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港股通标的中 来凯医药-B以14.55%涨幅领跑市场
Group 1 - The leading stock in the Hong Kong Stock Connect is Lykai Pharmaceutical-B, which recorded a gain of 14.55% [1] - Following closely are Master Kong Holdings and Jitu Express-W, with gains of 9.42% and 9.11% respectively [1] Group 2 - Youbao Online and Laopu Gold also performed well, with increases of 8.28% and 6.98% [2] - Jinli Permanent Magnet and Hong Teng Precision rose by 6.94% and 6.51% respectively, while ZTE Corporation and Jiantao Laminated Board saw gains exceeding 6% [2] - Anta Sports and Dongyue Group had increases of 5.78% and 5.95% respectively, while SMIC and Uni-President China recorded gains of 5.24% and 5.12% [2] - Baijie Shenzhou, Kingsoft Cloud, China Aluminum, and Cathay Pacific all had increases of over 4% [2]
来凯医药(02105) - 自愿公告LAE123针对重症疗法的IND支持性研究(IND-enabli...
2024-11-28 00:25
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。 Act RII信號失調與多種疾病包括肥胖症、肌肉減少症和其他嚴重疾病相關。我們 將探索LAE123作為治療嚴重威脅生命的疾病,如肺動脈高壓和脊髓性肌萎縮症的 新療法。 關於LAE123 LAE123是本集團自主研發的單克隆抗體,可同時抑制由其配體誘導的Act RIIA和 Act RIIB信號,包括肌生長抑制素、激活素( 如激活素A、激活素B、激活素AB、 激活素C和激活素E )及生長╱分化因數( GDF,如GDF3和GDF11 )。Act RII信號失 調與多種疾病,包括肥胖症、肌肉減少症和其他嚴重疾病相關。 – 1 – (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. 自願公告 LAE123針對重症療法的IND支持性研究(IND -enabling study)已經啟動 本 公 告 由 ...
来凯医药(02105) - 翌日披露报表
2024-11-27 13:13
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別: 股票 狀態: 新提交 公司名稱: 來凱醫藥有限公司 呈交日期: 2024年11月27日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | | 已發行股份(不包括庫 ...
来凯医药(02105) - 完成根据一般授权配售新股
2024-11-27 13:11
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 或任何部分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。 本公告僅作參考,並非收購、購買或認購本公司證券的邀請或要約。 本公告或其任何副本概不得直接或間接在美國,或在刊發或派發本公告屬違法的 任何其他司法權區內刊發或派發。 本公告並非在美國購買或認購任何證券之要約或招攬,亦不構成其一部分。本公 告所述證券並未且將不會根據《1933年美國證券法》(「美國證券法」)登記,亦不會 在美國提呈或出售,除非根據美國證券法作出登記或獲豁免或為毋須根據美國證 券 法 作 出 登 記 之 交 易 。 本 公 司 無 意 根 據 美 國 證 券 法 登 記 本 公 告 內 所 指 之 任 何 證 券,或在美國進行證券之公開發售。 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) 完成根據一般授權配售新股 獨家整體協調人及獨家配售代理 董事會欣然宣佈,配售所有條件 ...
来凯医药-B:拟配售1763.6万股 净筹约2.3亿港元
Group 1 - The company, Lai Kai Pharmaceutical-B, announced an agreement with a sole placement agent to issue 17.636 million shares at a price of HKD 13.36 per share, representing a discount of 15.01% compared to the previous trading day's closing price [1] - The expected net fundraising amount is approximately HKD 230 million, which will be used to accelerate the research and development of drug assets such as LAE102 [1]
来凯医药(02105) - 根据一般授权配售新股
2024-11-21 00:13
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 或任何部分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。 本公告僅作參考,並非收購、購買或認購本公司證券的邀請或要約。 本公告或其任何副本概不得直接或間接在美國,或在刊發或派發本公告屬違法的 任何其他司法權區內刊發或派發。 本公告並非在美國購買或認購任何證券之要約或招攬,亦不構成其一部分。本公 告所述證券並未且將不會根據《1933年美國證券法》(「美國證券法」)登記,亦不會 在美國提呈或出售,除非根據美國證券法作出登記或獲豁免或為毋須根據美國證 券 法 作 出 登 記 之 交 易 。 本 公 司 無 意 根 據 美 國 證 券 法 登 記 本 公 告 內 所 指 之 任 何 證 券,或在美國進行證券之公開發售。 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) 根據一般授權配售新股 獨家整體協調人及獨家配售代理 董事會欣然宣佈,於2024年11 ...
来凯医药(02105) - 自愿公告与礼来在美国就LAE102针对肥胖症治疗的临床合作
2024-11-20 04:12
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. 自願公告 與禮來在美國就LAE102針對肥胖症治療的臨床合作 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 」)自 願 作 出,以告知本公司股東及潛在投資者本集團最新業務進展。 本 公 司 董 事(「 董 事 」)會(「 董 事 會 」)欣 然 宣 佈 , 本 集 團 已 與 禮 來 公 司(「 禮 來 」) ( NYSE:LLY )簽訂一項臨床合作協議,旨在支持和加速LAE102針對肥胖症治療 的全球臨床開發。禮來將負責在美國執行一項I期研究並承擔相關費用。 本集團保留LAE102的全球權益。本集團致力於將這種精准治療帶給需要新型治療 選擇以實現高質量體重控制的超 ...
来凯医药-B大涨11%
Group 1 - The core viewpoint of the article highlights the significant increase in the stock price of Lakai Pharmaceutical-B, which surged by 11% following the initiation of Phase I clinical trials for its LAE102 injection in mid-October [1] - The LAE102 is a monoclonal antibody targeting ActRIIA, aimed at providing new treatment options for overweight and obese patients [1]
来凯医药-B:ATK抑制剂乳腺癌3期启动,ActRIIA顺利进入临床
Great Wall Securities· 2024-09-03 03:11
2 期试验获得积极疗效,且耐受性良好。2024 年 5 月,临床 3 期试验方案已 获得 FDA 批准。 证券研究报告 | 公司动态点评 2024 年 09 月 02 日 来凯医药-B(02105.HK) ATK 抑制剂乳腺癌 3 期启动,ActRIIA 顺利进入临床 | --- | --- | --- | --- | --- | --- | --- | --- | |--------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------|------------------------|------------------------------------------|--------------|--------------------------------------------|------------------| | 财务指标 | 20 ...
来凯医药(02105) - 2024 - 中期财报
2024-08-26 14:01
Financial Performance - Laekna, Inc. reported a revenue of $10 million for the first half of 2024, representing a 25% increase compared to the same period in 2023[5]. - The company expects to achieve a revenue growth of 40% for the full year 2024, driven by new product launches and market expansion[2]. - The company reported a net loss of $1 million for the first half of 2024, a reduction from a $1.5 million loss in the same period last year[5]. - The total comprehensive loss for the six months ended June 30, 2024, was RMB 138.5 million, a decrease from RMB 285.8 million in the same period of 2023[19]. - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.40, significantly improved from RMB 2.63 in the same period of 2023[104]. - The loss from operations for the six months ended June 30, 2024, was RMB 142.4 million, a slight improvement from a loss of RMB 145.0 million in the same period of 2023[104]. Research and Development - The company has allocated $2 million for research and development of new therapies in the next fiscal year[5]. - R&D expenses increased by 23.3% to RMB 126.1 million for the six months ended June 30, 2024, primarily due to clinical trial milestones related to the Phase III trial[19]. - The company achieved significant progress in clinical and preclinical development of candidate drug assets as of June 30, 2024[11]. - The company has initiated seven clinical trials targeting unmet medical needs in obesity and cancer as of June 30, 2024[21]. - The company is actively pursuing strategic partnerships to accelerate the development and commercialization of its drug candidates[15]. Product Development and Clinical Trials - The company has initiated clinical trials for its new drug candidate Afuresertib, targeting a market with an estimated value of $5 billion[4]. - Laekna has received regulatory approval for two new drugs, which are expected to launch in Q4 2024[2]. - LAE102, a monoclonal antibody targeting ActRIIA for obesity, received IND approval from CDE and FDA in Q2 2024, with Phase I clinical trials starting in June 2024[12]. - The Phase I trial for LAE102 aims to complete the single ascending dose portion by Q4 2024, focusing on safety, tolerability, and pharmacokinetics[12]. - The Phase III clinical trial AFFIRM-205 for LAE002 (afuresertib) combined with fulvestrant in HR+/HER2- breast cancer patients was initiated in May 2024, ahead of schedule[13]. - The company plans to present clinical data from the Phase I study of LAE002 at the ESMO conference in September 2024[13]. Market Expansion and Strategy - Laekna is planning to expand its market presence in Europe, aiming for a 15% market share by the end of 2025[6]. - The global obesity patient population is projected to exceed 1.2 billion by 2030, highlighting significant market opportunities in obesity and cancer treatment[23]. - The market potential for HR+/HER2- metastatic breast cancer remains substantial, with billions of dollars at stake due to unmet medical needs[28]. - The company is actively enhancing its global network and business development activities with an allocation of HKD 55.1 million, or 7.6% of the net proceeds[53]. Financial Position and Cash Flow - Cash and cash equivalents decreased by RMB 33.5 million or 7.6% from RMB 440.8 million as of December 31, 2023, to RMB 407.3 million as of June 30, 2024[43]. - The group’s current assets amounted to RMB 666.8 million as of June 30, 2024, with cash and cash equivalents of RMB 407.3 million[43]. - The company reported a foreign exchange gain of RMB 11,962,000 for the six months ended June 30, 2024, compared to a loss of RMB 40,350,000 in the same period of 2023[104]. - Operating cash used for the six months ended June 30, 2024, was RMB (143,382) thousand, a decrease from RMB (155,769) thousand for the same period in 2023, representing a reduction of approximately 7.8%[108]. Shareholder Information and Equity - The total number of issued shares as of June 30, 2024, is 390,100,350[61]. - The company has a total of RMB 72,484,000 in accrued expenses and other payables as of June 30, 2024, compared to RMB 68,445,000 as of December 31, 2023[132]. - The company’s authorized share capital is $50,000, divided into 5,000,000,000 ordinary shares with a par value of $0.00001 each[139]. - The total number of stock options granted to employees, directors, and consultants is 33,618,520, with 20% expected to vest after 12 months from the grant date[136]. Governance and Compliance - The company has adopted the corporate governance code as its own, ensuring compliance with all relevant provisions during the reporting period, except for the deviation regarding the separation of the roles of Chairman and CEO[97]. - The audit committee, consisting of two independent non-executive directors and one non-executive director, has reviewed the interim financial report and discussed internal controls and financial reporting matters[99]. - The independent auditor, KPMG, conducted a review of the interim financial report and found no issues that would lead to a belief that the report was not prepared in accordance with the relevant standards[103].