年销售额突破十亿元的肾病药物耐赋康（布地奈德肠溶胶囊）被仿制成功，导致云顶新耀 （01952.HK）股价在过去一个多星期内跌幅累计超过两成。 2025.12.30 本文字数：2257，阅读时长大约4分钟 作者 |第一财经 林志吟 针对仿制药已获批上市问题，云顶新耀称公司的原研产品耐赋康专利目前处于有效状态，专利权有效期 直至2029年5月7日届满。公司保留依法采取一切后续行动的权利。 被仿制 云顶新耀的耐赋康，于2019年6月从瑞典Calliditas公司引入，并于2023年11月获得中国药监局批准上 市，用于治疗具有进展风险的原发性IgA肾病成人患者，填补了中国从疾病源头治疗IgA肾病的空白。 2024年5月，这款产品在中国大陆正式商业化上市，之后又成功纳入中国医保报销目录。根据云顶新耀 披露的信息，耐赋康在2025年前三季度销售额已突破10亿元。 耐赋康是一款靶向肠道黏膜B细胞的创新免疫调节剂，其临床作用高度依赖其在目标组织的精准释放。 它通过独特的迟释及缓释双重制剂工艺，将药物精准递送至回肠末端靶向作用，从源头干预疾病进程， 能显著延缓肾功能衰退。 2025年12月22日，国家药监局官网发布药品批准证明 ...

2025.12. 30 本文字数：2257，阅读时长大约4分钟 作者 | 第一财经 林志吟 年 销 售 额 突 破 十 亿 元 的 肾 病 药 物 耐 赋 康 （ 布 地 奈 德 肠 溶 胶 囊 ） 被 仿 制 成 功 ， 导 致 云 顶 新 耀 （01952.HK）股价在过去一个多星期内跌幅累计超过两成。 针对仿制药已获批上市问题，云顶新耀称公司的原研产品耐赋康专利目前处于有效状态，专利权有效 期直至2029年5月7日届满。公司保留依法采取一切后续行动的权利。 不过，对于云顶新耀而言，当前需要应对的不只是一家药企的仿制问题，还有其他潜在仿制药企竞 争。 | 商品类型: | · | W | 批准文号/注册证 | 量滤入肥源文号注册证号 | 受理日期: | 图 开始日期 | 蛋 日 植原日期 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | 号: | | | | | 受理号: | 道城人使理费 | | 药品名称: | 布地泵德局溶胶着 | 企业名称: | 进给入空会名称 | | | | | | | ○ 宣教 | | | | | | 化学仿 ...

2024年5月，这款产品在中国大陆正式商业化上市，之后又成功纳入中国医保报销目录。根据云顶新耀 披露的信息，耐赋康在2025年前三季度销售额已突破10亿元。 年销售额突破十亿元的肾病药物耐赋康（布地奈德肠溶胶囊）被仿制成功，导致云顶新耀 （01952.HK）股价在过去一个多星期内跌幅累计超过两成。 针对仿制药已获批上市问题，云顶新耀称公司的原研产品耐赋康专利目前处于有效状态，专利权有效期 直至2029年5月7日届满。公司保留依法采取一切后续行动的权利。 不过，对于云顶新耀而言，当前需要应对的不只是一家药企的仿制问题，还有其他潜在仿制药企竞争。 | 药品类型: | 化学药品 | | 2 | 批准文号/注册证 调验入批准文号/注册证号 | 受理日期: | ■ 开始日期 | 至 ■ 结束日期 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | 号: | | | | | 受理号: | 请输入受理号 | | | 药品名称: 布地资德脉溶胶囊 | 企业名称: | 请输入企业名称 | | | | | | | Q 查找 | | | | | | | 化学仿 ...

如何应对石药和齐鲁的仿制挑战？ 年销售额突破十亿元的肾病药物耐赋康（布地奈德肠溶胶囊）被仿制成功，导致云顶新耀 （01952.HK）股价在过去一个多星期内跌幅累计超过两成。 针对仿制药已获批上市问题，云顶新耀称公司的原研产品耐赋康专利目前处于有效状态，专利权有效期 直至2029年5月7日届满。公司保留依法采取一切后续行动的权利。 根据《药品专利纠纷早期解决机制实施办法（试行）》规定，化学仿制药申请人提交药品上市许可申请 时，应当对照已在中国上市药品专利信息登记平台公开的专利信息，针对被仿制药每一件相关的药品专 利作出声明。 海南合瑞在该平台登记的专利声明类型为"3类"，即承诺在相应专利权有效期届满之前所申请的仿制药 暂不上市。 云顶新耀表示，针对任何涉嫌违反上述规定及承诺的侵权行为，公司保留依法采取一切后续行动的权 利。 云顶新耀耐赋康被仿制的危机，还未彻底解除，因为除了海南合瑞首仿布地奈德肠溶胶囊成功外，还有 石药集团中诺药业（石家庄）有限公司、齐鲁制药有限公司这两家药企也在仿制布地奈德肠溶胶囊中， 且相关药物已到申请上市阶段。 不过，对于云顶新耀而言，当前需要应对的不只是一家药企的仿制问题，还有其他潜在仿 ...

本公司致力于将突破性疗法引入中国，以满足极待解决的医疗需求。健全的专利保护体系与有效的该办 法，对于保障此类重大创新药物的持续可及性、激励医药研发创新、以及推动仿制药产业在尊重知识产 权基础上的公平有序竞争至关重要。正是这样的体系保障了像耐赋康这样的突破性疗法能够成功研发并 引入中国。 云顶新耀(01952)发布公告，公司董事会注意到有针对本公司上市许可产品布地奈德肠溶胶囊(耐赋康)的 仿制药品的上市许可在中国获得中国国家药品监督管理局批准。董事会强调本公司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，其专利权有效期直至2029 年5月7日届满。本公司已依法将该专利相关资讯登记于中国上市药品专利资讯登记平台。 近年来，中国医药行业的知识产权保护环境持续优化与完善，为医药创新和产业健康发展提供了有力保 障。未来，本公司将继续携手各方，共同尊重和维护知识产权，恪守相关法律法规，营造合法公平的竞 争环境，以促进创新药物的持续发展与可及，最终惠及广大中国患者。 根据中国《专利法》第11条及《药品专利纠纷早期解决机制实施办法(试行)》(该办法)的相关规定，任 何 ...

12月11日，云顶新耀(HKEX1952.HK)宣布，其全资附属公司云顶新耀医药科技与海森生物签署两项战 略合作协议：商业化服务协议以及授权许可协议。两项协议将在财务与战略上形成显著协同效应，提升 现有商业化平台的运营效率，加快云顶新耀产品全生命周期、全渠道覆盖的商业化能力建设，同时为公 司在心血管疾病领域打造具有吸引力的业务版图。 对于两项协议的价值，云顶新耀表示，将在财务与战略上形成显著协同效应，提升现有商业化平台的运 营效率，加快产品全生命周期、全渠道覆盖的商业化能力建设。通过此次合作，公司将巩固在中国的商 业化基础，提升市场份额，为心血管业务的长期增长注入核心动力。 根据商业化服务协议，云顶新耀医药科技将依托现有销售与市场体系，为海森生物旗下六款成熟产品提 供商业化服务，覆盖急重症、心血管和代谢三大治疗领域。云顶新耀医药科技将按相关产品季度净销售 总额的20%-55%收取服务费，预计2026-2028年海森生物拟支付的年度交易金额上限分别为5.6亿元、 6.16亿元和6.77亿元。 在业内人士看来，云顶新耀此次合作既体现出其商业化能力的应用延伸，既为海森生物的成熟产品提供 市场支持，也能借助自身渠道将 ...

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]

Core Insights - The article discusses the recent trends and developments in the pharmaceutical industry, particularly focusing on the performance of innovative drug companies and their clinical trials [5][11][18]. Group 1: Market Performance - The pharmaceutical and biotechnology indices experienced a decline, with the pharmaceutical index dropping by 1.21%, underperforming the Shanghai Composite Index by 0.91 percentage points [5]. - The Hang Seng Healthcare Index fell by 1.55%, and the Hong Kong innovative drug ETF decreased by 1.52% during the same period [5]. Group 2: Company Developments - Xianweida Biotechnology submitted an A1 listing application to the Hong Kong Stock Exchange, with cumulative losses exceeding 1 billion yuan over the past two and a half years [6][7]. - Xianweida's core product, Ecnoglutide, is expected to submit applications for overweight/obesity and type 2 diabetes indications by the end of 2024, with anticipated approval in early 2026 [7][8]. - The company reported no revenue for 2023 and 2024, with losses of 620 million yuan and 486 million yuan, respectively [8]. Group 3: Clinical Trials - Bai Li Tianheng's ADC drug BL-M07D1 has entered a phase III clinical trial for HER2-positive gastric cancer, with a focus on overall survival and progression-free survival as primary endpoints [15][16]. - The SLIMMER study, a significant phase III trial for Ecnoglutide, showed that participants could lose up to 13.8 kg over 48 weeks, with minimal weight regain after stopping the treatment [7]. Group 4: Stock Market Dynamics - The stock of Yaojie Ankang-B experienced extreme volatility, with a price drop from 679.5 HKD to 192 HKD per share, reflecting the high-risk nature of the Hong Kong market for uncommercialized biotech firms [12][13]. - The market's reaction to Yaojie Ankang-B's inclusion in the Hong Kong Stock Connect innovative drug index raised concerns about the decision-making process for including emerging companies in such indices [13]. Group 5: Regulatory Recognition - Yunding Xinyao's core product, Budesonide enteric-coated capsules, has been included in the global kidney disease guidelines, marking it as the only recommended treatment for IgA nephropathy [18].

Core Insights - A significant observational study confirms that NEFECON (budenoside enteric-coated capsules) provides substantial clinical benefits in the "etiological treatment" of IgA nephropathy, supporting a new management strategy focused on early and long-term treatment [1][4] Group 1: Study Findings - After 12 months of treatment, the NEFECON group showed a reduction in 24-hour urinary protein from 1016 mg to 114 mg, significantly lower than the control group's 291 mg [3] - The estimated glomerular filtration rate (eGFR) slope in the NEFECON group was significantly better than the control group, at 5.4 ml/min/1.73m²/year compared to -3.4 ml/min/1.73m²/year [3] - No severe infections occurred in the NEFECON group, indicating a better safety profile compared to traditional treatments [3] Group 2: Clinical Implications - The 2025 version of the "Clinical Practice Guidelines for Adult IgA Nephropathy" emphasizes the importance of long-term treatment strategies, including immunotherapy, to maintain kidney function and reduce the risk of renal failure [4] - NEFECON is the only approved drug for the etiological treatment of IgA nephropathy, recommended by both domestic and international guidelines for its ability to intervene at the disease's source [4][5] - The latest real-world study results presented at IIgANN 2025 reinforce NEFECON's position as a cornerstone treatment for IgA nephropathy, demonstrating sustained patient benefits after extending treatment beyond the initial 9 months [4][5] Group 3: Market Context - There are over 5 million IgA nephropathy patients in China, with more than 100,000 new cases diagnosed annually, highlighting a significant unmet clinical need [5] - NEFECON is the first and only drug for IgA nephropathy to receive full approval in China, the US, and Europe, not limited by urinary protein levels, thus reshaping treatment pathways for this condition [5]