Core Viewpoint - The company has received official approval from the National Medical Products Administration of China for its G-BranchTM thoracoabdominal aortic stent graft system, which is designed for the treatment of thoracoabdominal aortic aneurysms (TAAA) [1][2] Group 1 - The G-BranchTM system is a pioneering product featuring a "dual inner and dual outer" hybrid branch design, allowing for full endovascular reconstruction of TAAA while maintaining blood supply to vital organs during the procedure [1] - The company holds independent intellectual property rights for the G-BranchTM product, which is expected to provide a systematic solution for TAAA patients [1] - The approval of the G-BranchTM system follows the earlier approvals of the aortic arch stent system and aortic covered stent system, enhancing the company's product portfolio in the peripheral vascular intervention field [2] Group 2 - The company aims to offer more flexible, comprehensive, safe, effective, and easy-to-operate solutions for thoracoabdominal aortic aneurysm endovascular reconstruction as commercialization progresses [2] - The company is committed to collaborating with industry experts to advance the development and launch of more urgently needed medical device products, driving growth in the medical device sector [2]

Core Viewpoint - The company has received official registration approval from the National Medical Products Administration of China for its G-BranchTM thoracoabdominal aortic stent graft system, developed in collaboration with a team from the First Medical Center of the Chinese People's Liberation Army General Hospital, marking a significant advancement in the treatment of thoracoabdominal aortic aneurysms (TAAA) [1][2] Group 1 - The G-BranchTM system is designed for the treatment of TAAA involving the celiac trunk, superior mesenteric artery, and bilateral renal arteries, enabling complete endovascular reconstruction of the thoracoabdominal aorta [1] - The product features a world-first "dual inner and dual outer flip" hybrid branch design, with different diameters for the upper and lower segments of the stent body, aligning with the starting positions of the body's visceral branch vessels [1] - The company holds independent intellectual property rights for the G-BranchTM product, which is expected to provide a systemic solution for TAAA patients through a fully endovascular approach, promising less trauma, simpler operation, and better adaptability [1] Group 2 - Following the approval of the aortic arch stent system and aortic covered stent system in the first half of 2025, the G-BranchTM product further enriches the company's product portfolio in the peripheral vascular intervention field [2] - The company is positioned as a leading innovative enterprise globally with a complete endovascular repair solution for the aorta, enhancing its commercial offerings [2] - The ongoing commercialization process aims to provide more flexible, comprehensive, safe, effective, and easy-to-operate solutions for thoracoabdominal aortic aneurysm reconstruction, while collaborating with industry experts to advance the development and launch of urgently needed medical devices [2]

Core Viewpoint - The announcement by Xianjian Technology (01302.HK) regarding the approval of the G-Branch™ thoracoabdominal aortic stent-graft system by the National Medical Products Administration of China signifies a significant advancement in the treatment of thoracoabdominal aortic aneurysms (TAAA) [1] Group 1 - The G-Branch™ system is developed in collaboration with Professor Guo Wei's team from the First Medical Center of the Chinese People's Liberation Army General Hospital [1] - The product is specifically designed for the treatment of TAAA involving the celiac trunk, superior mesenteric artery, and bilateral renal arteries [1] - The system enables complete endovascular reconstruction of thoracoabdominal aortic aneurysms [1]

香港交易及結算所有限公司與香港聯合交易所有限公司對本公佈的內容概不負責，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佈全部或任何部分內容而產生或因依賴該等內容 而引致的任何損失承擔任何責任。 LifeTech Scientific Corporation 先健科技公司 （在開曼群島註冊成立的有限公司） （股份代號：1302） 自願性公佈 G-BranchTM胸腹主動脈覆膜支架系統 獲得中國國家藥品監督管理局的正式註冊批准 本公佈乃由先健科技公司（「本公司」，連同其附屬公司稱為「本集團」）自願作出，旨 本公司董事（「董事」）會（「董事會」）欣然宣佈，於二零二五年十一月六日，由中國人 民解放軍總醫院第一醫學中心郭偉教授團隊與本集團聯合研發的 G-BranchTM胸腹主 動脈覆膜支架系統（「G-BranchTM」或「該產品」）獲中國國家藥品監督管理局（「國家 藥品監督管理局」）正式註冊批准。該產品適用於胸腹主動脈瘤（「TAAA」）累及腹腔 病變類型之一，瘤體一旦破裂，患者死亡率高達 95%。傳統開放手術風險極高， 創傷巨大，胸腹聯合切口可長達 1 米，手術耗時需 12 個小時，手術全身縫合超過 1, ...

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10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: 先健科技公司 (在開曼群島註冊成立的有限公司) 呈交日期: 2025年11月5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) | 01302 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 40,000,000,000 | USD | 0.00000125 | USD | | 50,000 ...

Core Insights - The demand for fully biodegradable vascular stents is increasing due to the aging population and rising incidence of cardiovascular diseases, with the market size in China expected to reach approximately 980 million yuan in 2024, representing a year-on-year growth of 12.64% [1][5]. Industry Overview - Fully biodegradable vascular stents are designed to gradually degrade and be absorbed by the body after fulfilling their vascular support function, addressing issues associated with traditional metal stents such as chronic inflammation and late thrombosis [2][4]. - The industry can be categorized into metal biodegradable stents and polymer biodegradable stents based on material type [2]. Industry Development History - The first domestic fully biodegradable stent (XINSORB) was tested in humans in September 2013, marking the beginning of clinical applications in China [3]. - The first domestically approved biodegradable stent, NeoVas by Lepu Medical, was launched in February 2019, utilizing polylactic acid materials that degrade within 2-3 years [4][6]. - By 2024, the XINSORB stent technology received recognition at the China International Industry Fair, with domestic stents capturing over 50% of the market share [4]. Industry Value Chain - The upstream of the industry includes raw materials such as magnesium alloys, nickel-titanium alloys, and biodegradable polymers, along with production equipment like 3D printers and sterilization devices [3]. - The midstream involves the manufacturing of fully biodegradable vascular stents, while the downstream applications target conditions like coronary artery disease and myocardial infarction [4]. Market Size - The market for fully biodegradable vascular stents is projected to grow significantly, driven by the increasing demand for advanced treatment technologies [5]. Key Companies' Performance - Lepu Medical leads the market with its NeoVas stent, which has a high clinical acceptance rate due to its precise degradation cycle [6]. - MicroPort Medical follows closely with its Firesorb stent, which features a thin-wall design and targeted drug-eluting technology, enhancing its competitive position in the high-end market [7]. Industry Development Trends 1. **Technological Innovation and Material Upgrades**: The industry is experiencing breakthroughs in material science and manufacturing processes, with a focus on matching degradation cycles with vascular remodeling [8]. 2. **Market Expansion and Internationalization**: Domestic demand is rising, supported by policies and price reductions, while exports are increasing through international certifications [8]. 3. **Policy Support and Regulatory Strengthening**: National procurement policies are driving down prices, and regulatory approvals are accelerating, enhancing market order and quality control [9].

Core Viewpoint - The company has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS absorbable drug-eluting coronary stent system, with results to be presented at the TCT 2025 conference in the U.S. [1][2] Group 1: Clinical Study Results - The two-year follow-up results of the Phase II clinical study showed that the late lumen loss in the lesion segment was 0.28±0.52mm in the experimental group and 0.23±0.43mm in the control group, achieving non-inferiority for the primary endpoint [1] - No stent thrombosis events occurred in the experimental group, while one event was reported in the control group [1] - The two-year clinical follow-up results of the Phase III clinical study indicated a target lesion failure (TLF) rate of 5.5%, with only five stent thrombosis cases reported, resulting in a thrombosis event rate of 0.5% [1] Group 2: Product Innovation and Market Potential - The IBS coronary stent is the world's first fully biodegradable iron-based absorbable coronary stent, made from high-strength and high-plasticity high-purity nitrided iron tubing, featuring a thin wall and strong support [2] - The innovative material research and unique technical approach allow the product to retain the advantages of permanent metal stents while also being fully absorbable, effectively avoiding long-term prognosis issues associated with permanent metal stents [2] - The publication of the two-year follow-up results for the Phase II and Phase III clinical studies enhances the evidence base for this innovative product, with data submitted for regulatory approval in China and the EU, potentially providing a safe and effective treatment for coronary heart disease patients globally [2]

Core Insights - The company has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS absorbable drug-eluting coronary stent system, with results to be presented at the TCT2025 conference [1][2] Group 1: Clinical Study Results - The two-year follow-up results of the Phase II clinical study showed that the late lumen loss in the lesion segment was 0.28±0.52mm for the experimental group and 0.23±0.43mm for the control group, achieving non-inferiority for the primary endpoint [1] - No stent thrombosis events occurred in the experimental group, while one event was reported in the control group [1] - The two-year clinical follow-up results of the Phase III clinical study indicated a target lesion failure (TLF) rate of 5.5%, with only five stent thrombosis events occurring, resulting in a thrombosis event rate of 0.5% [1] Group 2: Product Innovation and Regulatory Progress - The IBS coronary stent is the world's first fully biodegradable iron-based absorbable coronary stent, made from high-strength and high-plasticity high-purity nitrided iron tubing, featuring a thin wall and strong support [2] - The innovative material research and unique technical approach allow the product to retain the advantages of permanent metal stents while also being fully absorbable, effectively avoiding long-term prognosis issues associated with permanent metal stents [2] - The clinical study follow-up data for the IBS coronary stent has been submitted for approval to the National Medical Products Administration and EU CE registration, potentially providing a groundbreaking and safe treatment option for coronary heart disease patients globally [2]

Core Viewpoint - The company, Xianjian Technology (01302.HK), has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS® absorbable drug-eluting coronary stent system, with results to be presented at the TCT 2025 conference [1] Group 1 - The IBS® coronary stent has completed two-year follow-ups for both Phase II and Phase III clinical studies [1] - The results will be presented by Professor Song Lei from the Chinese Academy of Medical Sciences at the TCT 2025 conference held on October 26-27, 2025 [1] - The studies include major endpoint imaging follow-up results from the Phase II clinical study and clinical endpoint follow-up results from the Phase III clinical study [1]

Core Viewpoint - The company, Xianjian Technology (01302.HK), has successfully completed the two-year follow-up of Phase II and Phase III clinical studies for its self-developed IBS absorbable drug-eluting coronary stent system, which will be presented at the TCT 2025 conference in the U.S. [1] Group 1 - The IBS coronary stent has completed two-year follow-ups for both Phase II and Phase III clinical studies [1] - The results of the Phase II clinical study's two-year imaging follow-up and the Phase III clinical study's two-year clinical endpoint follow-up will be announced at the TCT 2025 conference [1] - The presentation will be made by Professor Song Lei from the Fuwai Hospital of the Chinese Academy of Medical Sciences on behalf of Academician Gao Runlin and all researchers [1]