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]

先健科技公司 （在開曼群島註冊成立的有限公司） 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份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 （股份代號：1302） 自願公告 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團自主研發的IBS®可吸收藥物洗 脫冠脈支架系統（「IBS®冠脈支架」或「本產品」）已順利完成II期臨床研究（「II期臨床 研究」）和III期臨床研究（「III期臨床研究」）兩年隨訪，並於美國當地時間二零二五 年十月二十六至二十七日，由中國醫學科學院阜外醫院宋雷教授代表高潤霖院士和 全體研究者於二零二五年經導管心血管治療年會（「TCT 2025」）向全球公佈IBS®冠 脈支架II期臨床研究的兩年主要終點影像隨訪結果和III期臨床研究的兩年臨床終點 隨訪結果。 IBS®冠脈支架II期臨床研究是一項前瞻性、多中心、單盲、隨機對照臨床研究， 主要研究終點為冠脈支架植入術後兩年病變節段內晚期管腔丟失。II期臨床研究於 ...

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9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: 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10月6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 ...

LifeTech Scientific Corporation 先 健 科 技 公 司 (Incorporated in the Cayman Islands with limited liability) The English and Chinese versions of the Company's Current Corporate Communication are available on the Company's website at www.lifetechmed.com and the website of The Stock Exchange of Hong Kong Limited (the "Stock Exchange") at www.hkexnews.hk respectively (the "Website Version"). The Company strongly recommends that you access the Website Version of Current Corporate Communication. If you have difficult ...

LifeTech Scientific Corporation 先 健 科 技 公 司 (Incorporated in the Cayman Islands with limited liability) （於開曼群島註冊成立之有限公司） （Stock Code 股份代號：1302） NOTIFICATION LETTER 通知信函 Dear Registered Shareholders, LifeTech Scientific Corporation (the "Company") – Notice of publication of Interim Report 2025 (the "Current Corporate Communication") The English and Chinese versions of the Company's Current Corporate Communication are now available on the Company's website at www.lifetechmed.com and the website of The Stock E ...