CBT-199是一种新型局部眼用乳液，适用于治疗老花眼，而老花眼为常见的年龄相关性病症，患者眼内 晶状体逐渐增厚且失去弹性，导致聚焦近物能力持续衰退。CBT-199采用集团专有的非水溶性平台制 剂，含副交感神经性缩瞳剂，透过诱导瞳孔收缩形成针孔效应，增加焦距深度从而改善近距离视力。此 无水配方旨在防止活性成分随时间分解以提升药物稳定性，并采用对消费者友善的自保存多剂量瓶装设 计，具备长效保质期，提供舒适、舒缓的用药体验。 格隆汇12月15日丨拨康视云-B(02592.HK)宣布，于2025年12月15日，公司全资附属公司ADS Therapeutics LLC向美国食品及药物管理局("美国药管局")提交有关CBT-199(一种由集团开发的潜在同类 最佳眼科候选药物)的新药临床试验申请。 诚如公司日期为2025年6月24日的招股章程所披露，集团已于2023年在中华人民共和国开始CBT-199的 药物发现过程。CBT-199已自2023年6月起于临床前动物研究中进行安全性和耐受性评估，有关研究预 期将有助于未来的临床试验。提交新药临床试验申请为美国药管局启动药物审查程序以及取得监管批准 以展开CBT-199的临床 ...

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。 本公司董事會（「董事會」）宣佈，於2025年12月15日，本公司全資附屬公司ADS Therapeutics LLC向美 國食品及藥物管理局（「美國藥管局」）提交有關CBT-199（一種由本集團開發的潛在同類最佳眼科候選 藥物）的新藥臨床試驗申請（「新藥臨床試驗申請」）。 CBT-199是一種新型局部眼用乳液，適用於治療老花眼，而老花眼為常見的年齡相關性病症，患者 眼內晶狀體逐漸增厚且失去彈性，導致聚焦近物能力持續衰退。CBT-199採用本集團專有的非水溶 性平台製劑，含副交感神經性縮瞳劑，透過誘導瞳孔收縮形成針孔效應，增加焦距深度從而改善近 距離視力。此無水配方旨在防止活性成分隨時間分解以提升藥物穩定性，並採用對消費者友善的自 保存多劑量瓶裝設計，具備長效保質期，提供舒適、舒緩的用藥體驗。 CLOUDBREAK PHARMA INC. 撥康視雲製藥有限公司 * （於開曼群島註冊成立的有限公司） （股份 ...

Market Overview - The Hong Kong stock market opened lower on December 15, with the Hang Seng Index down 1% at 25,718.14 points, the Hang Seng Tech Index down 1.34% at 5,562.67 points, and the State-Owned Enterprises Index down 1.09% at 8,980.13 points [1] - Major tech stocks declined, including Alibaba down 2.14%, Tencent down 1.62%, and JD.com down 0.61% [1] - The innovative drug sector saw several stocks open lower, with Genscript Biotech down 5.92% and Zai Lab down 3.48% [1] - Chinese brokerage stocks collectively fell, with Everbright Securities dropping over 1% [1] - The automotive sector also experienced declines, with Li Auto down over 2% and XPeng down nearly 2% [1] - However, three-child policy concept stocks and photovoltaic stocks mostly rose, with star stock Jinxin Fertility rising about 3% [1] Company News - China Merchants Energy (01138.HK) signed shipbuilding contracts for one ethylene ship and eighteen oil tankers, totaling RMB 7.882 billion [2] - ZhongAn Online (06060.HK) reported cumulative original insurance premium income of approximately RMB 32.904 billion for the first eleven months [3] - R&F Properties (02777.HK) achieved total sales revenue of approximately RMB 12.7 billion in the first eleven months, a year-on-year increase of 24.63% [4] - Yida China (03639.HK) reported contract sales amounting to approximately RMB 681 million in the first eleven months, a year-on-year decrease of 23.22% [5] - Bole Technology (02592.HK) successfully held a meeting after the second phase of clinical trials for CBT-004 [6] - Junshi Biosciences (02696.HK) received acceptance for its marketing application for Hansizhuang® in combination with chemotherapy for gastric cancer [6] - CSPC Pharmaceutical Group (01093.HK) received approval for a new indication for its drug, Donyin® (liposomal irinotecan injection), for first-line treatment in metastatic pancreatic cancer patients [6] - Biyuan (00926.HK) increased its investment in ERX to maintain a 3% stake to support innovative research and development of non-GLP-1 weight loss therapies [7] - Hengrui Medicine (01276) received approval for clinical trials for HRS-1780 tablets [8] - AVIC Industry (02357.HK) plans to acquire a 59.1816% partnership interest in Hangtou Yuhua for a consideration of RMB 202 million [9] - China Environmental Resources (01130.HK) intends to acquire 90% equity in Sichuan Yuanlai Shun Recycling Resources Co., Ltd. for RMB 9 million [10] - AVIC Industry (02357.HK) proposed to implement full circulation of H-shares [11] - Yabo Technology Holdings (08279.HK) signed a framework agreement with Alipay (Hangzhou) [12] Institutional Insights - Guosen Securities indicated that the short-term adjustment in the Hong Kong stock market opens up space for a market rise in 2026, with net inflows from southbound funds exceeding RMB 110 billion in November [13] - CITIC Securities noted strong performance in gold and silver, while other risk assets were weak, predicting a segmented market for precious metals in 2025 [13] - CITIC Securities also emphasized the importance of resource self-sufficiency in the lithium industry, highlighting the need for low-cost quality resources to navigate market cycles [14]

Company News - China COSCO Shipping Energy Transportation Co., Ltd. (中远海能) has signed shipbuilding contracts with Dalian COSCO Shipping Heavy Industry, Yangzhou COSCO Shipping Heavy Industry, and Guangdong COSCO Shipping Heavy Industry for the construction of one ethylene ship and eighteen oil tankers, with a total cost of RMB 7.882 billion [1] - ZhongAn Online P&C Insurance Co., Ltd. (众安在线) reported a total original insurance premium income of approximately RMB 32.904 billion for the first eleven months [2] - R&F Properties Co., Ltd. (富力地产) achieved total sales revenue of approximately RMB 12.7 billion in the first eleven months, representing a year-on-year increase of 24.63% [3] - Yida China Holdings Limited (亿达中国) reported a contracted sales amount of approximately RMB 681 million for the first eleven months, a year-on-year decrease of 23.22% [4] - Karsen International Holdings Limited (卡森国际) has entered into a steel structure procurement contract with suppliers, involving an investment of RMB 43.5366 million [4] Clinical and Regulatory Updates - Bolex Cloud-B (拨康视云-B) successfully held a meeting after the second phase of clinical trials for CBT-004 [5] - Innovent Biologics, Inc. (复宏汉霖) has had its application for the marketing registration of Hansizhuang® combined chemotherapy for gastric cancer accepted by the National Medical Products Administration, and it has been included in the priority review [5] - CSPC Pharmaceutical Group Limited (石药集团) received approval for a new indication for Donyi® (Irinotecan Liposome Injection) for first-line treatment in patients with metastatic pancreatic cancer [5] - Heng Rui Medicine (恒瑞医药) received a clinical trial approval notice for HRS-1780 tablets [7] Investment and Acquisition Activities - AVIC Aviation Industry Corporation (中航科工) plans to acquire a 59.1816% partnership interest in Hangtou Yuhua for a consideration of RMB 202 million [8] - China Environment Resources Holdings Limited (中国环境资源) intends to acquire 90% equity in Sichuan Yuanlai Shun Recycling Resources Co., Ltd. for RMB 9 million [9] - AVIC Aviation Industry Corporation (中航科工) has proposed to implement full circulation of H-shares [10] - Yabo Technology Holdings Limited (亚博科技控股) has entered into a framework agreement with Alipay (Hangzhou) [11] Financing and Buyback Activities - Yum China Holdings, Inc. (百胜中国) has entered into a share buyback agreement with a total repurchase amount of approximately USD 460 million, including about HKD 880 million under the Hong Kong plan, as part of a plan to return USD 1.5 billion to shareholders through dividends and share buybacks by 2026 [12] - Tencent Holdings Limited (腾讯控股) repurchased approximately 1.044 million shares for about HKD 636 million, with repurchase prices ranging from HKD 601.5 to HKD 616 [13] - Xuanwu Cloud (玄武云) repurchased 6,000 shares for a total of HKD 6,467.79, with prices between HKD 1.05 and HKD 1.07 [14] - China COSCO Shipping Holdings Co., Ltd. (中远海控) repurchased approximately 4.461 million shares for about HKD 60.8605 million, with prices ranging from HKD 13.38 to HKD 13.82 [15] - Geely Automobile Holdings Limited (吉利汽车) repurchased approximately 1.362 million shares for about HKD 23.9241 million, with prices between HKD 17.29 and HKD 17.82 [16] - China Anshun Energy (中国安储能源) plans to issue a total of 524 million shares at a discount of approximately 19.12%, aiming to raise about HKD 288.2 million [16]

Core Viewpoint - Company Cloudbreak USA successfully held a Phase 2 clinical trial meeting with the FDA regarding CBT-004, a preservative-free eye drop intended for treating vascularized eyelid lesions, marking significant progress in its clinical development [1][2] Group 1: Clinical Trial Results - The Phase 2 clinical trial meeting was based on results completed in May 2025, showing that CBT-004 is safe and well-tolerated, achieving primary and several secondary efficacy endpoints [2] - CBT-004 demonstrated efficacy in reducing conjunctival hyperemia, with effects observable as early as 7 days after the first dose [2] - During the 28-day treatment period, improvements were noted in symptoms such as burning or stinging, itching, and foreign body sensation, with some effects persisting significantly for 4 weeks post-treatment [2] Group 2: FDA Feedback and Next Steps - The FDA provided feedback on drug stability, specifications research, and non-clinical studies required for the New Drug Application (NDA), as well as the design and endpoints for the Phase 3 clinical study [1] - A consensus was reached with the FDA to use the reduction of hyperemia symptoms as the primary endpoint for CBT-004's approval, with symptom relief as a potential co-primary endpoint [1][2] - The successful Phase 2 clinical trial meeting is seen as a major step towards advancing CBT-004 into Phase 3 clinical research, paving the way for its NDA and subsequent commercialization [2]

拨康视云-B(02592)公布，于2025年12月10日，公司全资附属公司Cloudbreak USA与美国食品及药物管 理局成功举行第2期临床试验后会议，该会议涉及CBT-004的临床开发，而CBT-004为一种潜在的同类首 创无防腐剂滴眼液，适用于治疗血管化睑裂斑，该病症常见于紫外线照射过度者及年长者。 于第2期临床试验后会议上，美国食品及药物管理局就下列事项提供意见回馈：药物稳定性及规格研 究、支持向美国食品及药物管理局提交拟议新药申请所需的非临床研究，以及CBT-004第3期临床研究 的设计及终点。其中，美国食品及药物管理局与Cloudbreak USA就以下事项达成共识：将充血症状减轻 作为CBT-004获批的主要终点，其统计学及临床意义，并将症状缓解作为潜在的共同主要终点。 第2期临床试验后会议乃基于2025年5月完成的第2期临床试验结果及2025年7月完成的临床试验报告而举 行，该报告显示CBT-004在受试者中具有安全性且耐受性良好，并达到主要疗效终点及若干次要疗效终 点。尤其是，第2期临床试验结果显示CBT-004在减轻结膜充血方面具疗效，首次用药后最快7天即可见 效。于28天治疗期间，亦观 ...

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。 CLOUDBREAK PHARMA INC. 撥康視雲製藥有限公司 * （於開曼群島註冊成立的有限公司） （股份代號：2592） 自願公告 業務最新進展 有關成功舉行第2期臨床試驗後會議 本公告乃由撥康視雲製藥有限公司（「本公司」，連同其附屬公司，統稱「本集團」）自願作出，以知會 本公司股東及潛在投資者有關本集團的最新業務發展。 茲提述本公司日期為2025年12月8日的公告（「該公告」），內容有關與美國食品及藥物管理局舉行第 2期臨床試驗後（「第2期臨床試驗後」）會議的安排，該會議涉及本集團臨床階段候選藥物之一CBT- 004。除另有界定者外，所用詞彙具有該公告所賦予的相同涵義。 警告聲明：概無保證CBT-004或本集團任何其他候選藥物最終能成功開發、推出或上市。 本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 撥康視雲製藥有限公司* 董事會主席、執行董事兼首席執行官 成功舉行CBT ...

本文源自：智通财经网 消息面上，拨康视云此前公告，本公司于美国加利福尼亚州注册成立的全资附属公司Cloudbreak USA排 定于2025年12月10日与美国食品及药物管理局正式举行第2期临床试验后会议，该会议涉及集团临床阶 段候选药物 CBT-004。此次第2期临床试验后会议是CBT-004研发进程中一个重要的里程碑，用于讨论 CBT-004研发进程中潜在的第三阶段临床试验开发以及新药申请的相关要求。 智通财经获悉，拨康视云-B(02592)现涨超4%，截至发稿，涨4.13%，报8.58港元，成交额1182.43万港 元。 ...

消息面上，拨康视云此前公告，本公司于美国加利福尼亚州注册成立的全资附属公司Cloudbreak USA排 定于2025年12月10日与美国食品及药物管理局正式举行第2期临床试验后会议，该会议涉及集团临床阶 段候选药物CBT-004。此次第2期临床试验后会议是CBT-004研发进程中一个重要的里程碑，用于讨论 CBT-004研发进程中潜在的第三阶段临床试验开发以及新药申请的相关要求。 拨康视云-B(02592)现涨超4%，截至发稿，涨4.13%，报8.58港元，成交额1182.43万港元。 ...

Core Viewpoint - The stock of Bolekang Shiyun-B (02592) has increased by over 4%, currently trading at 8.58 HKD with a transaction volume of 11.82 million HKD, following the announcement of a significant milestone in the development of its candidate drug CBT-004 [1] Group 1 - Bolekang Shiyun has a wholly-owned subsidiary, Cloudbreak USA, registered in California, which is scheduled to hold a post-phase 2 clinical trial meeting with the U.S. Food and Drug Administration on December 10, 2025 [1] - The upcoming meeting is a crucial milestone in the development process of CBT-004, aimed at discussing the potential requirements for phase 3 clinical trial development and new drug application [1]