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8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: 維昇藥業 (於開曼群島註冊成立的有限公司) 呈交日期: 2025年9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) | 02561 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 500,000,000 | USD | 0.0001 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 ...

Core Viewpoint - The Hong Kong IPO market is active, with 57 new listings and a total fundraising amount of 131.9 billion HKD as of August 25. However, many companies face challenges in meeting both domestic and Hong Kong regulatory requirements for listing [1]. Group 1: Hong Kong IPO Overview - As of August 25, 2023, there have been 57 new IPOs on the Hong Kong Stock Exchange, raising a total of 131.9 billion HKD [1]. - There are currently 211 companies that have submitted applications for listing in Hong Kong [1]. Group 2: Listing Challenges - Companies looking to list in Hong Kong must comply with both domestic laws and Hong Kong's regulatory framework, making the IPO preparation process complex and demanding [1]. Group 3: Resources for Companies - A compilation of Hong Kong listing rules and disclosure documents for domestic companies planning to list in Hong Kong has been organized to assist businesses in understanding the latest regulatory dynamics [1].

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，並明確表示不會就因本公告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。 VISEN Pharmaceuticals 本公司謹此對過往公告及通函進行補充說明，提供以下有關商業化供應框架協議 訂約方的資料。 商業化供應框架協議的訂約方 根據商業化供應框架協議，VISEN HK已同意由其本身或其附屬公司向Ascendis Europe及╱或其附屬公司購買藥物套裝、自動注射器及適用輔助產品。於2025 年8月29日，VISEN HK與Ascendis Europe訂立商業化供應框架協議的修訂協 議（「修訂協議」），據此，雙方同意VISEN HK（由其本身或其附屬公司）可向 Ascendis A/S及╱或其附屬公司（「Ascendis Group」）購買相關產品。根據修訂協 議，更廣泛的實體將獲准根據協議條款供應產品。 修訂協議主要因Ascendis Group的內部安排而訂立，旨在更好地分配內部資源以 通過集團內不同實體供應產品。該安排亦為VISEN與Ascendis Group雙方 ...

Core Viewpoint - The company reported a mid-year performance with a significant increase in R&D spending and a strategic focus on commercializing its core product, lonapegsomatropin, expected to receive BLA approval by Q4 2025 [1][2] Financial Performance - R&D expenditure for the first half of 2025 was approximately RMB 46.62 million, representing a year-on-year increase of 19.80% [1] - The company incurred a loss of RMB 118 million during the same period [1] - As of June 30, 2025, cash and cash equivalents amounted to RMB 806 million, an increase of RMB 602 million compared to the end of 2024 [1] - The company secured an unsecured bank credit facility of RMB 300 million to enhance financial flexibility [1] Product Development and Commercialization - The company anticipates that its core product, lonapegsomatropin, will receive BLA approval in Q4 2025, followed by commercialization efforts later in the year [1] - To support commercialization, the company is expanding its commercial team, including hiring more medical representatives and enhancing training and customer service [1] Strategic Partnerships - The company has entered into a strategic cooperation agreement with Shanghai Pharmaceuticals to establish a necessary management framework compliant with GSP [2] - A partnership with United Family Healthcare was formed to develop diagnostic and service capabilities for children with growth and development medical needs [2] - Discussions with Anke Bio regarding joint promotion of lonapegsomatropin in specific geographic areas are underway, with a strategic cooperation framework agreement signed on July 14, 2025 [2]

Core Viewpoint - The company reported a mid-term performance for the six months ending June 30, 2025, highlighting a total other income of 5.301 million RMB and an increase of 19.8% in research and development costs to 46.621 million RMB [1] Group 1: Financial Performance - The company achieved other income of 5.301 million RMB during the reporting period [1] - Research and development costs rose to 46.621 million RMB, reflecting a year-on-year increase of 19.8% [1] Group 2: Strategic Collaborations - The company is collaborating with WuXi Biologics, designated as the local CDMO in China, for the commercialization of lonapegsomatropin [1] - In July 2023, the company entered into a comprehensive technology transfer plan with Ascendis Pharma for its core product [1] - A cooperation agreement was signed with WuXi Biologics in December 2023, where WuXi will act as the local CDMO for process development and validation [1] Group 3: Technology Transfer and Development Timeline - As of June 2025, the company has completed the small-scale research and development for key reagents and intermediates [1] - The goal is to complete the small-scale research and development for the core product's active ingredient by the end of 2025 [1] - Full technology transfer and localization are expected to be completed by 2027, enabling the company to produce the core product's active ingredient in collaboration with WuXi Biologics [1]

Core Insights - The company reported other income of 5.301 million RMB for the six months ending June 30, 2025, while research and development costs increased by 19.8% to 46.621 million RMB [1] Group 1 - The company is collaborating with WuXi Biologics, its designated local CDMO in China, for the commercialization of lonapegsomatropin [1] - In July 2023, the company signed a master technology transfer agreement with Ascendis Pharma, marking the beginning of technology transfer for core product manufacturing [1] - A cooperation agreement was established with WuXi Biologics in December 2023, where WuXi will act as the local CDMO for process development and validation, facilitating local production technology [1] Group 2 - As of June 2025, the company has completed the small-scale research and development for key reagents and intermediates, aiming to finish the small-scale R&D for core product bulk solution technology transfer by the end of 2025 [1] - The entire technology transfer and localization process is expected to be completed by 2027, which will enable the company to produce core product drug bulk solutions in collaboration with WuXi Biologics [1]

VISEN Pharmaceuticals 維昇藥業 （於開曼群島註冊成立的有限公司） （股份代號：2561） 董事名單及其角色與職能 維昇藥業（「本公司」）董事（「董事」）會（「董事會」）成員載列如下： 執行董事 付山先生 （董事會主席） 曹弋博先生 獨立非執行董事 YAO Zhengbin (Bing)博士 陳炳鈞先生 倪虹女士 張勍先生 董事會下設三個委員會。下表載列該等委員會的成員資料： | 董事會委員會 | 審計委員會 | 薪酬委員會 | 提名委員會 | | --- | --- | --- | --- | | 董事 | | | | | 盧安邦先生 | | M | | | 付山先生 | | | C | | 曹弋博先生 | | | | | YAO Zhengbin (Bing)博士 | M | | M | | 陳炳鈞先生 | C | M | | | 倪虹女士 | | C | M | | 張勍先生 | M | | | 附註： C 相關董事會委員會主席 盧安邦先生 非執行董事 M 相關董事會委員會成員 2025年8月27日 ...

Company Announcements and Financial Summary This section details recent corporate announcements and provides a financial overview, highlighting increased losses and a significant rise in cash and cash equivalents [Announcement Information](index=1&type=section&id=1.1%20%E5%85%AC%E5%91%8A%E4%BF%A1%E6%81%AF) Visen Pharmaceuticals released its unaudited condensed consolidated interim results for the six months ended June 30, 2025, and announced directorate and audit committee changes - The company released its unaudited condensed consolidated interim results announcement for the six months ended June 30, 2025[2](index=2&type=chunk) - The announcement also included the resignation of a non-executive director, appointment of an independent non-executive director, and changes to the audit committee composition[2](index=2&type=chunk) [Financial Summary](index=1&type=section&id=1.2%20%E8%B4%A2%E5%8A%A1%E6%A6%82%E8%A6%81) For the six months ended June 30, 2025, the company's R&D costs and administrative expenses increased, leading to an expanded loss of **RMB 118 million**, while cash and cash equivalents significantly grew to **RMB 806 million** due to global offering proceeds Financial Summary for the Six Months Ended June 30 | Metric | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Research and development costs | (46,621) | (38,917) | | Administrative expenses | (60,045) | (43,643) | | Loss for the period | (118,020) | (83,471) | **Cash and Cash Equivalents at Period End:** | Metric | June 30, 2025 (RMB '000) | December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Cash and cash equivalents | 805,909 | 203,587 | - Loss for the period increased by **41.4%** year-on-year to **RMB 118 million**[4](index=4&type=chunk) - Cash and cash equivalents significantly increased from **RMB 204 million** at the end of 2024 to **RMB 806 million** as of June 30, 2025, primarily due to net proceeds from the global offering[4](index=4&type=chunk)[33](index=33&type=chunk) Business Overview and Product Pipeline This section outlines the company's profile, strategic focus, and detailed progress of its core and key product pipeline candidates [Company Profile and Strategy](index=4&type=section&id=2.1%20%E5%85%AC%E5%8F%B8%E7%AE%80%E4%BB%8B%E4%B8%8E%E6%88%98%E7%95%A5) Established in November 2018, Visen Pharmaceuticals is a late-stage biopharmaceutical company focused on endocrine disease treatments in China, with one core and two key products under exclusive license - Established in November 2018, the company is a late-stage biopharmaceutical company with products nearing commercialization, focused on providing specific endocrine disease treatments in China (including Hong Kong, Macau, and Taiwan)[9](index=9&type=chunk) - The company possesses one core product, **lonapegsomatropin**, and two key products, **palopegteriparatide** and **navepegritide**[9](index=9&type=chunk) - The company has secured exclusive licenses to develop, manufacture, and commercialize all candidate drugs in China (including Hong Kong, Macau, and Taiwan)[12](index=12&type=chunk) [Core Product: Lonapegsomatropin](index=2&type=section&id=2.2%20%E6%A0%B8%E5%BF%83%E4%BA%A7%E5%93%81%EF%BC%9A%E9%9A%86%E5%9F%B9%E7%94%9F%E9%95%B7%E6%BF%80%E7%B4%A0(lonapegsomatropin)) Lonapegsomatropin, the company's core product for pediatric growth hormone deficiency, has completed China Phase 3 trials, submitted BLA, and is advancing towards commercialization, local production, and market access - **Lonapegsomatropin** is the only long-acting growth hormone to demonstrate superiority and comparable safety in a positive drug-controlled, parallel-group trial against daily human growth hormone for pediatric growth hormone deficiency[5](index=5&type=chunk)[15](index=15&type=chunk) - The BLA was accepted by the NMPA on March 7, 2024, and entered its second technical review on May 21, 2025, with approval anticipated in **Q4 2025**[10](index=10&type=chunk)[17](index=17&type=chunk) [Product Overview and Clinical Progress](index=2&type=section&id=2.2.1%20%E4%BA%A7%E5%93%81%E6%A6%82%E8%A7%88%E4%B8%8E%E4%B8%B4%E5%BA%8A%E8%BF%9B%E5%B1%95) Lonapegsomatropin is a once-weekly long-acting growth hormone replacement therapy, demonstrating superior annualized height velocity (AHV) and comparable safety to daily injections in China Phase 3 trials - **Lonapegsomatropin** has completed a Phase 3 pivotal trial in China for children aged 3 to 17 with growth hormone deficiency, demonstrating statistically significant superior 52-week AHV compared to short-acting (daily injection) human growth hormone[15](index=15&type=chunk) - This product is the only long-acting growth hormone that continuously releases unmodified human growth hormone in vivo between weekly doses, with a molecular composition identical to endogenous growth hormone[15](index=15&type=chunk) [Registration and Commercialization Progress](index=6&type=section&id=2.2.2%20%E6%B3%A8%E5%86%8C%E4%B8%8E%E5%95%86%E4%B8%9A%E5%8C%96%E8%BF%9B%E5%B1%95) Lonapegsomatropin's BLA is in its second technical review, with expected approval in Q4 2025, supported by approved auto-injector devices and a commercial supply agreement with Ascendis Pharma - **Lonapegsomatropin's** BLA application was accepted by the NMPA on March 7, 2024, and initiated its second technical review on May 21, 2025, with approval expected in **Q4 2025**[17](index=17&type=chunk) - Import medical device registration applications for the auto-injector and needles were approved in **April 2024** and **April 2025**, respectively[5](index=5&type=chunk)[17](index=17&type=chunk) - On June 12, 2025, the company entered into a commercial supply framework agreement with Ascendis Pharma to ensure the supply of its core product post-launch[5](index=5&type=chunk)[18](index=18&type=chunk) [Local Production and Global Development](index=6&type=section&id=2.2.3%20%E6%9C%AC%E5%9C%B0%E7%94%9F%E4%BA%A7%E4%B8%8E%E5%85%A8%E7%90%83%E5%BC%80%E5%8F%91) The company is collaborating with Wuxi Biologics for local production of lonapegsomatropin, developing Dual Chamber Device (DCD) technology, and noting global trial results and US FDA approval for adult GHD - The company is collaborating with Wuxi Biologics for the commercial production of **lonapegsomatropin**, having completed technology transfer for key reagents and intermediates, aiming to complete drug substance technology transfer by **end of 2025** and full technology transfer and localization by **2027**[19](index=19&type=chunk) - The company successfully developed Dual Chamber Device (DCD) technology as a drug delivery platform for its self-developed formulations and has obtained multiple patents[5](index=5&type=chunk)[20](index=20&type=chunk) - Results from the enliGHten trial, published in *Hormone Research in Paediatrics*, showed **lonapegsomatropin** treatment for pediatric growth hormone deficiency patients resulted in sustained height improvement for up to **6 years**[22](index=22&type=chunk) - Ascendis Pharma announced that the US FDA approved SKYTROFA® (**lonapegsomatropin-tcgd**) for replacement of endogenous growth hormone in adult growth hormone deficiency[22](index=22&type=chunk) [Commercialization Plan and Market Access](index=7&type=section&id=2.2.4%20%E5%95%86%E4%B8%9A%E5%8C%96%E8%AE%A1%E5%88%92%E4%B8%8E%E5%B8%82%E5%9C%BA%E5%87%86%E5%85%A5) To prepare for lonapegsomatropin's anticipated Q4 2025 approval, the company is expanding its commercial team and forming strategic partnerships to broaden market coverage and accelerate product adoption - The company is expanding its field medical representatives, medical training, channel management, medical affairs, and customer service personnel to strengthen its commercial team in anticipation of the core product's expected approval in **Q4 2025**[23](index=23&type=chunk) - Strategic cooperation agreements have been signed with Shanghai Pharmaceuticals Holding Co., Ltd. and United Family Healthcare to jointly develop diagnostic and service capabilities for pediatric growth and development medical needs[23](index=23&type=chunk) - A strategic cooperation framework agreement was signed with Anke Bio to jointly promote **lonapegsomatropin** in certain geographical regions in China to expand commercial coverage and accelerate product adoption[5](index=5&type=chunk)[23](

Core Viewpoint - Vison Pharmaceutical - B (02561.HK) has announced a board meeting scheduled for August 27, 2025, to consider and approve the interim results for the six months ending June 30, 2025, along with other matters [1] Summary by Category - **Company Announcement** - The board meeting will focus on the interim performance results for the first half of 2025 [1] - The meeting is set to take place on a Wednesday, indicating a structured approach to corporate governance [1] - **Financial Reporting** - The interim results will cover the period ending June 30, 2025, which is crucial for assessing the company's financial health [1] - The announcement reflects the company's commitment to transparency and timely reporting to stakeholders [1]

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。 承董事會命 維昇藥業 執行董事兼首席執行官 盧安邦先生 香港，2025年8月15日 VISEN Pharmaceuticals 維昇藥業 （於開曼群島註冊成立的有限公司） （股份代號：2561） 董事會召開日期 維昇藥業（「本公司」及其附屬公司「本集團」）董事會（「董事會」）茲通告謹定於 2025年8月27日（星期三）舉行董事會會議，以考慮及通過本集團截至2025年6月 30日止六個月之中期業績，以及處理其他事項。 於本公告日期，董事會包括(i)執行董事盧安邦先生；(ii)非執行董事付山先生、 Michael J. CHANG先生及曹弋博先生；以及(iii)獨立非執行董事YAO Zhengbin (Bing)博士、陳炳鈞先生及倪虹女士。 ...