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简讯:云顶新耀达成重大独家商业化许可协议 新药申请获批
BambooWorks· 2026-02-09 09:30
Bamboo Works 咏竹坊 专注于报道中概股新闻。用高质量的中英文 内容帮助中国企业讲好中国股事,触达全球投资者。 我们的报道也通过全球各大财经平台进行分发。日均触达200,000 人次的全球投资者。 如需咨询,请联系 info@thebambooworks.com About Us 协议约定,云顶新耀将向麦科奥特支付2亿元人民币首付款,以及最高达10.4亿元人民币的潜在监管与商业里程碑付款。中国III期临床 研究正在进行中,相关临床开发费用将由麦科奥特承担。 另据云顶新耀上周五公告,维适平获中国国家药品监督管理局批准上市,该药用于治疗对传统治疗或生物制剂应答不充分、失应答或 不耐受的中重度活动性UC成人患者。 维适平(艾曲莫德)是新一代高选择性S1P受体调节剂。云顶新耀表示,该药基于两项III期研究数据获批上市,证明其在试验过程 中"在所有主要及次要疗效终点上均达到统计学显著性和临床意义"。 受上述消息推动,云顶新耀股价在上周四、周五两个交易日内累计上涨5.5%,2026年年内涨幅随之扩大至7.2%。 云顶新耀 有限公司(1952.HK)上周四宣布与 麦科奥特 达成独家商业化许可协议,商业化后者用于治 ...
医药行业周报:本周申万医药生物指数上涨0.14%,关注中药高质量发展方案-20260209
Investment Rating - The report maintains a positive outlook on the pharmaceutical industry, indicating an "Overweight" rating, suggesting that the industry is expected to outperform the overall market [2][33]. Core Insights - The pharmaceutical sector saw a slight increase of 0.14% in the week, while the Shanghai Composite Index decreased by 1.27% [3][2]. - The report highlights the implementation of the "Traditional Chinese Medicine Industry High-Quality Development Implementation Plan (2026-2030)" by the Ministry of Industry and Information Technology and other departments, aiming to enhance the supply chain and technological advancements in the traditional Chinese medicine sector [11][12]. - Key pharmaceutical products such as Eli Lilly's Tirzepatide are projected to generate significant sales, with estimates of $36.5 billion in 2025, reflecting a 99% year-on-year growth for the diabetes version and a 175% growth for the weight loss version [15][17]. - The report notes active licensing and collaboration in the industry, with significant deals such as a $1.5 billion agreement between Saint's RNAi therapy and Genentech, and various other collaborations involving companies like Jichuan Pharmaceutical and Baiyunguan [18][20]. Market Performance Summary - The overall valuation of the pharmaceutical sector is reported at 29.6 times earnings, ranking 13th among 31 sectors [4][14]. - The performance of various sub-sectors includes: - Raw materials (+0.6%) - Traditional Chinese Medicine (+2.6%) - Chemical preparations (-0.8%) - Medical devices (+0.1%) [4][3]. Key Events and Developments - The report emphasizes the importance of the new plan for traditional Chinese medicine, which includes goals such as establishing 60 high-standard raw material production bases and developing 10 major traditional Chinese medicine products by 2030 [12][11]. - Notable company developments include: - Eli Lilly's projected revenue growth driven by Tirzepatide [15]. - And the announcement of significant profit forecasts from Heptares Pharmaceuticals, indicating a shift towards profitability [16]. Investment Recommendations - The report suggests focusing on domestic companies related to traditional Chinese medicine, such as Zoli Pharmaceutical and Yunnan Baiyao, as well as innovative drug companies like Heng Rui Pharmaceutical and Bai Jie Shen Zhou [2][18].
云顶新耀维适平 获国家药监局批准上市 开启中重度溃疡性结肠炎口服新时代
Zhi Tong Cai Jing· 2026-02-06 12:34
2026年2月6日,港股创新药企云顶新耀(01952)宣布,其自身免疫性疾病领域的核心产品维适平 (精氨酸 艾曲莫德片, VELSIPITY )获得中国国家药品监督管理局(NMPA)批准上市,用于治疗对传统治疗或生物 制剂应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎(UC)成人患者。 国际权威指南一线推荐 成熟商业化平台将加速维适平 市场落地 作为新一代高选择性S1P受体调节剂,维适平 每日一次口服,可实现快速起效和强效深度黏膜愈合,并 具有良好的安全性特征,具备最佳药物(best-in-disease)潜质,为成人溃疡性结肠炎患者提供新的一线治 疗选择,其商业化前景获业内广泛看好。据预测,其销售峰值或达50亿元,将成为云顶新耀继肾病领域 耐赋康 后的又一核心单品,此举也预示着其商业化版图有望迎来新一轮高速增长。 云顶新耀首席执行官罗永庆对此表示,此次维适平 在中国的获批,填补了中重度溃疡性结肠炎治疗领 域的重要空白,并为以深度黏膜愈合为目标的创新口服治疗提供了新的选择。公司将加快推进维适平 的商业化进程,并积极推动纳入国家医保目录,持续提升创新疗法在中国的可及性和可负担性,让更多 患者受益。 维 ...
云顶新耀(01952.HK):维适平®用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批
Ge Long Hui· 2026-02-06 04:44
在全球化能力建设方面,公司启动全球化战略,推进全球化的注册及临床开发能力建设。到2030年,公 司计划透过「海外授权+商业化」的双引擎驱动增长,加快国际化发展步伐。 格隆汇2月6日丨云顶新耀(01952.HK)宣布,中国国家药品监督管理局(NMPA)已批准维适平®(精氨酸艾 曲莫德片,VELSIPITY®)的新药上市申请(「新药上市申请」),在中国用于治疗对传统治疗或生物制剂 应答不充分、失应答或不耐受的中度至重度活动性溃疡性结肠炎("UC")成人患者。 在疾病领域,公司聚焦肾科、自身免疫、急重症、心血管及眼科等核心方向,通过引进创新资产与自主 研发并行推进,到2030年形成高价值产品组合,并拓展其他蓝海领域的大单品。 在商业化平台建设上,公司已布局三款商业化产品,并着力建立全渠道商业化体系及药品全生命周期商 业化能力。公司计划到2028年实现收入规模超过100亿元人民币,而到2030年收入规模超过150亿元人民 币(其中现有管线销售收入约90亿元人民币而新引进管线销售收入约60亿元人民币);收入的年复合增长 率预计在2025至2030年超过50%,2030年後保持超过15%。同时,商业化产品数量将提升至20 ...
云顶新耀:维适平 用于治疗成人患者中重度溃疡性结肠炎的新药上市申请在中国获批
Zhi Tong Cai Jing· 2026-02-06 04:26
云顶新耀(01952)发布公告,中国国家药品监督管理局(NMPA)已批准维适平 (精氨酸艾曲莫德片, VELSIPITY )的新药上市申请(新药上市申请),在中国用于治疗对传统治疗或生物制剂应答不充分、失 应答或不耐受的中度至重度活动性溃疡性结肠炎(UC)成人患者。 作为新一代高选择性鞘氨醇-1-磷酸(S1P)受体调节剂,维适平 每日一次口服,可实现快速起效和强效深 度黏膜癒合,并具有良好的安全性特征,为成人溃疡性结肠炎患者提供新的一线治疗选择。维适平 此 次获批,是基于亚洲多中心III期注册临床ENLIGHT UC研究(ES101002)的结果和全球III期注册研究 ELEVATE UC(包括ELEVATE UC 52和ELEVATE UC 12研究)的结果。ENLIGHT UC研究是迄今完成的最 大规模亚洲中重度活动性溃疡性结肠炎患者的III期注册临床研究,总计纳入340名患者。在12周诱导期 及40周维持期治疗中,维适平 治疗组在所有主要和次要疗效终点上均达到统计学显著性与临床意义, 且安全性良好,安全性特征与既往研究一致。ELEVATE UC III期注册研究中的ELEVATE UC 52和 ELEV ...
肾病领域双靶点多肽药物MT1013达成独家商业化合作
Xin Lang Cai Jing· 2026-02-05 12:24
Core Viewpoint - The strategic partnership between Macao and Yunding Xinyao grants the latter exclusive commercialization rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan), marking a significant step in the company's global expansion and realization of innovative drug value [1][6]. Group 1: Strategic Partnership - Macao has officially announced a strategic collaboration with Yunding Xinyao, granting exclusive commercialization rights for MT1013 [1][6]. - The agreement includes an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB, indicating a strong financial incentive for both parties [1][6]. Group 2: Drug Innovation and Mechanism - MT1013 is a first-in-class peptide drug developed by Macao, targeting both calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) pathways, representing a shift from passive bone resorption inhibition to active bone formation promotion [2][7]. - The drug aims to comprehensively regulate PTH secretion, correct calcium and phosphorus metabolism, and directly enhance bone health [2][7]. Group 3: Clinical Data and Efficacy - Key Phase II clinical trial data for MT1013 demonstrate significant efficacy and therapeutic potential, with a Phase III registration trial currently underway for SHPT patients undergoing maintenance hemodialysis [4][10]. - MT1013 shows superior performance in achieving triple targets of iPTH, blood calcium, and blood phosphorus levels, along with excellent phosphorus-lowering effects and a significant reduction in cardiovascular risk marker FGF-23 [8][10]. - After 52 weeks of treatment, patients exhibited significant improvements in bone density and sustained enhancements in bone metabolism markers [8][10].
12.4亿元!肾病创新药交易+1
Xin Lang Cai Jing· 2026-02-05 10:44
来源:市场资讯 (来源:动脉新医药) 今日,云顶新耀(HKEX:1952.HK)宣布与麦科奥特(Micot)达成许可协议,以2亿元人民币首付 款、最高10.4亿元里程碑付款的交易结构,引进继发性甲状旁腺功能亢进症(Secondary Hyperparathyroidism,SHPT)候选药物MT1013。根据协议约定,云顶新耀将获得该产品在中国及亚太 地区(日本除外)的独家开发与商业化权益。 01. 丰富肾病产品线,III期在研FIC被提前锁定 SHPT的布局恰好形成互补与协同。作为慢性肾脏病高发并发症,SHPT在维持性血液透析患者中需求突 出,治疗呈现"长期伴随用药"特征,且患者群体与耐赋康受众高度重叠。对云顶新耀而言,现有销售团 队可在推广耐赋康时同步推进MT1013的市场教育与准入,实现边际成本递减的商业化效率提升。 此次引进的MT1013作为同时作用于钙敏感受体(CaSR)与成骨生长肽(OGP)通路的多肽候选药,已 进入以西那卡塞为对照的确证性III期临床。当前SHPT治疗领域的主流药物(如西那卡塞、依特卡肽) 虽能有效降低甲状旁腺激素(iPTH),但存在明显短板:不仅易引发胃肠道反应等副作用,长期用 ...
肾科战略布局升级 云顶新耀引进全球首创双靶点新药
Huan Qiu Wang Zi Xun· 2026-02-05 09:00
Group 1 - The core viewpoint of the news is that CloudTop New Medicine has signed an exclusive commercialization license agreement with Macao to obtain global rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan) [1][2] - CloudTop will pay Macao a signing fee of 200 million RMB and potential regulatory and commercial milestone payments of up to 1.04 billion RMB [1] - The collaboration is a strategic move for CloudTop to enhance its innovative pipeline and expand its treatment capabilities in nephrology, creating a strong synergistic effect with its existing nephrology pipeline [1][2] Group 2 - The chairman of CloudTop, Wu Yifang, emphasized the significant unmet clinical needs in secondary hyperparathyroidism (SHPT) against the backdrop of a rising number of chronic kidney disease patients globally [2] - MT1013 is expected to provide a new treatment option for SHPT patients, positioning it as a potential best-in-class drug that will synergize with the company's existing nephrology product portfolio [2] - The partnership marks a shift in CloudTop's nephrology strategy from focusing on a single disease to a more systematic and platform-based approach, aiming to expand into broader treatment areas such as glomerulonephritis and chronic kidney disease and its complications [2]
A股重要信息回顾:海南自贸港岛内居民在指定经营场所购买进境商品实行“零关税”每人每年1万元人民币且不限购买次数,国家市场监督管理总局重拳打击直播电商乱象查处相关违法案件及头部主播虚假宣传案件
Jin Rong Jie· 2026-02-05 07:43
Industry Updates - The Ministry of Finance, General Administration of Customs, and State Taxation Administration jointly announced a policy allowing residents of Hainan Free Trade Port to purchase imported goods at "zero tariffs," with a tax exemption limit of 10,000 RMB per person per year and no limit on purchase frequency [1] - The State Administration for Market Regulation is intensifying efforts to combat issues in live-streaming e-commerce, focusing on counterfeit goods and false marketing, and has initiated a special rectification campaign [1] - The Ministry of Industry and Information Technology has prioritized addressing the internal competition in the photovoltaic industry, aiming to achieve a dynamic balance between supply and demand through enhanced departmental collaboration [1] - Anhui Province has set a regional GDP growth target of 5% to 5.5% for 2026 [1] - The Internationally first and largest single-unit power compressed air energy storage compressor, developed by the Institute of Engineering Thermophysics of the Chinese Academy of Sciences and China Storage Energy (Beijing) Technology Co., has passed third-party testing with CNAS accreditation, reaching an internationally leading level [1] Company Updates - Kweichow Moutai responded to issues with the iMoutai App, stating that recent high demand and a surge in orders have led to difficulties in app loading and customer service line congestion [1] - Tesla's energy super factory has begun supplying capacity to multiple domestic and international markets [1] - Foxconn's new energy vehicle R&D center officially commenced operations on February 4 in Zhengzhou Airport, focusing on next-generation electronic and electrical architecture and smart driving technologies [1] - NewEase has announced that its 1.6T optical module products have achieved mass delivery and are in the process of continuous capacity enhancement [1] - Lei Jun announced via Weibo that the next-generation SU7 is expected to launch in April 2026, with pre-orders now open [1] - Yunding Xinyao signed an exclusive commercialization licensing agreement with Macao Teo, obtaining exclusive commercialization rights for MT1013 in China and the Asia-Pacific region (excluding Japan) [1] - Changan Automobile, in collaboration with CATL, is introducing sodium-ion batteries, planning to implement them in multiple models by 2026 [1]
港股异动 | 云顶新耀(01952)涨超4% 引进全球首创双靶点多肽新药MT1013
智通财经网· 2026-02-05 07:20
另一方面,通过引入MT1013这一临床后期创新资产,云顶新耀也将进一步丰富肾科管线梯队,构建起 兼具短期收益、中期增长与长期潜力的可持续管线体系。根据协议,云顶新耀将向麦科奥特支付人民币 2亿元首付款,以及最高不超过人民币10.40亿元的潜在监管及商业里程碑付款。目前,MT1013中国III 期临床研究正在进行中,相关临床开发费用将由麦科奥特承担。 智通财经APP获悉,云顶新耀(01952)涨超4%,截至发稿,涨4.03%,报39.22港元,成交额8486.66万港 元。 消息面上,2月5日,云顶新耀宣布与麦科奥特签署独家商业化许可协议,获得全球首创双靶点多肽新药 MT1013在中国及亚太区(日本除外)的独家商业化授权。此次合作标志着云顶新耀肾科战略由聚焦单一 疾病领域向系统化和平台化的发展阶段升级,MT1013将与云顶新耀现有肾科管线形成协同效应,强化 产品布局,巩固公司在亚洲肾脏及自身免疫疾病领域的领导地位,并将产品覆盖从IgA肾病拓展至更广 泛的慢性肾脏病领域。 ...