从行业来看，高投入、高风险、长周期是创新药研发的典型特征，稳定且可预期的专利保护环境，是支撑创新持续投入的 重要基础，也是维护公平竞争秩序、为创新药研发成果提供必要的制度保障。 进一步资料显示，诉前行为保全是知识产权案件中的重要程序性制度安排，在法院对权利基础及紧急性进行初步审查后， 可依法采取临时措施，以避免权利人在案件审理期间遭受难以弥补的损害。 耐赋康于2023年11月在中国获批上市，是目前全球首个且唯一用于IgA肾病对因治疗的创新药物。本次案件涉及耐赋康所 依托的中国发明专利（专利号：ZL200980127272.5），目前仍处于有效保护期内，有效期至2029年5月。 本报讯 （记者金婉霞）近日，云顶新耀有限公司（以下简称"云顶新耀"）披露消息称，由该公司原研创新药耐赋康（布地 奈德肠溶胶囊）相关专利维权取得阶段性进展：广州知识产权法院已就案件作出诉前行为保全裁定，责令相关企业停止被诉行 为并停止产品挂网，裁定自作出之日起执行。 （编辑 郭之宸） 云顶新耀方面表示，公司将继续依法维护知识产权权益，推动创新疗法持续惠及患者。 ...

【#云顶新耀肾病药被强仿迎转机##相关仿制药企被裁定停止侵权# 】2月27日上午，云顶新耀 （01952.HK）盘中股价大涨超过5%，背后是公司核心产品肾病药物耐赋康（布地奈德肠溶胶囊）被强 仿一事迎来转机。 当天，云顶新耀宣布耐赋康专利维权取得关键进展。广州知识产权法院已于2026年2月26日作出民事裁 定书，全面支持公司提出的诉前行为保全申请，并责令相关仿制药企业立即停止侵权行为并停止挂网， 该裁定自作出之日起立即执行。 ...

Core Viewpoint - The successful imitation of the kidney disease drug Nefukang (Budesonide enteric-coated capsules) has led to a significant decline in the stock price of CloudTop New Medicine (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic drug manufacturers [2]. Group 1: Company Overview - Nefukang, introduced by CloudTop New Medicine in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [4]. - The product achieved sales exceeding 1 billion yuan in the first three quarters of 2025 [4]. Group 2: Patent and Competition - CloudTop New Medicine asserts that the patent for Nefukang is valid until May 7, 2029, and the company reserves the right to take legal action against any infringement [2]. - The first generic version of Budesonide enteric-coated capsules was approved for Hainan Huirui Pharmaceutical Co., Ltd. on December 16, 2025, with a commitment to not market the generic until the patent expires [5]. - Other companies, including Shijiazhuang Yiling Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., are also in the process of developing generic versions, potentially allowing them to enter the market before the patent expiration [6]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes aims to balance the interests of original drug manufacturers and generic drug developers, promoting high-level development of generic drugs while protecting innovation [7]. - CloudTop New Medicine can challenge the patent declarations of Shijiazhuang Yiling and Qilu within 45 days of the public announcement of their drug applications [8]. - The case is seen as a test of China's drug patent linkage system, with implications for how administrative and judicial bodies balance the interests of original and generic drug manufacturers [9].

Core Viewpoint - The article discusses the impact of successful generic drug approvals on the stock price of Cloudtop New Yao (01952.HK), particularly focusing on the generic version of its drug, Neficon (Budesonide Enteric-Coated Capsules), which has led to a significant decline in the company's stock price by over 20% in the past week [3][6]. Group 1: Drug Approval and Market Impact - Neficon, introduced by Cloudtop New Yao in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [6]. - The sales of Neficon exceeded 1 billion yuan in the first three quarters of 2025, indicating strong market performance [6]. - The approval of a generic version by Hainan Huirui Pharmaceutical on December 16, 2025, has raised concerns for Cloudtop New Yao, as it may lead to increased competition [6][7]. Group 2: Patent and Legal Considerations - Cloudtop New Yao maintains that its patent for Neficon is valid until May 7, 2029, and reserves the right to take legal action against any infringement [3][7]. - Hainan Huirui's patent declaration type is classified as "Category 3," indicating a commitment not to market the generic drug until the relevant patent expires [7]. - Other companies, such as Shijiazhuang Yiling Pharmaceutical and Qilu Pharmaceutical, are also in the process of developing generic versions, with their patent declarations classified as "Category 4.2," suggesting they may not infringe on the original patent [8]. Group 3: Response Strategies - Cloudtop New Yao is considering its options in response to potential challenges from generic competitors, emphasizing the need for clinical studies to confirm the efficacy and safety of any generic versions [10]. - The article highlights the importance of the early resolution mechanism for drug patent disputes established by the National Medical Products Administration and the National Intellectual Property Administration, which aims to balance interests between original and generic drug manufacturers [10][11]. - Legal experts suggest that Cloudtop New Yao has a 45-day window to challenge the patent declarations of generic applicants in court, which could influence the market dynamics [11][12].

Core Viewpoint - The approval of a generic version of the nephrology drug Neficon (Budesonide Enteric Capsules) has led to a significant decline in the stock price of Cloudy New Horizon (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic manufacturers [2]. Group 1: Company Overview - Neficon, introduced by Cloudy New Horizon in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [4]. - The product achieved sales exceeding 1 billion yuan in the first three quarters of 2025 [4]. - The original patent for Neficon is valid until May 7, 2029, and the company retains the right to take legal action against any infringement [2][5]. Group 2: Generic Competition - Hainan Huirui Pharmaceutical Co., Ltd. has successfully obtained approval for its generic Budesonide Enteric Capsules, with a patent declaration type of "Category 3," promising not to market the generic until the relevant patent expires [5]. - Other companies, including Shijiazhuang Yiling Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., are also in the process of developing generic versions, with their patent declarations classified as "Category 4.2," indicating they may not infringe on the original patent [5][6]. - If these companies succeed in obtaining approval, they could potentially launch their products before the original patent expiration date [5]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes, established by the National Medical Products Administration and the National Intellectual Property Administration, aims to balance interests between original and generic drug manufacturers [6][8]. - Cloudy New Horizon can challenge the patent declarations of Shijiazhuang and Qilu within 45 days of the public announcement of their drug applications [7]. - The case is seen as a test of the new patent linkage system in China, which seeks to protect innovation while promoting the development of high-quality generics [8][9].

Core Viewpoint - The successful generic challenge to the kidney disease drug Nefukang (Budesonide Enteric Capsules) by competitors has led to a significant decline in the stock price of CloudTop New Drug (01952.HK), which has dropped over 20% in the past week [1] Group 1: Company Overview - Nefukang, introduced by CloudTop New Drug in June 2019 and approved for market in November 2023, is aimed at treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [3] - The drug achieved sales exceeding 1 billion yuan in the first three quarters of 2025 and was included in China's medical insurance reimbursement list [3] Group 2: Patent and Generic Drug Challenges - The patent for Nefukang is valid until May 7, 2029, and CloudTop New Drug retains the right to take legal action against any infringement [1] - Competitors, including Hainan Huirui Pharmaceutical, Shijiazhuang Yiling Pharmaceutical, and Qilu Pharmaceutical, are also in the process of developing generic versions of Budesonide Enteric Capsules, with Hainan Huirui already receiving approval [4][5] - Hainan Huirui's patent declaration type is "Category 3," promising not to market the generic until the relevant patent expires, while Shijiazhuang and Qilu's declarations are "Category 4.2," indicating their generics may not infringe on existing patents [4][6] Group 3: Regulatory and Legal Framework - The early resolution mechanism for drug patent disputes aims to balance interests between original drug manufacturers and generic drug developers, promoting high-level development of generics while protecting innovation [6][8] - CloudTop New Drug can challenge the patent declarations of Shijiazhuang and Qilu within 45 days of the public announcement of their drug applications [7] - The case is seen as a potential test of China's drug patent linkage system, with implications for how administrative and judicial bodies balance the interests of original and generic drug manufacturers [8]

Group 1 - The company has noted the approval of a generic version of its proprietary product Budesonide Enteric-Coated Capsules (Nafukang) by the National Medical Products Administration of China [1] - The original product Nafukang is protected by patent ZL200980127272.5, which is valid until May 7, 2029, and the company has registered this patent information on the Chinese drug patent information registration platform [1] - According to Chinese patent law, any entity or individual must not manufacture, use, promise to sell, sell, or import products that fall under the patent protection without the company's legal permission before the patent expires, or it will constitute patent infringement [1] Group 2 - The company is committed to introducing breakthrough therapies to China to meet urgent medical needs, emphasizing the importance of a robust patent protection system and effective regulations for the sustainable accessibility of innovative drugs [2] - The environment for intellectual property protection in China's pharmaceutical industry has been continuously optimized, providing strong support for pharmaceutical innovation and healthy industry development [2] - The company will continue to collaborate with various parties to respect and uphold intellectual property rights, adhere to relevant laws and regulations, and foster a fair competitive environment to promote the ongoing development and accessibility of innovative drugs for the benefit of Chinese patients [2]

Core Insights - CloudTop New Horizon (HKEX: 1952) has signed two strategic cooperation agreements with Haisen Biotech, which are expected to create significant financial and strategic synergies, enhancing the operational efficiency of its commercialization platform and accelerating the commercialization capabilities in the cardiovascular disease sector [1][3] Group 1: Agreements Overview - The commercialization service agreement allows CloudTop New Horizon to provide commercialization services for six mature products from Haisen Biotech, covering critical care, cardiovascular, and metabolic treatment areas, with service fees ranging from 20% to 55% of quarterly net sales [1][2] - The licensing agreement grants CloudTop New Horizon exclusive rights for the further clinical development, registration, and commercialization of Lerodalcibep in Greater China, a third-generation PCSK9 inhibitor [2][3] Group 2: Product and Market Potential - Lerodalcibep offers advantages such as a monthly injection and small volume subcutaneous administration, addressing issues of high dosing frequency and storage convenience, which significantly enhances patient compliance [2][3] - Clinical trials involving over 2,500 patients demonstrate that Lerodalcibep can reduce LDL-C levels by over 60% in cardiovascular disease patients and over 55% in patients with familial hypercholesterolemia [2] - The PCSK9 inhibitor market in China is projected to grow rapidly, with an estimated market size of approximately 3 billion yuan in 2024, reflecting a year-on-year increase of 95%, and expected to reach 10 billion yuan by 2030 [3] Group 3: Strategic Implications - The agreements are expected to solidify CloudTop New Horizon's commercialization foundation in China, enhance market share, and inject core growth drivers into its cardiovascular business [3][4] - The collaboration reflects a strategic shift in the industry, where Chinese innovative pharmaceutical companies are transitioning from single product development to platform and diversified strategies [4]

Core Insights - YunTing New Drug's core product, Naisukan (Budesonide enteric-coated capsules), has demonstrated clinical value in the new management strategy for IgA nephropathy, focusing on "etiological treatment, early treatment, and long-term treatment" [1][3] - The drug has shown effectiveness in special populations, including patients with severe renal impairment and children, reinforcing its position as a first-line treatment for IgA nephropathy [1] - The cumulative sales revenue of Naisukan reached nearly 1 billion yuan from January to September this year, marking it as one of the fastest-growing chronic disease innovative drugs in recent years [2] Group 1 - The real-world studies presented at ASN Kidney Week 2025 validate the clinical advantages of Naisukan, with evidence supporting its efficacy in early treatment for patients with proteinuria levels below 0.5g/d [1][2] - The introduction of Naisukan into the National Medical Insurance Directory in 2024 is expected to activate clinical demand significantly, with the reimbursement policy effective from January 1, 2025 [2] - YunTing New Drug is developing diagnostic testing reagents for IgA nephropathy, which are expected to fill the gap in non-invasive diagnosis in China, potentially replacing kidney biopsy as an auxiliary diagnostic method [2] Group 2 - The company anticipates that the deepening of clinical consensus and insurance coverage will enhance the market penetration of Naisukan, making it a core pillar for the company's performance growth [3] - The new management strategy for IgA nephropathy aims to provide patients with hope for delaying disease progression and improving long-term outcomes [3] - The clinical data for the next-generation BTK inhibitor EVER001 is promising, indicating potential coverage for a broader range of kidney disease indications [2]

Core Insights - The ASN Kidney Week 2025 highlighted multiple real-world study results for the core product of Cloudtop New Horizon, Budesonide Enteric Capsules, which confirmed its core value in the new management strategy for IgA nephropathy, reinforcing its first-line treatment position [1][6] - The drug is accelerating market penetration due to endorsements from domestic and international guidelines and favorable healthcare policies, becoming a key driver of commercial growth for the company [1][5] Group 1: Clinical Evidence - Research from Huazhong University confirmed the effectiveness of Budesonide in special populations, including patients with severe renal impairment and children, showing significant improvement in proteinuria and renal function without serious adverse events [2] - A retrospective study from Sichuan University provided evidence for early treatment benefits, indicating that patients with proteinuria levels below 0.5g/d can also benefit from Budesonide therapy, thus supporting early intervention strategies [3] - Long-term treatment studies from Macau and Dalian Medical University demonstrated that Budesonide significantly reduces proteinuria and improves renal function over extended periods, supporting its use in long-term treatment plans [4] Group 2: Market Dynamics - The introduction of Budesonide into the National Medical Insurance Directory in 2024 and its subsequent reimbursement policy has rapidly activated clinical demand, with sales reaching nearly 1 billion yuan in the first nine months of 2025 [5] - The company has raised its annual sales guidance to 1.2 to 1.4 billion yuan, with projections for 2026 sales potentially reaching 2.4 to 2.6 billion yuan, and peak sales expected to hit 5 billion yuan [5] - Cloudtop New Horizon is building a comprehensive diagnostic and treatment ecosystem around IgA nephropathy, with ongoing clinical research for a non-invasive diagnostic test expected to launch in 2026, enhancing synergy with Budesonide [5] Group 3: Industry Outlook - The IgA nephropathy market is still in a blue ocean phase, with Budesonide establishing significant competitive barriers through its first-mover advantage, comprehensive evidence chain, and healthcare access [6] - The new data presented at ASN 2025 further validates the clinical advantages of Budesonide, with expectations for continued market penetration as guidelines and insurance coverage deepen [6] - The product is anticipated to be a core pillar of Cloudtop New Horizon's growth, advancing the treatment landscape for IgA nephropathy into a new era of targeted, early, and long-term treatment strategies [6]