公司名稱: 歐康維視生物 (「本公司」) （於開曼群島註冊成立的有限公司） 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 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) | 01477 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 USD | | 50,000 | 本月底法定 ...

OT-703是一款用于治疗糖尿病性黄斑水肿（DME）的可注射、非生物降解的氟轻松玻璃体植入剂，能 够在眼部连续释放最多36个月的微量非专有皮质类固醇醋酸氟轻松(FAc)。 1月20日，欧康维视生物发布公告称，其产品OT-703（ILUVIEN ，氟轻松玻璃体植入剂）在海南省博鳌 乐城国际医疗旅游先行区进行的真实世界研究已完成195例患者的入组。 ...

智通财经APP讯，欧康维视生物-B(01477)发布公告，本集团产品OT-703(ILUVIEN，氟轻松玻璃体植入 剂)(是一款可注射的、非生物降解的氟轻松玻璃体植入剂，用于治疗糖尿病性黄斑水肿(DME))最近已完 成于中华人民共和国海南省博鰲乐城国际医疗旅游先行区进行的真实世界研究合共195例患者的入组。 OT-703(即190微克氟轻松玻璃体内植入剂(0.19毫克))是一款可注射的、非生物降解的氟轻松玻璃体植入 剂，通过于眼部连续缓释最多36个月的微量非专有皮质类固醇醋酸氟轻松(FAc)治疗DME。其已获得美 国食品药品监督管理局(FDA) 的监管批准，并以商号"ILUVIEN"上市。OT-703是FDA批准的唯一一款缓 释长达3年的治疗DME的皮质类固醇眼内植入剂。于2021年4月，本公司与Alimera Sciences, Inc. (Alimera)订立一份独家许可协议，据此，本公司自Alimera获得 ILUVIEN在大中华区、韩国及东南亚11 个国家的独家开发及商业化许可权利。于2023年12月，OT-703获得香港药剂业及毒药管理局的批准， 可根据香港法例第 138章《药剂业及毒药条例》在香港 ...

Core Viewpoint - The announcement highlights the completion of patient enrollment for a real-world study of OT-703 (ILUVIEN), a non-biodegradable fluocinolone acetonide intravitreal implant for treating diabetic macular edema (DME) in Hainan, China [1] Group 1: Product Overview - OT-703 is an injectable, non-biodegradable fluocinolone acetonide implant that provides continuous release of the drug for up to 36 months [1] - It is the only FDA-approved intravitreal implant for DME that offers a sustained release for three years [1] Group 2: Regulatory Approvals - OT-703 has received regulatory approval from the U.S. Food and Drug Administration (FDA) and is marketed under the brand name "ILUVIEN" [1] - In December 2023, OT-703 was approved by the Hong Kong Pharmacy and Poisons Board for registration as a pharmaceutical product under the Pharmacy and Poisons Ordinance [1] Group 3: Licensing Agreement - In April 2021, the company entered into an exclusive licensing agreement with Alimera Sciences, Inc., granting the company exclusive rights to develop and commercialize ILUVIEN in Greater China, South Korea, and 11 Southeast Asian countries [1] Group 4: Study Details - The real-world study involved a total of 195 patients enrolled in Hainan, China [1]

Core Viewpoint - The company has successfully completed the enrollment of 195 patients in a real-world study for its product OT-703 (ILUVIEN®), which is used to treat diabetic macular edema (DME) [1] Group 1: Product Information - OT-703 is an injectable, non-biodegradable fluocinolone acetonide intravitreal implant that provides continuous release of a small amount of non-proprietary corticosteroid for up to 36 months to treat DME [2] - It is the only FDA-approved intravitreal implant that offers a sustained release for up to 3 years for the treatment of DME [2] - The product has received regulatory approval from the FDA and is marketed under the brand name "ILUVIEN®" [2] Group 2: Licensing and Approvals - In April 2021, the company entered into an exclusive licensing agreement with Alimera Sciences, Inc., granting it exclusive rights for the development and commercialization of ILUVIEN® in Greater China, South Korea, and 11 Southeast Asian countries [2] - In December 2023, OT-703 received approval from the Hong Kong Pharmacy and Poisons Board to be registered as a pharmaceutical product under the Pharmacy and Poisons Ordinance [2]

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。 OT-703於海南博鰲進行的真實世界研究完成患者入組 本公告乃由歐康維視生物（「本公司」，連同其附屬公司，統稱為「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5月13日有關OT-703獲批真實世界研究的公告。 本公司董事會（「董事會」）欣然宣佈，本集團產品OT-703（ILUVIEN®，氟輕鬆玻 璃體植入劑）（是一款可注射的、非生物降解的氟輕鬆玻璃體植入劑，用於治療糖 尿病性黃斑水腫(DME)）最近已完成於中華人民共和國海南省博鰲樂城國際醫療 旅遊先行區進行的真實世界研究合共195例患者的入組。 OT-703（即190微克氟輕鬆玻璃體內植入劑（0.19毫克））是一款可注射的、非生 物降解的氟輕鬆玻璃體植入劑，通過於眼部連續緩釋最多36個月的微量非專有皮 質類固醇醋酸氟輕鬆(FAc)治療DME。其已獲得美國食品藥品監督管理局(FDA) 的監管批 ...

FF301 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: 2025年12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: 歐康維視生物 (「本公司」) （於開曼群島註冊成立的有限公司） 呈交日期: 2026年1月7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) | 01477 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | 0.00001 | USD | | 50,00 ...

Share Repurchase - As of December 31, 2024, the company repurchased a total of 20,949,500 shares to hold as treasury stock[2] - The company plans to utilize the repurchased treasury shares for various purposes, including cash generation, transfer, and cancellation[2]

Core Insights - The article highlights the acceleration of business development (BD) activities in the medical device sector from September to November 2025, with a total of 58 transactions identified across various subfields, including cardiovascular, nuclear medicine, and AI-enabled devices [2][3][4]. Group 1: Mergers and Acquisitions - Mergers and acquisitions have become a prominent form of BD, with companies leveraging capital control and product integration for rapid market positioning [7][8]. - Notable acquisitions include HeartLink's $680 million all-stock acquisition of Micro-Invasive Cardiology, enhancing its structural heart disease and rhythm management capabilities [7]. - Hua'an Zhonghui's acquisition of Bangni Medical marks its entry into the absorbable suture market, indicating a shift in surgical instrument competition towards material innovation [7]. Group 2: Strategic Collaborations - Strategic partnerships have been formed during the China International Import Expo, with companies like Shanghai Pharmaceuticals collaborating with international giants such as Boston Scientific and Medtronic to enhance their supply chain and academic promotion systems [7][8]. - The collaboration between GuoYao Medical and BDI Medical aims to deepen market penetration in the biomedicine and medical device sectors, focusing on compliance and distribution channel construction [13]. Group 3: Cross-Border Cooperation - Cross-border transactions have become more active, with foreign companies establishing local R&D and production systems in China, while domestic firms are exporting their solutions globally [9][10]. - The partnership between Trasis SA and Beijing Pait Biotechnology to establish a joint venture reflects a trend towards localized production and phased integration in the Chinese market [12]. Group 4: Ecosystem Building and Channel Expansion - The integration of supply chains and ecosystem building is a key theme, with companies focusing on collaborative agreements to enhance their market presence [11][15]. - The collaboration between Baxter and Neusoft Medical aims to create a comprehensive surgical solution by integrating their respective technologies [12]. Group 5: AI and Smart Healthcare - AI and data-driven approaches are becoming central to BD collaborations, with companies increasingly focusing on smart healthcare solutions [16][17]. - The partnership between Kefu Medical and Tencent Cloud to develop AI-powered hearing aids exemplifies the trend of integrating technology into healthcare products [21]. Group 6: Research and Diagnostic Synergy - The frequency of research-oriented collaborations is rising, indicating a shift from manufacturing-driven to research-driven industry dynamics [18][19]. - The collaboration between BGI and Infinera to enhance clinical applications of sequencing technology highlights the growing importance of research in driving innovation in the medical device sector [21].

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: 2025年11月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 歐康維視生物 (「本公司」) （於開曼群島註冊成立的有限公司） 呈交日期: 2025年12月4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) | 01477 | 說明 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | 0.00001 | USD | | 50,000 | I ...