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歌礼制药:欧洲肥胖症大会报告ASC47研究成果
news flash· 2025-05-06 08:43
Core Insights - The company will present research results on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity [1] - The oral presentation is scheduled for May 13, 2025, and the poster presentation will take place on May 14, 2025, in Malaga, Spain [1] - ASC47 is a thyroid hormone receptor β selective small molecule agonist that targets fat and is designed for subcutaneous injection with a long duration of action [1] - The drug achieves dose-dependent high drug concentrations in adipose tissue [1] - The FDA has approved the clinical trial application for ASC47 in combination with semaglutide for the treatment of obesity [1]
港股收评:恒生指数涨0.51%,恒生科技指数涨1.35%
news flash· 2025-04-30 08:14
Group 1 - The Hang Seng Index closed up by 0.51% [1] - The Hang Seng Tech Index increased by 1.35% [1] - The Hong Kong Tech ETF (159751) rose by 1.44% [1] - The Hang Seng Hong Kong Stock Connect ETF (159318) gained 0.58% [1] Group 2 - Meitu Inc. saw a rise of over 10% [1] - Chow Tai Fook Jewelry Group increased by over 8% [1] - Lao Poo Gold experienced a decline of over 5% [1] - Genscript Biotech Corporation (B) fell by over 4% [1]
歌礼制药(01672) - 2024 - 年度财报
2025-04-28 08:52
Financial Performance - The company reported a revenue of RMB 1,283 thousand for the fiscal year 2024, a significant increase compared to RMB 56,596 thousand in 2023[15]. - The gross profit for 2024 was RMB 735 thousand, showing a recovery from a gross loss of RMB 24,692 thousand in 2022[15]. - The net loss margin for 2024 was reported at -23,455.7%, a significant increase from -255.7% in 2023, reflecting ongoing challenges[15]. - Total assets decreased to RMB 2,124,572 thousand in 2024 from RMB 2,332,756 thousand in 2023, indicating a reduction in financial resources[15]. - The annual loss increased from RMB 144.7 million for the year ended December 31, 2023, to RMB 300.9 million for the year ending December 31, 2024, primarily due to increased R&D expenditures for obesity and other metabolic diseases[19]. - Other income and gains decreased by 35.1% from approximately RMB 184.7 million for the year ended December 31, 2023, to approximately RMB 119.8 million for the year ended December 31, 2024[58]. - The total revenue decreased from approximately RMB 566 million for the year ended December 31, 2023, to RMB 1.3 million for the year ended December 31, 2024, due to strategic adjustments in response to the easing of the COVID-19 pandemic[55]. Research and Development - Research and development costs increased to RMB 302,394 thousand in 2024, up from RMB 216,781 thousand in 2023, indicating a strong focus on innovation[15]. - R&D expenses increased by 39.5% from approximately RMB 216.8 million for the year ended December 31, 2023, to approximately RMB 302.4 million for the year ending December 31, 2024[19]. - R&D costs for metabolic diseases surged to RMB 99,237 thousand in 2024 from RMB 12,290 thousand in 2023, reflecting a significant focus on this area[66]. - The company plans to initiate a 13-week IIa phase clinical study for ASC30 in the U.S. in 2025[28]. - The company expects to announce topline results from the Ib phase clinical study of ASC30 in the U.S. in 2025[32]. - The ASC30 subcutaneous injection, administered monthly or less frequently, is expected to show promising results as a first-in-class treatment for obesity, with interim data anticipated by March 2025[10]. - The ASC47 subcutaneous injection, also targeting obesity, demonstrated a half-life of up to 40 days in patients, indicating potential for effective weight loss without muscle loss[10]. - The ASC30 is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2044, showing strong competitive potential for obesity treatment[27]. - The ASC47 single-agent Ib phase study in Australia showed positive topline results, with an average weight loss of 1.7% at peak after a single injection[33]. Strategic Decisions and Initiatives - The company has made strategic decisions to terminate multiple plans and optimize R&D resources to focus on globally competitive pipeline products[11]. - The company remains committed to sustainability initiatives aimed at reducing its carbon footprint while enhancing operational efficiency[11]. - The management emphasized a commitment to sustainability, with plans to reduce carbon emissions by 30% by 2025[1]. - The company is exploring partnerships with leading universities to accelerate drug development processes[1]. - The company has decided to terminate the ASC22 project for chronic hepatitis B functional cure based on strategic planning and resource optimization[37]. Cash and Financial Position - As of December 31, 2024, the group's cash and cash equivalents are approximately RMB 1,980.8 million, down from RMB 2,299.4 million as of December 31, 2023, sufficient to support R&D activities until 2029[19]. - Cash and cash equivalents increased to approximately RMB 864.3 million as of December 31, 2024, from RMB 330.1 million as of December 31, 2023, reflecting a net increase of RMB 533.8 million[97]. - Net cash used in operating activities for the year ended December 31, 2024, was approximately RMB 341.6 million, primarily due to an operating loss of approximately RMB 355.4 million before changes in working capital[99]. - Net cash generated from investing activities for the year ended December 31, 2024, was approximately RMB 978.9 million, mainly due to a decrease in time deposits of approximately RMB 866.0 million[100]. - Net cash used in financing activities for the year ended December 31, 2024, was approximately RMB 103.5 million, primarily attributed to the repurchase of shares at a total cost of approximately RMB 98.5 million[101]. Employee and Operational Insights - The total employee cost for the year ending December 31, 2024, was approximately RMB 136.1 million, down from RMB 144.0 million for the year ending December 31, 2023[116]. - The company has 231 employees as of December 31, 2024, with 69.7% in R&D and over 81.3% holding a bachelor's degree or higher[116]. - The company recognizes the importance of attracting and retaining quality employees and provides regular training programs, including onboarding, technical, professional, and safety training[146]. Shareholder and Equity Information - As of December 31, 2024, the total number of issued shares was 1,012,758,000, including treasury shares[168]. - Dr. Wu holds 514,393,664 shares through JJW12 Limited, representing 50.79% of the company's equity[162]. - The company repurchased a total of 41,692,000 shares as treasury shares, authorized by shareholders at the annual general meeting on May 23, 2024[168]. - The company has decided to reallocate 30.8% of the unutilized proceeds to support the development of metabolic disease candidates such as ASC47 and ASC30[188]. - The board of directors did not recommend the payment of any final dividend for the year ending December 31, 2024[177]. Compliance and Risk Management - The company has established compliance procedures to ensure adherence to applicable laws and regulations that significantly impact its operations[144]. - The company has identified key risks, including regulatory approval for drugs in development and the ability to attract and retain senior management and key research staff[149]. - The company has received confirmation from its controlling shareholder regarding compliance with non-competition commitments during the reporting period[157].
港股创新药板块走强,歌礼制药(01672.HK)涨超20%,荣昌生物(09995.HK)、石药集团(01093.HK)涨超6%,百济神州(06160.HK)、信达生物(01801.HK)跟涨。
news flash· 2025-04-22 01:54
港股创新药板块走强,歌礼制药(01672.HK)涨超20%,荣昌生物(09995.HK)、石药集团(01093.HK)涨超 6%,百济神州(06160.HK)、信达生物(01801.HK)跟涨。 ...
港股创新药板块盘初大涨,歌礼制药-B涨超20%
news flash· 2025-04-22 01:46
港股创新药板块盘初大涨,歌礼制药-B涨超20%,荣昌生物、石药集团涨超6%,百济神州、信达生物 涨超3%。 ...
港股医药股持续走弱,歌礼制药(01672.HK)跌超12%,药明生物(02269.HK)跌超5%,再鼎医药(09688.HK)、昭衍新药(06127.HK)等跟跌。
news flash· 2025-04-16 03:13
港股医药股持续走弱,歌礼制药(01672.HK)跌超12%,药明生物(02269.HK)跌超5%,再鼎医药 (09688.HK)、昭衍新药(06127.HK)等跟跌。 ...
港股异动 | 歌礼制药-B(01672)早盘涨超12% 去年公司管线做出重大战略调整 减肥药物效果优异
智通财经网· 2025-04-15 03:25
该行续指,24年公司开展多个肥胖相关I期临床,包括:1)ASC30每日口服治疗肥胖患者,治疗28天后 两个队列患者体重相对基线平均下降4.2%和6.2%(经安慰剂调整);2)ASC30每月一次或更低频率皮下注 射治疗肥胖患者,此前在动物模型内其半衰期长达40天;3)ASC47每月一次或更低频率皮下注射治疗肥 胖患者,I b期试验中展现长半衰期(健康受试者26天,肥胖患者40天),单次皮下注射90mg后,肥胖患 者第 50天峰值减重达 1.7%,且未出现肌肉流失。公司口服与皮下注射减肥产品初步展现出优异的减重 效果与长半衰期,在同类竞品中具备独特优势。 光大证券发布研报称,2024年,歌礼制药对于公司管线做出重大战略调整。公司决定终止病毒性疾病治 疗管线,包括慢乙肝、HIV、RSV在研产品,以及终止MASH治疗产品ASC41的临床推进。同时公司新 增肥胖及代谢性疾病临床管线,分别是GLP受体激动剂ASC30与THR-β激动剂ASC47,截至24年末,二 者在海外均已推进至临床I期。24年公司研发开支同比增长39.5%至3.02亿元,其中代谢性疾病研发开支 近1亿元,痤疮治疗产品因进入临床3期产生研发开支近8千万 ...
歌礼制药-B(01672):2024年年报点评:战略转型代谢性药物研发,减肥药数据表现优异
EBSCN· 2025-04-07 11:09
Investment Rating - The report maintains a "Buy" rating for the company [6] Core Insights - The company has undergone a strategic transformation focusing on the development of metabolic drugs, particularly in the obesity treatment sector, with promising clinical data [1][2] - In 2024, the company reported a significant decline in revenue to 1.283 million (down 97.7% year-over-year) and a net loss of 301 million, attributed to reduced income post-COVID and increased R&D expenditures in the metabolic disease area [1][2] - The company has terminated its viral disease treatment pipeline and shifted its focus to obesity and metabolic disease clinical pipelines, with two new clinical candidates, ASC30 and ASC47, advancing to Phase I trials [2] Financial Summary - The company’s R&D expenses increased by 39.5% year-over-year to 302 million, with nearly 100 million allocated to metabolic disease research [2] - The projected net losses for 2025 and 2026 have been revised down to -493.14 million and -417.02 million respectively, reflecting a significant downward adjustment of 57.5% and 29.5% from previous estimates [3] - The company has approximately 1.98 billion in cash and equivalents, expected to support operations until 2029 [2] Clinical Development Highlights - The company has reported strong efficacy results for its obesity drugs, with ASC30 showing an average weight reduction of 4.2% and 6.2% after 28 days of treatment in two cohorts [3] - ASC47 demonstrated a long half-life in Phase Ib trials, with a peak weight loss of 1.7% observed on day 50 after a single injection [3]
东吴证券晨会纪要-2025-04-02
Soochow Securities· 2025-04-01 23:30
Macro Strategy - The March PMI data indicates three characteristics of economic recovery: the pre-positioning of work due to the Spring Festival, better recovery of manufacturing demand compared to supply, and weak consumer service consumption [1][30]. - The manufacturing PMI for March is 50.5%, showing a slight increase of 0.3 percentage points from the previous month, while the service PMI is at 50.3%, also up by 0.3 percentage points [1][30]. - The new order index for manufacturing increased by 0.7 points to 51.8%, indicating stronger demand recovery compared to supply [1][30]. Industry Insights - The report highlights the need for macro policies to be adjusted in response to potential economic pressures in the second quarter, particularly in exports and real estate [1][30]. - The construction industry PMI rose to 53.4%, reflecting seasonal recovery, but remains at a historically low level for this time of year [1][30]. - The report emphasizes the importance of monitoring the impact of tariff increases on exports and the ongoing trends in the real estate market [1][30]. Company Analysis - The report provides insights into various companies, including their performance forecasts and investment ratings, such as the significant growth in sales for Lao Pu Gold and the strategic partnerships for Jianghuai Automobile [9][15]. - Companies like Yubiquitous and Geli Pharmaceutical are noted for their innovative product developments and market potential, with investment ratings maintained at "buy" [11][12]. - Shanghai Pharmaceuticals reported a revenue of 275.25 billion yuan, reflecting a 5.75% year-on-year increase, with a net profit of 4.553 billion yuan, up 20.82% [14]. Financial Performance - The report indicates that the overall financial performance of companies is under scrutiny, with adjustments made to profit forecasts for several firms based on market conditions and operational challenges [15][19]. - Companies such as China Communications Construction Company and Orient Securities are highlighted for their revenue growth and strategic adjustments in response to market dynamics [22][23]. - The report also notes the importance of cash flow management and cost control in maintaining profitability amid fluctuating market conditions [22][24].
歌礼制药-B:全新GLP-1减重不减肌,有潜力成为Best-in-Class-20250401
Soochow Securities· 2025-04-01 12:28
Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 11.37 CNY, indicating potential upside from the current stock price [9][11]. Core Insights - The company is advancing into the weight loss market with its self-developed GLP-1 drugs, particularly ASC30 and ASC47, which show promising clinical data and potential to outperform existing treatments [9][11]. - ASC30 is the first product in the weight loss segment, being the only GLP-1 receptor agonist available in both oral and injectable forms, with early clinical trials indicating superior efficacy compared to competitors [9][11]. - ASC47 targets the clinical need for weight loss without muscle loss, showing promising results in preclinical studies [9][11]. Summary by Sections Company Overview - The company, founded in 2013 and listed in 2018, focuses on innovative drug development for metabolic diseases, with a strong management team experienced in the pharmaceutical industry [9][14][15]. - The core pipeline includes small molecule GLP-1 receptor agonists ASC30 and ASC47, which are expected to address unmet medical needs in the weight loss market [9][14]. Product Pipeline - ASC30 is positioned as a dual-action weight loss drug, with both long-acting injectable and oral formulations, currently undergoing Phase I clinical trials in the U.S. [9][20][24]. - ASC47 is designed to reduce weight without muscle loss, addressing a significant gap in the current market for weight loss medications [9][20][24]. Clinical Data and Competitive Landscape - Early clinical data for ASC30 shows it has a significantly longer half-life and better efficacy compared to existing GLP-1 drugs, suggesting a strong competitive advantage [9][28][30]. - The global landscape for weight loss drugs is competitive, with major players focusing on both peptide and small molecule approaches, highlighting the importance of clinical trial outcomes and speed of development [9][39][42]. Financial Projections - The company anticipates no revenue from its commercialized products in the near term, with ASC30 and ASC47 expected to launch by 2029 [9][11]. - Financial forecasts indicate a significant increase in net losses over the next few years, reflecting the investment in R&D and the long timeline to market for new products [9][11].