来凯医药-B(2105.HK)大涨超16%，最高触及17.05港元，创逾一个月新高。 LAE002是全球两种处于晚期临床开发阶段的针对乳腺癌及前列腺癌的AKT抑制剂之一。目前LAE002针 对HR+/HER2-乳腺癌III期临床试验(AFFIRM-205)招募正按计划进行。来凯将负责完成本次III期临床试 验(AFFIRM-205)，目标于2025Q4完成受试者入组，并计划于2026年向CDE提交NDA。(格隆汇) 消息面上，11月12日，来凯医药将乳腺癌候选新药LAE002 (afuresertib)中国地区权益授予齐鲁制药，交 易总金额达20.45亿元。此外，来凯医药还有权收取十余到二十余百分点的梯度销售分成。 ...

Core Insights - The collaboration between LaiKai Pharmaceuticals and Qilu Pharmaceutical involves an exclusive licensing agreement for the AKT inhibitor LAE002 (afuresertib) in China, with potential financial benefits for LaiKai reaching up to 2.045 billion yuan [1][10] - LAE002 is a potent AKT inhibitor that targets three AKT isoforms (AKT1, AKT2, and AKT3) and is one of only two AKT inhibitors in late-stage clinical development for breast and prostate cancer globally [4][10] - The ongoing Phase III clinical trial for LAE002 targeting HR+/HER2- breast cancer is progressing as planned, with an expected submission for new drug application (NDA) to the Chinese regulatory authority in 2026 [10] Financial Aspects - LaiKai Pharmaceuticals can receive an upfront payment of up to 530 million yuan and additional milestone payments, potentially totaling 2.045 billion yuan [1] - The agreement includes a tiered royalty structure based on future net sales in China, with rates ranging from over 10% to over 20% [1] Clinical Development - LAE002 is currently in Phase III clinical trials for HR+/HER2- breast cancer, with recruitment expected to be completed by Q4 2025 [10] - The drug is also in clinical trials for metastatic breast cancer and hormone-resistant prostate cancer in various regions, including China and the United States [8][10] Market Context - Breast cancer is the leading cause of cancer-related deaths among women globally, with approximately 2.29 million new cases and 666,000 deaths annually [7] - In China, breast cancer ranks as the second most common cancer among women, with 70% of patients being HR+/HER2- type [7]

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]

Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. for the development and commercialization of LAE002 (afuresertib) in the Chinese region, which includes mainland China, Hong Kong, Macau, and Taiwan [1] Group 1: Licensing Agreement Details - The licensing agreement grants Qilu Pharmaceutical exclusive rights to research, develop, and commercialize LAE002 in the specified regions [1] - The company will be responsible for completing the Phase III clinical trial for HR+/HER2- breast cancer [1] Group 2: Financial Terms - The company is entitled to receive a total of up to RMB 530 million in non-refundable upfront and clinical development milestone payments until the first indication receives new drug application approval in China [1] - The maximum total upfront and milestone payments the company can receive under the licensing agreement is RMB 2.045 billion [1] - The company will also receive a tiered sales royalty on future net sales of LAE002 in the licensed regions, with rates ranging from over ten percent to over twenty percent [1]

Core Viewpoint - The Hong Kong stock market's innovative pharmaceutical sector has rebounded strongly since 2025, with a cumulative increase of nearly 100%, and over 30 pharmaceutical companies have seen their stock prices double, indicating a significant capital market focus on this sector [1] Group 1: Company Performance - Lakai Pharmaceuticals has shown remarkable performance, with its stock price increasing over 300% in the past year, and multiple investment banks have set target prices above HKD 27 [2] - The company has made significant breakthroughs in the fields of metabolism and cancer treatment, showcasing its innovative research capabilities through the advancement of specific drug pipelines [5] Group 2: Metabolic Drug Development - Lakai Pharmaceuticals has established a comprehensive product portfolio centered around the ActRII pathway, gradually advancing these candidate drugs into clinical research to explore their therapeutic potential in muscle-related and other diseases [5] - The monoclonal antibody LAE102, targeting ActRIIA, has demonstrated clear therapeutic value, with data from Eli Lilly's Bimagrumab showing significant weight loss primarily from fat while preserving muscle mass [5][6] - LAE102's clinical trial results indicate good tolerability compared to Bimagrumab, with no serious adverse events reported, highlighting its potential as a best-in-class drug [6] Group 3: Strategic Collaborations - Eli Lilly's acquisition of Bimagrumab for USD 1.925 billion and subsequent clinical collaboration with Lakai Pharmaceuticals for LAE102 underscores the clinical value of LAE102 and accelerates its global development process [7] - The FDA has approved the clinical application of another ActRIIB monoclonal antibody, LAE103, which is set to initiate Phase I clinical trials in the second half of the year, further establishing Lakai's competitive advantage in the metabolic drug space [8] Group 4: Cancer Drug Development - In the oncology sector, LAE002 (afuresertib), an AKT inhibitor, is positioned to become the first domestic AKT inhibitor, with ongoing Phase III clinical trials for specific breast cancer patients [9] - The market potential for AKT inhibitors is significant, as evidenced by AstraZeneca's Capivasertib, which is projected to achieve global sales of USD 430 million in 2024 and potentially reach USD 1 billion in the future [9] Group 5: Long-term Growth Strategy - Lakai Pharmaceuticals' growth is driven by both international expansion and a robust self-research system, creating a solid foundation for sustainable development [10] - The collaboration with Eli Lilly not only validates the company's research capabilities but also opens up opportunities for further partnerships with multinational pharmaceutical companies [11] - The company is actively discussing strategic collaborations to accelerate the development and commercialization of the ActRII product portfolio, with expectations of significant market penetration [11] Group 6: Financial Position - Lakai Pharmaceuticals has a cash and bank balance of RMB 742 million, providing a stable financial foundation for ongoing innovative research and development [13] - The anticipated market recognition of the intrinsic value of Lakai Pharmaceuticals is expected to transition from growth expectations to value realization as innovative products reach the market [13]

Investment Rating - The report assigns an "Accumulate" rating to the company, with a target price of HKD 29.19 [5][15]. Core Insights - The report highlights that the company focuses on high-quality fat reduction and muscle gain in weight loss, as well as unmet needs in oncology, indicating a globally competitive pipeline in these areas [2][10]. - The company is positioned as a science-driven, clinical-stage biopharmaceutical firm, aiming to provide innovative therapies for metabolic diseases, cancer, and liver fibrosis [20][19]. Financial Summary - The projected financials for the company indicate no revenue until 2025, with expected revenues of RMB 280 million in 2027. The net profit is forecasted to be negative in the coming years, with estimates of -RMB 369 million in 2023, improving to -RMB 190 million by 2027 [4][15]. - The company’s financial ratios show a significant increase in the price-to-book (PB) ratio from 9.66 in 2024 to 429.89 in 2027, reflecting the anticipated growth in valuation as the company progresses [4][11]. Pipeline and Market Focus - The company’s pipeline includes several clinical trials targeting obesity and cancer, with a focus on LAE102, LAE002 (afuresertib), and LAE001, which are positioned to address unmet medical needs in these therapeutic areas [23][24]. - The report emphasizes the growing global market for weight loss drugs, projected to exceed USD 115 billion by 2030, driven by increasing obesity rates and demand for effective treatments [34][32]. Management and Team Experience - The management team possesses extensive experience in the pharmaceutical industry, with key members having backgrounds in leading global pharmaceutical companies, which enhances the company’s capability in drug development and clinical trials [30][25]. Competitive Landscape - The report notes that the company is innovating in the "fat reduction + muscle gain" space, which is becoming a critical focus in the weight loss drug market, with several multinational corporations also investing in this area [45][48].