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 ...

Group 1: Hong Kong Stocks - China Metallurgical Group (01618) rose nearly 7%, with institutions stating that the value of this resource-rich construction company needs urgent reassessment [1] - Rongchang Bio (09995) increased over 5%, as its innovative ophthalmic drug RC28 has been submitted for listing, following a partnership with Santen China [1] - Laikang Pharmaceutical-B (02105) surged nearly 6%, with a cumulative increase of 36% over the last three trading days, driven by positive preliminary results from the Phase I clinical MAD study of LAE102 [1] - UBTECH Robotics (09880) rose over 5%, with a report from CMB International recommending UBTECH as the top pick in the humanoid robot sector and raising its target price [1] - Innovent Biologics (09969) increased over 6%, as the company announced the first prescriptions for Tanshitumomab in several provinces [1] - BrainCo-B (06681) surged over 16%, benefiting from policy catalysts in the brain-computer interface industry, with its cognitive impairment digital therapy product having a first-mover advantage [1] - Yaoshi Bang (09885) rose over 10%, with high-margin business accelerating growth and POCT devices expected to see increased deployment in the second half of the year [1] - DCH Holdings (00179) fell over 7%, as Citigroup downgraded its investment rating from "Buy" to "Neutral," citing limited upside potential for the stock [1] - Minmetals Resources (01208) rose over 2%, planning to issue $500 million zero-coupon convertible bonds maturing in 2030 for overseas debt refinancing [1][2] Group 2: US Stocks - Alibaba (BABA.US) rose 4.65%, with Morgan Stanley reiterating an "Overweight" rating and raising the ADR target price from $165 to $200 [3] - Li Auto (LI.US) increased 3.57%, as the Li One officially commenced delivery at the Changzhou smart manufacturing base, with a report indicating that the i6 model's sales performance is expected to outperform the i8 [3] - JD.com (JD.US) rose 0.15%, announcing that the 2025 Double 11 shopping festival will start on October 9 at 8 PM, two days earlier than last year [3] - Xpeng Motors (XPEV.US) increased 1.76%, with the company announcing that the Xpeng MONA M03 has delivered a total of 180,000 units [3] - New Oriental (EDU.US) rose 4.38%, with a report indicating that the overall business development of the group is stabilizing [3] - Merus (MRUS.US) surged 35.97%, following an agreement with Danish biotech company Genmab for a cash acquisition at $97 per share [3] - Novo Nordisk (NVO.US) fell 0.20%, as Morgan Stanley downgraded its rating to "Sell" and reduced the target price from $99 to $47 [4] - MoonLake (MLTX.US) plummeted 89.93%, with trial results for its therapeutic drug falling far below expectations, leading to a significant target price cut by RBC [4] - TSMC (TSM.US) fell 0.05%, reaffirming that it has not engaged in discussions regarding potential investments or collaborations with any companies [4] - Micron Technology (MU.US) rose 4.22%, with Morgan Stanley predicting that the storage industry price increase cycle may continue into next year [4]

Core Viewpoint - The stock of Hong Kong-listed company Lai Kai Pharmaceutical-B (02105.HK) has experienced a significant increase, rising over 6% on September 30, with a cumulative gain of 36% over the past three trading days [1] Summary by Category - **Stock Performance** - The stock price rose by 6.11%, reaching 17.55 HKD [1] - The trading volume amounted to 118 million HKD [1]

Core Viewpoint - Lai Kai Pharmaceutical-B (02105) has seen a significant stock increase of over 36% in the last three trading days, driven by positive initial results from its LAE102 drug for obesity treatment in China [1] Group 1: Stock Performance - Lai Kai Pharmaceutical-B's stock rose by 6.11% to HKD 17.55, with a trading volume of HKD 118 million [1] - The stock has experienced a cumulative increase of 36% over the past three trading days [1] Group 2: Clinical Trial Results - The Phase I multi-dose escalation study (MAD study) for LAE102 has shown promising initial results, indicating a trend of muscle gain and fat loss [1] - In the 6 mg/kg dosage group, participants showed an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% by week 5 [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, while fat mass decreased by 3.6% [1] Group 3: Competitive Landscape - Eli Lilly's recent decision to halt the bimagrumab combination trial is seen as reducing potential competition for LAE102 [1] - The cessation of bimagrumab's diabetes trial highlights the value of Lai Kai's collaboration with Eli Lilly regarding the LAE102 pipeline [1] Group 4: Analyst Ratings - DBS has reiterated a "Buy" rating for Lai Kai Pharmaceutical, citing significantly increased potential for the LAE102 drug to prevent muscle loss [1] - Clinical trial information released by Eli Lilly in late September suggests that LAE102 may have a more pronounced competitive advantage than previously expected [1] - The Phase I clinical trial for LAE102 is expected to conclude in September, with subsequent data releases likely to attract interest from Eli Lilly and other international pharmaceutical companies for licensing agreements [1]

Core Viewpoint - Lai Kai Pharmaceutical-B (02105) has seen a significant stock increase of over 36% in the last three trading days, driven by positive initial results from its LAE102 drug for obesity treatment in China [1] Group 1: Stock Performance - Lai Kai Pharmaceutical-B's stock rose by 6.11% to HKD 17.55, with a trading volume of HKD 118 million [1] - The stock has experienced a cumulative increase of 36% over the past three trading days [1] Group 2: Clinical Trial Results - The Phase I multi-dose escalation study (MAD study) for LAE102 has shown promising initial results, indicating a trend of muscle gain and fat loss [1] - In the 5th week, participants in the 6mg/kg dose group showed an average lean body mass increase of 1.7% and a fat mass reduction of 2.2% [1] - After adjusting for the placebo group, the average lean body mass increase reached 4.6%, while fat mass decreased by 3.6% [1] Group 3: Competitive Landscape - Eli Lilly's recent decision to halt the bimagrumab combination trial is seen as reducing potential competition for LAE102 [1] - The collaboration between Lai Kai and Eli Lilly highlights the value of the LAE102 pipeline, especially in light of the competitive advantages revealed in recent clinical trial data [1] Group 4: Analyst Ratings - DBS has reiterated a "Buy" rating for Lai Kai Pharmaceutical, citing significantly increased potential for the LAE102 drug to prevent muscle loss [1] - The clinical trial information released by Eli Lilly in late September suggests that LAE102's competitive advantages may be more pronounced than previously expected [1] - The Phase I clinical trial for LAE102 is expected to conclude in September, with subsequent data releases likely to attract interest from Eli Lilly and other international pharmaceutical companies for licensing agreements [1]