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 Viewpoint - 来凯医药-B (02105) has seen a significant stock price increase following the announcement of a successful placement of 36 million shares at HKD 16.30 per share, raising approximately HKD 577 million for research and development purposes related to its ActRII product portfolio [1] Group 1: Financial Performance - The stock price rose over 8% to HKD 13.9, with a trading volume of HKD 34.24 million [1] - The net proceeds from the share placement are intended for R&D expenditures for the ActRII product portfolio, ongoing preclinical candidate drug development, and general corporate purposes [1] Group 2: Product Development - The ActRII pathway is identified as a key muscle regulation pathway, attracting interest from multiple multinational pharmaceutical companies [1] - The company has three muscle enhancement products centered around the ActRII pathway, with LAE102 having completed the SAD study and currently undergoing MAD studies [1] - A clinical collaboration agreement with Eli Lilly for LAE102 is set for November 2024, where Eli Lilly will conduct Phase I clinical trials in the U.S. and cover related costs, while the company retains global rights to LAE102 [1] - The company plans to submit clinical trial applications for LAE103 and LAE123 in Q2 2025 and Q3 2025, respectively [1]

Core Viewpoint - 来凯医药-B (02105) has seen a significant stock price increase of over 8% following the announcement of a successful placement of 36 million shares at HKD 16.30 each, raising approximately HKD 577 million for R&D and general corporate purposes [1] Group 1: Financial Details - The company completed the issuance of 36 million placement shares at a price of HKD 16.30 per share, resulting in net proceeds of about HKD 577 million [1] - The funds will be allocated for the R&D expenses of the ActRII product portfolio, ongoing preclinical candidate drug development, and general corporate purposes [1] Group 2: Product Development - The ActRII pathway is a key area for muscle regulation, attracting interest from multiple multinational pharmaceutical companies [1] - The company is developing three muscle-enhancing products around the ActRII pathway, with LAE102 having completed SAD studies and currently undergoing MAD studies [1] - A clinical collaboration agreement with Eli Lilly for LAE102 is set for November 2024, where Eli Lilly will conduct Phase I clinical trials in the U.S. and cover related costs, while the company retains global rights [1] - The company plans to submit clinical trial applications for LAE103 and LAE123 in Q2 2025 and Q3 2025, respectively [1]

Summary of the Conference Call for LaiKai Pharmaceuticals Company Overview - LaiKai Pharmaceuticals is focused on developing innovative therapies, particularly in the fields of obesity and cancer treatment, with several core products in various stages of clinical development [2][4][5]. Financial Performance - Cash reserves decreased from 700 million RMB in the same period last year to approximately 633 million RMB in the first half of this year, with net cash around 630 million RMB [2][4]. - The net loss slightly reduced from 173 million RMB to 129 million RMB year-over-year [4]. Core Products and Clinical Development - **LQA102**: Currently in Phase I clinical trials, expected to complete MAD (Multiple Ascending Dose) studies by the end of September [2][5]. - **LQA103**: Recently received FDA IND approval, with plans to initiate human trials in the second half of the year [2][5]. - **LAE123**: In the IND enabling stage, with human trials planned for next year [2][5]. - **LAE002**: An AKT inhibitor in Phase III trials for breast cancer in China, with patient enrollment expected to complete in Q4 this year and data readout in the first half of next year [2][5]. Key Clinical Data and Insights - **Bimagrumab**: Data from Eli Lilly indicates a weight loss of over 10% with bimagrumab alone, and over 22% when combined with semaglutide, validating the efficacy of receptor antibodies for obesity treatment [2][8]. - **L2Q a (LQA102)**: Demonstrated significant advantages in weight loss and muscle preservation, with over 41% fat reduction in three weeks during preclinical studies [3][10]. - **AKT Pipeline**: The AKT pipeline is positioned for breast and prostate cancer, with expectations for NDA submission in Q2 next year [12][29]. Market Interest and Strategic Positioning - International market interest is high, as evidenced by Eli Lilly's acquisition of bimagrumab for $1.925 billion and Merck's acquisition of Acero Farm for $11.5 billion, indicating the potential of LaiKai's product portfolio [2][9]. - Multiple multinational corporations (MNCs) are exploring opportunities in the weight loss sector post-ADA conference [9]. Future Directions and Collaborations - LaiKai is actively pursuing partnerships and collaborations, particularly for the 102 and 103 projects, which are expected to enhance business development (BD) opportunities and transaction sizes [18][34]. - The company is also focusing on the development of combination therapies with GLP-1 drugs to address muscle loss associated with obesity treatments [21][27]. Safety and Efficacy Considerations - The MAD study for LQA102 is designed to assess safety and efficacy, with no new safety signals observed thus far [13][14]. - Long-term safety of bimagrumab has shown positive metabolic outcomes, including significant reductions in waist circumference and inflammatory markers [32][33]. Conclusion - LaiKai Pharmaceuticals is positioned at the forefront of innovative drug development in obesity and cancer treatment, with a strong pipeline and significant market interest. The company is focused on advancing its clinical trials and exploring strategic partnerships to maximize shareholder value [35].

Core Viewpoint - The company, LaiKai Pharmaceuticals, focuses on high-quality fat reduction and muscle gain in weight loss, addressing unmet needs in the oncology field, and possesses globally competitive pipelines [1][2]. Group 1: Investment Highlights - LaiKai Pharmaceuticals is a science-driven, clinical-stage biopharmaceutical company expected to enter a revenue-generating phase, with projected revenues of 0, 0, and 280 million yuan for 2025, 2026, and 2027 respectively, and net profits of -300 million, -313 million, and -190 million yuan for the same years [1]. - The company is assigned a target price of 29.19 HKD using DCF absolute valuation method and is rated as a buy [1]. Group 2: Research and Development Focus - The focus on fat reduction and muscle gain is a key research area in the future weight loss drug sector, with a need for differentiated innovation in "fat reduction + muscle gain" to address high muscle loss during weight loss and rebound weight gain [1]. - LaiKai Pharmaceuticals has established a comprehensive pipeline targeting the ActRII signaling pathway, including LAE102, LAE103, and LAE123 [1]. Group 3: Oncology Pipeline - The core pipeline LAE002 (afuresertib) is one of only two late-stage clinical AKT inhibitors globally targeting breast and prostate cancer, offering higher efficacy, better drug action, and improved safety [2]. - LAE002 addresses unmet medical needs in oncology, covering indications such as breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1 resistant solid tumors [2]. Group 4: Management Team - The management team of LaiKai Pharmaceuticals has extensive experience and a deep understanding of relevant target pathways, with the chairman, Dr. Lü Xiangyang, being a co-inventor of Bimagrumab and having over 20 years of experience in the ActRII pathway [2]. - Key members of the board, including Dr. Ge Xiangju and Director Xie Ling, have backgrounds in international pharmaceutical companies like Novartis, specializing in new drug discovery, clinical development, and registration [2].

Core Viewpoint - The company reported a significant increase in other income and a reduction in R&D expenses, while also showing a decrease in losses, indicating a positive trend in financial performance and ongoing development of promising drug candidates [1][2][3] Financial Performance - The company achieved other income of RMB 19.908 million for the six months ending June 30, 2025, representing 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 net loss for the period was RMB 130 million, which is a 9.79% reduction compared to the previous year [1] - As of June 30, 2025, the company had current assets of RMB 762 million, including cash and cash equivalents of RMB 677 million, indicating strong financial reserves for future R&D projects [1] Drug Development - LAE102, a monoclonal antibody targeting ActRIIA, has shown potential for muscle regeneration and weight control, with successful completion of the single ascending dose part of Phase I clinical trials for obesity treatment in China by the end of 2024 [1] - The company initiated a Phase III clinical trial (AFFIRM-205) in May 2024 for LAE002 (afuresertib), an oral AKT inhibitor, 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 anti-tumor 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 has submitted an IND application for LAE103 to the FDA as of June 30, 2025, with plans to initiate Phase I clinical trials in the second half of 2025 [3]

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]

Core Viewpoint - The company, Lai Kai Pharmaceutical-B, reported a significant increase in other income and a reduction in losses for the first half of 2025, driven by government subsidies and ongoing clinical trials for its drug candidates targeting metabolic diseases and cancer [1]. Financial Performance - Other income for the first half of 2025 reached RMB 19.9 million, representing a year-on-year increase of 41.1% due to increased government subsidies [1]. - As of June 30, 2025, the company's cash and bank balance amounted to RMB 743.8 million [1]. Clinical Development - The company is focused on developing new therapies for metabolic diseases, cancer, and liver fibrosis, with seven clinical trials initiated for drug candidates LAE102, LAE002 (afuresertib), LAE001, and LAE005 [1]. - In the cancer sector, the company has established a comprehensive portfolio of drug candidates, including LAE002 (afuresertib), which is a potent AKT inhibitor targeting breast and prostate cancers [3]. Research and Development Team - The company has a skilled management team with extensive experience across the entire drug discovery and development cycle, supported by a research team of 60 employees, including 11 PhD holders and 33 master's degree holders [1]. Drug Candidates and Mechanism - LAE102 is positioned as a candidate drug for weight control by promoting muscle regeneration and fat reduction through the inhibition of the Activin-ActRII pathway [2]. - The company is also developing additional candidates, including LAE103 and LAE123, which are selective antibodies targeting ActRII receptors for muscle and other disease indications [2]. Strategic Partnerships - The company plans to seek strategic partnerships to accelerate the development and commercialization of its drug candidates, addressing significant unmet medical needs [3].

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]

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 ...