生物制剂

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注射剂可网上购买、冷链运到家?生物制剂切勿网购
Nan Fang Du Shi Bao· 2025-07-10 15:12
Core Viewpoint - The article discusses the rise of monoclonal antibody (mAb) injections, also known as "biological agents," in the treatment of chronic diseases, highlighting the issues surrounding their online sale and the importance of proper medical supervision for their use [1][11]. Group 1: Market Trends - Monoclonal antibodies are becoming mainstream treatments for chronic diseases such as autoimmune disorders and skin diseases due to the expansion of indications and domestic production [1][11]. - The demand for effective treatments in rheumatology and dermatology is increasing, with mAbs being recognized for their significant therapeutic effects [11][12]. Group 2: Online Sales and Regulations - Some pharmaceutical e-commerce platforms are attempting to sell injectable mAbs online, despite regulations prohibiting the online retail of such prescription drugs [2][6]. - Many sellers use terms like "appointment for medication" and "contact customer service after payment" to imply that they are not directly selling the drugs online, which raises compliance concerns [3][6]. Group 3: Safety and Usage - The use of biological agents requires strict adherence to indications and contraindications, necessitating a doctor's assessment and prescription before use [1][5][8]. - Proper cold chain logistics are essential for the safe transport of these drugs, but safety also depends on medical supervision and monitoring during treatment [8][10]. Group 4: Efficacy and Limitations - Biological agents have shown remarkable efficacy in treating various autoimmune diseases, but they are not a cure and require ongoing management [12][13]. - The high cost of mAbs, often thousands of yuan per injection, poses a barrier to access, and their effectiveness can vary among patients [13].
可持续农业潜力无限 先正达如何挖掘北极海藻里的绿色农业奥秘
Xin Lang Cai Jing· 2025-07-01 12:15
郝倩/发自挪威克里斯蒂安松 千百年以来,挪威北极峡湾孕育着一种独特的冷水海藻,当地人一直有收割此类海藻的传统,以往只是 主要用来作为动物饲料,剩下些残渣再用来培沃土壤。如今,随着科技的发展,这种挪威峡湾随处可见 的冷水海藻焕发了新的生命力,成为农业生物制剂的重要成分,销往全球各地,他们是怎么做到的呢? 百年前当地人只是觉得海藻有营养,可以用来做牲畜饲料,剩下的残余用来沤肥。包括Algea以前的生 产工艺,也是单纯的烘干和研磨,这样的产品适合做饲料,其营养物质却无法被土壤直接吸收。 邦迪坦言,过去20年生物工程、数据科学等领域的发展,才让萃取泡叶藻活性物质成为可能。在传统的 烘干,研磨之后,Algea增加了溶解提取活性素的工艺,每天都有数以百吨计的海藻被制成液态和固态 两种可溶性肥料。 我前几日走访了北极圈边缘的挪威克里斯蒂安松(Kristiansund),实地考察了当地企业Algea的海藻采 收与加工的全过程。该公司始建于1937年,原为一家挪威当地家族企业,后为先正达集团收购,其生产 的海藻提取物已经成为先正达生物制剂产品的核心原材料。近年来,生物制剂已成为最"热门"农业科技 创新领域之一。 — 科技解锁冷 ...
生物科技助力中国农业绿色转型
人民网-国际频道 原创稿· 2025-06-30 02:38
人民网克里斯蒂安松6月29日电 (记者郭梓云)在挪威北极圈边缘的城市克里斯蒂安松,海水冷冽 澄净,气温常年较低。这里的泡叶藻(Ascophyllum Nodosum)生长在北大西洋沿岸的潮汐区冷水环境 中,因而进化出更加适应恶劣环境的基因和分子构成。它富含海藻酸、氨基酸、有机酸等多种天然活性 物质,以它为核心原料制作的生物制剂产品能够助力农作物在恶劣环境生长、增强抗逆性。泡叶藻提取 物制成的肥料,还能被作物快速吸收,提高肥水利用效率,对作物产品和品质均有积极作用。 目前,由泡叶藻制成的生物制剂产品已经应用于中国农田中,帮助农民更好改善作物品质和土壤健 康。先正达生物制剂中国区负责人房栋介绍,由于受到五一前后气温变化的影响,今年四川眉山柑橘开 花情况不佳,出现落果现象。在此情况下,农户使用了海藻生物制剂产品作为"维生素",通过无人机或 喷洒车开进果园进行叶面喷雾,明显提高了坐果率和保果率,平均能提高30%,减少了农户的损 失。"海藻中的活性物质能在关键时刻促进植物活力,或促进植物达到某种特定生理特性和具体品质。 这正是生物制剂对农户的价值。"房栋说。 围情况类似,中国农业也面临着传统化学农药抗药性问题以及无法有 ...
2025年皮肤病药物品牌推荐:创新药物探秘,精准匹配患者需求
Tou Bao Yan Jiu Yuan· 2025-06-26 13:10
2025 年皮肤病药物品牌推荐 创新药物探秘,精准匹配患者需求 | 一、市场背景 | | 2 | | --- | --- | --- | | 1.1 摘要 | | 2 | | 1.2 皮肤病药物定义 | | 2 | | 1.3 市场演变 | | 2 | | 二、市场现状 | | 3 | | 2.1 市场规模 | | 3 | | 2.2 市场供需 | | 3 | | 三、市场竞争 | | 4 | | 3.1 市场评估维度 | | 4 | | 3.2 市场竞争格局 | | 5 | | 3.3 十大品牌推荐 | | 5 | | 四、发展趋势 | | 7 | | 4.1 技术革新将成为核心驱动力 | | 7 | | 4.2 竞争格局方面,本土企业将凭借渠道优势和创新升级巩固主导地位 | | 7 | | 4.3 政策与资本共振将加速产业升级 | | 7 | 2025 年皮肤病药物品牌推荐 一、市场背景 1.1 摘要 皮肤病药物行业专注于治疗皮肤疾病,产品多样,市场需求强劲。行业受高监管壁垒 和政策影响大,但患者需求增长驱动市场扩容。预计未来市场规模将持续增长,新型 外用治疗方式的获批将推动行业进一步发展,如科笛集团等企 ...
72岁印度女富豪:从酿啤酒到做“假药”
Sou Hu Cai Jing· 2025-06-07 06:36
Core Insights - Kiran Mazumdar-Shaw transformed her initial setbacks in pursuing a brewing career into a successful international biopharmaceutical company, Biocon, making her one of the wealthiest self-made female entrepreneurs globally [2][3] Company Overview - Biocon was founded in 1978 in a makeshift facility in Bangalore, India, initially producing fermentation enzymes for clients like Ocean Spray [3] - The company transitioned to biopharmaceuticals in 2000, launching its first product, insulin, using yeast instead of genetically modified E. coli, which provided a cost advantage over Western pharmaceutical companies [6][8] - Biocon's revenue reached $1.9 billion, with a significant portion derived from biosimilars, which account for approximately 55% of the company's revenue [8] Market Position and Strategy - The biopharmaceutical market is expanding, with spending on biologics reaching $324 billion in 2023, although this figure does not account for discounts provided by brand-name companies [6][8] - Biocon has launched nine biosimilars, including products that compete with AbbVie's Humira and Genentech's Herceptin, with seven approved for sale in the U.S. [9][10] - The company aims to introduce a new drug annually in the U.S. and Europe until 2030, with plans to launch a biosimilar for Regeneron's Eylea by the end of the year [11] Competitive Landscape - Biocon competes with major players like Sandoz, Samsung Biologics, and Amgen, particularly in emerging markets where it holds a significant market share of up to 80% for several biosimilars [10] - The U.S. market presents challenges due to the need to negotiate with pharmacy benefit managers (PBMs) for drug inclusion in insurance coverage, alongside potential tariffs on imported drugs [10] Future Outlook - The company is positioned for growth, with an estimated 118 biologic drug patents expiring by 2035, creating opportunities for biosimilar development [8] - Mazumdar-Shaw emphasizes the humanitarian aspect of the business, aiming to provide affordable healthcare solutions [12]
Bioceres Crop Solutions (BIOX) - 2025 Q3 - Earnings Call Transcript
2025-05-21 13:30
Financial Data and Key Metrics Changes - Total revenues for the quarter were $60.6 million, down from $84 million in the same period last year, primarily due to the absence of a significant accrual from Syngenta's initial down payment [9][10] - Gross profit decreased to $24 million from $42.6 million year-over-year, with gross margin declining from 51% to 39% due to the previous year's accrual effect [14][15] - Adjusted EBITDA for the quarter was $9 million, down from $21.1 million last year, reflecting the impact of the Syngenta down payment accrual [17][18] - Cash from operating activities improved significantly to $23.3 million, a $40.7 million increase compared to the prior year's cash requirement of $17 million [20][21] - Total debt decreased by $13 million, leading to a leverage ratio of 4.1 at the end of the quarter [23] Business Line Data and Key Metrics Changes - Crop Protection revenues decreased due to lower sales of non-core products in Argentina, partially offset by higher sales of bioprotection solutions [14] - Integrated Products revenues increased by 26%, driven by accelerated sales of HB4 grain from existing inventory [14] - Inoculant sales showed underlying operational growth, slightly offset by seasonal effects on fertilizers [14] Market Data and Key Metrics Changes - The Argentine market experienced reduced commercial activity, with purchasing behavior becoming more aligned with the agronomic calendar rather than speculative patterns [10][11] - The U.S. and Mexico markets showed good growth, indicating early signs of recovery, while Brazil remained in a low season with positive sentiment due to improved soybean prices [12][13] - Overall, the performance in Argentina was not indicative of market status, with expectations for better conditions in the upcoming summer crop season [12][13] Company Strategy and Development Direction - The company is transitioning to a more sustainable agricultural model, focusing on cash flow performance and working capital efficiency [6][20] - The long-awaited EPA approval of Rhinotech allows the company to offer a full suite of biological solutions for pest control and plant health [6] - The company aims to reduce reliance on the Argentine market, targeting growth in Brazil, the U.S., and Europe [70] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about the Argentine market, noting improved macroeconomic conditions and stable farmer sentiment [51][52] - The company anticipates a healthy winter crop season in Argentina, with expectations for a stronger summer crop season [52][53] - Management highlighted the importance of maintaining operational excellence and leveraging technology platforms for future growth [60][70] Other Important Information - The company has implemented a significant reduction in payroll and structural costs, resulting in annualized savings of approximately $5 million [28] - The Rhinotech platform is positioned for a prelaunch year in 2025, with registrations ongoing in key markets [30][31] Q&A Session Summary Question: Inquiry about cash advancement and working capital unwind - Management indicated an expected additional $10 million from the transition to a lighter model with HB4, aiming for a return to historical net working capital levels of four to four and a half months of sales [44][45] Question: Sentiment in Argentina and macroeconomic conditions - Management noted that sentiment in Argentina is slowly building up, with stable macroeconomic conditions leading to normalized purchasing behavior [50][51] Question: Non-operating income payment details - The $7.5 million non-operating income payment was primarily non-cash, involving an exchange of IP and intangible assets [65] Question: Field trial results for Neovil product - Management confirmed ongoing replicated third-party field trials for Neovil, with positive feedback from strategic and channel partners [94] Question: Interest in HB4 traits from seed companies - Management confirmed ongoing collaboration with public and private institutions for HB4 wheat in the U.S., with a focus on Latin America for HB4 soybeans [97][98]
市场简报:国内首个卡泊三醇倍他米松软膏仿制药获批上市,能否改变市场格局?
Tou Bao Yan Jiu Yuan· 2025-05-17 00:55
中国银屑病药物行业调研简报 | 2025/04 www.leadleo.com 报告标签:银屑病、自免产品、仿制药 2025年4月 1 报告提供的任何内容(包括但不限于数据、文字、图表、图像等)均系头豹研究院独有的高度机密性文件(在报告中另行标明出处者除外)。未经头豹 研究院事先书面许可,任何人不得以任何方式擅自复制、再造、传播、出版、引用、改编、汇编本报告内容,若有违反上述约定的行为发生,头豹研究 院保留采取法律措施、追究相关人员责任的权利。头豹研究院开展的所有商业活动均使用"头豹研究院"或"头豹"的商号、商标,头豹研究院无任何前述名 称之外的其他分支机构,也未授权或聘用其他任何第三方代表头豹研究院开展商业活动。 头豹调研简报 | 2025/04 银屑病药物行业 Q1:为什么卡泊三醇倍他米松软膏的首仿获批具有里程碑意义? 银屑病患者 有关节症状 评估其活动指数、并发症,并进行患者教育 红皮病型及脓疱型 寻常型 轻度 中重度 外用药 外用药物治疗 系统治疗 光疗 无效 生物制剂 证实诊断 记录严重程度 评估并发症 NSAID DMARD 无效 NSAID:非甾体类抗炎药 DMARD:抗风湿病药物 图表1:中国 ...
规范诊疗之下,红斑狼疮病情可控(服务窗)
Ren Min Ri Bao· 2025-05-08 22:10
近些年,"红斑狼疮"一词频频走进大众视野。如何科学看待这一疾病?常规体检能发现吗?记者采访了 深圳市人民医院风湿免疫科主任医师刘冬舟。 刘冬舟介绍,系统性红斑狼疮(以下简称"红斑狼疮")是一种累及多系统多脏器的慢性自身免疫病,多 见于育龄期年轻女性。正常情况下,免疫系统会保护自身机体不受病原体伤害,但红斑狼疮患者的免疫 系统出现紊乱,错误地攻击自身健康组织和器官。 "很多人将红斑狼疮理解为一种无法治愈的致命疾病。事实上,虽然目前没有根治方法,但它并不是无 法控制的。"刘冬舟说,随着医学水平的进步,尤其是红斑狼疮生物制剂领域的发展,红斑狼疮患者的 生存率大幅提升,5年生存率可达90%以上,10年生存率也将近90%。患者应树立对疾病治疗的信心, 尽早规范诊疗,有效控制病情。绝大多数患者病情可实现长期缓解,回归正常生活。 刘冬舟表示,红斑狼疮患者的临床表现差异很大,有些患者只累及皮肤、关节,部分患者可能同时累及 肾脏、心脏、肺、脑等多个器官系统,因此须基于患者的临床表现、受累器官系统类型、疾病严重程度 及药物治疗反应等综合考量制定并调整治疗方案,目前仍主要采用激素及传统免疫抑制剂治疗。近几 年,生物制剂在治疗中的地 ...
Bioatla (BCAB) 2025 Conference Transcript
2025-05-07 15:00
Bioatla (BCAB) 2025 Conference May 07, 2025 10:00 AM ET Speaker0 Alright. Well, good morning, and, welcome to the annual Citizens Life Science Conference. It's my pleasure to introduce the next presenting company, BioAtla. Joining us on the stage is the team from BioAtla, Jay Short, CEO, joined by Eric Sievers, CMO, Sherry Leidich, chief commercial officer, and Rick Waldron, CFO. So welcome everyone. Appreciate you guys being here. Speaker1 Thank you, Rudy. Speaker0 I I never know who exactly is in the audi ...
《过敏科学》出版中国专刊,生物制剂将成过敏患者新希望
Xin Jing Bao· 2025-05-07 04:18
专刊还发表了中国学者制定的生物制剂治疗慢性鼻窦炎鼻息肉的中国意见书,该意见书重点关注中国临 床数据研究,系统规范了生物制剂治疗慢性鼻窦炎鼻息肉过程中的患者选择、治疗方案以及疗效评估等 临床关键环节,为生物制剂临床实践提供了权威指导。这是中国学者首次在本领域学术顶刊发表指南类 文件,将为全球生物制剂临床应用贡献中国经验。 本次专刊中,还有中国学者在环境污染与哮喘发病机制、肠道菌群失调与过敏、药物过敏的发生机制等 领域发表了最新研究成果,以前瞻性的学术视野与创新性的科研突破,为全球过敏学科发展贡献"中国 智慧"。 今年,《过敏科学》第五次出版中国主题,共刊登中国学者文章32篇,聚焦过敏科学、鼻科学、呼吸病 学以及皮肤病学等多个领域。其中,由《过敏科学》主编、瑞士哮喘研究所Cezmi Akdis教授与北京同 仁医院张罗教授共同撰写的述评,指出了生物制剂在治疗慢性鼻窦炎鼻息肉、哮喘、特应性皮炎等过敏 性疾病中的突破性进展以及未来发展方向。 张罗告诉新京报记者,过敏性疾病近年来在国内越发受到关注,传统的鼻喷药物、口服药能起到好的症 状控制效果,但患者仍期待有更加长期有效的治疗手段。近年来,生物制剂是过敏性疾病治疗领域非 ...