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 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] - 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]

Zhaoke Ophthalmology Limited （於英屬處女群島註冊成立並於開曼群島存續的有限公司） 兆科眼科有限公司 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。 （股份代號：6622） 兆科眼科的夥伴TENPOINT THERAPEUTICS, LTD. 接 獲FDA在美國 就BRIMOCHOL™ PF發出的批准 本 公 告 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 本 公 司 董 事 會 欣 然 宣 佈，本 公 司 的 夥 伴Tenpoint Therapeutics, Ltd.（「Tenpoint」）已 接 獲 美 國 食 品 藥 品 監 督 管 理 局（「FDA」）批 准 商 業 化 卡 巴 膽 鹼 及 酒 石 酸 溴 莫 尼 丁 滴 眼 液（2.75%/0.1%）的 監 管 批 准。此 滴 眼 液 於 臨 床 試 驗 期 間 ...

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has expanded its global commercialization rights for its core presbyopia treatment drug BRIMOCHOL™ PF to Singapore and Vietnam, enhancing its market presence in eight countries [1] Group 1: Company Developments - Zhaoke Ophthalmology has granted exclusive commercialization rights for BRIMOCHOL™ PF to AFT Pharmaceuticals in Singapore and to Santen Pharmaceutical in Vietnam [1] - The company’s global commercial footprint now includes South Korea, Australia, New Zealand, Thailand, Indonesia, Taiwan, Singapore, and Vietnam [1] Group 2: Partner Companies - AFT Pharmaceuticals is a multinational pharmaceutical company based in New Zealand, focusing on developing and licensing products in over 125 countries [1] - Santen Pharmaceutical is a Japan-based private pharmaceutical company with a strong emphasis on research and development, particularly in the ophthalmology sector [1]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has seen a stock price increase of over 5%, currently trading at 3.44 HKD, with a transaction volume of 1.707 million HKD, following the announcement of expanded partnerships for the commercialization of BRIMOCHOL™ PF in Singapore and Vietnam [1] Group 1: Partnerships and Commercialization - The company has expanded its partnership agreement with AFT Pharmaceuticals Limited to commercialize BRIMOCHOL™ PF in Singapore [1] - Zhaoke has also established a strategic partnership with Santen Pharmaceutical Co., Ltd. to commercialize the product in Vietnam [1] - AFT and Santen have been granted exclusive distribution rights in their respective markets, which include registration, import, promotion, distribution, marketing, and sales of BRIMOCHOL™ PF [1] Group 2: Product Information - BRIMOCHOL™ PF is a potential therapy for correcting near vision loss due to presbyopia, representing a core asset acquired through a partnership with Tenpoint Therapeutics, Ltd. [1] - The addition of AFT and Santen as commercialization partners marks the seventh and eighth partnerships for BRIMOCHOL™ PF, highlighting the company's commitment to global expansion [1]

Core Viewpoint - Zhaoke Ophthalmology-B (06622) has expanded its partnership with AFT Pharmaceuticals Limited for the commercialization of BRIMOCHOL™ PF in Singapore and established a strategic partnership with Santen Pharmaceutical Co., Ltd. for commercialization in Vietnam, indicating a strong commitment to global expansion [1] Group 1: Partnerships and Agreements - The company has granted exclusive distribution rights for BRIMOCHOL™ PF to AFT in Singapore and to Santen in Vietnam, which includes rights for registration, import, promotion, distribution, marketing, and sales in these markets [1] - AFT and Santen become the seventh and eighth commercialization partners for BRIMOCHOL™ PF, respectively, highlighting the company's strategy to broaden its market reach [1] Group 2: Product Information - BRIMOCHOL™ PF is a potential therapy aimed at correcting near vision loss due to presbyopia, representing a core asset acquired through a partnership with Tenpoint Therapeutics, Ltd. [1]

Group 1 - The company has expanded its partnership agreement with AFT Pharmaceuticals Limited to commercialize BRIMOCHOL™ PF in Singapore [1] - The company has also established a strategic partnership with Santen Pharmaceutical Co., Ltd. to commercialize the product in Vietnam [1] - AFT and Santen have been granted exclusive distribution rights for BRIMOCHOL™ PF in their respective markets, highlighting the company's commitment to global expansion [1] Group 2 - BRIMOCHOL™ PF is a potential therapy for correcting near vision loss due to presbyopia, acquired through a partnership with Tenpoint Therapeutics, Ltd. [2] - Tenpoint announced that the FDA has accepted the new drug application for BRIMOCHOL™ PF, with a review deadline set for January 28, 2026 [2] - The FDA has established a Prescription Drug User Fee Act (PDUFA) date for the drug, indicating progress towards commercialization [2]

（於英屬處女群島註冊成立並於開曼群島存續的有限公司） （股份代號：6622） 兆科眼科有限公司 自 願 性 公 告－ 透過與AFT及 千 寿 建 立 夥 伴 關 係，推 動 用 於 治 療 老 花 眼 的 BRIMOCHOL™ PF於新加坡及越南的商業化進程 本 公 告 乃 由 兆 科 眼 科 有 限 公 司（「本公司」）董 事 會（「董事會」）自 願 作 出。 本公司董事會欣然宣佈，本公司已擴大與領先健康護理產品製造商及分銷商AFT Pharmaceuticals Limited（「AFT」）的 夥 伴 協 議，以 於 新 加 坡 商 業 化BRIMOCHOL™ PF （「該產品」）。本 公 司 亦 已 與 亞 洲 領 先 眼 科 公 司 千 寿 製 薬 株 式 会 社（「千 寿」）建 立 策 略 夥 伴 關 係，以 於 越 南 商 業 化 該 產 品。 兆科分別授予AFT及 千 寿 於 新 加 坡 及 越 南 的 獨 家 分 銷 權，當 中 包 括 於 相 關 市 場 註 冊、進 口、推 廣、分 銷、營 銷 及 銷 售BRIMOCHOL™ PF的 權 利。透 過 該 等 協 議， AFT及千寿成為BRIM ...

Core Viewpoint - The company has established a strategic partnership with Taiwan-based Dongshenghua Pharmaceutical Co., Ltd. to jointly advance the clinical introduction and future commercialization of BRIMOCHOL™ PF in Taiwan [1] Group 1: Partnership Details - The agreement grants Dongshenghua Pharmaceutical exclusive rights as a distributor in Taiwan for the registration, importation, promotion, distribution, marketing, and sale of BRIMOCHOL™ PF [1] Group 2: Regulatory Milestones - In June 2025, Tenpoint Therapeutics, Ltd., the developer of BRIMOCHOL™ PF, announced that the FDA has accepted the new drug application for the product [1] - The FDA has set a review deadline for BRIMOCHOL™ PF under the Prescription Drug User Fee Act (PDUFA) for January 28, 2026 [1]