2月6日，《自然-通讯》杂志发表了一项徐兵河院士领衔、来凯医药AKT抑制剂Afuresertib（LAE002）联合氟维司群治疗经治HR+/HER2-晚期乳腺癌1b期临 床研究结果，该联合疗法在携带PIK3CA/AKT1/PTEN通路改变乳腺癌患者中展现出潜力的疗效、安全性结果。 该刊文的发表，不仅展现了该临床研究在设计严谨性、过程透明度、结果质量等达到了国际水平；徐院士在论文结尾强调了研究验证了Afuresertib （LAE002）组合的疗效前景和良好安全性表现，同时也一定程度揭示了齐鲁制药为何在即将到来的三期揭盲前就率先以不菲的交易金额先拿下来凯医药的 大中华区权益。 目前，来凯医药Afuresertib关键III期（AFFIRM-205）临床进行中，并有望在2026上半年读出数据并递交国内一类新药申请（NDA）。最新刊登的1b结果展 示了不少增量信心，给未来三期大概率阳性结果的读出注入了一剂强心剂。 01 开放性探索研究：AKT抑制剂的精准疗效 来凯医药Afuresertib的1b期及III期（AFFIRM-205）研究均针对HR+/HER2-乳腺癌患者，是乳腺癌领域最大的细分市场；HR+/HER2- ...

《自然-通讯》发布全文DOI：https://doi.org/10.1038/s41467-026-69225-2 在伴有PIK3CA/AKT1/PTEN通路改变的患者中，研究者评估的确认客观缓解率（confirmed ORR）为 33.3% 在ESR1突变并伴随PIK3CA/AKT1/PTEN通路改变人群中，确认客观缓解率（confirmed ORR）达42.9% 徐兵河院士团队在文章结论中表示，此次Ib研究证实，对于经治的HR+/HER2-晚期乳腺癌患者， LAE002（afuresertib）联合氟维司群治疗方案展现出有前景的疗效和良好的安全性。其疗效在 PIK3CA/AKT1/PTEN通路改变患者中尤为突出。LAE002（afuresertib）良好的安全性特征，以及便捷的 每日一次口服的给药方式，使其成为该患者群体一个颇具吸引力的治疗选择。这些数据有力地支持了 LAE002（afuresertib）在晚期乳腺癌治疗领域的进一步开发和应用。 目前，由徐兵河院士牵头的LAE002（afuresertib）联合氟维司群，针对治疗HR+/HER2-局部晚期或转移 性乳腺癌（LA/mBC）伴随PIK3CA/A ...

Core Viewpoint - The announcement by Lai Kai Pharmaceutical-B (02105) regarding the licensing agreement for its breast cancer candidate drug LAE002 (afuresertib) to Qilu Pharmaceutical is a significant development in the domestic biopharmaceutical sector, with a total agreement value of up to 2.045 billion yuan [1] Group 1: Company Developments - Lai Kai Pharmaceutical's stock rose over 6%, currently trading at 17.27 HKD with a transaction volume of 32.1493 million HKD [1] - The licensing agreement includes an upfront payment and a revenue-sharing model where Lai Kai will receive 10%-20% of sales, ensuring funding for further research and development [1] Group 2: Product and Market Potential - LAE002 is a potent AKT inhibitor, with its global development progress second only to AstraZeneca's Capivasertib in the HR+/HER2- breast cancer indication [1] - The peak sales potential for LAE002 in the Chinese market is estimated to reach 2 billion yuan, while global sales could reference Capivasertib, which is projected to achieve 700-800 million USD in sales this year, with peak sales potentially exceeding 1-2 billion USD [1]

Core Viewpoint - LaiKai Pharmaceutical-B (02105) has seen a significant stock increase of over 6%, currently trading at 17.27 HKD, with a transaction volume of 32.15 million HKD, following the announcement of a major licensing deal for its breast cancer candidate drug LAE002 (afuresertib) in China [1] Group 1: Licensing Agreement - On November 12, LaiKai Pharmaceutical announced the licensing of its breast cancer candidate drug LAE002 to Qilu Pharmaceutical for a total agreement value of up to 2.045 billion RMB [1] - In addition to the upfront payment, LaiKai Pharmaceutical will receive a tiered revenue share of 10%-20% from sales, providing substantial funding for future research and development [1] - This transaction is noted as one of the larger licensing agreements in the domestic biopharmaceutical sector this year [1] Group 2: Drug Profile and Market Potential - LAE002 is a potent AKT inhibitor, with its global development progress second only to AstraZeneca's Capivasertib in the HR+/HER2- breast cancer indication [1] - Industry expectations suggest that LAE002 could achieve peak sales of 2 billion RMB in the Chinese market, while global performance may be benchmarked against Capivasertib, which is projected to generate sales of 700-800 million USD this year, with peak sales potentially exceeding 1-2 billion USD [1]

Core Viewpoint - Lai Kai Pharmaceutical-B (2105.HK) has seen a significant stock price increase of over 7%, surpassing HKD 16, with a total market capitalization of HKD 7.1 billion, following a nearly 50% rise over the past eight trading days [1] Group 1: Company Developments - On November 12, Lai Kai Pharmaceutical granted rights for its breast cancer candidate drug LAE002 (afuresertib) to Qilu Pharmaceutical in China, with a total transaction amount of HKD 2.045 billion [1] - Lai Kai Pharmaceutical is entitled to receive a tiered sales commission ranging from 10% to over 20% from the sales of LAE002 [1] - LAE002 is one of the two AKT inhibitors in late-stage clinical development for breast and prostate cancer globally, ranking among the top two in progress and being the first domestically developed [1]

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) has seen a significant increase, rising over 9% and currently trading at 14.32 HKD, with a transaction volume of 92.6587 million HKD, following the announcement of a strategic partnership for its breast cancer candidate drug LAE002 [1] Group 1: Company Developments - On November 12, Lai Kai Pharmaceutical granted the rights for LAE002 in China to Qilu Pharmaceutical, with a total transaction value of 2.045 billion RMB [1] - The company is entitled to receive a tiered sales commission ranging from over 10% to over 20% [1] Group 2: Product Information - LAE002 is one of the two AKT inhibitors in late-stage clinical development targeting breast and prostate cancer [1] - It is a potent AKT inhibitor that can suppress all three AKT isoforms (AKT1, AKT2, and AKT3), with its indication for HR+/HER2- breast cancer being second globally only to AstraZeneca's Capivasertib [1] Group 3: Market Potential - Domestic sales peak for LAE002 is estimated to be around 2 billion RMB, while global sales peak can be referenced from Capivasertib [1] - Capivasertib is projected to have sales of 700-800 million USD this year, with a sales peak estimated between 1-2 billion USD [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 - 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 - 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]