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来凯医药-B(02105)上半年核心管线临床进展显著 研发费用逾1亿元
智通财经网· 2025-08-13 09:33
Core Viewpoint - The company reported a significant increase in other income due to government subsidies, while R&D expenses decreased, leading to a reduced loss compared to the previous year [1][2]. Financial Performance - Other income reached RMB 19.908 million, a year-on-year increase of 40.7% [1] - R&D expenses amounted to RMB 105 million, a decrease of 16.61% year-on-year [1] - The loss for the period was RMB 130 million, a reduction of 9.79% compared to the previous year [1] - As of June 30, 2025, current assets totaled RMB 762 million, with cash and cash equivalents at RMB 677 million, indicating strong financial reserves for future R&D projects [1] Clinical Development - LAE102, a monoclonal antibody targeting ActRIIA, has shown potential for muscle preservation and weight control, with successful completion of the single ascending dose part of Phase I clinical trials for obesity treatment in China by December 2024 [1] - The company initiated a Phase III clinical trial (AFFIRM-205) in May 2024 for LAE002 (afuresertib) in combination with Fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer patients [2] - The Phase III trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of the combination therapy, with plans to complete subject enrollment by Q4 2025 and submit a New Drug Application (NDA) in H1 2026 [2] - The company is in discussions with potential partners to accelerate the regulatory approval and commercialization of LAE002 and LAE001 [2] Future Plans - The IND application for LAE103 was submitted to the FDA by the end of June 2025, with plans to initiate Phase I clinical trials in the second half of 2025 [3] - The company aims to evaluate the efficacy and safety of monoclonal antibodies targeting ActRIIA and ActRIIB through the Phase I clinical study of LAE103 [3] - Plans are also in place to advance LAE123 to Phase I clinical trials in 2026 [3]
国泰海通 · 晨报0805|固收、医药、通信
国泰海通证券研究· 2025-08-04 14:50
Group 1: Government Bond Tax Policy Impact - The Ministry of Finance and the State Taxation Administration announced that from August 8, 2025, interest income from newly issued government bonds, local government bonds, and financial bonds will be subject to value-added tax, reversing the previous tax exemption [2][3] - The market is particularly concerned about whether this change will lead to cross-period arbitrage opportunities or short squeeze phenomena in government bond futures, which hinges on whether there will be a switch in the cheapest-to-deliver (CTD) bonds [2][4] Group 2: CTD Bond Switching Dynamics - Generally, new bonds find it difficult to replace old bonds as CTD bonds unless they offer a yield premium of over 15 basis points, which is challenging to achieve in practice [3] - However, exceptions exist for T contracts and TS contracts, where new bonds can more easily become CTD bonds due to their shorter duration and lower required discount [3][4] Group 3: Cross-Period Arbitrage Opportunities - The potential for cross-period arbitrage in government bond futures depends on whether the CTD bonds for near and far month contracts switch, which could lead to price discrepancies [4] - The upcoming issuance of new 2-year and 7-year bonds on September 12 may trigger CTD bond switches, creating arbitrage opportunities between TS2512-TS2603 and T2512-T2603 [4] Group 4: Short Squeeze Potential - There is a possibility of a short squeeze in government bond futures if new bonds become CTD bonds, especially given the limited supply of new bonds initially [5] - The market's lack of experience with new bonds as CTD bonds could exacerbate the short squeeze pressure, particularly for contracts like T and TS2603, which are associated with new 7-year and 2-year bonds [5] Group 5: Domestic Weight Loss Drug Innovations - Domestic pharmaceutical companies are making significant progress in the development of innovative weight loss drugs, with several companies completing key clinical trials and receiving regulatory approvals [9][10] - The year 2025 is anticipated to be a pivotal year for the commercialization of competitive domestic weight loss drugs, with notable advancements in clinical data and market readiness [10][11] Group 6: Fund Holdings in Communication Sector - The fund holdings in the communication sector have shown a positive trend, with a 1.31 percentage point increase in the market value share, indicating a recovery in investor confidence [15] - The AI computing power supply chain remains a focal point for investment, with significant capital expenditures expected from major domestic internet companies [14][15]
来凯医药-B(02105):LAE103的新药临床试验已获得美国食品药品监督管理局批准
智通财经网· 2025-07-31 04:29
Core Viewpoint - Kai Medical-B (02105) has received FDA approval for LAE103's IND, aiming to provide precision treatment for patients with metabolic diseases [1] Group 1 - LAE103 is a selective antibody targeting ActRIIB [1] - The company is actively advancing this candidate drug into clinical research [1] - The goal is to offer innovative therapies for sarcopenic obesity and other muscle-related diseases [1]
来凯医药(02105) - 自愿公告LAE103的新药临床试验(IND)已获得美国食品药品监督管理局...
2025-07-31 04:01
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 風險提示 LAE103最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 自願公告 LAE103的新藥臨床試驗(IND) 已獲得美國食品藥品監督管理局(FDA)批准 本 公 告 由 來 凱 醫 藥 有 限 公 司(「 本 公 司 」, 連 同 其 附 屬 公 司 統 稱「 本 集 團 」)自 願 作 出,以告知本公司股東及潛在投資者本集團最新業務進展。 謹參照本公司於2025年6月30日就LAE103向美國食品藥品管理局(「美國FDA」)提 交新藥臨床試驗「( IND」)申請所發佈之公告。LAE103( 一種針對Act RIIB的單克隆 抗體 )為本公司自主研發、潛在用於治療肌少性肥胖症及其他肌肉相關疾病。 公司董事(「董事」)會(「董事會」)欣然宣佈,LA ...
来凯医药(02105) - 自愿公告LAE103向美国食品药品监督管理局(FDA)递交新药临床试验(...
2025-06-30 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 LAE103向美國食品藥品監督管理局(FDA) 遞交新藥臨床試驗(IND)申請 本 公 告 由 來 凱 醫 藥 有 限 公 司(「 本 公 司 」, 連 同 其 附 屬 公 司 統 稱「 本 集 團 」)自 願 作 出,以告知本公司股東及潛在投資者本集團最新業務進展。 關於LAE103 LAE103是一款Act RIIB選擇性抗體。本集團正積極推動該候選藥物進入臨床研究 階段,旨在為肌少性肥胖症及肌肉相關疾病提供創新療法。 – 1 – 風險提示 LAE103最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 公司董事(「董事」)會(「董事會」)欣然宣佈,本集團已就自主研發的LAE103( 一 ...
来凯医药-B(2105.HK):多项产品管线登上ADA 创新管线持续引领公司成长
Ge Long Hui· 2025-06-27 00:23
Core Viewpoints - The company showcased multiple early clinical products at the 2025 ADA conference, demonstrating excellent early data, particularly for LAE102, which showed good safety and pharmacokinetic properties [1][2] - The clinical and preclinical studies of LAE102, LAE103, and LAE123 indicate promising fat reduction and muscle gain effects, with LAE102 outperforming LAE103 [1][3] Events - On June 23, 2025, the company announced the clinical and preclinical research results of LAE102, LAE103, and LAE123 at the 2025 ADA conference [1] Safety and Efficacy - LAE102 demonstrated good safety with no serious adverse events (SAE) reported in both intravenous and subcutaneous administration groups, and no cases of diarrhea were noted [2] - Initial efficacy signals were observed for LAE102, with a significant increase in Actvin A levels correlating with drug dosage, indicating promising pharmacokinetic and pharmacodynamic effects [2] Clinical Pipeline - The company has a balanced pipeline focused on cancer and metabolic diseases, with several candidates in various stages of development, including LAE103 and LAE123, both in the IND application stage [3] - LAE001 and LAE005 are also in clinical trials, with LAE001 having completed Phase I trials and LAE005 showing potential in treating triple-negative breast cancer [3] Financial Projections - The company has a globalized and integrated approach to its cancer and metabolic drug development, with expectations for LAE102 to meet market demand upon commercialization [4] - Revenue projections for 2025, 2026, and 2027 are estimated at 0, 0, and 169 million respectively, with a target valuation of 16.85 billion HKD and a revised target price of 41.30 HKD [4]
来凯医药(02105) - 自愿公告LAE102、LAE103及LAE123临床和临床前研究结果在2...
2025-06-22 23:56
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。 (於開曼群島註冊成立之有限公司) (股份代號:2105) 來凱醫藥有限公司 Laekna, Inc. 本公司董事(「董事」)會(「董事會」)宣佈:(i)用於治療肥胖症的LAE102( 一種針對 Act RI IA 的 單 克 隆 抗 體 )的 I 期 單 劑 量 遞 增 (SAD ) 研 究 結 果 ; 以 及 (ii) LAE102 、 LAE103( 一種針對Act RIIB的單克隆抗體 )及LAE123( 一種針對Act RIIA / IIB雙靶點 的單克隆抗體 )作為增肌減脂療法的臨床前研究結果,已於美國糖尿病協會(ADA) 第85屆科學年會上公佈。 相關海報詳情如下: 海報編號1 – 1 – 摘要編號: 2205 -LB 標題: LAE102在健康志願者中的首次人體研究:評估其安全性、耐受 性、藥代動力學及藥效學 時間: 202 ...
来凯(2105.HK)将在2025美国糖尿病协会年会上展示多项ActRII领域自主研发成果
Ge Long Hui· 2025-05-27 00:49
Group 1 - The core announcement is that 来凯医药 will present multiple research results in the field of muscle gain and fat loss at the 85th Annual Scientific Sessions of the American Diabetes Association (ADA) [1] - The company will showcase preclinical data for three monoclonal antibodies targeting ActRII: LAE102, LAE103, and LAE123, along with initial human study data for LAE102 [1] - LAE102 has shown significant effects in preclinical models, increasing muscle and reducing fat, with strong target inhibition indicated by elevated activin A levels in completed Phase I trials in China [1] Group 2 - The company is advancing its research on the ActRII pathway, with LAE103 and LAE123 entering IND supportive research stages, aimed at exploring innovative therapies for muscle and critical illness [2] - The poster presentations will take place on June 22, 2025, at the McCormick Place Convention Center in Chicago, Illinois [2] - The first human study of LAE102 will assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers [2]
来凯医药LAE102肥胖症I期试验启动皮下注射研究,预计年内完成单次剂量递增研究
IPO早知道· 2024-10-17 13:15
10月16日及17日,来凯医药股价涨幅分别为8.44%和16.21%。 已全面布局ActRII通路。 本文为IPO早知道原创 作者|罗宾 微信公众号|ipozaozhidao 据IPO早知道消息,10月16日,来凯医药(2105.HK)宣布其自主研发的LAE102(ActRIIA单克隆 抗体)针对超重/肥胖在中国开展的I期临床试验单次剂量递增(SAD)研究的皮下注射(SC)部分 已启动。 该I期临床系一项随机、双盲、安慰剂对照、单次和多次给药剂量递增研究,旨在通过静脉输注 (IV)和皮下注射(SC)两种给药方式,评价LAE102注射液在健康成年受试者及超重/肥胖受试者 中的安全性、耐受性及药代动力学。 截至2024年9月30日,已有过半数的静脉输注队列完成了给药,并在低剂量组中就观察到靶点结合 的早期迹象和预期的PD生物标志物变化。此次启动的为皮下注射研究部分,2024年底前有望完成单 次剂量递增研究。 LAE102是来凯医药自主研发、全球首创的一种单克隆抗体,针对参与调控肌肉再生和脂代谢的重要 靶点ActRIIA。临床前研究显示,可增加肌肉并减少脂肪 。 LAE102 与 GLP-1 受体激动剂联用,可 进 ...