来源：智通财经网 歌礼制药-B(01672)早盘涨超5%，截至发稿，涨3.9%，报14.38港元，成交额5323.98万港元。 消息面上，歌礼制药近日公告称，拟以先旧后新方式配售5240万股股份，每股16.45港元，较前一日收 盘价折让约9.9%，所得款项净额4.68亿港元，约90%建议用于其皮下注射多肽及口服多肽候选药物有关 的肥胖症临床试验研发。同时，歌礼制药的控股股东、创办人吴劲梓还将以每股16.45港元的价格先出 售5240万股股份，再认购2882万股新股，即控股股东配股套现3.88亿港元。 花旗发布研报称，关注歌礼制药具备同类最佳潜力的小分子GLP-1受体激动剂ASC30，将于今年第四季 发表二期数据，相信可成为公司关键催化剂。管理层透露截至目前ASC30二期A组盲法临床试验安全性 数据表现良好，无任何中止案例，预期最迟于2026年上半年就ASC30达成业务发展合作。此外，花旗认 为歌礼包括ASC47及ASC50等其他候选药物仍未获市场充分认可，若未来有新数据公布，预料可带来潜 在上行空间。 ...

花旗发布研报称，关注歌礼制药具备同类最佳潜力的小分子GLP-1受体激动剂ASC30，将于今年第四季 发表二期数据，相信可成为公司关键催化剂。管理层透露截至目前ASC30二期A组盲法临床试验安全性 数据表现良好，无任何中止案例，预期最迟于2026年上半年就ASC30达成业务发展合作。此外，花旗认 为歌礼包括ASC47及ASC50等其他候选药物仍未获市场充分认可，若未来有新数据公布，预料可带来潜 在上行空间。 歌礼制药-B(01672)早盘涨超5%，截至发稿，涨3.9%，报14.38港元，成交额5323.98万港元。 消息面上，歌礼制药近日公告称，拟以先旧后新方式配售5240万股股份，每股16.45港元，较前一日收 盘价折让约9.9%，所得款项净额4.68亿港元，约90%建议用于其皮下注射多肽及口服多肽候选药物有关 的肥胖症临床试验研发。同时，歌礼制药的控股股东、创办人吴劲梓还将以每股16.45港元的价格先出 售5240万股股份，再认购2882万股新股，即控股股东配股套现3.88亿港元。 ...

Core Viewpoint - The company has shown strong progress in its core pipelines and financial performance in the first half of 2025, with significant revenue growth and promising clinical data expected in the near future [1][2][3] Financial Performance - The company's main operating revenue for H1 2025 was 1.08 million, primarily from R&D services [1] - R&D expenses for H1 2025 were 146 million, a year-on-year increase of 10.9%, with effective pipeline adjustments and cost optimizations [1] - Cash and cash equivalents at the end of H1 2025 reached 1.58 billion, a year-on-year increase of 361.9%, mainly due to the maturity of time deposits [1] Pipeline Development - ASC30, the company's core small molecule GLP-1 pipeline, demonstrated a 6.5% weight loss in a 4-week Phase I trial in the U.S., outperforming Eli Lilly's small molecule GLP-1 [1] - The company is currently conducting a Phase IIa trial for ASC30, with top-line data expected in Q4 2025 [1] - ASC47, a new THR-β target pipeline, is in Phase I clinical trials in the U.S., with top-line data anticipated in Q4 2025 [2] - ASC50, an oral small molecule for IL-17, is also in Phase I clinical trials, with top-line data expected by the end of 2025 [2] - The oral small molecule FASN inhibitor, Denifasita, is projected to submit a market application in China by 2026 based on excellent Phase III data [2] Profit Forecast and Investment Rating - The company’s pipeline progress aligns with expectations, increasing the likelihood of successful product launches [3] - Revenue forecasts for 2025-2027 have been adjusted to 0.02 billion, 0.64 billion, and 2.03 billion respectively [3] - The target price has been raised to 29.26 HKD, maintaining a "buy" rating based on improved pipeline success rates [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The report highlights that the company has made significant progress in its overseas clinical trials, which enhances the probability of success for its long-term pipeline [1] - The revenue forecast for 2025 has been adjusted upwards to 0.02 billion, 0.64 billion, and 2.03 billion for the years 2025, 2026, and 2027 respectively, indicating a positive outlook [1] - The target price has been raised to 29.26 HKD, reflecting increased confidence in the company's pipeline success [1] Financial Performance Summary - Total revenue for 2023 is projected at 56.69 million, with a year-on-year growth of 4.81% [1] - The net profit attributable to the parent company is expected to be negative at (144.72) million for 2023, with a year-on-year increase of 54.04% [1] - The earnings per share (EPS) for 2025 is estimated at (0.43) HKD, with a price-to-earnings (P/E) ratio of (18.70) [1] Pipeline Development - ASC30, the company's core GLP-1 pipeline, is currently in Phase IIa clinical trials in the US, with expected top-line data release in Q4 2025 [1] - ASC47, a new THR-β target pipeline, is also in clinical trials, with data expected in Q4 2025 [1] - ASC50, an oral small molecule for psoriasis, is in Phase I clinical trials, with top-line data anticipated by the end of 2025 [1] - The company has a strong cash position of 1.58 billion at the end of H1 2025, which supports ongoing research and development [1]

Core Viewpoint - The company is advancing its clinical pipeline, particularly ASC30, which has shown promising results in weight loss and is expected to generate top-line data by Q4 2025 [1][2]. Group 1: ASC30 Clinical Trials - The ASC30 oral formulation has completed enrollment in a 13-week Phase IIa study with 125 patients, aiming to read out top-line data in Q4 2025 [1]. - ASC30 has U.S. and global compound patent protection until 2044, excluding any patent extensions [1]. - The Phase IIa study is randomized, double-blind, placebo-controlled, and multi-center, targeting overweight individuals with at least one weight-related comorbidity [1]. Group 2: Efficacy and Comparison - In a previous Phase I trial in the U.S., ASC30 demonstrated excellent pharmacokinetics and efficacy, achieving a maximum weight loss of 6.5% over four weeks, outperforming Eli Lilly's Orforglipron, which achieved 3.4% [2]. - The ASC30 subcutaneous injection formulation has also commenced its first patient dosing in the U.S. Phase IIa trial, showing a half-life of up to 36 days, which is advantageous compared to Amgen's AMG133 [2]. Group 3: Additional Pipeline Potential - The company has several other promising pipelines, including ASC47, which targets THR-β for fat reduction and muscle gain, and ASC50, an oral IL-17 small molecule for psoriasis treatment [3]. - ASC47's unique mechanism may enhance weight loss effects while mitigating muscle loss side effects when used in conjunction with GLP-1 drugs [3]. - ASC50 is one of the few oral IL-17 small molecules in clinical stages, potentially offering a competitive edge in the psoriasis market [3]. Group 4: Financial Outlook - The company maintains its revenue forecasts for 2025-2027 at 0, 0.4, and 1 billion RMB, respectively [3]. - The target price has been raised to 14.02 RMB based on the FCFF valuation model, with a "buy" rating maintained [3].

Group 1: Clinical Trial Progress - ASC30's Phase IIa trial in the US has completed patient enrollment, with data expected in Q4 2025[2] - The trial involves 125 participants, all of whom are either obese (BMI ≥ 30 kg/m²) or overweight with at least one weight-related comorbidity (27 kg/m² ≤ BMI < 30 kg/m²)[2] - The primary endpoint is the percentage change in average weight from baseline at week 13[2] Group 2: Product Efficacy and Market Position - ASC30 demonstrated a 6.5% average weight reduction relative to baseline over a 4-week treatment period in the Phase Ib trial[3] - ASC30 is the first and only small molecule GLP-1 receptor agonist that can be administered both as a monthly injection and a daily oral tablet for obesity treatment[3] - The company holds global compound patent protection until 2044, enhancing its competitive edge in the obesity treatment market[3] Group 3: Future Prospects and Recommendations - The company is positioned as an innovative biotech firm with a strong pipeline, including ASC30 and ASC47 for obesity treatment[4] - ASC40's Phase III trial data is expected in June 2025, showing significant efficacy compared to existing therapies[4] - The company has sufficient cash reserves to support multiple ongoing research projects, indicating a robust financial position[4]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Insights - The ASC30 pipeline has successfully completed patient enrollment for the Phase IIa trial, with top-line data expected in Q4 2025. This compound has patent protection in the U.S. and globally until 2044 [7] - ASC30 has shown superior efficacy in previous trials, achieving a maximum weight loss of 6.5% over four weeks, outperforming a competitor's product [7] - The company has multiple promising pipelines, including ASC47 and ASC50, which are expected to have strong business development potential [7] - Revenue forecasts for 2025-2027 are projected at 0, 0.4, and 1 billion RMB respectively, with an updated target price of 14.02 RMB [7] Financial Summary - Total revenue for 2023 is projected at 566.9 million RMB, with a significant decline expected in 2024 [1] - The company is expected to incur net losses, with a projected net profit of -300.94 million RMB in 2024 and -454.44 million RMB in 2025 [1] - The price-to-earnings ratio is forecasted to improve from -49.48 in 2023 to -15.76 in 2025 [1][8]

Core Viewpoint - The company's ASC30 and ASC47 drugs showcased at the ADA conference have promising future prospects, with ASC30 demonstrating good pharmacokinetic characteristics and safety, while ASC47 shows potential for fat reduction and muscle gain in preclinical studies [1][2]. Event Summary - On June 18, the company announced the completion of the first dosing of subjects in the U.S. Phase I clinical trial for ASC50, an oral small molecule IL-17 inhibitor for psoriasis [1]. - On June 23, ASC30 and ASC47 were presented at the ADA conference, highlighting their clinical research data [1]. ASC30 Insights - The SAD study for ASC30 included 30 subjects divided into five groups with doses of 2mg, 5mg, 10mg, 20mg, and 40mg, showing a half-life of 30-55 hours for the 5-40mg groups, indicating favorable pharmacokinetic properties [1][2]. - The study reported that all side effects were mild to moderate, with no vomiting in the 2mg and 5mg groups, confirming the drug's controllable safety profile [2]. ASC47 Insights - Preclinical studies of ASC47 indicated its potential for fat reduction, muscle gain, and weight loss, particularly when combined with semaglutide in mouse models, showing a greater weight loss trend compared to the semaglutide-only group [2]. ASC50 Potential - ASC50 is positioned as a promising oral treatment for psoriasis, currently undergoing Phase I clinical trials in the U.S. The preclinical data suggest higher oral exposure, longer half-life, and strong efficacy, supporting its potential as a best-in-class oral medication [2]. Future Development Outlook - The company plans to continue advancing its core pipeline, with ASC30's oral Phase IIa study and ASC40's Phase III study expected to be completed by 2025, alongside the publication of ASC30's subcutaneous Phase Ib results [3]. - The focus remains on ASC30 and ASC47, with multiple pipeline developments anticipated in the coming years [3]. Financial Forecast - The core drugs ASC30 and ASC47 are in early development stages, showing excellent safety and efficacy in early clinical results. The company estimates a reasonable market value of HKD 19.29 billion, raising the target price to HKD 19.93, maintaining a "buy" rating [3].

Core Insights - Ascletis Pharma Inc. has initiated a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting interleukin-17 (IL-17), aimed at treating psoriasis [2][3] - The trial is randomized, double-blind, and placebo-controlled, involving both healthy participants and patients with mild-to-moderate plaque psoriasis [3] - Preclinical data suggests that ASC50 has higher oral exposure, a longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [1] Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing innovative therapeutics for metabolic diseases [4] - The company utilizes its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) to develop drug candidates in-house [4] - Ascletis is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [4]

Core Viewpoint - The company announced the completion of the first dosing of healthy subjects in a Phase I clinical trial for its orally administered small molecule IL-17 targeted inhibitor ASC50, aimed at treating psoriasis [1] Group 1 - The trial is designed to evaluate the safety, tolerability, and preliminary efficacy of ASC50 [1] - Preclinical data suggests that ASC50 has the potential to become a best-in-class oral medication for psoriasis, administered once daily [1]