Core Viewpoint - The stock of Gilead Sciences (01672) has risen over 5%, marking five consecutive days of gains, with a cumulative increase of over 30% this week, currently trading at 12.56 HKD with a transaction volume of 18.19 million HKD [1] Group 1: Clinical Development - Gilead announced that its next-generation amylin receptor agonist ASC36 and next-generation GLP-1R/GIPR dual-target agonist ASC35 combination formulation have entered clinical development [1] - The company expects to submit a new drug clinical trial application for ASC36 and ASC35 for the treatment of obesity to the US FDA in the second quarter of 2026 [1] Group 2: Drug Characteristics - ASC36 and ASC35 are proprietary ultra-long-acting combination formulations with superior physicochemical stability, showing no aggregation or precipitation due to fibrosis at neutral pH [1] - Gilead aims to position ASC36 as a cornerstone for monthly therapies targeting cardiovascular metabolic diseases, including obesity [1] - ASC36 is anticipated to achieve better efficacy and tolerability compared to GLP-1 therapies, making it an ideal candidate for both monotherapy and combination formulations with other long-acting agents like ASC35 or THRβ agonist ASC47 [1]

Core Viewpoint - The company, Gilead Sciences-B (01672.HK), has announced the initiation of clinical development for its next-generation amylin receptor agonist ASC36 and the dual-target GLP-1R/GIPR agonist ASC35 combination formulation, both designed for monthly administration. The company plans to submit an Investigational New Drug (IND) application to the FDA for these treatments aimed at obesity in the second quarter of 2026 [1]. Group 1 - The ASC36 and ASC35 combination formulations are expected to provide more significant weight loss effects in obese populations compared to monotherapy [1]. - The founder and CEO of the company, Dr. Wu Jinzi, highlighted the encouraging preclinical data supporting the potential of these formulations [1]. - The company has demonstrated its capability in designing, optimizing, and developing multiple long-acting peptide injections for monthly subcutaneous administration [1].

据悉，ASC36是利用歌礼研发的胰淀素受体激动剂多肽，其经设计优化后能实现了更长的表观半衰期及 更高的每毫克多肽生物利用度，从而支持每月一次皮下给药。歌礼创始人、董事会主席兼首席执行官吴 劲梓博士表示，ASC36的临床前特性表明，其有望实现同类最佳疗效及每月一次的给药频率，这些特点 可能带来优越的减重效果和更简便、对患者更友好的剂量滴定(titration)方案。 智通财经APP获悉，歌礼制药-B(01672)尾盘涨超7%，截至发稿，涨7.05%，报11.08港元，成交额 5993.81万港元。 消息面上，歌礼制药近日宣布，已选定一款潜在"best-in-class"每月一次皮下注射胰淀素（amylin）受体 激动剂ASC36作为临床开发候选药物。歌礼预计将于2026年第二季度向美国FDA递交ASC36治疗肥胖症 的新药临床试验申请。 ...

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 7% following the announcement of a new clinical development candidate, ASC36, which is a potential "best-in-class" once-monthly subcutaneous amylin receptor agonist for obesity treatment [1] Company Summary - Gilead Sciences has selected ASC36 as a clinical development candidate, with plans to submit a new drug clinical trial application to the FDA in the second quarter of 2026 [1] - ASC36 is designed to have a longer apparent half-life and higher bioavailability per milligram of peptide, enabling once-monthly subcutaneous administration [1] - The CEO, Dr. Wu Jinzi, indicated that ASC36's preclinical characteristics suggest it may achieve best-in-class efficacy and a more convenient dosing regimen, potentially leading to superior weight loss effects and a patient-friendly titration scheme [1] Market Activity - As of the report, Gilead Sciences-B's stock increased by 7.05%, reaching HKD 11.08, with a trading volume of HKD 59.9381 million [1]

Core Viewpoint - The stock price of Lai Kai Pharmaceutical-B (2105.HK) surged by 31.72% to HKD 19.6, reaching a new high since August 15, following the announcement of positive preliminary results from the Phase I multi-dose escalation study (MAD study) of LAE102 for obesity treatment in China [1] Group 1: Study Results - The MAD study showed encouraging trends in muscle gain and fat loss [1] - In the 5th week, participants in the LAE102 6mg/kg dosage group had an average lean body mass increase of 1.7% compared to baseline, while average fat mass decreased by 2.2% [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, and average fat mass decreased by 3.6% [1]

Core Insights - The company, 来凯医药-B (02105), announced positive preliminary results from the Phase I Multiple Ascending Dose (MAD) study of LAE102 for obesity treatment in China [1][2] - The MAD study demonstrated safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered LAE102 in overweight/obese subjects [1] Group 1: Study Results - The MAD study included overweight/obese subjects with an average BMI of 29.4 kg/m² and involved three ascending dose groups (2 mg/kg, 4 mg/kg, and 6 mg/kg) administered weekly for four weeks [1] - At week 5, subjects in the LAE102 6 mg/kg group showed an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% compared to baseline [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, while fat mass decreased by 3.6% [1] Group 2: Safety and Tolerability - The MAD study confirmed good tolerability and safety, with no serious adverse events reported [1] - Most adverse events during treatment were mild (Grade 1) laboratory abnormalities, with no reports of diarrhea, muscle cramps, or acne [1] - Safety results were consistent with previous findings from the single ascending dose (SAD) study, with no new safety signals observed [1] Group 3: Future Development and Partnerships - LAE102 reached steady state after five subcutaneous weekly injections, with pharmacokinetic characteristics consistent with the SAD study [2] - The positive results from the MAD study support the continued clinical development of LAE102 for obesity treatment [2] - The company is actively negotiating with potential partners to accelerate the clinical development and commercialization of LAE102, maintaining a strong financial position to ensure selective evaluation of potential partnership structures [2]

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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 自願公告 I期臨床MAD研究取得積極初步結果 LAE102展現出令人鼓舞的增肌減脂趨勢 與先前LAE102的I期單次劑量遞增研究（ SAD ）結果一致，本次MAD研究顯示出良 好的耐受性和安全性，未發生嚴重不良事件。大多數治療期間出現的不良事件為 輕度（ 1 級 ）實驗室檢查異常。沒有報告任何腹瀉、肌肉痙攣或痤瘡病例。安全性 結果與已知的安全性評估相符，未觀察到新的安全信號。 – 1 – LAE102在5次皮下週注射後基本達到穩態，其藥代動力學特徵與SAD研究結果一 致 。 強 有 力 的 PK / PD 相 關 性 進 一 步 證 實 了 LAE102 在 超 重 及 肥 胖 人 群 中 的 潛 在 療 效。詳細研究結果將在後續的科學會 ...

Group 1 - Company Gilead Sciences announced a pre-market placement agreement to issue 52.4 million shares at HKD 16.45 per share, representing a discount of approximately 9.9% from the previous closing price [1] - The total gross and net proceeds from the placement are expected to be HKD 474 million and HKD 468 million, respectively, with about 90% of the funds allocated for clinical trials related to obesity treatments [1] - Following the announcement, Gilead's stock price fell over 13%, closing at HKD 15.79, with a market capitalization of HKD 15.32 billion [1] Group 2 - In the first half of the year, Gilead reported revenue of HKD 104 million, a year-on-year increase of 111.4%, and a net loss of HKD 87.95 million, narrowing by 32.5% [2] - As of mid-2025, Gilead's cash and cash equivalents reached HKD 1.58 billion, indicating sufficient reserves to support R&D activities until 2029 [2] - R&D expenses increased by approximately 10.9% to HKD 147 million, facilitating progress in metabolic and immune disease pipelines, particularly in obesity treatments with candidates ASC30 and ASC47 [2]

Core Viewpoint - The stock price of Gilead Sciences-B (01672) has increased over 3%, with a cumulative rise of over 100% in the past month, reflecting strong market performance and positive developments in its drug pipeline [1] Financial Performance - For the six months ending June 30, 2025, the company reported total revenue of RMB 104 million, representing a year-on-year increase of 111.4% [1] - Research and development costs amounted to RMB 147 million, showing a year-on-year increase of 10.9% [1] - The loss attributable to equity shareholders was RMB 87.95 million, a reduction of 32.5% compared to the previous year [1] - The loss per share was reported at 9.14 cents [1] Drug Development Progress - Significant advancements were made in the metabolic disease pipeline, immune disease pipeline, and expanded indication product pipeline [1] - The ASC30 oral tablet for obesity treatment demonstrated a weight reduction of up to 6.5% after 28 days in a U.S. Phase Ib study, indicating its potential as a best-in-class candidate for obesity treatment [1] - The company initiated a U.S. Phase IIa study and rapidly enrolled 125 participants within just over a month [1] - The ASC30 subcutaneous injection, administered once monthly or less frequently, showed a half-life of 36 days in obesity patients during a U.S. Phase Ib study, supporting its potential for less frequent dosing [1]