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烧钱研发、持续亏损,来凯医药借力加速商业化突围
Bei Jing Shang Bao· 2025-11-13 11:01
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]
港股医药股走强 百济神州涨超6%
Xin Lang Cai Jing· 2025-11-13 01:45
Core Viewpoint - The stocks of several biotechnology companies, including BeiGene, WuXi AppTec, and Legend Biotech, have experienced notable increases in their share prices, indicating positive market sentiment towards these companies [1] Group 1 - BeiGene (06160.HK) shares rose by 6.59% [1] - WuXi AppTec (02126.HK) shares increased by 3.97% [1] - Legend Biotech (02105.HK) shares went up by 3.33% [1]
港股公告掘金 | 荣利营造:拟携手宁德时代共同开发高效储能系统及解决方案
Zhi Tong Cai Jing· 2025-11-12 15:19
Major Events - Hong Kong Stock Exchange (00388) plans to make a strategic investment in Xunqing Settlement Holdings Limited [1] - Lai Kai Pharmaceutical-B (02105) signs an exclusive licensing agreement with Qilu Pharmaceutical for LAE 002 (AFURESERTIB) in China [1] - TECHSTARACQ-Z (07855) is expected to inherit the company Tuda Tong's listing on the main board of the Stock Exchange on December 10 [1] - Superstar Legend (06683) intends to establish a joint venture with Yushu Technology to develop consumer-grade IP robots and IP derivative products [1] - Beijing Enterprises Holdings (00392) plans to acquire 100% equity of Beijing Beiran Special Equipment Inspection and Testing Co., Ltd. for 54.6 million yuan [1] - CSPC Pharmaceutical Group (01093) has its application for the marketing of Pertuzumab Injection accepted by the National Medical Products Administration [1] - Rongli Construction (09639) plans to collaborate with CATL to develop efficient energy storage systems and solutions [1] Operating Performance - BeiGene (06160) reports a net profit attributable to shareholders of 1.139 billion yuan for the first three quarters, turning from loss to profit year-on-year [1] - Tencent Music-SW (01698) reports a net profit attributable to equity holders of 2.15 billion yuan in the third quarter, a year-on-year increase of 36.0% [1] - Zhou Li Fu (06168) sees a 32% year-on-year increase in e-commerce revenue for the first ten months, with net profit rising 71% year-on-year [1] - China Resources Land (01109) reports a cumulative contract sales amount of approximately 169.6 billion yuan for the first ten months, a year-on-year decrease of 16.6% [1]
来凯医药与齐鲁制药就LAE002签订中国地区独家许可协议
Zhong Zheng Wang· 2025-11-12 02:57
Core Insights - The collaboration between LaiKai Pharmaceuticals and Qilu Pharmaceutical marks a significant commercialization milestone for LaiKai, focusing on the breast cancer candidate drug LAE002 (afuresertib) in China [1][2] Group 1: Agreement Details - LaiKai Pharmaceuticals has signed an exclusive licensing agreement with Qilu Pharmaceutical for the commercialization of LAE002 in China [1] - The agreement includes a non-refundable upfront payment of up to RMB 530 million and milestone payments for clinical development, totaling up to RMB 2.045 billion [1] - LaiKai will also receive a tiered sales revenue share in China, ranging from over ten percent to over twenty percent [1] Group 2: Product Information - LAE002 (afuresertib) is a potent AKT inhibitor that targets all three AKT isoforms (AKT1, AKT2, and AKT3) and is one of the two AKT inhibitors in late-stage clinical development for breast and prostate cancer globally [2] - The Phase III clinical trial (AFFIRM-205) for LAE002 targeting HR+/HER2- breast cancer is currently recruiting participants as planned [2] - LaiKai aims to complete participant enrollment by Q4 2025 and plans to submit a New Drug Application (NDA) to the China National Medical Products Administration (NMPA) in 2026 [2]
港股异动 | 来凯医药-B(02105)高开逾4% 与齐鲁制药就LAE002订立独家许可协议
Zhi Tong Cai Jing· 2025-11-12 01:40
Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) opened over 4% higher following the announcement of an exclusive licensing agreement with Qilu Pharmaceutical for the commercialization of the breast cancer candidate drug LAE002 in China [1] Group 1: Licensing Agreement - Lai Kai Pharmaceutical has entered into an exclusive licensing agreement with Qilu Pharmaceutical to accelerate the commercialization of LAE002 (Afuresertib) for HR+/HER2- breast cancer in China [1] - The agreement includes a non-refundable upfront payment of up to RMB 530 million and milestone payments related to clinical development [1] - Additionally, Lai Kai is entitled to receive a tiered sales revenue share from future net sales in China, with the share percentage ranging from over ten percent to over twenty percent [1] Group 2: Clinical Trials - The Phase III clinical trial (AFFIRM-205) for LAE002 is currently progressing as planned, with patient recruitment ongoing [1]
来凯医药-B高开逾4% 与齐鲁制药就LAE002订立独家许可协议
Zhi Tong Cai Jing· 2025-11-12 01:32
Core Viewpoint - The announcement of a licensing agreement between Lai Kai Pharmaceutical and Qilu Pharmaceutical for the commercialization of the breast cancer candidate drug LAE002 (Afuresertib) in China has positively impacted Lai Kai's stock price, which rose by 4.24% to HKD 11.8 [1] Group 1: Licensing Agreement Details - Lai Kai Pharmaceutical has entered into an exclusive licensing agreement with Qilu Pharmaceutical for LAE002, aimed at accelerating its commercialization in China [1] - The agreement stipulates that Lai Kai is entitled to receive a non-refundable upfront payment of up to RMB 530 million and milestone payments related to clinical development until the first indication receives new drug application approval in China [1] - Additionally, Lai Kai is eligible for a total of up to RMB 2.045 billion in upfront and milestone payments, along with a tiered sales revenue share ranging from over ten percentage points to over twenty percentage points on future net sales in China [1] Group 2: Clinical Trial Progress - The Phase III clinical trial (AFFIRM-205) for LAE002 targeting HR+/HER2- breast cancer is currently progressing as planned [1]
来凯医药:与齐鲁制药订立独家许可协议,最高可获20.45亿元首付款及里程碑款项
Xin Lang Cai Jing· 2025-11-12 00:51
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]
来凯医药-B与齐鲁制药就LAE 002 (AFURESERTIB)签订中国地区的独家许可协议
Zhi Tong Cai Jing· 2025-11-12 00:34
Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical for the research, development, and commercialization of LAE002 (afuresertib) in specified regions of China, which is expected to enhance its financial strength and accelerate the drug's regulatory approval and commercialization process [1][2]. Group 1: Licensing Agreement Details - The licensing agreement grants Qilu Pharmaceutical exclusive rights to LAE002 (afuresertib) in China, including mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive a non-refundable upfront payment and milestone payments totaling up to RMB 5.3 billion until the first indication receives new drug application approval in China [1]. - The total potential upfront and milestone payments from the agreement could reach RMB 20.45 billion, along with a tiered sales revenue share ranging from over ten percent to over twenty percent [1]. Group 2: Clinical Development and Strategic Goals - LAE002 (afuresertib) is a potent AKT inhibitor that targets all three AKT isoforms and is one of only two AKT inhibitors in late-stage clinical development for breast and prostate cancer [2]. - The company has initiated the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer, with recruitment progressing as planned, aiming to complete subject enrollment by Q4 2025 [2]. - The company plans to submit a new drug application to the National Medical Products Administration in China in 2026 [2]. - The board believes that the licensing agreement aligns with the best interests of the company and its shareholders, providing an opportunity to maximize the commercial value of LAE002 (afuresertib) [2]. - The upfront and milestone payments will strengthen the company's financial position to support future developments [2]. - The company is actively engaging with multiple potential partners to establish strategic collaborations to expedite the clinical development and commercialization of its candidate drug assets [2].
来凯医药-B(02105)与齐鲁制药就LAE 002 (AFURESERTIB)签订中国地区的独家许可协议
智通财经网· 2025-11-12 00:29
Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. for the research, development, and commercialization of LAE 002 (afuresertib) in specified regions of China, which is expected to enhance its financial strength and accelerate the drug's regulatory approval and commercialization process [1][2]. Group 1 - The licensing agreement allows Qilu Pharmaceutical to exclusively develop and commercialize LAE 002 (afuresertib) in mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive a non-refundable upfront payment of up to RMB 530 million and milestone payments until the first indication receives new drug application approval in China [1]. - The total potential upfront and milestone payments could reach RMB 2.045 billion, along with a tiered sales revenue share ranging from over ten percent to over twenty percent [1][2]. Group 2 - LAE 002 (afuresertib) is a potent AKT inhibitor that targets all 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 [2]. - The company has initiated a Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer, with recruitment progressing as planned, aiming to complete subject enrollment by Q4 2025 and submit a new drug application to the Chinese National Medical Products Administration in 2026 [2]. - The board believes that the licensing agreement aligns with the best interests of the company and its shareholders, providing an opportunity to maximize the commercial value of LAE 002 (afuresertib) [2].
来凯医药-B(02105.HK)与齐鲁制药签独家许可,获高额首付款及里程碑款
Ge Long Hui· 2025-11-12 00:27
Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical for the research, development, and commercialization of LAE002 (afuresertib) in specified regions of China, which is expected to enhance its financial strength and accelerate the drug's market approval process [1][2]. Group 1 - The licensing agreement grants Qilu Pharmaceutical exclusive rights to LAE002 (afuresertib) in China, including mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive a total of up to RMB 5.3 billion in non-refundable upfront and milestone payments until the first indication receives new drug application approval in China [1]. - The total potential upfront and milestone payments from the agreement could reach RMB 20.45 billion, along with a tiered sales revenue share ranging from over ten percent to over twenty percent [1]. Group 2 - The board believes that the licensing agreement aligns with the best interests of the company and its shareholders, allowing for accelerated regulatory approval and commercialization of LAE002 (afuresertib) [2]. - The upfront and milestone payments are expected to strengthen the company's financial position, supporting future development initiatives [2]. - The company is actively engaging with multiple potential partners to establish strategic collaborations aimed at expediting the clinical development and commercialization of its drug candidates [2].