依嘉(依拉环素)

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云顶新耀(01952.HK):耐赋康超预期上调指引 双基石双驱动战略明确
Ge Long Hui· 2025-09-05 19:16
Group 1 - The company reported a revenue of RMB 446 million for H1 2025, representing a 48% year-on-year increase, with a significant reduction in non-IFRS losses by 31% [1] - The gross margin, excluding non-cash items, was 76.4%, and the cash reserves reached RMB 1.6 billion by the end of June 2025 [1] - Sales of the drug NAI Fukan reached RMB 303 million in H1 2025, an 81% increase year-on-year, with expectations for annual sales to reach RMB 1.2-1.4 billion [1] Group 2 - The drug NAI Fukan is the first targeted therapy for IgA nephropathy, successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [1] - The company anticipates that NAI Fukan will be included in the KDIGO 2025 guidelines and the first IgA nephropathy guidelines in China [1] - Sales of the drug Yijia reached RMB 143 million in H1 2025, a 6% increase year-on-year, with a 37% increase in pure sales from core hospitals [1] Group 3 - The drug EVER001 (Hibutinin) is positioned as a potential best-in-class product, with positive results from ongoing clinical trials presented at the ERA 2025 conference [2] - The drug Aiqumide has completed a significant clinical study in Asia for moderate to severe ulcerative colitis and is expected to receive approval in mainland China by H1 2026 [2] - The company is leveraging its proprietary mRNA technology platform to develop globally competitive products, including personalized cancer vaccines [3] Group 4 - The mRNA-based cancer vaccine EVM16 completed its first patient dosing in March 2025, while EVM14 received FDA IND approval, marking a significant milestone for the company [3] - The company expects to complete preclinical milestones for its CAR-T project based on the mRNA technology platform in the second half of 2025 [3] - The revenue forecast for the company has been raised, with projected total revenues of RMB 1.738 billion, RMB 2.869 billion, and RMB 3.351 billion for 2025-2027 [3]
云顶新耀(01952):耐赋康超预期上调指引,双基石双驱动战略明确
Tianfeng Securities· 2025-09-05 11:14
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 73.6 per share, up from the previous target of HKD 59.15 [7]. Core Insights - The company has significantly raised its guidance for the drug Naisukan, expecting sales to reach RMB 12-14 billion in 2025, with continued high growth projected for 2026 at RMB 24-26 billion [2]. - The company reported a revenue of RMB 4.46 billion for the first half of 2025, marking a 48% year-on-year increase, with a notable reduction in non-IFRS losses by 31% [1]. - The company is focusing on innovative products with differentiated competitive advantages, particularly in the fields of anti-infection and kidney disease treatments [7]. Summary by Sections Naisukan Performance - Naisukan achieved sales revenue of RMB 3.03 billion in H1 2025, representing an 81% year-on-year growth, with August sales reaching RMB 5.20 billion [2]. - The drug was successfully commercialized in mainland China in May 2024 and included in the medical insurance directory in November 2024 [2]. Other Drug Developments - The drug Yijia generated revenue of RMB 1.43 billion in H1 2025, a 6% increase, with a 37% growth in direct sales to hospitals [3]. - EVER001 (Hibutinib) is showing promising clinical trial results, positioning it as a potential best-in-class product for broad-spectrum autoimmune kidney diseases [4]. Clinical Trials and Approvals - The drug Aiqumide has completed a significant clinical study in Asia and is expected to receive approval in mainland China by H1 2026 [5]. - The company is advancing its mRNA technology platform, with the EVM16 personalized cancer vaccine having completed its first patient dosing and EVM14 receiving FDA IND approval [6]. Financial Projections - The company has revised its revenue forecasts for 2025-2027 to RMB 17.38 billion, RMB 28.69 billion, and RMB 33.51 billion respectively, reflecting the strong performance of Naisukan and the anticipated approval of Aiqumide [7].
云顶新耀首次实现年度商业化盈利,称医保产品落地符合预期
Peng Pai Xin Wen· 2025-03-26 11:13
Core Viewpoint - Cloud-based pharmaceutical company, CloudTop New Medicine, achieved its first annual commercial profitability in 2024, driven by significant revenue growth from its core products, despite an increase in net losses due to impairment losses on intangible assets related to mRNA COVID-19 vaccines [3][4]. Financial Performance - The company reported a total revenue of 707 million yuan, representing a year-on-year increase of 461% [3]. - The net loss for the year was 1.041 billion yuan, which widened from 845 million yuan in 2023, primarily due to a one-time impairment loss on intangible assets [3]. - Excluding the impairment loss, the net loss narrowed to 685 million yuan [3]. Product Performance - The revenue growth was largely attributed to three core products, with the IgA nephropathy treatment, Naimu Kang, contributing 353 million yuan in revenue since its launch in May 2024, marking a 1581% increase [3]. - Naimu Kang has successfully reached over 600 to 700 core hospitals, covering more than 60% of the target patient population [3]. Market Access and Policy - Naimu Kang was included in the 2024 National Medical Insurance Directory, becoming the only IgA drug covered by insurance [4]. - The company anticipates that the implementation of insurance policies will continue to progress positively, with over 10,000 patients having used Naimu Kang in the first quarter of the year [4]. - The government work report for 2025 emphasized the need to improve drug pricing mechanisms and support innovative drug development [4]. Competitive Landscape - The IgA nephropathy market is considered a hot sector, with multiple domestic and international companies involved [5]. - The company believes that its IgA drug has advantages in long-term safety and combination therapy, with a potential market of approximately 5 million patients in China [5]. Pipeline and Future Developments - The company is also focusing on its innovative fluoroquinolone antibiotic, Yijia, which generated 353 million yuan in revenue in 2024, reflecting a 256% increase [5]. - The autoimmune disease drug, Yichuomode, has been approved in Macau and Singapore, with a new drug application submitted to the Chinese regulatory authority [5]. - The company is advancing its mRNA drug pipeline, including a personalized tumor therapeutic vaccine, EVM16, which has completed its first patient dosing [6].