Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) in China for the clinical trial application (IND) of its oral, highly active, and selective small molecule KRAS G12D inhibitor, ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The clinical trial application for ABSK141 has been approved by NMPA [1] - ABSK141 is designed for patients with advanced solid tumors that have the KRAS G12D mutation [1] - The drug is characterized as an oral, highly active, and highly selective small molecule inhibitor [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) in China for its new drug clinical trial application for the oral, highly active, and selective small molecule KRAS G12D inhibitor ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The subsidiary involved is Shanghai Heyu Biopharmaceutical Technology Co., Ltd. [1] - The drug ABSK141 targets a specific mutation (KRAS G12D) associated with advanced solid tumors [1] - The approval marks a significant step in the development of targeted therapies for cancer treatment [1]

Core Viewpoint - The company He Yu-B (02256.HK) has received approval from the National Medical Products Administration (NMPA) in China for its clinical trial application of the oral, highly active, and selective small molecule KRAS G12D inhibitor ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The drug ABSK141 is specifically designed for patients with advanced solid tumors that have the KRAS G12D mutation [1] - The approval from NMPA marks a significant milestone for the company in advancing its oncology pipeline [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，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 上海，2025年12月24日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥宣佈口服小分子KRAS G12D抑制劑ABSK141的IND獲NMPA批准 2025年12月24日，上海和譽生物醫藥科技有限公司（「和譽醫藥」）宣佈，其口 服、高活性、高選擇性小分子KRAS G12D抑制劑ABSK141用於治療攜帶KRAS G12D突變的晚期實體瘤患者的新藥臨床試驗（「IND」）申請已獲中國國家藥品監 督管理局（「NMPA」）批准。 此次獲批的是一項開放性I/II期臨床研究，旨在評估ABSK141在攜帶KRAS G12D 突變的晚期實體瘤患者中的安全性、耐受性、有效性和藥代動力學特徵。 自願性 ...

Market Performance - The Hong Kong stock market opened high but experienced fluctuations, closing with the Hang Seng Index down 0.11% at 25,774.14 points, the Hang Seng Tech Index down 0.69% at 5,488.89 points, the National Enterprises Index down 0.29% at 8,913.83 points, and the Red Chip Index down 0.19% at 4,067.53 points [1] Sector Performance - Large tech stocks showed mixed performance: Alibaba rose 0.55%, Tencent fell 2.03%, JD.com increased by 0.45%, Xiaomi dropped 1.51%, NetEase decreased by 0.65%, Meituan rose 0.39%, Kuaishou fell 3.52%, and Bilibili decreased by 0.05% [1] - Gold stocks continued to rise, with WanGuo Gold Group up over 5%, Shandong Gold up over 4%, and Zhaojin Mining up over 2% [1] - Wind power stocks led gains, with Dongfang Electric up over 8% [1] - Biotech stocks declined, with Yaojie Ankang down over 18% [1] - Chinese brokerage stocks opened high but closed lower, with Dongfang Securities down over 1% [1] Company News - Cathay Pacific reported 2.5304 million passengers in November, a year-on-year increase of 26% [2] - Shandong High New Energy's subsidiary signed an EPC contract worth RMB 405.5 million [2] - China General Nuclear Power's units are in testing, with adjusted operational timelines for 2026 [2] - Lehua Entertainment signed a business cooperation framework agreement with Youku [3] - Dipo Technology entered a strategic cooperation agreement with Muxi Co., focusing on enterprise-level AI applications [4] - Nanshan Aluminum's alumina design capacity has been increased to 4 million tons [7] Institutional Insights - Huatai Securities noted that the market is still in a left-side layout phase, with supply and demand pressures expected to persist into the year-end [10] - Guotou Securities highlighted the historical strength of U.S. stocks at year-end, despite uncertainties regarding interest rates and inflation paths for 2026 [10] - Galaxy Securities recommended focusing on the tech sector as a long-term investment theme, anticipating a rebound due to multiple favorable factors [10]

Market Overview - The Hong Kong stock index opened higher but showed mixed performance, with the Hang Seng Index up 0.18% at 25,848.99 points, the Hang Seng Tech Index down 0.42% at 5,503.87 points, the National Enterprises Index up 0.11% at 8,949.28 points, and the Red Chip Index up 0.39% at 4,091.24 points [1] - Major tech stocks exhibited varied movements, with Alibaba up 0.68%, Tencent down 1.46%, JD.com up 0.98%, Xiaomi down 1.66%, NetEase up 0.19%, Meituan up 0.39%, Kuaishou down 3.6%, and Bilibili up 0.41% [1] - Wind power stocks led the gains, with Dongfang Electric rising over 5%, while gold stocks continued their upward trend, with Shandong Gold also up over 5% [1] - The lithium battery sector saw significant increases, with Ganfeng Lithium up over 4%, and building materials and cement stocks remained active, with Dongwu Cement reaching a historical high [1] - Mobile game stocks, Apple concept stocks, and new energy vehicle companies mostly declined [1] - Newly listed company Relax Health saw a first-day increase of over 145%, while Nobi Kan surged 338.75% in half a day [1] Corporate News - Vanke Enterprises (02202.HK) extended the grace period for the principal and interest payment of its fourth phase of medium-term notes (total principal of 2 billion yuan) to 30 trading days [2] - Cathay Pacific (00293.HK) reported 2.5304 million passengers in November, a year-on-year increase of 26% [3] - Shanhigh New Energy (01250.HK) signed an EPC contract with China Railway 17th Bureau for a total price of 405.5 million yuan [3] - China General Nuclear Power (01816.HK) announced that the commissioning of Units 1 and 2 in Huizhou has been adjusted to the first half and second half of 2026, respectively [3] - Lehua Entertainment (02306.HK) entered into a business cooperation framework agreement with Youku Information Technology [4] - Xinyang Global Holdings (00723.HK) signed a cooperation agreement with Guangxi Fenglin (601996.SH) to jointly develop the EU wood board and related product market [4] - Tabo (06110.HK) reported a high single-digit year-on-year decline in total sales for its retail and wholesale business in Q3 of the 2025/26 fiscal year [4] - Dipo Technology (01384.HK) entered into a strategic cooperation agreement with Muxi Co., aiming to deepen their strategic partnership in enterprise-level large model AI applications [4] - He Yu-B (02256.HK) received approval from China's NMPA for its CSF-1R inhibitor Beijiemai® [5] - Saint Noble Pharmaceuticals-B (02257.HK) completed Phase I trials for its experimental drug STP707 and formally submitted a clinical research report to the FDA [6] - Nanshan Aluminum International (02610.HK) increased its annual production capacity for alumina to 4 million tons [7] - Rungo Interactive (02422.HK) plans to sell 75% of its stake in Xi'an Tiantai Innovation Technology Co., Ltd. for 11.3 million yuan [8] - China Tianhua Chemical (00362.HK) received guidance from the Hong Kong Stock Exchange for resuming trading, but remains suspended [9] Institutional Insights - Huatai Securities noted that the market is still in a left-side layout phase, with the right-side turning point not yet clear. There is strong consensus on an early spring rally, but year-end supply and demand pressures create uncertainty for a "Santa rally." The first quarter may present a higher probability phase for investment [10] - CITIC Securities observed that after a unilateral rise in September, the Hong Kong stock market has experienced fluctuations since October due to repeated overseas macro expectations. Quality assets in the Hong Kong market have re-entered a high cost-performance zone, and with continued northbound capital inflow and improved profit expectations, the market is entering a significant year-end trading window [10] - China Galaxy suggested focusing on the technology sector as a long-term investment theme, which is expected to rebound after previous adjustments. The consumer sector is anticipated to receive substantial policy support, with current valuations at relatively low levels, indicating significant long-term upside potential [11]

Core Viewpoint - The Hong Kong stock market has experienced a significant rise in innovative pharmaceuticals, with the Hang Seng Healthcare Index increasing by 102.76% from the beginning of the year to its peak in September, followed by a decline of 19.06% by December 22. Despite this, the company He Yu has seen a remarkable stock price increase of 370.95% this year, driven by the approval of its core product, Pimicotinib, in China [1][2][5]. Group 1: Product Approval and Market Impact - He Yu announced the approval of its drug Beijiemai (Pimicotinib) by the NMPA, marking it as the first systemic treatment for tenosynovial giant cell tumor (TGCT) in China [2][5]. - The approval process for Beijiemai was expedited, receiving priority review in May and being approved within six months after its NDA application was accepted [6][7]. - The drug has shown strong and durable tumor relief efficacy in clinical trials, providing significant evidence for its long-term safety and effectiveness [6][7]. Group 2: Financial and Market Potential - Pimicotinib is expected to generate substantial revenue, with estimates suggesting it could reach peak sales of approximately $1.5 billion globally [8][9]. - The company has secured a lucrative partnership with Merck, which includes an upfront payment of $70 million and potential total transaction value of up to $606 million, reflecting strong confidence in the drug's market potential [7][9]. - The approval of Pimicotinib is anticipated to enhance the company's cash flow, supporting further innovation and development of its oncology pipeline [9][10]. Group 3: Innovation Pipeline and Valuation - He Yu has established a robust pipeline of 22 differentiated innovative drugs, focusing on precision oncology and immunotherapy, with several candidates showing potential for being first-in-class or best-in-class [9][10]. - The company has been actively repurchasing shares, with a total of 39 buybacks this year, indicating a commitment to returning value to shareholders [10]. - Compared to other biopharma companies, He Yu's price-to-sales (P/S) ratio of 13.38 suggests significant upside potential in valuation, especially with the successful commercialization of Pimicotinib [10].

Core Viewpoint - The Hong Kong stock market has experienced a significant rise in innovative pharmaceuticals, with the Hang Seng Healthcare Index increasing by 102.76% from the beginning of the year to its peak in September, followed by a decline of 19.06% by December 22. Despite this, the company He Yu has seen a remarkable stock price increase of 370.95% this year, driven by the approval of its core product, Pimicotinib, in China, marking a critical milestone for the company [1][4]. Group 1: Product Approval and Market Impact - He Yu's Pimicotinib, a first-in-class drug for treating tenosynovial giant cell tumors (TGCT), has received approval from the National Medical Products Administration (NMPA) in China, representing a significant step towards global commercialization [4][5]. - The approval process for Pimicotinib was expedited, with the drug being accepted for priority review in May and receiving approval just over six months later, highlighting the efficiency of He Yu's research and development system [5][6]. - The MANEUVER study presented at the European Society for Medical Oncology (ESMO) demonstrated Pimicotinib's strong and durable tumor relief efficacy, providing critical evidence for its long-term safety and effectiveness [6][7]. Group 2: Financial and Strategic Developments - He Yu has entered a lucrative partnership with Merck, which includes a high upfront payment and potential milestone payments, indicating strong confidence in Pimicotinib's market potential, with total deal value potentially reaching $606 million [6][8]. - The market for TGCT treatment is currently dominated by Pexidartinib, which has significant safety concerns, positioning Pimicotinib as a safer and more effective alternative, with expectations of substantial revenue growth [7][8]. - He Yu's innovative pipeline includes multiple promising candidates, with ongoing developments in various drug candidates that could further enhance the company's market position and revenue streams [8][9]. Group 3: Valuation and Investor Returns - He Yu has been actively repurchasing shares, with a total of 39 buybacks this year, reflecting a commitment to returning value to shareholders while maintaining a low price-to-sales (PS) ratio of 13.38, suggesting significant upside potential compared to peers [9]. - The successful commercialization of Pimicotinib is expected to generate stable revenue and cash flow, supporting further innovation and development within the company [8][9]. - The company is well-positioned to transition into a leading global biopharmaceutical player, leveraging its innovative capabilities and expanding its market presence [9].

Company News - Vanke Enterprise (02202.HK) has extended the grace period for the principal and interest payment of its fourth tranche of medium-term notes (total principal of 2 billion yuan) to 30 trading days [1] - Cathay Pacific Airways (00293) reported a passenger count of 2.5304 million in November, representing a year-on-year increase of 26% [1] - Shandong High New Energy (01250.HK) announced that its subsidiary Wuxiang Beiqing Smart Energy has signed an EPC contract with China Railway 17th Bureau, with a total contract value of 405.5 million yuan [1] - China General Nuclear Power (01816) reported that the commissioning of Units 1 and 2 in Huizhou has been adjusted, with expected operational dates moved to the first half and second half of 2026, respectively [1] Strategic Partnerships - Lehua Entertainment (02306.HK) has signed a business cooperation framework agreement with Youku Information Technology and Youku for 2026 [2] - Xinbao Global Holdings (00723.HK) has entered into a cooperation agreement with Guangxi Fenglin (601996.SH) to jointly develop the EU wood board and related product market [2] - Dipo Technology (01384.HK) has established a strategic cooperation agreement with Muxi Co., aiming to deepen collaboration in enterprise-level large model AI applications across key industries such as manufacturing, commercial circulation, transportation, and healthcare [2] Product Development - He Yu-B (02256.HK) announced that its CSF-1R inhibitor Beijiemai® has received approval from China's NMPA [3] - Saint Noble Pharmaceuticals-B (02257.HK) has completed Phase I trials for its investigational drug STP707 and has formally submitted the clinical research report to the FDA [4] - Nanshan Aluminum International (02610.HK) has increased its annual production capacity for alumina to 4 million tons [5] Share Buybacks - Tencent Holdings (00700.HK) repurchased 1.035 million shares at a cost of 636 million HKD, with repurchase prices ranging from 610.5 to 620 HKD [8] - Xiaomi Group-W (01810.HK) spent approximately 149 million HKD to repurchase 3.75 million shares, with prices between 37.61 and 42.50 HKD [9] - Giant Bio (02367.HK) repurchased approximately 14.43 million HKD worth of 400,000 shares, with prices between 34.71 and 36.34 HKD [10]

Core Viewpoint - The National Medical Products Administration (NMPA) has approved Pimicotinib capsules for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients, which may lead to functional limitations or serious complications [1] Group 1: Product Approval - Pimicotinib (development code: ABSK021) is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor developed independently by He Yu Pharmaceutical [1] - The approval was granted through the CDE priority review process [1] Group 2: Licensing Agreement - In December 2023, He Yu Pharmaceutical entered into an exclusive licensing agreement with Merck for Pimicotinib [1] - Under the agreement, Merck obtained exclusive rights for the commercialization of Pimicotinib for all indications in mainland China, Hong Kong, Macau, and Taiwan, along with exclusive options for global commercialization rights [1]