Core Viewpoint - CloudTop New Drug (1952.HK) reported a strong performance in its 2025 interim results, with a revenue increase of 48% year-on-year, driven by its core product, Nefukang, which is expected to achieve significant sales growth in the coming years [1][2][4]. Financial Performance - The company achieved a revenue of 446 million RMB, with a gross margin of 76.4% after excluding non-cash items [1]. - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, and the total loss under non-IFRS standards narrowed by 31% [1]. - Cash reserves stood at 1.6 billion RMB, bolstered by a recent fundraising of approximately 1.553 billion HKD [1]. Product Performance - Nefukang, a treatment for IgA nephropathy, generated sales of 825 million RMB from January to August, with August sales alone reaching 520 million RMB [2][3]. - The company anticipates Nefukang's annual sales to reach between 1.2 billion and 1.4 billion RMB, with projections for 2026 sales between 2.4 billion and 2.6 billion RMB [2][3]. - The product is the only IgA nephropathy drug included in the medical insurance system across 29 provinces, significantly enhancing patient accessibility [3]. Market Potential - The market for IgA nephropathy treatment is substantial, with over 5 million patients in China and 1 million diagnosed cases [3]. - The company has expanded its nephrology sales team to 160 members to meet growing demand and has received approval for production capacity expansion [3]. R&D Progress - The company has made significant advancements in its self-developed pipeline, particularly in mRNA cancer therapeutic vaccines and CAR-T platforms [4]. - The personalized tumor therapeutic vaccine EVM16 has initiated its first human clinical trial in China, with positive preliminary data [4]. - The universal tumor therapeutic vaccine EVM14 has received FDA approval for clinical trials, with patient enrollment expected to begin by September 2025 [4]. Strategic Developments - The company successfully removed the "B" mark from its Hong Kong stock, reflecting market confidence in its R&D pipeline and commercialization capabilities [7]. - A recent fundraising effort raised approximately 1.5725 billion HKD, indicating strong interest from international long-term funds [7]. - The company has increased its stake in I-Mab to 16.1%, becoming its largest shareholder, which complements its mRNA vaccine and CAR-T pipeline [7]. Future Outlook - The company aims to leverage its dual-driven strategy focusing on Nefukang and VisiPing as key products, with projected peak sales exceeding 25 billion RMB [8]. - The integration of AI and mRNA technology platforms is expected to drive early-stage R&D and internationalization efforts [8].

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [12][14] - Revenue from Nephicon alone reached RMB 520 million in August, indicating a strong recovery from earlier supply issues [13] - Full year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [13][14] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [14] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [14] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August, with strong market demand leading to a significant uptick in sales after regulatory approval [4][5] - The autoimmune disease franchise, particularly Velsipiti, is progressing well with NDA reviews and expected early 2026 approval [7][8] - XERAVA in the anti-infective segment showed steady growth, with revenue increasing by 37% year-over-year [23] Market Data and Key Metrics Changes - The company aims to expand Nephicon's market coverage to 1,000 hospitals, targeting approximately 30,000 new patients [18][20] - The estimated market for IgAN in China includes about 5 million patients, with significant growth potential as the company expands its reach [19][20] - The ulcerative colitis market is projected to grow, with peak sales for Velsipiti expected to reach RMB 5 billion [34] Company Strategy and Development Direction - The company is focused on a dual strategy of commercialization and in-house discovery, with significant investments in R&D to support long-term growth [35][72] - Plans include localizing production for various products and preparing for NRDL negotiations to enhance market access [72] - The company is also exploring partnerships and in-licensing opportunities to bolster its product pipeline and market presence [76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving operational profitability earlier than previously guided, now targeting Q4 2025 [15] - The company is optimistic about the upcoming regulatory approvals and market launches, which are expected to drive revenue growth [71][72] - Management highlighted the strong clinical data supporting their products, which positions them favorably in the market [82] Other Important Information - The company completed a strategic investment of USD 30.9 million in I Mab, becoming the largest shareholder with a 16.1% stake [12][70] - The company is advancing its proprietary mRNA technology platform, which is expected to enhance its R&D capabilities and product offerings [48][49] Q&A Session Summary Question: Peak sales for Etrasimod - Management noted that the potential for Etrasimod is higher than previously stated due to strong clinical data and an underdeveloped market, with preparations underway for commercial launch [80][82][86] Question: Development plans for EVER-one - Management confirmed that they are in the design stage for pivotal trials and are planning to initiate these studies in 2026, with ongoing discussions for potential partnerships [89][90][92]

Financial Data and Key Metrics Changes - The company reported revenue of RMB 446 million for 2025, representing a 48% year-over-year growth, although the first half was impacted by supply constraints [14][15] - Revenue from Nephicon alone reached RMB 520 million in August 2025, indicating a strong recovery from earlier supply issues [15] - The full-year revenue guidance for 2025 is set between RMB 1.6 billion to RMB 1.8 billion, with Nephicon expected to contribute RMB 1.2 billion to RMB 1.4 billion [16] - The gross margin on a cash basis was 76.4%, slightly lower than 2024 due to price reductions after NRDL inclusion, but expected to recover above 80% in the long run [17] - The non-IFRS net loss was approximately RMB 147 million, down 31% year-over-year, indicating improved operational efficiency [18] Business Line Data and Key Metrics Changes - Nephicon generated RMB 825 million in revenue from January to August 2025, with NRDL coverage achieved in 29 provinces [6][7] - The autoimmune disease franchise, particularly Velsipiti, is in the final stages of NDA review, with expectations for early 2026 approval [9] - XERAVA in the anti-infective franchise showed steady growth, with revenue growth of 37% year-over-year [26] Market Data and Key Metrics Changes - The company plans to expand Nephicon's market coverage to 1,000 hospitals, targeting 30,000 new IGAM patients [22] - The estimated market for IGAM in China includes about 5 million patients, with 100,000 new confirmed cases each year [23] - The ulcerative colitis market is projected to reach RMB 14 billion, with significant unmet medical needs [29] Company Strategy and Development Direction - The company aims to achieve operational profitability in 2025, with a focus on expanding its commercial platform and advancing its R&D pipeline [19][37] - The strategy includes leveraging a combination of commercial execution and in-house discovery to drive growth [72] - The company is also pursuing strategic investments, such as a USD 30.9 million investment in I Mab, to enhance its oncology platform [70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong market potential for Nephicon and Velsipiti, citing robust clinical data and regulatory approvals [81][82] - The company is optimistic about achieving peak sales of RMB 5 billion for Nephicon, supported by a growing patient base and favorable market conditions [80] - Future growth is expected to be driven by multiple near-term catalysts, including upcoming NDA approvals and market expansions [71][72] Other Important Information - The company has made significant progress in its R&D platform, including advancements in mRNA technology and CAR T therapies [48][49] - The company is preparing for pivotal trials in 2026 for its autoimmune renal disease treatments, indicating a strong pipeline for future growth [45][46] Q&A Session Summary Question: Peak sales for Etrasimod - The company raised peak sales estimates for Etrasimod to RMB 5 billion due to strong clinical data and an underdeveloped market with significant unmet needs [80][81] Question: Clinical development plan for EVER-one - The company is finalizing the design for a Phase II basket trial and plans to initiate pivotal studies in 2026, with ongoing regulatory interactions [88][89]

Financial Performance & Outlook - The company reported revenue of RMB 446 million, a 48% year-over-year increase, primarily driven by NEFECON® and XERAVA®[10, 12] - Gross margin was 76.4%, excluding amortization of intangible assets, reflecting NRDL price reduction of NEFECON® in mainland China and product cost optimization[10, 13] - Non-IFRS net loss decreased by 31% year-over-year to RMB 147 million[10] - The company expects full-year revenue to be between RMB 1.6 billion and RMB 1.8 billion, with NEFECON® revenue projected at RMB 1.2 billion to RMB 1.4 billion[10] - The company anticipates achieving operational profitability in the second half of 2025[9, 11] Key Products & Commercialization - NEFECON® revenue reached RMB 825 million from January to August 2025, with full NRDL coverage achieved in target provinces[8, 20] - NEFECON® is projected to generate RMB 1.2 billion to RMB 1.4 billion in revenue for the full year 2025 and RMB 2.4 billion to RMB 2.6 billion in 2026[10, 25] - XERAVA® generated RMB 143 million in revenue in the first half of 2025, a 6% year-over-year increase, with in-market sales up by 37%[32] - VELSIPITY® demonstrated a 51.9% mucosal healing rate with one year of treatment and is estimated to reach peak sales exceeding RMB 5 billion[49, 52] R&D Pipeline & Investments - EVER001 (Civorebrutinib) showed rapid and deep reductions in both Anti-PLA2R and 24h Proteinuria with an excellent safety profile[67] - The company completed a share placement on August 1, 2025, with net proceeds of HKD 1.6 billion[8, 10] - The company increased its strategic investment in I-MAB, becoming its single largest shareholder with 16.1% ownership[8, 116]

Core Viewpoint - The company, CloudTop New Medicine (1952.HK), reported strong mid-year performance for the period ending June 30, 2025, showcasing significant growth in both commercialization and R&D efforts, laying a solid foundation for becoming a leading global Biopharma company [1] Financial Performance - Total revenue for the first half of 2025 reached RMB 446 million, a substantial increase of 48% year-on-year [1] - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, indicating improved operational efficiency [1] - Non-IFRS total loss narrowed significantly by 31%, with a gross margin of 76.4% after excluding non-cash items [1] - The company has a strong cash reserve of RMB 1.6 billion, bolstered by a recent fundraising of HKD 1.553 billion [1] Product Performance - The kidney disease treatment product, Nefukang®, saw impressive sales of RMB 303 million in the first half, an increase of 81% year-on-year [2] - Cumulative sales from January to August reached RMB 825 million, with August alone generating RMB 520 million [2] - The global first fluoroquinolone antibiotic, Yijia®, also showed steady growth with revenue of RMB 143 million, a 6% increase year-on-year [2] Strategic Initiatives - The company is advancing its "dual-wheel drive" strategy, focusing on high-potential products and enhancing its R&D capabilities [3] - The personalized tumor therapeutic vaccine EVM16 has initiated its first human clinical trial in China, with positive preliminary data [3] - The CAR-T project EVM18 is expected to start clinical trials by the end of 2025, with significant progress in its global R&D pipeline [4] Future Outlook - The company aims to achieve annual sales of RMB 1.6 to 1.8 billion and expects to reach operational profitability in the second half of 2025 [1][2] - The strategic focus will remain on the commercialization of Nefukang® and Weishiping®, alongside leveraging AI and mRNA technology platforms for early-stage R&D [5] - The company is targeting a peak sales potential exceeding RMB 25 billion in the future [5]

Core Viewpoint - Cloud-based innovative pharmaceutical company, CloudTop New Medicine, reported strong mid-year performance for the period ending June 30, 2025, showcasing robust growth and a solid foundation for becoming a leading global Biopharma company [1] Financial Performance - Total revenue for the first half of 2025 reached RMB 446 million, a significant increase of 48% year-on-year [1] - Operating expenses as a percentage of revenue decreased by 40.1 percentage points, indicating improved operational efficiency [1] - Non-IFRS total loss narrowed by 31%, with a cash reserve of RMB 1.6 billion, bolstered by a recent fundraising of HKD 1.553 billion [1] Product Performance - The kidney disease treatment product, Nefukang, achieved sales of RMB 303 million in the first half, a remarkable increase of 81% year-on-year [2] - Sales for Nefukang from January to August reached RMB 825 million, with August alone generating RMB 520 million [2] - The antibiotic drug, Yijia, also showed steady growth with sales of RMB 143 million, a 6% increase year-on-year [2] Strategic Initiatives - The company is advancing its "dual-engine" strategy, focusing on both commercialization and R&D to establish a competitive global pipeline [3] - The personalized tumor therapeutic vaccine, EVM16, has initiated its first human clinical trial in China, with positive preliminary data [3] - The CAR-T project, EVM18, is expected to start clinical trials by the end of 2025, while the new generation BTK inhibitor, EVER001, is progressing well in clinical trials [4] Future Outlook - The company aims to achieve annual sales of RMB 1.6 to 1.8 billion and expects to turn operationally profitable in the second half of 2025 [1][2] - The strategic investment in I-Mab enhances the company's global positioning in next-generation tumor immunotherapy [4] - The company targets a sales peak exceeding RMB 25 billion in the future, driven by its innovative platforms and product synergies [5]

Core Viewpoint - The company, Cloudtop New Horizon (01952.HK), reported a significant revenue increase of RMB 144.6 million or 48.0% to RMB 446.1 million for the six months ending June 30, 2025, primarily driven by the growth of its commercialized products, NAI Fukan® and Yijia® [1] Revenue Growth - Revenue growth is attributed to the inclusion of NAI Fukan® in the national medical insurance drug list, which has become a major growth driver [1] - Yijia® continues to deepen its market penetration, contributing to sustained revenue growth [1] - NAI Fukan® successfully launched in Taiwan, marking a significant milestone for the company [1] - The introduction of Weishiping® into the Singapore market in the first half of 2025 highlights the company's progress in expanding international markets and improving drug accessibility [1] Research and Development - R&D expenditure decreased from RMB 253.2 million for the six months ending June 30, 2024, to RMB 195.2 million for the same period in 2025, reflecting strategic resource optimization and a focus on core pipeline breakthroughs [1] - The company achieved multiple R&D milestones in the first half of the year while actively optimizing its R&D strategy [1] - The company is accelerating the development of autologous CAR-T and mRNA platforms to prepare for the next phase of research and clinical trials, while continuing to develop the value of EVER001 (Civorebrutinib) [1]

Core Insights - The company reported a revenue of 446 million, representing a year-on-year growth of 47.96% [1] - Gross profit reached 299 million, an increase of 29.56% compared to the previous year [1] - The loss attributable to shareholders narrowed to 250 million, a reduction of 60.5% year-on-year [1] Revenue Growth Drivers - Revenue growth was primarily driven by the continued expansion of Naisikan and Yijia in commercialized markets [1] - In the Chinese market, Naisikan was included in the national medical insurance drug list, significantly boosting its revenue [1] - Yijia's market penetration continued to deepen, contributing to sustained revenue growth [1] International Market Expansion - Naisikan successfully launched in Taiwan, marking a significant milestone for the company [1] - The company successfully introduced Weishiping to the Singapore market in the first half of 2025, showcasing progress in international market expansion and improving drug accessibility [1]

Core Insights - The company reported a revenue of 446 million yuan for the six months ending June 30, 2025, representing a year-on-year increase of 47.96% [1] - Gross profit reached 299 million yuan, up 29.56% compared to the previous year [1] - The loss attributable to shareholders narrowed to 250 million yuan, a reduction of 60.5% year-on-year [1] Revenue Growth Drivers - Revenue growth was primarily driven by the continued market expansion of Naisukan® and Yijia® in commercialized markets [1] - In the Chinese market, Naisukan® was included in the national medical insurance drug list, significantly boosting its revenue for the six months ending June 30, 2025 [1] - Yijia®'s market penetration continued to deepen, contributing to sustained revenue growth [1] International Market Expansion - Naisukan® successfully launched in Taiwan, marking a significant milestone for the company [1] - In the international market, Weishiping® was successfully introduced to the Singapore market in the first half of 2025 [1] - These achievements highlight the company's progress in expanding international markets and improving drug accessibility [1]

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全 部 或 任 何 部 份 內 容 而 產 生 或 因 倚 賴 該 等 內 容 而 引 致 的 任 何 損 失 承 擔 任 何 責 任。 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲頂新耀有限公司 截 至2025年6月30日 止 六 個 月 中 期 業 績 公 告 雲 頂 新 耀 有 限 公 司（「本 公 司」）董 事 會（「董 事 會」）宣 佈 本 公 司 及 其 附 屬 公 司 截 至2025年6月30日 止 六 個 月 的 未 經 審 計 中 期 業 績。本 公 告 載 有 本 公 司 2025中 期 報 告 全 文，符 合 香 港 聯 合 交 易 所 有 限 公 司（「聯 交 所」）證 券 上 市 規 則 中 有 關 中 期 業 績 初 步 公 告 附 載 資 料 的 相 關 要 求 ...