-phase clinical trials, with plans to enter the third phase in Q3 2026 [3] - The company is committed to progressing all its research pipelines according to clinical plans and aims for early market launch [3]
昭衍新药盘中涨超10% 机构称供需缺口或持续放大
Xin Lang Cai Jing· 2025-12-09 02:34
Core Viewpoint - The stock price of Zhaoyan New Drug (06127) has increased significantly, driven by a surge in the price of experimental monkeys, particularly the crab-eating macaque, which has seen a supply shortage and price increase [5]. Group 1: Company Performance - Zhaoyan New Drug's stock price rose by 7.33% to HKD 17.43, with a trading volume of HKD 211 million [5]. - The company is expected to benefit from the rising prices of experimental monkeys due to its acquisition of monkey breeding facilities, which aims to create an integrated industry chain [5]. Group 2: Industry Trends - The price of crab-eating macaques has surpassed HKD 100,000, with reports indicating prices have reached HKD 120,000 to HKD 130,000 due to supply shortages [5]. - Demand for experimental monkeys is projected to be between 51,300 to 62,600 annually from 2025 to 2027, while supply is estimated at 49,000 to 52,400, indicating a potential supply-demand gap [5]. - The resurgence in new drug development is expected to drive up the usage of experimental monkeys, exacerbating the supply constraints in the short term [5].
石药集团(01093):司美格鲁肽注射液的第二项上市许可申请获国家药监局受理
智通财经网· 2025-12-08 10:01
该产品为化学合成法制备的司美格鲁肽制剂,按照化药注册分类2.2类新药申报,属于含有已知活性成 份的新处方工艺且具有明显临床优势的药品。该产品既避免生物发酵过程引入的宿主蛋白等免疫原性物 质,又保证杂质水平不高于DNA重组技术制备的司美格鲁肽。该产品可通过与GLP-1受体结合而发挥作 用,并可通过多重机制实现减重、降糖以及心血管和肾臟保护等方面的综合获益。 本次申请基于一项Ⅲ期临床试验。该临床试验结果表明,在非糖尿病的肥胖成人受试者中,该产品可显 著降低体重及腰围,改善血糖、血脂及肝酶水平;与诺和诺德开发的司美格鲁肽相比,其有效性高度一 致,安全性特徵相似,且耐受性良好,不良事件发生率略低。基于在疗效、安全性、制剂方面的优势, 该产品具有显著的临床应用价值。 石药集团(01093)公布,公司附属公司石药集团百克(山东)生物制药股份有限公司开发的司美格鲁肽注射 液的第二项上市许可申请已获中华人民共和国国家药品监督管理局受理。本次申报的适应症为在控制饮 食和增加体力活动的基础上对成人超重╱肥胖患者的长期体重管理。此前,该产品拟用于成人2型糖尿 病血糖控制的适应症上市许可申请已于2025年8月获国家药监局受理。 ...
港股异动 | 亚盛医药-B(06855)涨超6% 耐立克POLARIS-1研究获美国FDA和欧洲EMA批准
智通财经网· 2025-12-05 02:12
Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in combination with chemotherapy for newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nilotinib approved by regulatory agencies in Europe and the U.S. [1] - The trial will enroll patients across multiple countries and centers, accelerating the market entry of Nilotinib, particularly in Europe and the U.S. [1] - The latest data from the POLARIS-1 study will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of this data [2] Group 2 - Preliminary results indicate that the molecular minimal residual disease (MRD) negative rate and complete response (CR) rate for patients treated with Nilotinib and low-intensity chemotherapy are around 65%, significantly higher than similar products under the same conditions [2] - The treatment has shown effective results even in high-risk subtypes, such as those with IKZF1plus gene mutations [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of side effects [2]
亚盛医药-B涨超6% 耐立克 POLARIS-1研究获美国FDA和欧洲EMA批准
Zhi Tong Cai Jing· 2025-12-05 01:41
Core Viewpoint - Ascentage Pharma-B (06855) saw a stock increase of over 6%, currently trading at 64.2 HKD with a transaction volume of 19.93 million HKD, following the announcement of the global registration Phase III clinical trial POLARIS-1 for its novel drug Olverembatin (brand name: Nairik) in treating newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) patients, which received approval from both the FDA and EMA [1][2]. Group 1 - The POLARIS-1 study is the second global registration Phase III trial for Nairik approved by regulatory agencies in Europe and the US, which will expedite its market entry, particularly in Europe and the US [1]. - The POLARIS-1 study's latest progress will be presented at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the study data [2]. - Preliminary data from the study indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response (CR) rate for patients treated with Nairik combined with low-intensity chemotherapy reached approximately 65%, significantly outperforming similar products under comparable conditions [2]. Group 2 - The treatment regimen demonstrated excellent safety profiles, with a low and manageable incidence of side effects, even for high-risk subtypes such as those carrying the IKZF1plus gene mutation [2].
港股异动 | 亚盛医药-B(06855)涨超6% 耐立克®POLARIS-1研究获美国FDA和欧洲EMA批准
智通财经网· 2025-12-05 01:39
Core Viewpoint - Ascentage Pharma-B (06855) has seen a stock price increase of over 6%, currently trading at 64.2 HKD, following the announcement of the global Phase III clinical trial POLARIS-1 for its novel drug Olverembatinib (brand name: Nilotinib) in treating newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) patients, which has received approval from both the FDA and EMA [1][2] Group 1 - The POLARIS-1 study is the second global Phase III trial for Nilotinib approved by major regulatory agencies in Europe and the U.S., which will expedite its market entry, particularly in Europe and the U.S. [1] - The study will present its latest findings at the upcoming 2025 American Society of Hematology (ASH) annual meeting, marking the first public disclosure of the data [2] - Preliminary data indicates that the molecular MRD (minimal residual disease) negative rate and molecular MRD negative complete response rate for patients treated with Nilotinib combined with low-intensity chemotherapy are around 65%, significantly outperforming similar products under comparable conditions [2] Group 2 - The treatment has shown promising efficacy even in high-risk subtypes, such as those with IKZF1plus gene mutations, demonstrating good therapeutic outcomes [2] - The safety profile of the combination therapy is favorable, with a low and manageable incidence of adverse effects [2]
歌礼制药-B早盘涨逾10% 昨日公司耗资1592.75万港元回购130.6万股
Xin Lang Cai Jing· 2025-12-04 03:24
歌礼制药-B(01672)盘中涨超10%,截至发稿,股价上涨9.76%,现报13.05港元,成交额3508.53万港 元。 歌礼制药发布公告,12月3日,公司耗资1592.75万港元回购130.6万股。据悉,歌礼制药今年10月份公 布,董事会已决定行使购回授权,并根据市况不时于公开市场购回股份,以使用最多3亿港元的资金进 行建议股份购回。 值得注意的是,歌礼制药上月发布公告,每月一次新一代胰淀素受体激动剂ASC36和每月一次新一代 GLP-1R/GIPR双靶点激动剂ASC35复方制剂进入临床开发阶段。歌礼预计将于2026年第二季度向美国 FDA递交ASC36和ASC35复方制剂用于治疗肥胖症的新药临床试验申请。 责任编辑:卢昱君 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 热点栏目 自选股 数据中心 行情中心 资金流向 模拟交易 客户端 客户端 歌礼制药-B(01672)盘中涨超10%,截至发稿,股价上涨9.76%,现报13.05港元,成交额3508.53万港 元。 歌礼制药发布公告,12月3日,公司耗资1592.75万港元回购130.6万股。据悉,歌礼制药今年10月份公 布,董事会已决定行使购 ...
优瑞科生物科技CEO刘诚:让世界读懂中国对全球新药研发的贡献
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-01 06:21
(原标题:优瑞科生物科技CEO刘诚:让世界读懂中国对全球新药研发的贡献) 美国优瑞科生物科技公司创始人兼CEO刘诚在接受南方财经全媒体集团记者采访时,强调中国举办更多 科学及新药研发领域国际会议与专题研讨会的重要性。他认为,这类专业交流不仅能够帮助全球更全 面、更深入地了解中国在相关领域的最新进展,也能让国际社会充分理解与认可中国科学家在全球药物 研发方面的贡献。 策划:赵海建 监制:黄燕淑 南方财经 21世纪经济报道记者 黄子豪 庄欢 郑全怡 广州报道 11月30日至12月1日,2025年"读懂中国"国际会议在广州举行。大会以"新布局、新发展、新选择——中 国式现代化与全球治理新格局"为主题,汇聚全球知名政治家、学者、业界领袖及国际组织代表等重量 级嘉宾,聚焦"十五五"规划及其世界意义,就中国式现代化创新发展的新布局及其为世界现代化提供的 新机遇,携手践行全球治理倡议等相关议题展开研讨。 海外运营监制: 黄燕淑 海外运营内容统筹: 黄子豪 海外运营编辑:庄欢 吴婉婕 龙李华 郑全怡 出品:南方财经全媒体集团 内容:黄子豪 庄欢 郑全怡 ...
Ascendis Pharma Hit By FDA Delay As TransCon CNP Decision Slips To 2026
Benzinga· 2025-11-28 15:13
Core Viewpoint - The FDA has extended the review period for Ascendis Pharma's New Drug Application for TransCon CNP, a treatment for children with achondroplasia, by three months to February 28, 2026, due to a major amendment related to post-marketing requirements [1][3]. Company Overview - Ascendis Pharma is focused on developing treatments for rare diseases, with TransCon CNP being a key product aimed at addressing achondroplasia, the most common form of skeletal dysplasia caused by a mutation in the FGFR3 gene [2][4]. - The company has reported positive results from its ApproaCH Trial, demonstrating significant improvements in annualized growth velocity and health-related quality of life for children treated with TransCon CNP compared to placebo [4][5]. Regulatory Update - The FDA's extension of the PDUFA target action date is a response to the major amendment submitted by Ascendis Pharma, which included a revised protocol for the post-marketing study [3]. - The company has addressed all outstanding requests from the FDA, indicating proactive engagement in the regulatory process [3]. Clinical Data - The pivotal week 52 results from the ApproaCH Trial were published in JAMA Pediatrics, highlighting the efficacy of TransCon CNP in improving growth metrics and overall health outcomes for children with achondroplasia [4][5]. - The treatment showed a safety and tolerability profile similar to that of placebo, reinforcing its potential as a viable therapeutic option [5]. Market Performance - Ascendis Pharma's stock price increased by 1.44%, reaching $213.03 at the time of publication, reflecting positive market sentiment regarding the company's developments [7].