【财华社讯】截至发稿，拨康视云-B(02592.HK)涨9.75%，报8.78港元。消息面上，该公司午间公布， 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。 本文源自：财华网 CBT-004是一种潜在的同类首创眼科药物，采用多激酶抑制剂，靶向血管內皮生长因子受体及血小板衍 生生长因子受体，适用于治疗血管化睑裂斑。是次第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。 ...

CBT-004是一种潜在的同类首创眼科药物，采用多激酶抑制剂，靶向血管内皮生长因子受体及血小板衍 生生长因子受体，适用于治疗血管化睑裂斑。本集团于2023年12月开始CBT-004的第2期临床试验，并 于2025年5月完成。结果表明，CBT-004 在受试者中是安全且耐受性良好的，并在疗效方面达到了主要 终点以及若干次要终点。本集团已于2025年7月完成临床试验报告并计划与美国食品及药物管理局举行 第2期临床试验后会议。 是次第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。本公司将适时发布进一步公告，以确保本公司股东 及潜在投资者能及时掌握本集团业务的最新进展。 拨康视云-B(02592)发布公告，本公司于美利坚合众国(美国)加利福尼亚州注册成立的全资附属公司 Cloudbreak Therapeutics LLC(Cloudbreak USA)排定于2025年12月10日与美国食品及药物管理局(美国食 品及药物管理局)正式举行第2期临床试验后会议，该会议涉及本集团临床阶段候选药物 CBT-004。 诚如本公司 ...

CBT-004是一种潜在的同类首创眼科药物，采用多激酶抑制剂，靶向血管内皮生长因子受体及血小板衍 生生长因子受体，适用于治疗血管化睑裂斑。本集团于2023年12月开始CBT-004的第2期临床试验，并 于2025年5月完成。结果表明，CBT-004 在受试者中是安全且耐受性良好的，并在疗效方面达到了主要 终点以及若干次要终点。本集团已于2025年7月完成临床试验报告并计划与美国食品及药物管理局举行 第2期临床试验后会议。 诚如本公司于日期为2025年6月24日的招股章程及本集团截至2025年6月30日止六个月的中期报告所披 露: 智通财经APP讯，拨康视云-B(02592)发布公告，本公司于美利坚合众国(美国)加利福尼亚州注册成立的 全资附属公司Cloudbreak Therapeutics LLC(Cloudbreak USA)排定于2025年12月10日与美国食品及药物管 理局(美国食品及药物管理局)正式举行第2期临床试验后会议，该会议涉及本集团临床阶段候选药物 CBT-004。 是次第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 ...

CBT-004是一种潜在的同类首创眼科药物，采用多激酶抑制剂，靶向血管内皮生长因子受体及血小板衍 生生长因子受体，适用于治疗血管化睑裂斑。集团于2023年12月开始CBT-004的第2期临床试验，并于 2025年5月完成。结果表明，CBT-004 在受试者中是安全且耐受性良好的，并在疗效方面达到了主要终 点以及若干次要终点。集团已于2025年7月完成临床试验报告并计划与美国食品及药物管理局举行第2期 临床试验后会议。 格隆汇12月8日丨拨康视云-B(02592.HK)宣布，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(「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。 是次第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。 ...

Core Viewpoint - The successful patent grants for CBT-009 represent a significant milestone in the product's development, enhancing its global reach and commercial potential [1][3]. Group 1: Patent Achievements - ADS Therapeutics LLC, a wholly-owned subsidiary of the company, has been granted patents in Japan and Europe for CBT-009, which involves various ophthalmic compositions aimed at treating myopia [1]. - The Japanese patent (No. 7749020) was issued on September 25, 2025, and published on October 3, 2025, covering non-aqueous ophthalmic compositions containing specific amounts of atropine and other compounds [1]. - The European patent (No. 4225284) was granted on November 26, 2025, and published on the same day, also focusing on ophthalmic compositions for treating myopia [1]. Group 2: Product Development - CBT-009 is a novel atropine ophthalmic formulation designed for treating myopia in children and adolescents aged 5 to 19, offering improved stability, safety, and patient tolerance compared to existing aqueous formulations [2]. - The combined Phase 1 and Phase 2 clinical trials for CBT-009 were completed in Australia in January 2023, demonstrating good safety and efficacy [2]. - The company received a non-objection letter from the FDA in September 2024, allowing the initiation of Phase 3 clinical trials after a six-month ocular toxicity study [2]. Group 3: Commercialization Potential - The successful patent applications are expected to facilitate collaborations with major pharmaceutical companies for the production, development, and distribution of CBT-009 in key markets like Japan and Europe [3]. - These collaborations and licensing arrangements are anticipated to enhance and accelerate the global commercialization potential of CBT-009 [3].

Core Viewpoint - The successful patent grants for CBT-009 represent a significant milestone in the product's development, enhancing its global reach and commercial potential [1][3]. Group 1: Patent Achievements - ADS Therapeutics LLC has been granted patents in Japan and Europe for CBT-009, which involves non-aqueous ophthalmic compositions aimed at treating myopia [1]. - The Japanese patent (No. 7749020) was issued on September 25, 2025, and published on October 3, 2025, covering various ophthalmic compositions including atropine and specific compounds [1]. - The European patent (No. 4225284) was granted on November 26, 2025, and published the same day, also focusing on compositions for treating myopia [1]. Group 2: Product Development - CBT-009 is a novel atropine ophthalmic formulation designed for treating myopia in children and adolescents aged 5 to 19, offering improved stability, safety, and patient tolerance compared to existing aqueous formulations [2]. - Preclinical studies for CBT-009 began in China and the U.S. in 2021 and 2022, respectively, with combined Phase 1 and 2 clinical trials completed in Australia in January 2023, demonstrating good safety and efficacy [2]. - The company received a non-objection letter from the FDA in September 2024, allowing for the initiation of Phase 3 clinical trials, with ongoing preparations for these trials in China [2]. Group 3: Commercialization Potential - The successful patent applications are expected to facilitate collaborations with major pharmaceutical companies for the production, development, and distribution of CBT-009 in key markets like Japan and Europe [3]. - These collaborations and licensing arrangements are anticipated to enhance and accelerate the global commercialization potential of CBT-009 [3].

Core Viewpoint - ST Unimed (002581.SZ) reported a significant increase in revenue for Q3, achieving 141 million yuan, which is double the total revenue of the first two quarters of the year, leading to a total revenue of 212 million yuan for the first three quarters [1] Group 1: Financial Performance - The company faced challenges in the first half of the year due to the suspension of production and sales at its subsidiary Tianjin Unimed, resulting in poor revenue and profit performance [1] - The financial performance improved in Q3, aided by the accelerated investment and consolidation of Sichuan Gukang Pharmaceutical Co., which is expected to contribute significantly to the company's overall financial results [1] - Gukang Pharmaceutical is projected to achieve revenues of 73.93 million yuan and a net profit of 4.15 million yuan in 2024, with net profit accelerating to 9.85 million yuan in the first four months of 2025, surpassing the total for 2024 [1] Group 2: Business Development - The company is focusing on sustainable development and has a robust pipeline of core products, including the nerve growth factor injection product [2] - The fully-owned subsidiary Shandong Yandu Biotechnology is developing a range of biopharmaceuticals, including a second-generation nerve growth factor eye drop, which is entering Phase III clinical trials [2] - The Chinese ophthalmic drug market is expected to grow at a compound annual growth rate of 19.1% from 2024 to 2030, indicating a significant market opportunity for the company's products [2] Group 3: Strategic Initiatives - The company is actively promoting rectification measures for Tianjin Unimed and is progressing with the construction of the Shandong Unimed Biopharmaceutical Industrial Park, which is set to commence in 2024 [3] - These initiatives are expected to enhance the company's operational performance and governance, potentially leading to continued revenue and profit recovery in the future [3]

Core Insights - The company reported a revenue of 1.904 billion yuan, representing a year-on-year growth of 32.27%, and a net profit attributable to shareholders of 599 million yuan, with a significant increase of 105.98% [1] - The product portfolio includes a wide range of ophthalmic drugs, covering ten categories, which positions the company well in the market [1] - The company is enhancing its R&D capabilities and has made significant progress in clinical trials for new products, indicating a strong focus on innovation [1][2] Group 1 - The company has established a comprehensive ophthalmic drug product system, addressing various eye diseases such as myopia, dry eye, and glaucoma [1] - R&D investment has been consistently increasing, with breakthroughs in key areas, including the initiation of Phase II clinical trials for new eye drops [1][2] - The company is actively expanding its market presence through a multi-channel strategy, including partnerships with hospitals, retail pharmacies, and e-commerce platforms [2] Group 2 - The rising prevalence of eye diseases due to lifestyle changes and an aging population presents a significant market opportunity for ophthalmic drugs [3] - The company is capitalizing on these market trends by broadening its product line and enhancing its innovative R&D capabilities [3] - The ongoing development and market expansion efforts are expected to support the company's sustained growth and competitive positioning in the ophthalmic sector [3]

Core Insights - Shenyang Xingqi Eye Pharmaceutical Co., Ltd. continues to experience rapid growth in revenue and profit, with a significant increase in both metrics for the third quarter of 2025 [1] Financial Performance - For the first three quarters of this year, the company achieved operating revenue of 1.904 billion yuan, a year-on-year increase of 32.27% [1] - The net profit attributable to shareholders reached 599 million yuan, reflecting a year-on-year growth of 105.98% [1] - In the third quarter alone, the company reported operating revenue of 741 million yuan, up 35.34% year-on-year, and a net profit of 264 million yuan, which is a 117.45% increase year-on-year [1] Product Development and Market Position - The company specializes in the ophthalmic drug sector, maintaining a leading position in research and development, with a comprehensive product line [1] - Xingqi Eye Pharmaceutical has developed a diverse range of ophthalmic products, including treatments for myopia, dry eye, infections, inflammation, and glaucoma, covering ten subcategories of ophthalmic drugs [1] - The growth in revenue is primarily attributed to increased sales of eye drop products [1] Innovation and R&D Focus - Since its inception, the company has prioritized the development of new products with independent intellectual property rights as a key goal for continuous improvement and innovation [2] - Recent product approvals include cyclosporine eye drops and atropine sulfate eye drops, contributing to rapid revenue and profit growth [2] - New products such as tafluprost eye drops have received drug registration certificates, and several others are in various stages of clinical trials [2]

Core Viewpoint - The launch of OC-01, a novel nasal spray for treating dry eye syndrome, marks a significant advancement in the treatment landscape for dry eye patients in China, transitioning from external substitutes to internal stimulation of tear production [1][6]. Group 1: Product Launch and Market Impact - OC-01 was officially launched in mainland China during the 11th Global Dry Eye Academic Conference, indicating a new era in dry eye treatment [1]. - The product is expected to capture a significant share of the dry eye medication market, which is projected to reach 180 billion yuan, providing effective and convenient treatment for millions of dry eye patients [7]. Group 2: Clinical and Market Validation - OC-01 has shown promising results in the U.S. market, with over 97,000 prescriptions written within a year of its approval and approximately $42 million in sales revenue in 2023 [6]. - The product's innovative mechanism, which stimulates natural tear production through nasal administration, addresses the limitations of traditional eye drops, enhancing patient compliance and treatment efficacy [6][5]. Group 3: Industry Context and Future Prospects - The dry eye syndrome is a prevalent condition, affecting 21.0%-52.4% of the population in China, with a notable increase in younger patients, particularly those aged 18-35, whose incidence has risen by 400% over the past decade [5]. - The broader ophthalmic market in China is expected to grow significantly, with projections estimating the eye care drug market to reach 440 billion yuan by 2025 and 1,084 billion yuan by 2030 [9]. Group 4: Company Pipeline and Innovation Strategy - The company has developed a comprehensive pipeline of innovative ophthalmic products, including treatments for dry eye syndrome, meibomian gland dysfunction, and other eye conditions, enhancing its market position [9][12]. - Recent approvals and clinical advancements in the company's pipeline indicate a strong commitment to innovation and market expansion, with multiple products expected to be launched in the coming years [13].