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歌礼制药-B(01672.HK):ASC30完成IIA期患者入组 预计25年Q4读出顶线数据
Ge Long Hui· 2025-08-07 16:55
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].
“预告式”商务拓展兴起,港股创新药将走向何方
Group 1: Market Activity and Trends - The Hong Kong innovative drug sector is experiencing significant activity, with the innovative drug ETF (159567) rising by 0.53% and trading volume exceeding 2.7 billion yuan on June 27 [1] - From June 16 to June 25, medical-themed ETFs saw a net inflow of over 6.4 billion yuan, with several leading innovative drug ETFs receiving more than 1.5 billion yuan [1] - As of June 25, the Hong Kong innovative drug index has increased by 65.50% year-to-date, while the innovative drug index rose by 24.83% [1] Group 2: Business Development (BD) Expectations - The practice of pre-announcing potential BD transactions has become more common in the Chinese pharmaceutical industry, particularly since 2025 [2] - Notable companies like CSPC Pharmaceutical and Rongchang Biopharmaceutical have engaged in pre-announcing BD activities, leading to significant stock price increases [3][4] - Rongchang Biopharmaceutical's announcement of a licensing deal with Vor Bio could yield up to 4.105 billion USD in milestone payments, although the initial payment is only 45 million USD [4][5] Group 3: Market Sentiment and Investment Dynamics - The recent surge in BD announcements has created a speculative environment, with investors increasingly reacting to potential deals, which may lead to volatility in stock prices [7] - The innovative drug sector has seen a significant influx of southbound capital, with net inflows exceeding 40 billion HKD since 2025 [9] - Despite recent market corrections, the long-term investment logic in the innovative drug sector remains strong, with a year-to-date increase of 54.09% in the Hang Seng Biotechnology Index [10][11] Group 4: Structural Challenges and Future Outlook - The domestic innovative drug market faces structural challenges, with a ceiling effect limiting growth potential, leading to increased reliance on BD transactions for valuation and stock price movements [5][6] - Analysts emphasize that while BD transactions can provide short-term financial relief, systemic support is necessary for sustainable industry growth [11]