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港股异动丨来凯医药一度飙升超30%,LAE102针对治疗肥胖症I期MAD研究取得积极初步结果
Ge Long Hui· 2025-09-29 03:07
来凯医药-B(2105.HK)盘初一度飙升31.72%,报19.6港元,股价创8月15日以来新高。消息面上,来凯医 药今日公布,LAE102针对治疗肥胖症在中国进行的I期多剂量递增研究(MAD研究)取得积极初步结果。 公告显示,该MAD研究初步结果展现出令人鼓舞的增肌减脂趋势。在第5周时,LAE1026mg/kg剂量组 的受试者平均瘦体重较基线增加了1.7%,同时平均脂肪质量也减少了2.2%。经安慰剂对照组调整后, 平均瘦体重增加达4.6%,而平均脂肪质量则减少了3.6%。 ...
来凯医药-B:I期临床MAD研究取得积极初步结果 LAE102展现出令人鼓舞的增肌减脂趋势
Zhi Tong Cai Jing· 2025-09-29 00:23
LAE102在5次皮下周注射后基本达到稳态,其药代动力学特征与SAD研究结果一致。强有力的PK/PD相 关性进一步证实了LAE102在超重及肥胖人群中的潜在疗效。详细研究结果将在后续的科学会议上公 佈。 此外,MAD研究的积极结果为LAE102继续开展针对肥胖症治疗的临床开发提供了支持。目前,集团正 积极与多家潜在合作伙伴进行磋商,计划寻求具备严肃承诺和资金实力,且意愿将此项目列为优先的合 作伙伴,以加速LAE102的临床开发与商业化进程。集团维持稳健的财务状况,使公司能够在评估潜在 合作架构时保持选择性,确保各方利益协同,从而最大化公司资产的全球潜力。 MAD研究是一项随机、双盲、安慰剂对照研究,旨在评估皮下给药的LAE102在超重╱肥胖受试者中的 安全性、耐受性、药代动力学和药效学特征。该MAD研究入组了平均身体质量指数(BMI)为29.4kg/m2 的超重╱肥胖受试者,包含3个剂量递增皮下注射组(分别为2mg/kg、4mg/kg和6mg/kg剂量组,每周皮下 给药一次,持续4周)。初步结果展现出令人鼓舞的增肌减脂趋势。在第5周时,LAE1026mg/kg剂量组的 受试者平均瘦体重较基线增加了1.7%,同 ...
来凯医药(02105) - 自愿公告I期临床MAD研究取得积极初步结果LAE102展现出令人鼓舞的增...
2025-09-29 00:11
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 ...
高位折价10%配股,歌礼制药跌超13%
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]
歌礼制药-B涨超3% 中期股东应占亏损同比收窄32.5% ASC30美国Ib期研究数据向好
Zhi Tong Cai Jing· 2025-08-18 06:53
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]