乌司奴单抗
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中信证券:新老管线数据读出频现 MNC加速IBD领域布局
智通财经网· 2025-12-11 01:44
智通财经APP获悉,中信证券发布研报称,IBD作为自身免疫疾病中的"硬骨头",拥有巨大的未满足临 床需求和广阔的市场空间。尽管IBD领域的靶点不断丰富,但诱导期的临床缓解率(经安慰剂调整后)依 然非常有限,大多数药物的临床缓解率在10%-20%之间的水平,已获批药物的高剂量组临床缓解率通常 在15%以上。当前IBD的治疗新老产品更新迭代,对新机制新疗法的需求急迫,注射长效化+口服多点 开花。MNC加速IBD领域布局,中国创新药企业在差异化赛道崭露头角。该行建议关注新靶点新机制, 密切跟踪相关临床试验的开展和进度以及重点数据的读出。 中信证券主要观点如下: MNC加速IBD领域布局,中国创新药企业在差异化赛道崭露头角 作为自身免疫疾病领域中,患者人数众多且当前一年维持期疗效仍仅有30%-50%临床缓解率的适应症, IBD吸引了众多MNC布局。老玩家通过新产品巩固领先优势;慢病头部企业通过资源倾斜快速布局;肿瘤 领域核心玩家通过BD、收购等模式进入。根据过往交易规模以及MNC对产品峰值的预期,该行预计一 项临床阶段的优质IBD资产的交易对价在20亿美金以上。 中国企业紧跟全球趋势并展现出差异化创新能力:云顶新耀引 ...
医保准入:上市即入保,大幅提升药品可及性
Yang Zi Wan Bao Wang· 2025-12-09 05:31
25岁的小陈是一名公司职员,本该是活力满满的年纪,却在三年前被确诊为克罗恩病,从此开启了与这 种慢性肠道疾病的长期"共处"。 而此次喜开悦实现 "获批上市当年即入医保",堪称克罗恩病用药消费市场的一次重大突破。这款今年9 月才刚在国内北京、广州、深圳等城市开出处方的创新药,是全球首个针对中重度活动性克罗恩病的 IL-23抑制剂,在全球超40个国家和地区已有超3年真实世界用药经验,累计惠及超四万例患者。其核心 疗效数据十分亮眼,黏膜愈合效果约为同类药物乌司奴单抗(Q8W)的2倍,且85%的患者能维持2年临床 缓解,还获得了欧洲克罗恩病和结肠炎组织、美国胃肠病学会等多个国际权威机构的一线治疗推荐。 在此之前,尽管喜开悦的治疗效果得到临床认可,但作为原研进口创新药,其定价让不少患者望而却 步,属于"高价值但高消费"的治疗选择。纳入医保后,患者的自付比例将大幅下降,原本可能需要数万 元的用药开销,在医保报销后将降至普通家庭可承受的范围,彻底打破了"好药贵用"的消费壁垒。 小陈最初只是频繁感觉右下腹隐痛,还伴着反复的糊状腹泻,起初以为是普通肠胃炎,直到症状加重出 现黏液血便,去医院检查才知道自己患上了克罗恩病——一种病 ...
烧钱23年却无产品上市 和美药业赴港IPO求生
Bei Jing Shang Bao· 2025-12-03 16:01
Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][4]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion yuan and incurred losses exceeding 1.1 billion yuan, achieving a valuation of 3.9 billion yuan without any products on the market [1][3]. - The company has been in a continuous state of high cash burn, with significant R&D expenditures primarily focused on Mufemilast, which has taken over 16 years to develop [2][3]. Product Development - Mufemilast's development timeline began in 2009, with clinical trials starting in 2012, and it received approval for treating moderate to severe plaque psoriasis in September 2025 [2]. - The R&D costs for Mufemilast accounted for 60% of the total R&D expenses from 2023 to mid-2025, reflecting the heavy investment required for its development [2]. Market Competition - The psoriasis drug market in China is highly competitive, with 18 approved targeted therapies, including 5 small molecules and 13 biologics, leading to a fierce price war [4][5]. - Major competitors include established products from international pharmaceutical giants, which have already captured significant market shares [4][5]. Pricing Strategy - He Mei Pharmaceutical plans to set Mufemilast's initial annual treatment cost between 52,700 and 119,900 yuan, positioning it above some small molecule competitors but below the price of leading biologics [7]. - The relatively high pricing strategy may hinder Mufemilast's competitiveness, especially among price-sensitive patients requiring long-term treatment [7][8]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the nature of psoriasis as a chronic disease, which requires extensive academic promotion and trust-building among healthcare professionals [8]. - Even if Mufemilast successfully launches, it may not generate significant revenue quickly enough to offset the company's ongoing losses [8].
烧钱23年零产品,和美药业赴港IPO求生
Bei Jing Shang Bao· 2025-12-03 11:56
Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][6]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion RMB and incurred losses exceeding 1.1 billion RMB, achieving a valuation of 3.9 billion RMB despite having no products on the market [1][5]. - The company has been heavily reliant on external financing, completing six rounds of funding from 2021 to the end of 2024, with a post-investment valuation reaching 3.9 billion RMB after the E round [5]. Product Development - The development of Mufemilast has taken 16 years, starting from preclinical research in 2009 to receiving approval for treating moderate to severe plaque psoriasis in September 2025 [3]. - Research and development expenses for Mufemilast accounted for 60% of the total R&D costs, with losses reported at 156.4 million RMB for 2023 and projected losses of 123.4 million RMB for 2024 [3][4]. Market Competition - The psoriasis drug market in China is projected to grow from 18.2 billion RMB in 2024 to 48.3 billion RMB by 2028, with 18 approved targeted therapies already available, including 13 biologics [6][7]. - He Mei Pharmaceutical faces intense competition from established players like Novartis and Eli Lilly, which have already captured significant market shares with their products [6][7]. Pricing Strategy - He Mei Pharmaceutical plans to price Mufemilast between 52,700 RMB and 119,900 RMB annually, positioning it above some small molecule competitors but below the price of established biologics [8]. - The higher pricing strategy may hinder Mufemilast's competitiveness in a market where patients are sensitive to treatment costs, especially for chronic conditions requiring long-term medication [8][9]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the need for long-term academic promotion and building trust among healthcare professionals [9]. - Even with successful market entry, Mufemilast is unlikely to generate significant revenue quickly, making it difficult for He Mei Pharmaceutical to reverse its overall loss situation [9].
百奥泰业绩会:预计未来两年会有更多产品加速进入海外市场
Zheng Quan Shi Bao Wang· 2025-11-25 02:35
Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]
强生(JNJ.US)first-in-class新药在国内申报上市 CDE将其纳入拟优先审评
智通财经网· 2025-11-20 13:32
在所有研究中,汇总安全性数据显示,Icotrokinra 组 (49.1%) 和安慰剂组 (51.9%) 之间经历不良事件 (AE) 的患者比例相似,未发现新的安全信号。 盐酸伊可白滞素片(Icotrokinra)是强生斥资近10亿美元从 Protagonist 引进的 first-in-class 口服多肽药物(IL-23R 拮抗剂)。今年7月该药在美国申报上市,9月在 欧洲申报上市。值得一提的是,Icotrokinra 是当前全球首个也是唯一一个报上市的 IL-23R 靶向药物。强生对此寄予厚望,预计年峰值销售额有望达到50亿 美元以上。 此外,强生还启动了 III 期 ICONIC-ASCEND研究,这是首个旨在证明口服药 Icotrokinra 优于注射生物制剂乌司奴单抗的头对头研究。长期数据方面, ICONIC-LEAD 研究中,Icotrokinra 在第 52 周时表现出对成人和青少年患者持续的皮肤清除率和良好的安全性。 此前该药在美国和欧盟的上市申请包含四项关键性 III 期研究的数据,包括 ICONIC-LEAD、ICONIC-TOTAL 以及 ICONIC-ADVANCE 1 和 ICON ...
国泰海通晨报-20251112
GUOTAI HAITONG SECURITIES· 2025-11-12 09:09
Group 1: Non-Metallic Building Materials - The building materials industry shows signs of structural growth that gradually outweigh environmental impacts, with Q3 2025 reports indicating a recovery in revenue and profitability for several companies [2][25] - The cement sector continues to perform well overseas, particularly in Africa, while domestic demand and prices have weakened, suggesting a potential bottoming out in 2024 [4][26] - In the consumer building materials sector, revenue growth disparities among sub-industries are widening, driven by the impacts of real estate and local debt [5][27] Group 2: Biopharmaceuticals - Huadong Medicine's industrial segment maintains steady growth, with Q3 2025 revenue of 37.28 billion yuan, up 14.95% year-on-year, and net profit of 8.94 billion yuan, up 18.43% [7][8] - The medical aesthetics business faces short-term pressure due to economic factors, with a decline in revenue for both domestic and overseas operations [8] - The company is advancing its innovative pipeline, with several clinical trials ongoing for various cancer treatments [9][33] Group 3: Power Equipment and New Energy - Haibo Sichuang, a leader in energy storage, is expected to benefit from high industry demand, with Q3 2025 revenue reaching 3.39 billion yuan, a year-on-year increase of 124.4% [10][11] - The company's profitability has improved significantly, with a gross margin of 18.64% and a net margin of 9.05% in Q3 2025 [11] - The global energy storage market is projected to grow by 40%-50% in 2026, with significant contributions from both domestic and international markets [13] Group 4: Financial Engineering - The report highlights various asset allocation strategies, with the macro-factor-based strategy yielding a return of 4.23% in 2025, outperforming other strategies [14][15] - The performance of domestic asset strategies shows a positive trend, with October returns indicating a stable investment environment [15][16] - The overall economic outlook remains cautious, with manufacturing PMI indicating a contraction, while service sector activity shows slight improvement [16]
自免行业报告(一):双靶协同拓展治疗边界,重视TSLP类双抗迭代潜力
China Post Securities· 2025-09-29 08:56
Investment Rating - The industry investment rating is "Strong Outperform" [2] Core Insights - The report emphasizes the potential of TSLP-targeted bispecific antibodies in addressing unmet needs in the autoimmune sector, particularly in asthma and atopic dermatitis [4][6] - The success of Dupilumab (Dupi) illustrates the demand for long-acting, multi-indication therapies in a market characterized by high patient numbers and chronic conditions [5][15] - The report identifies a significant market opportunity driven by high disease prevalence and the need for new therapeutic options [5][15] Summary by Sections High Disease Prevalence Creates Market Opportunities - The report highlights the large patient populations for conditions like asthma and atopic dermatitis, with millions affected, indicating a substantial market for new treatments [14][15] - Existing therapies have unmet needs, particularly in terms of long-acting formulations and improved efficacy [18][19] Focus on Bispecific Antibodies - The report suggests prioritizing bispecific antibodies that target TSLP and IL-13, as they have shown clinical promise in enhancing efficacy and expanding patient populations [6][22] - Companies such as 康诺亚, 信达生物, 荃信生物, and 联邦制药 are identified as key players in this space [6] Respiratory Diseases and Bispecific Antibodies - In the respiratory disease sector, particularly asthma and COPD, the report notes the need for long-term management and the potential of bispecific antibodies to address this challenge [25][37] - The market for asthma biologics is projected to reach approximately $7.5 billion by 2023, with significant growth expected [25][28] Clinical Data and Efficacy - The report discusses the clinical efficacy of various biologics, noting that Dupilumab and Tezepelumab have shown significant improvements in asthma control and quality of life [34][35] - The combination of TSLP and IL-4R is highlighted as a promising therapeutic strategy, with early clinical data supporting its potential [37][47]
IBD治疗:MNC押注大市场,关注新靶点新机制
Huafu Securities· 2025-09-17 12:54
Investment Rating - The industry investment rating is "Outperform" [1] Core Viewpoints - The global market for Inflammatory Bowel Disease (IBD) drugs is expected to reach $37 billion by 2030, with major pharmaceutical companies investing in this area [4][26] - There is a significant unmet clinical need for new therapies due to the complexity of IBD mechanisms and the high percentage of patients who do not respond to initial treatments [4][18] - The report emphasizes the importance of new targets and mechanisms in drug development, particularly focusing on TL1A, which has garnered interest from multiple multinational corporations (MNCs) [4][32] Summary by Sections IBD Treatment Overview - IBD includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [4][10] - The market for IBD drugs is projected to grow at a compound annual growth rate (CAGR) of 5.88% from $23.26 billion in 2022 to $37 billion by 2030 [26][29] Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are increasing in sales [4][29] - Ustekinumab is expected to contribute approximately $7.8 billion to the market by 2024, while Vedolizumab is projected to reach $6.107 billion [4][29] Clinical Needs and Drug Development - There is a pressing need for new therapies as up to 30% of patients do not respond to initial treatments, and 40% lose response over time [4][18] - The report suggests focusing on new targets and mechanisms, including companies like Abivax, Chenxin Pharmaceutical, and others for potential investment opportunities [4][32] Long-term Investment Strategy - The report recommends a strategic focus on leading innovative drug companies and those involved in the development of new therapies for IBD, highlighting companies such as Innovent Biologics, BeiGene, and others [4][32] - The report also notes the potential for significant market transactions in the IBD space, with several deals exceeding $5 billion in value [4][30]
华福证券-生物医药行业IBD治疗:MNC押注大市场,关注新靶点新机制-250917
Xin Lang Cai Jing· 2025-09-17 12:15
Core Insights - Inflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn's Disease (CD), affecting over 3 million patients in the US and Europe, with no current cure available [1] - The global IBD drug market is expected to reach $37 billion by 2030, with a shift in sales from TNF inhibitors to IL-23 inhibitors and JAK inhibitors [2] - The emergence of new therapeutic targets and mechanisms is crucial due to the high percentage of patients who do not respond to initial treatments [2] Group 1: IBD Overview - IBD encompasses UC and CD, with symptoms that can lead to severe complications like bowel perforation [1] - Current first-line treatments for mild to moderate CD include corticosteroids and traditional immunosuppressants, while anti-TNF agents are preferred for moderate to severe cases [1] - There is a significant need for new therapies as up to 30% of patients do not respond to initial treatments, and up to 40% may lose response over time [1] Group 2: Market Dynamics - The sales proportion of TNF inhibitors is declining, while IL-23 inhibitors and JAK inhibitors are gaining market share [2] - Ustekinumab contributes approximately $7.8 billion to the IBD market, while Vedolizumab is projected to reach $6.107 billion in global sales by 2024 [2] - Major pharmaceutical companies like AbbVie, Johnson & Johnson, and Merck are actively involved in the IBD market [2] Group 3: Investment Opportunities - New therapeutic targets such as TL1A are being explored, with several phase 3 studies currently underway [2] - Companies to watch include Abivax, Chenxin Pharmaceutical, and others focusing on new mechanisms and dual antibodies [2] - The industry is expected to see significant growth driven by differentiated second-line therapies and innovative product development [2][3]