人民财讯12月22日电，来凯医药12月22日早间在港交所公告，集团已在中国启动LAE102针对治疗肥胖 症的I期多剂量扩展研究(多剂量扩展研究)受试者入组工作，并已完成首位受试者给药。 ...

该I期多剂量扩展研究为一项随机、双盲、安慰剂对照研究，旨在评估LAE102(皮下注射)在60名超重╱ 肥胖受试者中的安全性、耐受性、药代动力学及药效学特性。受试者将随机分配至LAE102组或安慰剂 组，接受为期6个月的治疗。基于此前MAD研究中观察到积极的一个月治疗结果，本次预先规划的多剂 量扩展研究旨在进一步评估更长时间的持续治疗后的疗效与安全性特征。集团致力于为需要新型治疗选 择的肥胖或代谢病患者提供这种精准治疗。 智通财经APP讯，来凯医药-B(02105)发布公告，集团已在中国启动LAE102针对治疗肥胖症的I期多剂量 扩展研究受试者入组工作，并已完成首位受试者给药。 ...

该I期多剂量扩展研究为一项随机、双盲、安慰剂对照研究，旨在评估LAE102(皮下注射)在60名超重╱ 肥胖受试者中的安全性、耐受性、药代动力学及药效学特性。受试者将随机分配至LAE102组或安慰剂 组，接受为期6个月的治疗。基于此前MAD研究中观察到积极的一个月治疗结果，本次预先规划的多剂 量扩展研究旨在进一步评估更长时间的持续治疗后的疗效与安全性特征。集团致力于为需要新型治疗选 择的肥胖或代谢病患者提供这种精准治疗。 来凯医药-B(02105)发布公告，集团已在中国启动LAE102针对治疗肥胖症的I期多剂量扩展研究受试者入 组工作，并已完成首位受试者给药。 ...

该I期多剂量扩展研究为一项随机、双盲、安慰剂对照研究，旨在评估LAE102(皮下注射)在60名超重╱ 肥胖受试者中的安全性、耐受性、药代动力学及药效学特性。受试者将随机分配至LAE102组或安慰剂 组，接受为期6个月的治疗。基于此前MAD研究中观察到积极的一个月治疗结果，本次预先规划的多剂 量扩展研究旨在进一步评估更长时间的持续治疗后的疗效与安全性特征。集团致力于为需要新型治疗选 择的肥胖或代谢病患者提供这种精准治疗。 格隆汇12月22日丨来凯医药-B(02105.HK)发布公告，集团已在中国启动LAE102针对治疗肥胖症的I期多 剂量扩展研究("多剂量扩展研究")受试者入组工作，并已完成首位受试者给药。 ...

智通财经获悉，来凯医药-B(02105)早盘涨超5%，截至发稿，涨5.63%，报16.9港元，成交额2869.72万 港元。 消息面上，来凯医药此前与齐鲁制药签订独家协议，许可齐鲁制药在中国地区进行LAE002 的研究、开 发及商业化。公司负责完成HR+/HER2-乳腺癌III 期临床试验，直至首个适应症在中国获得新药申请批 准，有权获得最高5.3 亿人民币不可退还的首付款与临床开发里程碑付款，并最高可获得20.45 亿元的首 付款和里程碑付款，同时可收取许可区域内未来净销售额的十余个至二十余个百分点梯度销售分成。 甬兴证券发布研报称，LAE002预计26年上半年提交NDA。公司管线推进顺利，LAE002授权予齐鲁， LAE102的MAD数据优秀，LAE103的IND申请已获FDA批准；该行对LAE102采用DCF估值法，首次覆 盖，给予公司"买入"评级。 本文源自：智通财经网 ...

智通财经APP获悉，来凯医药-B(02105)早盘涨超5%，截至发稿，涨5.63%，报16.9港元，成交额2869.72 万港元。 甬兴证券发布研报称，LAE002预计26年上半年提交NDA。公司管线推进顺利，LAE002授权予齐鲁， LAE102的MAD数据优秀，LAE103的IND申请已获FDA批准；该行对LAE102采用DCF估值法，首次覆 盖，给予公司"买入"评级。 消息面上，来凯医药此前与齐鲁制药签订独家协议，许可齐鲁制药在中国地区进行LAE002 的研究、开 发及商业化。公司负责完成HR+/HER2-乳腺癌III 期临床试验，直至首个适应症在中国获得新药申请批 准，有权获得最高5.3 亿人民币不可退还的首付款与临床开发里程碑付款，并最高可获得20.45 亿元的首 付款和里程碑付款，同时可收取许可区域内未来净销售额的十余个至二十余个百分点梯度销售分成。 ...

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose over 5% following the announcement of an exclusive agreement with Qilu Pharmaceutical for the research, development, and commercialization of LAE002 in China [1] Group 1: Financial Details - Lai Kai Pharmaceutical is set to receive a non-refundable upfront payment of up to 530 million RMB and milestone payments related to clinical development [1] - The total potential upfront and milestone payments could reach up to 2.045 billion RMB, in addition to a tiered sales revenue share of over 10% to 20% from future net sales in the licensed region [1] Group 2: Clinical Development - The company is responsible for completing the Phase III clinical trial for HR+/HER2- breast cancer until the first indication receives new drug application approval in China [1] - According to Yongxing Securities, LAE002 is expected to submit its New Drug Application (NDA) in the first half of 2026 [1] Group 3: Pipeline Progress - The company’s pipeline is progressing smoothly, with promising data for LAE102 and FDA approval for the IND application of LAE103 [1] - Yongxing Securities has initiated coverage on LAE102 using the DCF valuation method and has given the company a "buy" rating [1]

Core Insights - The collaboration between LaiKai Pharmaceuticals and Qilu Pharmaceutical for the breast cancer candidate drug LAE002 is a significant deal valued at 2.045 billion RMB, with potential for additional sales royalties [1][4][5] - LAE002 is one of the leading AKT inhibitors in late-stage clinical development for breast and prostate cancer, indicating strong market potential and a promising partnership for commercialization [1][3][8] - The partnership exemplifies an optimal allocation of innovative and commercial resources, enhancing the prospects for both companies in the competitive oncology market [11] Financial Aspects - LaiKai Pharmaceuticals is set to receive a non-refundable upfront payment of up to 530 million RMB and milestone payments, with total potential earnings from the deal reaching 2.045 billion RMB [4][5] - The expected peak sales for LAE002 in China are projected to be around 2 billion RMB, with global peak sales potentially mirroring those of Capivasertib, which is estimated to reach 1-2 billion USD [9] Market Context - Breast cancer is a prevalent disease, with approximately 2.3 million new cases globally in 2022, making it a fertile ground for innovative therapies [6] - The HR+/HER2- subtype accounts for 60-70% of breast cancer cases, highlighting a significant unmet need for new treatment options, particularly for patients who develop resistance to existing therapies [6][8] Competitive Landscape - LAE002 is positioned as a strong competitor to other AKT inhibitors, demonstrating superior efficacy and safety profiles in clinical studies [8] - Qilu Pharmaceutical, recognized for its rapid market entry and strong performance in the pharmaceutical industry, is expected to leverage its capabilities to maximize the commercial potential of LAE002 [10][12] Strategic Implications - The partnership is indicative of a trend towards complementary resource matching between different types of pharmaceutical companies, which may lead to more effective drug development and commercialization strategies [11] - LaiKai's successful licensing of LAE002 not only validates its business development capabilities but also strengthens its financial position, allowing for further investment in its pipeline [12][13]

Core Insights - Laekai Pharmaceutical has entered a key commercialization phase by signing an exclusive licensing agreement with Qilu Pharmaceutical for LAE002, with a total agreement value of up to 2.045 billion yuan [1][2] - The company has accumulated losses exceeding 700 million yuan since its listing, with no products yet commercialized, highlighting the urgency of this partnership to enhance its market position [1][4] - LAE002, an AKT inhibitor, is facing competition from AstraZeneca's Capivasertib, which has already been approved for similar indications, emphasizing the need for Laekai to accelerate its commercialization efforts [3][4] Company Overview - Laekai Pharmaceutical's core focus is on oncology drugs, primarily those licensed from Novartis, with LAE002 and LAE001 being the most advanced in its pipeline [2] - LAE002 is positioned for multiple indications, with the HR+/HER2- breast cancer indication progressing to Phase III clinical trials set to start in 2024 [2][4] - The company is also developing LAE102, a monoclonal antibody for obesity treatment, which has shown promising results in early clinical trials [4][5] Financial Performance - Laekai Pharmaceutical reported net losses of 369 million yuan in 2023, 254 million yuan in 2024, and 130 million yuan in the first half of 2025, totaling over 700 million yuan in losses [4] - Research and development expenses for the same periods were 230 million yuan, 215 million yuan, and 105 million yuan, indicating a significant investment in R&D despite ongoing losses [4] Strategic Partnerships - The collaboration with Qilu Pharmaceutical aims to leverage their commercialization experience to expedite LAE002's market entry and alleviate financial pressures during clinical development [3][6] - Laekai has also partnered with Eli Lilly for the global development of LAE102, with plans to submit an IND amendment to the FDA in 2025 [5][6] Future Outlook - The success of Laekai Pharmaceutical in overcoming its current challenges will depend on the effectiveness of its external partnerships and the progress of its internal R&D pipeline [6]

Core Insights - The company, LaiKai Pharmaceutical, has entered a critical commercialization phase by signing an exclusive licensing agreement with Qilu Pharmaceutical for the development and commercialization of LAE002 in China, with a total agreement value of up to 2.045 billion yuan [1][3][4] Financial Performance - LaiKai Pharmaceutical has reported cumulative losses exceeding 700 million yuan since its listing, with net profits projected to be -369 million yuan for 2023, -254 million yuan for 2024, and -130 million yuan for the first half of 2025 [1][5] - Research and development expenses for the same periods are 230 million yuan, 215 million yuan, and 105 million yuan respectively [5] Product Development - LAE002, an AKT inhibitor, is one of the company's core products, currently in advanced clinical development for breast and prostate cancer, with a Phase III trial for HR+/HER2- breast cancer set to start in 2024 [3][4] - The company is also advancing LAE102, a monoclonal antibody for obesity treatment, which has shown promising results in early clinical trials [5][6] Competitive Landscape - LaiKai Pharmaceutical faces significant competition, particularly from AstraZeneca's Capivasertib, which has already received FDA approval for similar indications [4] - The partnership with Qilu Pharmaceutical is seen as a strategic move to leverage Qilu's commercialization experience and alleviate financial pressures during the clinical development and commercialization phases [4][6] Future Outlook - The success of the collaboration with Qilu and the advancement of LAE102 and other candidates will be critical for LaiKai Pharmaceutical to overcome its current challenges and enhance its market competitiveness [6]