股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2026年1月31日 | 狀態: 新提交 | | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | 公司名稱: | 兆科眼科有限公司 | | | 呈交日期: | 2026年2月3日 | | | I. 法定/註冊股本變動 | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06622 | 說明 | 兆科眼科有限公司 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,600,000,000,000 | USD | 0.00000025 | USD | | 400,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 1,60 ...

Group 1 - The stock of Zhaoke Ophthalmology-B (06622.HK) has increased by over 5%, currently up 5.28% at HKD 3.79 [1] - The trading volume reached HKD 6.119 million [1]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has seen a stock price increase of over 5%, currently trading at HKD 3.79, with a transaction volume of HKD 6.119 million, following the announcement of FDA approval for its eye drop product [1] Group 1: FDA Approval and Product Details - Zhaoke Ophthalmology announced that its partner, Tenpoint Therapeutics, has received FDA approval for the commercialization of Carbachol and Bromonidine Tartrate Eye Drops (2.75%/0.1%) [1] - The eye drop, known as BRIMOCHOL PF during clinical trials, will be marketed in the U.S. under the name YUVEZZI, aimed at treating presbyopia [1] Group 2: Commercial Strategy and Partnerships - The FDA approval is considered a strong catalyst for Zhaoke Ophthalmology as it formulates its commercialization strategy [1] - The company has established a partnership network for BRIMOCHOL PF, which currently includes eight commercial partners across the Asia-Pacific region (including South Korea, Australia, New Zealand, Thailand, Indonesia, Taiwan/Hong Kong/Macau, Singapore, and Vietnam) and the Middle East [1] - With FDA recognition, Zhaoke anticipates accelerating the market launch of the drug, marking a significant global milestone [1]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has seen a stock price increase of over 5% following the announcement of FDA approval for its eye drop product, marking a significant milestone for the company [1] Group 1: Company Developments - Zhaoke Ophthalmology announced that its partner, Tenpoint Therapeutics, Ltd., received FDA approval for the commercialization of Carbachol and Bromfenac eye drops (2.75%/0.1%) [1] - The eye drop, known as BRIMOCHOL™ PF during clinical trials, will be marketed in the U.S. under the name YUVEZZI™ for the treatment of presbyopia [1] - The FDA approval is seen as a strong catalyst for Zhaoke's commercialization strategy, with the company having established a partnership network across the Asia-Pacific region and the Middle East [1] Group 2: Market Impact - Following the FDA approval announcement, Zhaoke Ophthalmology's stock rose by 5.28%, reaching HKD 3.79, with a trading volume of HKD 6.119 million [1] - The approval is expected to accelerate the market entry of the drug, representing an important global milestone for the company [1]

Core Insights - The approval of BRIMOCHOL™ PF marks a significant breakthrough in the treatment of presbyopia, introducing the world's first combination eye drop for this condition [2][4][11] - The drug's approval by the FDA highlights its efficacy and safety, addressing a substantial unmet clinical need in the presbyopia treatment market [4][5][11] Drug Approval and Clinical Data - BRIMOCHOL™ PF has been validated through two key Phase III clinical trials, demonstrating superior efficacy compared to its individual active components [4][5] - The first Phase III trial (BRIO-I) confirmed the drug's effectiveness, while the second trial (BRIO-II) showed significant improvements in uncorrected near visual acuity without compromising distance vision [4][5] - The drug has shown good tolerability with no serious treatment-related adverse events reported during over 72,000 treatment days [4][5] Market Potential and Strategic Positioning - Approximately 1.2 billion people globally are affected by presbyopia, with a significant portion of the population over 50 years old impacted [5] - The approval of BRIMOCHOL™ PF fills a market gap for combination therapies in presbyopia, positioning the company favorably against competitors [5][11] - The company is actively pursuing global business development (BD) partnerships, having licensed the drug to eight countries in the Asia-Pacific region and six in the Middle East [2][6][8] Business Development Strategy - The company's BD strategy focuses on leveraging partnerships to expedite market entry in key regions, contrasting with the self-reliant approach of some competitors [6][8] - The FDA's approval is expected to facilitate faster regulatory processes in other countries, potentially simplifying or waiving clinical trial requirements based on FDA data [8][9] - This proactive approach is anticipated to significantly shorten the commercialization timeline compared to the typical 3-5 year approval cycle in the region [9] Financial Outlook and Growth Potential - The approval of BRIMOCHOL™ PF is expected to be a core revenue driver for the company in the coming years, alongside other innovative products in its pipeline [9][11] - The company's stock has shown a recovery, with a more than 150% increase since 2025, reflecting positive market expectations for its growth [11] - The ongoing development of other products, such as cyclosporine eye gel and low-concentration atropine, further supports the company's international expansion and diversification strategy [9][11]

Core Viewpoint - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL PF, an innovative eye drop treatment for presbyopia, which will be marketed as YUVEZZI in the U.S. [1] Group 1 - The approval follows the successful completion of Phase 3 clinical trials, with the first key Phase 3 study (BRIO I) demonstrating the combination therapy's superiority over individual therapies [1] - The second Phase 3 study (BRIO II) achieved all primary endpoints for near vision improvement, showing a statistically significant increase in binocular uncorrected near visual acuity (BUCNVA) by three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decrease by one line or more [1] Group 2 - During the BRIO II study, BRIMOCHOL PF showed good tolerability with no serious treatment-related adverse events reported, and the incidence of eye redness was low [2] - The report rate of eye redness for subjects receiving BRIMOCHOL PF was 2.8%, significantly lower than the 10.7% for those receiving only carbachol [2] Group 3 - This FDA approval serves as a strong catalyst for the company's commercialization strategy, with a partnership network established across the Asia-Pacific region and the Middle East, including eight commercial partners [2] - With FDA recognition, the company anticipates accelerating the market entry of BRIMOCHOL PF, marking an important global milestone [2]

Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL™ PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI™ in the U.S. [1][2] - The approval follows the successful completion of Phase 3 clinical trials, with the BRIO I study demonstrating the combination therapy's superiority over individual therapies [1] - The BRIO II study showed that BRIMOCHOL™ PF significantly improved binocular uncorrected near visual acuity (BUCNVA) by three lines or more, with no significant decline in binocular uncorrected distance visual acuity (BUCDVA) [1] Clinical Trial Results - In the BRIO II study, BRIMOCHOL™ PF was well-tolerated, with no serious treatment-related adverse events reported during over 72,000 treatment days [2] - The incidence of eye redness (conjunctival hyperemia) as a side effect was low, with a report rate of 2.8% for BRIMOCHOL™ PF compared to 10.7% for those receiving only carbachol [2] Commercial Strategy - The approval serves as a strong catalyst for the company's commercialization strategy, having established a partnership network that includes eight commercial partners across the Asia-Pacific region and the Middle East [2] - With FDA recognition, the company anticipates accelerating the market entry of BRIMOCHOL™ PF, marking a significant global milestone [2]

Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI in the U.S. [1][2] Group 1: Clinical Trial Results - The approval follows the successful completion of Phase 3 clinical trials, with the first key Phase 3 study (BRIO I) demonstrating that the combination therapy is more effective than individual active drug compounds [1] - In the second placebo-controlled Phase 3 study (BRIO II), BRIMOCHOL PF met all primary endpoints for near vision improvement, showing a statistically significant increase in binocular uncorrected near visual acuity (BUCNVA) by three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decrease by one line or more [1] Group 2: Safety and Tolerability - During the monitoring of over 72,000 treatment days in the BRIO II study, BRIMOCHOL PF was well-tolerated, with no treatment-related serious adverse events observed [2] - The incidence of eye redness (conjunctival hyperemia) as a reported adverse event was low, with a rate of 2.8% in BRIMOCHOL PF recipients compared to 10.7% in those receiving only carbachol [2] Group 3: Commercial Strategy - The FDA approval serves as a strong catalyst for the company's commercialization strategy, as it has established a partnership network for BRIMOCHOL PF, including eight commercial partners across the Asia-Pacific region and the Middle East [2] - With FDA recognition, the company anticipates accelerating the market entry of the drug, marking a significant global milestone [2]

Core Insights - Tenpoint Therapeutics, Ltd. has received FDA approval for the commercialization of BRIMOCHOL™ PF (2.75%/0.1%), an innovative eye drop for the treatment of presbyopia, which will be marketed as YUVEZZI™ in the U.S. [1][2] - The approval follows the successful completion of Phase 3 clinical trials, with the BRIO I study demonstrating the combination therapy's superiority over individual therapies [1] - The BRIO II study showed significant improvement in binocular uncorrected near visual acuity (BUCNVA), with a statistically significant increase of three lines or more, while binocular uncorrected distance visual acuity (BUCDVA) did not decline by one line or more [1] Clinical Trial Results - In over 72,000 treatment days monitored during the BRIO II study, BRIMOCHOL™ PF exhibited good tolerability, with no serious treatment-related adverse events observed [2] - The incidence of eye redness as a side effect was low, with only 2.8% of subjects experiencing this adverse event compared to 10.7% in those receiving only carbachol [2] Commercial Strategy - The FDA approval serves as a strong catalyst for the company's commercialization strategy, with established partnerships across the Asia-Pacific region and the Middle East [2] - The company anticipates that FDA recognition will expedite the market entry of BRIMOCHOL™ PF, marking a significant global milestone [2]

Core Viewpoint - The approval of BRIMOCHOL™PF by the FDA represents a significant milestone for the company, enabling the commercialization of an innovative treatment for presbyopia, which is expected to accelerate the drug's market entry [1][2]. Group 1: FDA Approval and Clinical Trials - The company's partner, Tenpoint Therapeutics, received FDA approval for the commercialization of BRIMOCHOL™PF, a combination eye drop treatment for presbyopia [1]. - The approval followed successful completion of Phase 3 clinical trials, with the BRIOI study demonstrating the combination therapy's superiority over individual treatments [1]. - In the BRIOII study, BRIMOCHOL™PF met all primary endpoints for improving near vision, showing a statistically significant increase in binocular uncorrected near visual acuity (BUCNVA) by three lines or more, while maintaining binocular uncorrected distance visual acuity (BUCDVA) [1]. Group 2: Safety and Tolerability - The BRIMOCHOL™PF showed good tolerability during over 72,000 treatment days monitored in the BRIOII study, with no serious treatment-related adverse events reported [2]. - The incidence of eye redness as a side effect was low, with only 2.8% of participants in the BRIOII study reporting this compared to 10.7% in those receiving only carbachol [2]. Group 3: Commercial Strategy and Partnerships - The FDA approval serves as a strong catalyst for the company's commercialization strategy, as it has established a network of eight commercial partners across the Asia-Pacific region and the Middle East [2]. - The recognition from the FDA is expected to expedite the market entry of BRIMOCHOL™PF, marking an important global milestone for the company [2].