Workflow
ASCLETIS(01672)
icon
Search documents
歌礼制药-B:ASC40痤疮适应症III期临床达到所有终点,疗效数据优秀-20250605
Soochow Securities· 2025-06-05 00:23
Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The company has successfully completed all primary and secondary endpoints in the Phase III clinical trial for ASC40, a treatment for moderate to severe acne, demonstrating excellent efficacy [7] - ASC40's treatment success rate was 33.2% compared to 14.6% in the placebo group, with a significant reduction in total lesions and inflammatory lesions [7] - The company is expected to submit for regulatory approval in 2025, with projected revenues starting in 2026 [7] Financial Projections - Total revenue is projected to be 1.28 million in 2024, with a significant increase to 40 million in 2026 and 100 million in 2027 [1] - The net profit attributable to the parent company is expected to decline to (300.94) million in 2024 and further to (454.44) million in 2025, before slightly improving to (445.21) million in 2027 [1] - The earnings per share (EPS) is forecasted to be (0.31) in 2024, (0.47) in 2025, and (0.46) in 2027 [1] Market Data - The closing price of the stock is 8.07 HKD, with a market capitalization of approximately 7,169.28 million HKD [5] - The company has a price-to-book ratio of 3.81 and a price-to-earnings ratio of (54.06) [5][1]
整理:每日港股市场要闻速递(6月4日 周三)
news flash· 2025-06-04 01:11
Group 1 - Tencent Holdings (00700.HK) reduced its stake in Crystal Technology Holdings (02228.HK) from 6.47% to 5.93% [1] - Goldman Sachs raised the target price for Li Auto (02015.HK) to HKD 138 and increased earnings estimates for 2025 to 2027 [1] - UBS reduced its stake in Midea Group (00300.HK) from 5.05% to 4.95% on May 28 [1] Group 2 - Red Star Macalline (01528.HK) approved the draft restructuring plan for Red Star Macalline Holdings Group [1] - Genscript Biotech (01672.HK) achieved all endpoints in the Phase III trial of its first-in-class oral FASN inhibitor, ASC40, for acne [1] - Yaoshi Bang (09885.HK) signed a strategic cooperation and business deployment agreement with Yujian Technology to explore the application of collaborative robots and related AI products in drug development [1] Group 3 - NIO Inc. (09866.HK) reported Q1 2025 revenue of CNY 12.035 billion, up from CNY 9.91 billion in the same period last year; Q1 net loss was CNY 6.89 billion, compared to a net loss of CNY 5.258 billion in the previous year; the company expects delivery numbers for the second quarter to be between 72,000 and 75,000 vehicles [1]
歌礼制药-B(01672):同类首创、每日一次口服FASN抑制剂地尼法司他(ASC40) 痤疮III期试验达到所有终点
智通财经网· 2025-06-03 23:15
Core Viewpoint - The announcement from Gilead Sciences-B (01672) highlights the successful completion of a Phase III clinical trial for the first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, denifasirt (ASC40), for the treatment of moderate to severe acne, achieving all primary, key secondary, and secondary endpoints [1][6]. Group 1: Clinical Trial Results - The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center study conducted in China, involving 480 patients with moderate to severe acne [1]. - The primary endpoint of treatment success was defined as a decrease of at least 2 points in the Investigator's Global Assessment (IGA) score from baseline at week 12, with a treatment success rate of 33.2% in the denifasirt group compared to 14.6% in the placebo group (p < 0.0001) [2][7]. - Key secondary endpoints showed a 57.4% reduction in total lesion count and a 63.5% reduction in inflammatory lesion count in the denifasirt group compared to 35.4% and 43.2% in the placebo group, respectively (p < 0.0001) [2][7]. Group 2: Safety and Tolerability - Denifasirt demonstrated good safety and tolerability over the 12-week treatment period, with treatment-emergent adverse events (TEAEs) occurring at rates not exceeding 10% [3]. - The only TEAEs exceeding 5% were dry skin (6.3% in the denifasirt group) and dry eye (5.9% in the denifasirt group), with all reported adverse events being mild or moderate [3]. Group 3: Mechanism of Action - Denifasirt's mechanism of action involves inhibiting de novo lipogenesis (DNL) in sebocytes, directly reducing sebum production, and suppressing inflammation through decreased cytokine secretion and Th17 differentiation [3][6]. Group 4: Competitive Advantage - Denifasirt is positioned as a promising treatment option due to its significant efficacy, high patient compliance, and favorable safety profile, with no reported severe adverse events such as hepatotoxicity or antibiotic resistance [5]. - Compared to other common oral and topical acne medications, denifasirt showed superior efficacy, with treatment success rates and lesion count reductions significantly higher than those of sarecycline, doxycycline, and clascoterone [4][9].
歌礼制药:ASC40痤疮III期试验达到所有终点
news flash· 2025-06-03 23:06
Core Viewpoint - The announcement from the company indicates that the oral FASN inhibitor, denifasertib (ASC40), has successfully met all primary, key secondary, and secondary endpoints in its Phase III clinical trial for the treatment of moderate to severe acne vulgaris, demonstrating significant statistical and clinical improvements compared to placebo [1] Group 1 - Denifasertib achieved a treatment success percentage of 18.6% after placebo adjustment, which is significantly higher than the FDA-approved treatments: sarecycline (9.4%) and doxycycline (6.7%), showing improvements of 98% and 178% respectively [1] - The efficacy of denifasertib also surpassed that of the FDA-approved clascoterone cream (11.6%) by 60% [1] - The drug exhibited good safety and tolerability characteristics throughout the trial [1]
速递|每月仅需一次!歌礼制药减肥不减肌新药患者用药
GLP1减重宝典· 2025-05-23 07:14
整理 | GLP1减重宝典内容团队 关于ASC47-103研究 ASC47-103研究在美国开展,是一项随机、双盲、安慰剂对照的临床研究,旨在评估单剂量超长效皮下注射(SQ)ASC47联合 司美格鲁肽治 疗肥胖症(体质指数≥30 kg/m²)患者的安全性和初步疗效。ASC47-103研究包含三个队列:队列1的参与者将接受单剂量10 mg ASC47或容量 匹配的安慰剂皮下注射,以及四剂 司美格鲁肽(0.5 mg,每周一次)皮下注射。队列2的参与者将接受单剂量30 mg ASC47或容量匹配的安慰 剂皮下注射,以及四剂 司美格鲁肽(0.5 mg,每周一次)皮下注射。第 3 组参与者将通过皮下注射接受单剂量 60 毫克 ASC47 或体积匹配的 安慰剂,并通过皮下注射接受四剂量的司美格鲁肽(0.5 毫克,每周一次)。 *本文仅供医疗卫生专业人士参考 版权声明:所有「GLP1减重宝典」的原创文章,转载须联系授权,并在文首/文末注明来源、作者、微信ID,否则减重宝典将向其追究法律责 任。部分文章推送时未能与原作者或公众号平台取得联系。若涉及版权问题,敬请原作者联系我们。合作事宜,请添加微信:andyxu365 歌礼制 ...
医药行业周报:关税短期冲击减弱,出海仍是主要趋势
Huaxin Securities· 2025-05-19 03:00
Investment Rating - The industry investment rating is "Recommended" (Maintained) [1] Core Viewpoints - The trend of "going abroad" remains a major focus, with short-term impacts from tariffs diminishing. In Q1 2025, China's pharmaceutical exports reached $26.632 billion, a year-on-year increase of 4.39%, with exports to the U.S. at $4.639 billion, up 9.6% [3] - The market for gout and uric acid reduction presents significant potential, with the number of patients expected to rise from 1.7 billion in 2020 to 2.4 billion by 2030 in China. Current treatments show poor adherence and efficacy, indicating a need for safer and more effective drugs [4] - The oral weight loss drug sector is seeing major players like Novo Nordisk intensifying their efforts, with significant collaborations and clinical advancements. Chinese companies are also making rapid progress in this area [6] - Breakthroughs in universal CAR-T and autoimmune applications are emerging, with promising clinical data from companies like Kintor Pharmaceutical and Bangyao Biotech [8] Summary by Sections 1. Pharmaceutical Export Trends - Pharmaceutical exports are on the rise, with a notable increase in trade volume and value. The U.S. remains the largest single market for Chinese pharmaceutical exports [3] 2. Gout Treatment Market Potential - Gout is a global health issue, particularly in China, where the prevalence is increasing. The market for gout treatments is expected to grow significantly due to the high number of patients and the need for better treatment options [4] 3. Weight Loss Drug Developments - Major pharmaceutical companies are investing heavily in oral weight loss drugs, with significant collaborations and clinical trials underway. Chinese firms are also positioned to capitalize on this growing market [6] 4. Advances in CAR-T Therapy - New developments in universal CAR-T therapies are showing promise, with initial clinical results indicating high efficacy and safety. This could lead to broader applications in various diseases [8] 5. Stock Recommendations - The report recommends several companies based on their potential in various segments, including those focusing on international collaborations, innovative drug development, and market expansion [10]
港股午评:恒生指数涨0.93%,恒生科技指数涨1.91%
news flash· 2025-05-12 04:01
Group 1 - The Hang Seng Index closed up 0.93%, while the Hang Seng Tech Index rose by 1.91% [1] - Apple-related stocks led the gains, with Sunny Optical Technology rising over 10% and AAC Technologies increasing by more than 9% [1] - The innovative drug sector experienced declines, with Genscript Biotech falling over 8% and BeiGene dropping more than 7% [1]
港股创新药板块盘初走低,歌礼制药(01672.HK)跌超8%,百济神州(06160.HK)跌超7%,石药集团(01093.HK)跌超5%。
news flash· 2025-05-12 01:50
港股创新药板块盘初走低,歌礼制药(01672.HK)跌超8%,百济神州(06160.HK)跌超7%,石药集团 (01093.HK)跌超5%。 ...
港股创新药板块盘初走低,歌礼制药-B跌超8%
news flash· 2025-05-12 01:46
港股创新药板块盘初走低,歌礼制药-B跌超8%,百济神州跌超7%,石药集团跌超5%,信达生物、荣昌 生物、君实生物纷纷下挫。 ...
港股概念追踪|传闻世卫组织计划将减肥药纳入基本目录 减肥药研发进展加速(附概念股)
智通财经网· 2025-05-07 07:16
Group 1 - The World Health Organization (WHO) is planning to include weight loss medications in its essential medicines list for the treatment of adult obesity, with guidelines expected to be finalized by August or September 2025 [1] - The guidelines will clarify the clinical indications, applications, and considerations for GLP-1 receptor agonists (RAs) as part of chronic disease management, including clinical and lifestyle interventions [1] - The WHO's expert committee is currently reviewing these medications independently to assess their inclusion in the essential medicines lists, which guide procurement agencies in selecting drugs that meet public health needs [1] Group 2 - Citic Securities reports that overseas giants are consistently exceeding performance expectations, and domestic R&D progress is accelerating, indicating a clearer trend for the weight loss drug industry [2] - Future catalysts for the weight loss drug sector include better-than-expected sales data from major drugs, disclosures of R&D results for overseas GLP-1 drugs in other indications, and successful approvals for domestic products [2] Group 3 - Gilead Sciences (01672) will present early research on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity (ECO 2025) in Malaga, Spain [3] - LianKai Pharmaceuticals (02105) has reported smooth progress in its Phase I clinical trial for LAE102, a monoclonal antibody targeting overweight/obesity, with all 64 participants completing dosing [3] - LianKai has a clinical collaboration agreement with Eli Lilly for LAE102's Phase I study in the U.S., with Eli Lilly covering related costs [3] Group 4 - Innovent Biologics (01801) is at the forefront of domestic GLP-1 innovation with its dual agonist Mazdutide, which has received acceptance for two NDA applications in China targeting obesity and type 2 diabetes [4] - The weight loss indication for Mazdutide is expected to be approved in the first half of next year, with potential to replicate the success of Eli Lilly's weight loss drug in Western countries [4] - The dual-target product Mazdutide is in the application stage for market approval and is expected to be approved within the next two years [4]