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 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].

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].

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].

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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 內幕消息 與齊魯製藥就LAE 002 (AFURESERTIB)簽訂 中國地區的獨家許可協議 本公告由來凱醫藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）根據香港 聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及香港法例第571章證 券及期貨條例第XIVA部項下的內幕消息條文（ 定義見《上市規則》）的規定作出。 緒言 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年11月12日，本集團與齊魯 製藥有限公司（「齊魯製藥」）已訂立獨家許可協議（「許可協議」）。 許可協議的主要條款 據 本 公 司 所深 知 及 確 信 ， 齊 魯 製 藥及 其 股 東 均 獨 立 於 本公 司 及 其 關 連 人 士（ 定 義 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 446,466,350 | | 0 | | 446,466,350 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 446,466,350 | | 0 | | 446,466,350 | 公司名稱: 來凱醫藥有限公司 呈交日期: 2025年11月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | ...

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]

Core Insights - The biotechnology sector in the Hong Kong stock market has shown strong performance, with several stocks experiencing significant gains today, particularly药捷安康-B which surged over 30% [1] Stock Performance Summary - 药捷安康-B: Increased by 31.25%, latest price at 218.000, total market value of 86.524 billion, year-to-date increase of 1557.79% [2] - 康宁杰瑞制药-B: Increased by 7.15%, latest price at 14.680, total market value of 14.245 billion, year-to-date increase of 319.43% [2] - 帝王国际投资: Increased by 5.50%, latest price at 0.115, total market value of 0.0213 billion, year-to-date increase of 155.56% [2] - 映恩生物-B: Increased by 5.00%, latest price at 336.000, total market value of 29.58 billion, year-to-date increase of 255.18% [2] - 基石药业-B: Increased by 4.66%, latest price at 7.190, total market value of 10.612 billion, year-to-date increase of 212.61% [2] - 三叶草生物-B: Increased by 4.39%, latest price at 2.140, total market value of 2.776 billion, year-to-date increase of 787.97% [2] - 百奥塞图-B: Increased by 3.86%, latest price at 24.220, total market value of 9.673 billion, year-to-date increase of 184.94% [2] - 来凯医药-B: Increased by 3.71%, latest price at 14.540, total market value of 6.49217 billion, year-to-date increase of 55.18% [2] - 君实生物: Increased by 3.29%, latest price at 27.600, total market value of 28.337 billion, year-to-date increase of 138.34% [2] - MIRXES-B: Increased by 3.26%, latest price at 72.900, total market value of 20.145 billion, year-to-date increase of 212.88% [2]

Core Insights - The weight loss sector is emerging as a significant variable impacting the global pharmaceutical landscape in the coming years, with major pharmaceutical companies prioritizing research and development in this area [1] - Pfizer's acquisition of Metsera for $7.3 billion highlights the active mergers and business development (BD) transactions in the weight loss drug pipeline [1] - Chinese innovative pharmaceutical companies have also seen substantial deals, with multiple agreements exceeding $100 million for weight loss drug pipelines from major multinational firms [1] Group 1: Clinical Data and Safety - LAE102, an ActRII monoclonal antibody from Chinese biotech company LaiKai Pharma, has shown promising results in a Phase I clinical trial, indicating a trend of muscle gain and fat loss [2][3] - In the trial, participants receiving a 6mg/kg dose of LAE102 experienced an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% by week 5, with adjusted averages showing a 4.6% increase in lean body mass and a 3.6% reduction in fat mass compared to the placebo group [3] - The safety profile of LAE102 is notable, with no severe adverse events reported during the trial, and most adverse events being mild [4][5] Group 2: Competitive Landscape - LAE102's safety results align with previous assessments, indicating no new safety signals, which is crucial given the safety concerns surrounding other ActRII-targeting drugs like Bimagrumab [5][10] - Bimagrumab has shown significant weight loss results but has been associated with adverse reactions such as diarrhea and muscle cramps, contrasting sharply with LAE102's safety profile [10] - The potential for LAE102 to become a "best in class" drug in the ActRII-targeting category is highlighted by its superior safety and efficacy compared to Bimagrumab [10][19] Group 3: Business Development Potential - LaiKai Pharma's recent clinical trial data significantly increases the likelihood of business development opportunities for LAE102, especially with interest from major companies like Eli Lilly [11][12] - Eli Lilly has already engaged in a clinical trial collaboration with LaiKai Pharma, indicating strong interest in LAE102 [12] - The expiration of Bimagrumab's patent in 2030 presents a strategic opportunity for LaiKai Pharma, as LAE102's patent extends to 2042, providing a longer commercial window [18][19] Group 4: Financial Position and Future Prospects - LaiKai Pharma recently completed a Hong Kong stock placement, raising approximately HKD 578 million, with a significant portion allocated to research and development [23] - The company now has over HKD 1.2 billion in cash, enhancing its ability to fund R&D and negotiate from a position of strength in potential partnerships [25] - LaiKai Pharma is actively seeking partnerships with firms that have strong commitments and financial capabilities to expedite the clinical development and commercialization of LAE102 [25][26]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 來凱醫藥有限公司 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 第 1 頁 共 10 頁 v ...