Core Viewpoint - Lai Kai Pharmaceutical-B (02105) experienced a significant stock increase of nearly 15% following the announcement of positive preliminary results from its Phase I multi-dose escalation study (MAD study) of LAE102 for obesity treatment in China [1] Group 1: Clinical Trial Results - The preliminary results of the LAE102 study show encouraging trends in muscle gain and fat loss, with the 6mg/kg dose group showing an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% by week 5 [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, while the average fat mass reduction was 3.6% [1] Group 2: Strategic Partnerships - The company is actively negotiating with multiple potential partners to accelerate the clinical development and commercialization of LAE102, seeking partners with serious commitments and financial strength [1] Group 3: Competitive Landscape - On September 25, Eli Lilly withdrew its Phase IIb clinical trial of bimagrumab in combination with tirzepatide for treating type 2 diabetes, citing "strategic business reasons," which analysts believe may weaken potential competition and highlight the value of Lai Kai's LAE102 pipeline in collaboration with Eli Lilly [1]

Core Viewpoint - LAE102, developed by the company, shows promising preliminary results in a Phase I multi-dose escalation study for obesity treatment in China, indicating potential for effective weight management [1] Group 1: Study Overview - The MAD study is a randomized, double-blind, placebo-controlled trial aimed at assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered LAE102 in overweight/obese subjects [1] - The study included participants with an average Body Mass Index (BMI) of 29.4 kg/m² and involved three dose escalation groups (2 mg/kg, 4 mg/kg, and 6 mg/kg), with weekly subcutaneous administration over four weeks [1] Group 2: Preliminary Results - Initial results indicate a positive trend in muscle gain and fat loss, with the 6 mg/kg dose group showing an average lean body mass increase of 1.7% compared to baseline [1] - Adjusted for the placebo group, the average lean body mass increase reached 4.6%, while the 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]

Core Viewpoint - Lai Kai Pharmaceutical-B (02105.HK) announced positive preliminary results from the Phase I Multiple Ascending Dose (MAD) study of LAE102 for the treatment of obesity in China [1] Group 1: Study Overview - The MAD study is a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered LAE102 in overweight/obese subjects [1] - The study enrolled participants with an average Body Mass Index (BMI) of 29.4 kg/m², including three ascending dose groups (2 mg/kg, 4 mg/kg, and 6 mg/kg), with weekly subcutaneous administration for four weeks [1] Group 2: Preliminary Results - Initial results show a promising trend in muscle gain and fat loss, with the 6 mg/kg dose group experiencing 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 the average fat mass reduction was 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 dosing groups (2 mg/kg, 4 mg/kg, and 6 mg/kg) administered weekly for four weeks [1] - In the 6 mg/kg dosing group, subjects showed an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% by week 5 [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 cases of diarrhea, muscle cramps, or acne reported [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 - 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 who have serious commitments and financial strength to prioritize this project, aiming to accelerate clinical development and commercialization [2] - The company maintains a robust financial position, allowing for selective evaluation of potential partnership structures to maximize global asset potential [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 - The top three companies with the highest short positions as of September 19 are ZTE Corporation (00763) at 15.35%, COSCO Shipping Holdings (01919) at 14.10%, and CATL (03750) at 13.44% [1][2] - The companies with the largest absolute increase in short positions are China Education Holdings (00839) with an increase of 2.61%, Dongfang Electric (01072) with an increase of 2.06%, and Xiexin Technology (03800) also with an increase of 2.06% [1][2] - The companies with the largest absolute decrease in short positions are Hua Hong Semiconductor (01347) with a decrease of -2.52%, Chifeng Jilong Gold Mining (06693) with a decrease of -1.77%, and Laikai Pharmaceutical-B (02105) with a decrease of -1.72% [1][2] Group 2 - The latest short position data shows that ZTE Corporation maintained 116 million shares, COSCO Shipping Holdings had 406 million shares, and CATL had 20.95 million shares [2] - The companies with the largest increase in short positions include China Education Holdings, which rose from 3.73% to 6.33%, and Dongfang Electric, which rose from 7.34% to 9.40% [2] - The companies with the largest decrease in short positions include Hua Hong Semiconductor, which fell from 9.00% to 6.48%, and Chifeng Jilong Gold Mining, which fell from 3.30% to 1.53% [2][3]

Core Insights - Eli Lilly has withdrawn its Phase IIb clinical trial for bimagrumab combined with tirzepatide for treating type 2 diabetes due to "strategic business reasons" [1] - The company is shifting focus to more promising obesity indications, with a Phase II trial for non-diabetic obese adults still ongoing [1][2] - The decision reflects a prioritization of resources towards areas with higher potential for approval and market success [2][3] Clinical Trial Details - The original trial aimed to enroll 180 participants with obesity and diabetes, monitoring weight loss and body composition over 70 weeks, scheduled from October 21, 2024, to January 2027 [1] - The ongoing obesity trial is expected to yield results by 2026, a year earlier than the diabetes trial [3] - The complexity of diabetes evaluation and established efficacy of GLP-1 drugs may have influenced the decision to halt the diabetes trial [3] Market Reaction - Following the news of the trial cancellation, the stock price of Lai Kai Pharmaceutical surged over 15%, indicating reduced competition and highlighting the value of its collaboration with Eli Lilly on the LAE102 pipeline [4] LAE102 Development - LAE102, developed by Lai Kai, is an ActRIIA monoclonal antibody that aims to provide high-quality weight loss by preserving lean body mass while reducing fat [6][9] - Lai Kai plans to announce preliminary results from its multi-dose study in China and Phase I trials in the U.S. in the second half of 2025 [5][6] Industry Trends - The market for muscle-protecting weight loss drugs is projected to reach hundreds of billions by 2035, with various companies exploring combinations of GLP-1 drugs and muscle-regulating factors [9] - The shift in Eli Lilly's focus towards obesity treatments may signal a broader industry trend towards prioritizing high-quality weight loss solutions that minimize muscle loss [9]

Core Viewpoint - 来凯医药-B (02105) has seen a significant stock price increase following the announcement of a successful placement of 36 million shares at HKD 16.30 per share, raising approximately HKD 577 million for research and development purposes related to its ActRII product portfolio [1] Group 1: Financial Performance - The stock price rose over 8% to HKD 13.9, with a trading volume of HKD 34.24 million [1] - The net proceeds from the share placement are intended for R&D expenditures for the ActRII product portfolio, ongoing preclinical candidate drug development, and general corporate purposes [1] Group 2: Product Development - The ActRII pathway is identified as a key muscle regulation pathway, attracting interest from multiple multinational pharmaceutical companies [1] - The company has three muscle enhancement products centered around the ActRII pathway, with LAE102 having completed the SAD study and currently undergoing MAD studies [1] - A clinical collaboration agreement with Eli Lilly for LAE102 is set for November 2024, where Eli Lilly will conduct Phase I clinical trials in the U.S. and cover related costs, while the company retains global rights to LAE102 [1] - The company plans to submit clinical trial applications for LAE103 and LAE123 in Q2 2025 and Q3 2025, respectively [1]

Core Viewpoint - 来凯医药-B (02105) has seen a significant stock price increase of over 8% following the announcement of a successful placement of 36 million shares at HKD 16.30 each, raising approximately HKD 577 million for R&D and general corporate purposes [1] Group 1: Financial Details - The company completed the issuance of 36 million placement shares at a price of HKD 16.30 per share, resulting in net proceeds of about HKD 577 million [1] - The funds will be allocated for the R&D expenses of the ActRII product portfolio, ongoing preclinical candidate drug development, and general corporate purposes [1] Group 2: Product Development - The ActRII pathway is a key area for muscle regulation, attracting interest from multiple multinational pharmaceutical companies [1] - The company is developing three muscle-enhancing products around the ActRII pathway, with LAE102 having completed SAD studies and currently undergoing MAD studies [1] - A clinical collaboration agreement with Eli Lilly for LAE102 is set for November 2024, where Eli Lilly will conduct Phase I clinical trials in the U.S. and cover related costs, while the company retains global rights [1] - The company plans to submit clinical trial applications for LAE103 and LAE123 in Q2 2025 and Q3 2025, respectively [1]