云顶新耀(1952.HK)2024年财报：首次实现年度商业化层面盈利，营收同比增长增长461%达7.067亿

Core Insights - CloudTop New Drug (1952.HK) achieved its first annual commercialization profit in 2024, with revenue reaching 706.7 million RMB, a year-on-year increase of 461%, exceeding the target of 700 million RMB [3][4] - The company reported a high gross margin of 83% and a significant reduction in operating expenses as a percentage of revenue, down 562% [3] - The stock price increased by 132% over the year, outperforming the Hang Seng Biotechnology sector [3] Revenue Growth - The core products, including Naisfukang®, Yijia®, and Yiqumoude, have shown strong commercial performance, with Naisfukang® alone contributing 353 million RMB in revenue since its launch in May 2024, a staggering increase of 1581% year-on-year [4] - Yijia® also demonstrated robust growth, with revenue increasing by 256% to 353 million RMB, expanding its coverage to 300 core hospitals [4] Product Pipeline and Approvals - The autoimmune disease drug Yiqumoude (VELSIPITY®) has been approved for sale in Macau and Singapore, and is now accessible to mainland Chinese patients through the "Hong Kong-Macau Drug and Device Pass" policy [5] - The company plans to submit a new drug application for a fourth commercial product, Cefepime-Tanibobactam, targeting complicated urinary tract infections (cUTI) in mainland China by 2025 [6] Research and Development Progress - CloudTop New Drug is advancing its global rights pipeline, focusing on high-value areas, with significant milestones achieved in self-developed and globally licensed products [7] - The new generation covalent reversible BTK inhibitor EVER001 has shown positive results in clinical trials for primary membranous nephropathy, with global rights held by the company [7] - The company is developing mRNA-based cancer treatments and has received FDA approval for the clinical trial application of the universal tumor therapeutic vaccine EVM14 [8] Future Outlook - The company aims to leverage the solid commercialization foundation established in 2024 to achieve its vision of becoming a leading global biopharmaceutical company in Asia by 2030 [10] - Multiple catalysts are expected in 2025, including the implementation of Naisfukang®'s insurance policy and further market expansion [10] - The company is also focused on advancing the regulatory approval process for Yiqumoude in mainland China, with expectations for approval in 2026 [11]