耐赋康®
Search documents
港股公告掘金 | 云顶新耀:原研产品耐赋康®的相关技术在中国受到专利ZL200980127272.5的保护,该专利目前处于有效状态
Zhi Tong Cai Jing· 2025-12-30 15:10
Major Events - Cloudtop New Horizon (01952) has its original product, Nanfukang®, protected by patent ZL200980127272.5 in China, which is currently valid [1] - Linkang Biotechnology Group (00690) has reached a strategic cooperation with Wenzhou Medical University National Engineering Research Center and the People's Government of Ouhai District, Wenzhou [1] - Auhua Pharmaceutical (00013) announced that the new drug application for Savolitinib for treating gastric cancer patients with MET amplification has been accepted and included in priority review in China [1] - Fosun Pharma (02196) has initiated Phase I clinical trials for its integrated diagnosis and treatment nuclear medicine project SRT-007 within China [1] - Postal Savings Bank of China (01658) has received approval from the National Financial Supervision Administration for the absorption and merger with Postal Huai Wanjia Bank [1] - MicroPort Cardiac Devices-B (02160) has officially published the one-year follow-up results of the early feasibility study for AltaValveTM [1] Operating Performance - New Fire Technology Holdings (01611) reported an annual loss attributable to shareholders of HKD 9.212 million, a shift from profit to loss year-on-year [1] - Xingqian Development (00640) reported an annual net profit of approximately HKD 122 million, an increase of 21.7% year-on-year [1] - Zijin Mining Group (02899) expects a net profit attributable to shareholders of approximately RMB 51-52 billion for the fiscal year 2025, representing a year-on-year increase of about 59%-62% [1] - Zijin Gold International (02259) issued a profit warning, expecting a net profit attributable to shareholders of approximately USD 1.5-1.6 billion for 2025, a year-on-year increase of about 212%-233% [1]
中国创新药迈入全球化临界点 云顶新耀擘画进阶新篇
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-23 09:25
这一跨越式发展的背后,是过去十年药监改革、创新创业生态培育与资本通道畅通的多重共振,更依托 于中国庞大的人口基数、高效的产业制造能力与突出的成本效益优势。 亮眼成绩之下,行业发展的挑战亦不容忽视。一方面,中国上市的生物科技企业(Biotech)总市值不 足美国同类企业的15%,授权预付款通常比全球同类交易低2/3,交易总金额约为全球平均水平的1/2; 另一方面,部分药企商业化能力薄弱,已成为制约其价值释放的重要因素。 2025年,中国创新药行业的成绩单已跃然纸上:生物医药市场规模居全球第二,在研创新药约占全球比 重达30%;创新资产的全球吸引力持续攀升,截至11月18日,国产创新药对外授权总金额突破千亿美 元,较2024年实现翻倍式增长。 权威期刊《经济学人》直言,中国创新药正处于全球化的临界点,"从中国临床试验到对外授权许可, 中国药企的全球占比都显著上升,过去一年中国生物科技企业的股价涨幅甚至远超美国同类企业,这都 说明过去一个世纪中全球生物医药创新的'西方主导'格局已经生变。" 在此背景下,价值重塑的序曲已然奏响,一批头部创新药企已率先蹚出进阶之路,向着全球价值链顶端 全速迈进。今年上半年迎来商业化进程 ...
云顶新耀2030战略落地:创新与全球化实力获认可
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-18 09:56
日前,由数字化智库型财经媒体领跑者《21世纪经济报道》与21世纪新健康研究院发起2025年第九届21 世纪大健康产业竞争力研究「阳光」案例正式揭晓。作为大健康产业领域极具权威性的年度评选成果, 本次公布的案例集中展现了当下产业内的创新活力、技术突破与实践典范,为行业高质量发展树立了鲜 明标杆。 管线深耕进入收获期 作为一家专注于创新药及疫苗开发、制造及商业化的生物制药企业,云顶新耀自2017年起通过license-in 筑牢发展根基,历经多年布局,云顶新耀在肾科、感染性疾病及自身免疫性疾病等核心领域的产品管线 已正式迈入关键收获期,多款核心产品表现亮眼,成为业绩增长的核心引擎。 肾科治疗领域大单品耐赋康®的市场表现尤为突出。2025年上半年,该产品实现销售收入3.03亿元,同 比大幅增长81%;1-9月累计销售收入已近10亿元。云顶新耀预估耐赋康®2025年全年销售额将达12-14 亿元,并有望在2026年持续高速增长,冲击24-26亿元的销售目标。 产能与全球布局的协同发力为增长保驾护航。今年8月,耐赋康®扩产补充申请获中国国家药品监督管 理局正式批准。作为全球首个且目前唯一在中、美、欧三地均获得完全批准的 ...
云顶新耀未来五年战略蓝图:引入20款以上产品与发力自研管线并举
Di Yi Cai Jing· 2025-12-18 05:14
在过去的八年时间里,港股创新药企云顶新耀(01952.HK)通过授权引进(license-in)引入创新资 产,建立了坚实的基础,并依靠"双轮"驱动战略,聚焦蓝海领域,打造卓越商业化平台并完善研发和生 产能力。同时,以科学及商业洞察为战略出发点,加速推进自研mRNA In vivo CAR-T平台及mRNA肿 瘤疫苗平台的临床开发进程。 在立足现有基础上,如何将公司的差异化优势进一步发挥出来,打造中国创新药企发展样本? 近日,云顶新耀的2030年发展战略正式发布,系统规划了公司未来五年的发展路径,该战略以"BD合作 +自主研发"双轮驱动为核心,明确2030年营收突破150亿元、商业化产品超20款的目标,最终冲刺千亿 市值,跻身全球领先综合性生物制药公司行列。 拟大手笔引入 按照云顶新耀的2030年发展战略规划,在产品管线方面,公司将聚焦肾科、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。到2030年,公司计划将商业化产品数量提升至20款以上,包括耐赋康®、艾曲莫 德、依嘉®、头孢吡肟-他尼硼巴坦及莱达西贝普等。 云 ...
云顶新耀(01952.HK)发布2030战略 董事及主要股东增持彰显长期信心
Ge Long Hui· 2025-12-15 01:51
12月15日,港股创新药企云顶新耀(1952.HK)正式发布2030年发展战略,勾勒出未来五年成为全球领先 综合性生物制药公司的发展蓝图。与此同时,公司董事及主要股东增持股份,以实际行动传递对公司未 来发展的坚定信心。 云顶新耀2030战略以"BD合作+自研"双轮驱动为核心,明确通过引进创新资产与自主研发并行推进,实 现商业化创造确定性价值、自研创造成长性价值。 规划显示,到2030年公司计划实现收入规模超过150亿元人民币,其中现有管线销售收入约90亿元,新 引进管线销售收入约60亿元,并探索潜在对外授权(License-out)收入,预计2025至2030年年复合增长率 超过50%。 产品管线方面,公司将聚焦肾科、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。到2030年,公司计 划将商业化产品数量提升至20款以上,包括耐赋康®、维适平®、依嘉®、头孢吡肟-他尼硼巴坦及乐瑞 泊®(莱达西贝普)等。 研发平台建设上,公司将以全球权益的mRNA平台为基础,到2030年,在mRNA in vivo CAR-T和mRNA ...
云顶新耀召开公司发展战略交流会 未来6至12个月将再引进至少3个重磅产品
Zhong Guo Jin Rong Xin Xi Wang· 2025-10-22 09:36
Core Insights - The company, CloudTop New Medicine, held a strategic investor meeting on October 21, where the new chairman, Wu Yifang, outlined the company's strategic direction focusing on key initiatives such as strategic transactions, R&D innovation, and stakeholder management [1] - The controlling shareholder, Kangqiao Capital, will not reduce its stake in the company in the short term [1] - The company aims to enhance its product pipeline through self-research, licensing, acquisitions, and capital empowerment, with a goal to maximize commercial value and expand globally [1] Product Pipeline and Financial Projections - CloudTop New Medicine's product pipeline in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases is entering a critical harvest period [1] - The company estimates that sales for its product, Naisankang®, will reach between RMB 1.2 billion and RMB 1.4 billion for the year, with a target of RMB 2.4 billion to RMB 2.6 billion by 2026 [1] - The product Weishiping® (Aicuo Mod) is expected to become the next significant product for the company [1] Future Plans and Collaborations - The company plans to introduce more than three heavyweight products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 10 billion, aiming for an overall domestic sales peak of over RMB 20 billion [2] - CloudTop New Medicine has signed a cooperation development letter of intent with I-Mab for the treatment of retinal diseases, which will strengthen collaboration in innovative R&D and international development [2] - The global anti-VEGF ophthalmic drug market is projected to reach approximately USD 40 billion by 2030, indicating significant growth potential in this sector [2]
云顶新耀召开公司发展战略交流会:加强全球布局 实现跨越式发展战略
Zheng Quan Ri Bao· 2025-10-22 06:16
Core Insights - CloudTop New Horizon (云顶新耀) held a strategic investor communication meeting on October 21, 2023, with key management team members present, including the new chairman Wu Yifang [2] - The company aims to enhance its product pipeline and maximize commercial value through a "dual-driven" strategy, focusing on self-research, licensing, acquisitions, and capital empowerment [2] - CloudTop plans to introduce more than three significant products in the next 6 to 12 months [2] Product Development - The company has entered a critical harvest period in its product pipeline, particularly in nephrology, infectious diseases, and autoimmune diseases, with sales revenue from the product Renfu Kang® nearing RMB 1 billion by Q3 2025 [3] - The product Weishiping® (艾曲莫德) is expected to become a significant growth driver for the company [3] - CloudTop is leveraging its mRNA tumor therapeutic vaccine platform and autologous CAR-T platform to strengthen its self-research capabilities and explore high-growth areas like ophthalmology [3] Clinical Trials and Collaborations - The new generation covalent reversible BTK inhibitor EVER001 (希布替尼) has shown promising results, with sustained benefits observed in patients during a 104-week follow-up period [3] - The company plans to initiate pivotal registration clinical trials for EVER001 in 2026 and is set to start human trials for its autologous CAR-T project by the end of 2025 [3] - CloudTop has signed a collaboration agreement with I-Mab for the development of the eye disease treatment VIS-101 in Greater China, South Korea, and Southeast Asia, aiming to enhance cooperation in innovative research and international development [4]
云顶新耀(01952.HK)召开公司发展战略交流会 加强全球布局 实现跨越式发展战略
Ge Long Hui· 2025-10-22 02:15
Core Insights - The company, CloudTop New Drug (01952.HK), held a strategic investor communication meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the executive team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, enhancing shareholder structure stability [2] Group 2: Strategic Focus and Market Expansion - The company will implement a "dual-engine" strategy, focusing on self-research and external collaborations to enrich its product pipeline and maximize commercial value [3] - CloudTop New Drug aims to accelerate its global expansion and self-research initiatives, particularly in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases [3] Group 3: Product Pipeline and Financial Projections - The company’s products, including Nefukang® and Yijia®, have shown sustainable commercialization capabilities, with Nefukang® expected to achieve sales of approximately RMB 12 to 14 billion in 2025, and projected to grow to RMB 24 to 26 billion by 2026 [3] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 100 billion, aiming for an overall domestic sales peak of over RMB 200 billion [4] Group 4: R&D Innovations and Collaborations - The company is leveraging its mRNA cancer vaccine platform and CAR-T technology to establish a strong R&D foundation, with plans to enter high-growth areas such as ophthalmology [4] - A collaboration with I-Mab on the innovative product VIS-101 aims to enhance the company's presence in the ophthalmology market, which is projected to grow significantly [5][6] - VIS-101 has shown promising results in initial studies and is expected to enter Phase III trials by 2026, indicating a strong potential for market entry [5][6] Group 5: Overall Market Position and Future Outlook - The meeting highlighted the company's systematic progress in capital empowerment, innovation breakthroughs, and global expansion, reinforcing its competitiveness in the global innovative drug sector [6] - As core pipelines enter the value realization phase, the company is on a steady path toward becoming a leading comprehensive biopharmaceutical enterprise globally [6]
云顶新耀(01952)召开公司发展战略交流会 加强全球布局实现跨越式发展战略
智通财经网· 2025-10-22 00:09
Core Insights - The company, CloudTop New Medicine (01952), held a strategic investor meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the management team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, which stabilizes the shareholder structure [2] Group 2: Dual-Engine Strategy and Market Expansion - The company will implement a "dual-engine" strategy, focusing on both in-house R&D and external collaborations, acquisitions, and capital empowerment to maximize commercial value [3] - Key therapeutic areas include nephrology, infectious diseases, and autoimmune diseases, with products like Nefukang® and Yijia® showing sustainable commercialization capabilities [3] - Nefukang® is projected to achieve sales of approximately RMB 1 billion in the first nine months of 2025, with an annual forecast of RMB 1.2 to 1.4 billion and a target of RMB 2.4 to 2.6 billion by 2026 [3] Group 3: R&D Advancements - The company is leveraging its mRNA cancer vaccine platform and autologous CAR-T platform to strengthen its R&D capabilities and explore high-growth areas like ophthalmology [4] - The new generation covalent reversible BTK inhibitor, EVER001, has shown promising clinical results and is set to enter pivotal trials in 2026 [4] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peaks exceeding RMB 10 billion [4] Group 4: Strategic Collaboration with I-Mab - CloudTop New Medicine has signed a collaboration agreement with I-Mab for the development of VIS-101, a dual-specificity biologic for retinal diseases, enhancing its portfolio in the ophthalmology sector [5][6] - The global anti-VEGF ophthalmic drug market is projected to reach approximately $23 billion in 2024 and exceed $40 billion by 2030, indicating significant growth potential for innovative therapies [5][6] - The collaboration aims to accelerate the development of VIS-101 in the Asia-Pacific and the U.S., enhancing R&D efficiency and global expansion [6]
200亿嘉兴药企,空降新董事长
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-11 01:16
Core Insights - Wu Yifang has been appointed as the new Executive Director and Chairman of the Board at CloudTop New Drug, transitioning from Fosun Pharma after over 20 years [2][5] - His extensive experience in the pharmaceutical industry, particularly in transforming Fosun Pharma into an innovative drug company, is expected to bring new momentum to CloudTop during its critical self-research transformation phase [4][10] - The company aims to leverage Wu's expertise in strategic transactions, research innovation, and key stakeholder management to enhance its competitive edge [9][10] Company Overview - Wu Yifang, born in 1969, has over 30 years of experience in the pharmaceutical sector, having started his career in various roles at Xuzhou Biochemical Pharmaceutical Factory before rising to CEO of Fosun Pharma [5] - His leadership at Fosun included driving global strategic initiatives and introducing mRNA technology to China during the COVID-19 pandemic [5][10] - CloudTop has recently showcased advancements in its self-research technology and new mRNA tumor pipeline, including the personalized tumor therapeutic vaccine EVM16, which has shown efficacy in preclinical studies [5][8] Product Pipeline - The company has two key mRNA tumor vaccines: EVM16, which is in clinical trials, and EVM14, which has been approved for clinical use in China and targets multiple tumor-associated antigens [6][7][10] - EVM14's global multi-center Phase I clinical trial has commenced, with collaborations including MD Anderson Cancer Center [7] - CloudTop's core products, including Ejiya® and Naifukang®, are expected to generate significant revenue, with projected sales of 12-14 billion yuan for Naifukang® in 2023 and peak sales of 50 billion yuan for both Ejiya® and another product by 2030 [11][14][15] Financial Position - CloudTop raised 1.553 billion HKD in July, with 50% allocated for global R&D and new product pipeline development, ensuring a cash balance exceeding 2.5 billion yuan for future investments [18][19] - The management anticipates achieving sales targets of 1.6-1.8 billion yuan this year, with a positive cash flow expected in Q4 [15] Strategic Direction - The company is shifting from a purely commercial drug entity to a technology-driven innovative pharmaceutical company, focusing on self-research and high-certainty products with significant commercialization potential in China and the Asia-Pacific region [16][17] - Wu's experience in international markets and innovative drug launches is expected to accelerate CloudTop's drug application processes in Europe and the U.S. [15][22] Market Performance - Since early 2024, CloudTop's stock price has surged over 200%, with its market capitalization exceeding 20 billion HKD [23] - The company is committed to focusing on its major products, Ejiya® and Weishiping®, while leveraging high-potential combinations to achieve sales peaks exceeding 25 billion yuan in the future [24]