Market Overview - The Hong Kong stock market indices collectively rose on January 23, with the Hang Seng Index increasing by 0.45% to 26,749 points, the Hang Seng China Enterprises Index up by 0.51%, and the Hang Seng Tech Index rising by 0.62% [1][2]. Key Stock Movements - Major tech stocks saw gains, with Xiaomi Group and Kuaishou both rising nearly 3%, Alibaba up over 2%, and JD.com and Meituan also showing increases [2][4]. - The commercial aerospace sector experienced significant gains, with JunDa shares soaring over 51% following the launch of six platforms related to commercial aerospace in Beijing [6]. - Brain-computer interface stocks were active, with Lens Technology rising over 9% [7]. - Gold stocks continued to strengthen, with Zijin Mining International increasing by over 8% as gold prices reached new highs [9]. - Solar energy stocks surged, with Keyuan New Energy rising over 14% and several others following suit [10]. Sector Performance - The commercial aerospace sector led the market with notable gains, driven by the launch of new platforms aimed at enhancing the industry [6]. - The brain-computer interface sector showed strong activity, supported by advancements in flexible chip technology [7]. - Gold stocks benefited from rising gold prices, which reached a historical high of $4,940.78 per ounce [9]. - The solar energy sector was buoyed by positive remarks from Tesla's CEO regarding solar capacity expansion [10]. Individual Stock Highlights - JunDa shares rose by 51.40% to 39.00, while other aerospace-related stocks also saw significant increases [6]. - Lens Technology increased by 9.36% to 31.78, reflecting strong interest in brain-computer interface technologies [8]. - Zijin Mining International rose by 8.43% to 205.80, benefiting from the surge in gold prices [9]. - Keyuan New Energy saw a rise of 14.44% to 4.36, reflecting optimism in the solar energy market [11]. Future Outlook - The Hong Kong stock market is expected to see a recovery in profit growth by mid-2026, with a slowdown in competition among internet platforms and a reduction in the drag from non-essential consumer spending [26].

Core Viewpoint - Lai Kai Pharmaceutical (2105.HK) experienced a significant increase of over 18%, reaching a peak of 16.72 HKD, marking a new high in over a month following the announcement of its new drug LAE118, which has been accepted for clinical trial application by the FDA [1] Group 1 - The new drug LAE118 is designed to treat PIK3CA mutation-related solid tumors, representing a novel therapy in this area [1] - LAE118 is characterized as a novel PI3Kα pan-mutant selective inhibitor, targeting PIK3CA mutated solid tumors [1] - The company plans to work closely with regulatory authorities to complete the relevant application process for LAE118 [1] Group 2 - The company has a proven track record in clinical development and licensing with LAE002 (afuresertib), which enhances its credibility in providing new treatment options [1] - Lai Kai Pharmaceutical is committed to offering precision treatments for cancer patients in need of new therapeutic solutions [1]

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose nearly 5% in the afternoon, currently up 3.04% at HKD 13.88, with a trading volume of HKD 19.9183 million. The company announced that its new drug LAE118, aimed at treating PIK3CA-mutated solid tumors, has received acceptance for clinical trial application by the FDA [1]. Group 1 - Lai Kai Pharmaceutical's LAE118 is a novel PI3Kα pan-mutant selective inhibitor designed for PIK3CA mutated solid tumors [1]. - The company plans to work closely with regulatory authorities to complete the relevant application process [1]. - The company aims to provide this precision therapy to cancer patients in need of new treatment options, leveraging its proven track record in clinical development and licensing of LAE002 (afuresertib) [1].

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) rose nearly 5% in the afternoon trading session after the U.S. FDA accepted the clinical trial application for its new drug LAE118, which targets PIK3CA mutation solid tumors [1] Company Summary - Lai Kai Pharmaceutical announced that its new drug LAE118, designed to treat PIK3CA mutation solid tumors, has been accepted by the U.S. FDA for clinical trial application [1] - LAE118 is described as a novel PI3Kα pan-mutant selective inhibitor, representing a new therapeutic approach for PIK3CA mutated solid tumors [1] - The company plans to work closely with regulatory authorities to complete the relevant application process [1] - Lai Kai Pharmaceutical aims to provide this precision treatment for cancer patients in need of new therapeutic options, leveraging its successful track record in clinical development and licensing of LAE002 (afuresertib) [1]

Core Viewpoint - The stock price of Lai Kai Pharmaceutical-B (02105) increased by approximately 5.95% to HKD 14.24 following the announcement that the FDA has accepted the IND application for LAE118, a new drug developed by the company [1][5]. Group 1: Company Announcement - Lai Kai Pharmaceutical announced that the FDA has accepted the clinical trial application (IND) for LAE118 on January 14 [1][5]. - LAE118 is a novel PI3Kα pan-mutant selective inhibitor developed by the company, aimed at treating patients with PIK3CA mutations in solid tumors [1][5]. - PI3Kα mutations are commonly found in breast cancer, colorectal cancer, lung cancer, endometrial cancer, and other cancer patients [1][5]. Group 2: Market Reaction - Following the announcement, Lai Kai Pharmaceutical's stock price saw an initial increase of nearly 7% [1][5]. - The trading volume reached HKD 15.6168 million at the time of reporting [1][5].

Core Viewpoint - The announcement of the FDA's acceptance of the IND application for LAE118 by 来凯医药-B has positively impacted the company's stock price, reflecting investor optimism about the potential of this new drug in treating specific cancer mutations [1]. Company Summary - 来凯医药-B's stock rose nearly 7% in early trading, currently up 5.88% at HKD 14.23, with a trading volume of HKD 9.3424 million [1]. - The FDA has accepted the clinical trial application for LAE118, a novel PI3Kα pan-mutant selective inhibitor developed by the company [1]. - LAE118 targets PIK3CA mutations commonly found in various cancers, including breast cancer, colorectal cancer, lung cancer, and endometrial cancer [1]. Industry Summary - Current global PI3Kα inhibitors lack selectivity for mutant types, showing strong activity against wild types, which leads to poor tolerance and a high likelihood of developing resistance [1].

Core Viewpoint - The stock of Lai Kai Pharmaceutical-B (02105) experienced a significant increase, rising nearly 7% in early trading, with a current price of 14.23 HKD and a trading volume of 9.34 million HKD, following the announcement of the acceptance of their new drug clinical trial application by the FDA for LAE118 [1] Group 1: Company Developments - Lai Kai Pharmaceutical announced that the FDA has accepted the Investigational New Drug (IND) application for LAE118 on January 14 [1] - LAE118 is a novel PI3Kα pan-mutant selective inhibitor developed by Lai Kai, aimed at treating patients with PIK3CA mutations in solid tumors [1] Group 2: Industry Context - PI3Kα mutations are commonly found in patients with breast cancer, colorectal cancer, lung cancer, endometrial cancer, and other cancers [1] - Currently approved PI3Kα inhibitors globally lack selectivity for mutant types, exhibiting strong activity against wild types, which leads to poor tolerability and a high likelihood of developing resistance [1]

Core Viewpoint - The announcement highlights that the U.S. Food and Drug Administration (FDA) has accepted the clinical trial application for LAE118, a novel PI3Kα pan-mutant selective inhibitor aimed at treating patients with PIK3CA-mutated solid tumors [1] Company Summary - The company is committed to collaborating closely with regulatory authorities to complete the relevant application for LAE118 [1] - The company has a proven track record in clinical development and licensing with LAE002 (afuresertib), reinforcing its dedication to providing precision treatments for cancer patients in need of new therapeutic options [1] Industry Summary - LAE118 represents a new therapeutic approach in the oncology sector, specifically targeting PIK3CA mutations, which are prevalent in various solid tumors [1]

Core Viewpoint - The company, 来凯医药-B (02105), has announced that the U.S. Food and Drug Administration (FDA) has accepted the clinical trial application for LAE118, a novel PI3Kα pan-mutant selective inhibitor aimed at treating patients with PIK3CA-mutant solid tumors [1] Group 1 - LAE118 is a new type of PI3Kα pan-mutant selective inhibitor [1] - The company is committed to collaborating closely with regulatory authorities to complete the relevant application [1] - The company aims to provide this precision treatment for cancer patients in need of new therapeutic options, leveraging its successful track record in clinical development and licensing of LAE002 (afuresertib) [1] Group 2 - The candidate drug LAE118 is actively being advanced into clinical research as a novel therapy for PIK3CA-mutant solid tumors [1]

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。 本 公 司 將 與 監 管 機 構 緊 密 合 作 以 完 成 相 關 申 請 。 憑 藉 其 在 臨 床 開 發 和 對 外 授 權 LAE 002 (afuresertib)的良好及已驗證的實績，本公司致力於為需要新型治療方案的 癌症患者提供這種精准治療。 關於LAE118 LAE118是一種新型PI3Kα泛突變選擇性抑制劑。作為針對PIK3CA突變實體瘤的新 型療法，本集團正積極推進此候選藥物進入臨床研究。 – 1 – 風險提示 LAE118最終不一定能夠成功開發及商業化。本公司股東及潛在投資者於買賣本公 司證券時務請審慎行事。 （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 美國食品藥品監督管理局受理LAE118新藥臨床試驗申請 本 公 告 由 來 凱 醫 藥 有 限 ...