Group 1 - The total market capitalization of Chinese biotech stocks listed in Hong Kong has increased by 154% year-to-date, significantly outperforming the Hang Seng Index's 34% rise, indicating a major shift in market recognition of local pharmaceutical companies' innovation capabilities [1] - The expectation of the Federal Reserve accelerating interest rate cuts is anticipated to boost risk appetite, directing funds towards growth sectors such as Chinese biotech [1] - Individual stock performance will still depend on company fundamentals, including commercialization execution and innovation research progress [1] Group 2 - Companies with short-term catalysts that are favored include Kangfang Biotech (09926), Innovent Biologics (09969), Huyou-B (02256), Sinopharm (01801), and Eucure Biopharma-B (09606) [1] - Morgan Stanley has given "outperform" ratings to Weisheng Pharmaceutical-B (02561) and Zai Lab (09688) [1]

[Company Information](index=3&type=section&id=Company%20Information) This section provides essential corporate details, including board composition, committee memberships, and key contact and registration information [Board of Directors and Committees](index=3&type=section&id=Board%20of%20Directors%20and%20Committees) This section details Visen Pharmaceuticals' Board members and committee compositions, noting recent changes - Mr. Michael J CHANG resigned as a non-executive director on **August 27, 2025**[7](index=7&type=chunk) - Mr. ZHANG Qing was appointed as an independent non-executive director and joined the Audit Committee on **August 27, 2025**[7](index=7&type=chunk) - Mr. FU Shan ceased to be a member of the Audit Committee on **August 27, 2025**[7](index=7&type=chunk) [Company Contact and Registration Information](index=3&type=section&id=Company%20Contact%20and%20Registration%20Information) This section provides key contact and registration details for Visen Pharmaceuticals, including its registered office, headquarters, and official website - The auditor is **Ernst & Young**[7](index=7&type=chunk) - The company's headquarters are located at Room 3-108, 3/F, Building B, Hengtai Ideal Innovation Building, No. 69 Jiuzhang Road, Suzhou, China[8](index=8&type=chunk) - The stock code is **2561**, and the official website is **https://www.visenpharma.com**[9](index=9&type=chunk) [Financial Highlights](index=5&type=section&id=Financial%20Highlights) Visen Pharmaceuticals reported an expanded loss in H1 2025, but significantly increased cash and cash equivalents, improving its balance sheet structure after a global offering Key Financial Data for H1 2025 | Metric | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | | :--- | :--- | :--- | | Other income | 5,301 | 7,248 | | Net other gains and losses | (7,062) | 1,582 | | Research and development costs | (46,621) | (38,917) | | Administrative expenses | (60,045) | (43,643) | | Finance costs | (39) | (90) | | Listing expenses | (9,554) | (9,651) | | Loss for the period | (118,020) | (83,471) | | Loss per share (basic and diluted) (RMB) | (1.18) | (0.89) | Balance Sheet (Period-end) | Metric | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Cash and cash equivalents | 805,909 | 203,587 | | Total assets | 893,359 | 293,823 | | Total liabilities | 37,807 | 52,548 | | Total equity | 855,552 | 241,275 | [Management Discussion and Analysis](index=6&type=section&id=Management%20Discussion%20and%20Analysis) This section covers Visen Pharmaceuticals' business overview, product pipeline, financial status, R&D, IP, employees, and future strategy, highlighting core product progress and enhanced liquidity from its IPO [Overview and Product Pipeline](index=6&type=section&id=Overview%20and%20Product%20Pipeline) Visen Pharmaceuticals is a late-stage biopharmaceutical company focused on endocrine disease treatments in China, with core product lonapegsomatropin and two key products, palopegteriparatide and navepegritide, showing significant clinical and regulatory progress - The company, established in **November 2018**, is a late-stage biopharmaceutical company focused on providing treatment solutions for specific endocrine diseases in China (including Hong Kong, Macau, and Taiwan)[12](index=12&type=chunk) - The core product, lonapegsomatropin, has completed its China Phase 3 pivotal trial, with its BLA accepted by the NMPA in **March 2024** and currently undergoing a second round of technical review[13](index=13&type=chunk)[14](index=14&type=chunk) - The key candidate drug, palopegteriparatide, is undergoing a China Phase 3 pivotal trial, with the double-blind phase completed in **January 2023**[13](index=13&type=chunk)[14](index=14&type=chunk) - Another key candidate drug, navepegritide, has completed both the double-blind and open-label phases of its China Phase 2 clinical trial[13](index=13&type=chunk)[14](index=14&type=chunk) [Core Product: Lonapegsomatropin](index=7&type=section&id=Core%20Product%3A%20Lonapegsomatropin) Lonapegsomatropin, the company's core product for pediatric growth hormone deficiency, has completed China Phase 3 trials, submitted BLA, and is expected to be approved in Q4 2025, with active commercialization preparations underway - Lonapegsomatropin has demonstrated statistically significant superiority in 52-week AHV compared to daily human growth hormone, being the only long-acting growth hormone to show superiority and comparable safety in a positive drug-controlled, parallel-group trial against short-acting human growth hormone[18](index=18&type=chunk) - The BLA for lonapegsomatropin for PGHD treatment was accepted by the NMPA on **March 7, 2024**, with the second round of technical review initiated on **May 21, 2025**, and BLA approval anticipated in **Q4 2025**[20](index=20&type=chunk)[21](index=21&type=chunk) - The company has entered into a commercial supply framework agreement with Ascendis Pharma to ensure core product supply post-commercialization and is collaborating with WuXi Biologics for localized production technology transfer, expected to be completed by **2027** with commercialization of localized products by **2028**[23](index=23&type=chunk)[24](index=24&type=chunk)[26](index=26&type=chunk) - The US FDA has approved SKYTROFA® (lonapegsomatropin-tcgd) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD)[28](index=28&type=chunk) - The company is increasing its field medical representatives, medical training, channel management, medical affairs, and customer service personnel, and has formed strategic partnerships with Shanghai Pharma, United Family Healthcare, and Anhui Anke Biotechnology (Group) Co., Ltd. to strengthen its commercial team and market penetration[29](index=29&type=chunk) [Key Product: Palopegteriparatide](index=10&type=section&id=Key%20Product%3A%20Palopegteriparatide) Palopegteriparatide, a key product for adult hypoparathyroidism, has completed its China Phase 3 double-blind trial, achieving primary endpoints, with the open-label phase ongoing and expected to finish by late 2025 - The double-blind phase of the China Phase 3 pivotal trial was completed in **January 2023**, with key data indicating achievement of primary and key secondary efficacy endpoints[31](index=31&type=chunk) - The open-label phase of the China Phase 3 pivotal trial is ongoing, with the 3-year open-label phase expected to be completed by **late 2025**[32](index=32&type=chunk) - The company plans to introduce palopegteriparatide through the clinical urgent use channel in the Boao Lecheng International Medical Tourism Pilot Zone, with the first patient expected to receive prescription and treatment by **year-end 2025**[33](index=33&type=chunk) - Partner Ascendis Pharma's global Phase 2 and 3 trial data indicate that long-term use of palopegteriparatide for adult hypoparathyroidism continues to provide sustained efficacy[33](index=33&type=chunk) [Key Product: Navepegritide](index=11&type=section&id=Key%20Product%3A%20Navepegritide) Navepegritide, a key product for children with achondroplasia in China, has completed its Phase 2 clinical trial, achieving primary endpoints, with results submitted to the NMPA - The China Phase 2 trial for navepegritide in achondroplasia was completed on **May 12, 2025** (including 52-week double-blind and 52-week open-label phases), with results submitted to the NMPA drug registration platform[36](index=36&type=chunk) - Final results from the China Phase 2 trial showed that navepegritide maintained clinical efficacy and good safety in treating Chinese children with achondroplasia, with the 100μg CNP/kg/week navepegritide group achieving a higher AGV (**5.939 cm/year**) compared to placebo (**4.760 cm/year**)[37](index=37&type=chunk) - The company expects to hold a consultation meeting with the NMPA's Center for Drug Evaluation (CDE) before year-end regarding priority review eligibility and rare disease review procedures[38](index=38&type=chunk) - Partner Ascendis Pharma announced that the US FDA has accepted its NDA for navepegritide for pediatric achondroplasia for priority review, setting a PDUFA target date of **November 30, 2025**[38](index=38&type=chunk) [Financial Position](index=12&type=section&id=Financial%20Position) As of June 30, 2025, the company's cash and cash equivalents significantly increased to RMB 806 million, primarily due to net proceeds from its global offering, enhancing financial flexibility and liquidity Cash and Cash Equivalents | Metric | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Cash and cash equivalents | 805,909 | 203,587 | - Cash and cash equivalents increased by **RMB 602 million** from year-end 2024, primarily from net proceeds of the global offering upon the company's listing on the HKEX on **March 21, 2025**[39](index=39&type=chunk) - The company recently secured an unsecured bank credit facility of **RMB 300 million**, which will enhance capital utilization efficiency and financial flexibility[39](index=39&type=chunk) [Collaborations](index=12&type=section&id=Collaborations) The company signed a strategic cooperation agreement with the China Alliance for Rare Diseases to expand collaboration in pediatric growth and development, focusing on disease mechanisms, diagnosis, treatment, and prognosis - The company signed a strategic cooperation agreement with the **China Alliance for Rare Diseases**, continuing their partnership[40](index=40&type=chunk) - The collaboration will expand from achondroplasia to broader pediatric growth and development, jointly researching disease pathogenesis, diagnosis, clinical treatment, and prognosis[40](index=40&type=chunk) [Research and Development](index=12&type=section&id=Research%20and%20Development) The company maintains a strong internal R&D team focused on endocrinology and pediatrics, with 31 full-time employees as of June 30, 2025, and R&D expenses of approximately RMB 46.6 million for the period, primarily for technology transfer and localization - As of **June 30, 2025**, the R&D team comprised **31 full-time employees**, with approximately **42% holding PhD or MD degrees**[41](index=41&type=chunk) - The R&D team possesses an average of over **15 years of experience** in clinical development of drugs and/or endocrine therapies[41](index=41&type=chunk) R&D Expenditure Details | R&D Expenditure Item | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | | :--- | :--- | :--- | | Contract costs | 21,825 | 12,820 | | Raw materials and consumables | 2,824 | 3,318 | | Staff costs | 14,363 | 17,469 | | Share-based payment expenses | 5,368 | 993 | | Depreciation and amortization | 722 | 1,512 | | Others | 1,519 | 2,805 | | **Total** | **46,621** | **38,917** | - R&D expenses for the reporting period were approximately **RMB 46.6 million**, primarily due to increased costs associated with technology transfer and localization[42](index=42&type=chunk)[55](index=55&type=chunk) [Intellectual Property](index=13&type=section&id=Intellectual%20Property) The company holds exclusive IP rights in China for developing, manufacturing, and commercializing its core products and other candidates, including 58 granted patents and 56 pending applications under exclusive license, plus proprietary patents - The company holds exclusive licenses for **58 granted patents** and **56 pending patent applications** in China (including Hong Kong, Macau, and Taiwan) obtained from Ascendis Pharma[44](index=44&type=chunk) - The company also currently holds **4 proprietary pending patent applications** in China related to lonapegsomatropin[44](index=44&type=chunk) - The company co-owns **3 granted patents** and **13 pending patent applications** in China related to container closure systems[44](index=44&type=chunk)[46](index=46&type=chunk) - As of the report date, the company holds **127 registered trademarks** and **40 pending trademark applications** in China (including Hong Kong, Macau, and Taiwan)[46](index=46&type=chunk) [Employees and Remuneration Policy](index=14&type=section&id=Employees%20and%20Remuneration%20Policy) As of June 30, 2025, the group had 54 full-time employees with a remuneration package including salaries, benefits, bonuses, and share options, and total staff costs for the period increased to approximately RMB 66.3 million - As of **June 30, 2025**, the Group had **54 full-time employees**, all located in China (including Hong Kong, Macau, and Taiwan)[47](index=47&type=chunk) - The Group's employee remuneration package includes salaries, benefits, bonuses, and share options, designed to compensate employees based on performance[47](index=47&type=chunk) - Total staff costs (including directors' and CEO's emoluments) incurred by the Group for the six months ended June 30, 2025, were approximately **RMB 66.3 million**, compared to approximately **RMB 55.5 million** for the six months ended June 30, 2024[47](index=47&type=chunk) [Future Outlook](index=15&type=section&id=Future%20Outlook) The company plans to advance regulatory approvals and clinical development, build commercialization capabilities, ensure localized production, expand indications, and grow its product pipeline through strategic collaborations to become a leading endocrinology enterprise in China - Expedite regulatory approval for core products and clinical development and regulatory approval for other pipeline candidates[51](index=51&type=chunk) - Establish commercialization capabilities supported by patient support and market access, laying the groundwork for future candidate commercialization[51](index=51&type=chunk) - Establish localized production capabilities to ensure the supply of core products and future potential candidate drugs in China[51](index=51&type=chunk) - Further expand the product pipeline through strategic in-licensing, collaborations, and partnerships, introducing endocrine therapies seeking entry into China[51](index=51&type=chunk) [Financial Review](index=16&type=section&id=Financial%20Review) During the reporting period, the company experienced decreased other income, a shift from net other gains to losses, and increased R&D and administrative expenses, leading to a 41.4% expansion in loss for the period to RMB 118.0 million Financial Performance Review | Metric | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | Change | | :--- | :--- | :--- | :--- | | Other income | 5,301 | 7,248 | -26.9% | | Net other gains and losses | (7,062) | 1,582 | Shift from gain to loss | | Research and development costs | (46,621) | (38,917) | +19.8% | | Administrative expenses | (60,045) | (43,643) | +37.6% | | Loss for the period | (118,020) | (83,471) | +41.4% | - Other income decreased by **26.9%** to **RMB 5.3 million**, primarily due to a non-recurring government grant of **RMB 2.9 million** recognized in the six months ended June 30, 2024, partially offset by a **RMB 1.0 million** increase in bank interest income from higher average deposit balances post-listing[52](index=52&type=chunk) - Net other gains and losses shifted from a gain of **RMB 1.6 million** for the six months ended June 30, 2024, to a loss of **RMB 7.1 million** for the six months ended June 30, 2025, primarily due to unfavorable exchange rate fluctuations during the reporting period[53](index=53&type=chunk) - Research and development costs increased by **19.8%** to **RMB 46.6 million**, primarily due to increased costs associated with technology transfer and localization[55](index=55&type=chunk) - Administrative expenses increased by **37.6%** to **RMB 60.0 million**, primarily due to increased share-based payment expenses under the share award scheme and higher professional service fees post-listing[56](index=56&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company's cash and cash equivalents significantly increased to RMB 806 million, primarily from global offering proceeds, providing a strong financial foundation despite negative operating cash flow, with no outstanding borrowings and improved current ratio - As of **June 30, 2025**, cash and cash equivalents were **RMB 806 million**, an increase of **RMB 602 million** from year-end 2024, primarily from net proceeds of the global offering[39](index=39&type=chunk)[60](index=60&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2025, was **RMB 108.7 million**[60](index=60&type=chunk) - The current ratio increased from **4.3** as of December 31, 2024, to **23.0** as of June 30, 2025, primarily due to a significant increase in cash and cash equivalents[64](index=64&type=chunk) - As of **June 30, 2025**, the company had no outstanding borrowings[65](index=65&type=chunk) - As of **June 30, 2025**, the company recorded net current assets of **RMB 831.4 million**, an increase of **RMB 661.0 million** from **RMB 170.4 million** as of December 31, 2024[69](index=69&type=chunk) [Material Investments and Acquisitions/Disposals](index=19&type=section&id=Material%20Investments%20and%20Acquisitions%2FDisposals) During the reporting period, the Group made no material investments, had no future plans for significant investments or capital assets beyond those disclosed in the prospectus, and conducted no material acquisitions or disposals of subsidiaries, associates, or joint ventures - For the six months ended June 30, 2025, the Group made no material investments[71](index=71&type=chunk) - As of the report date, the Group has no material investment and capital asset plans other than those disclosed in the 'Use of Proceeds' section of this report[72](index=72&type=chunk) - For the six months ended June 30, 2025, the Group did not undertake any material acquisitions or disposals of subsidiaries, associates, or joint ventures[73](index=73&type=chunk) [Supplementary Information](index=20&type=section&id=Supplementary%20Information) This section covers interim dividend policy, corporate governance, securities trading, board changes, major shareholder interests, equity incentive plans, and use of global offering proceeds [Interim Dividend](index=20&type=section&id=Interim%20Dividend) The Board of Directors resolved not to recommend an interim dividend for the six months ended June 30, 2025 - The Board of Directors resolved not to recommend an interim dividend for the six months ended **June 30, 2025**[75](index=75&type=chunk) [Corporate Governance](index=20&type=section&id=Corporate%20Governance) The company adheres to high corporate governance standards, complying with the Listing Rules' Corporate Governance Code since its listing, with the Audit Committee reviewing the interim financial report - The company has adopted the principles and code provisions of the Corporate Governance Code set out in Appendix C1 to the Listing Rules as the basis for its corporate governance practices[77](index=77&type=chunk) - Former Board Chairman Mr. Michael Wolff JENSEN was unable to attend the AGM held on **June 27, 2025**, due to other work commitments, with the meeting chaired by Executive Director and CEO Mr. LU Anbang[77](index=77&type=chunk) - The Audit Committee has discussed and reviewed this interim report with management and external auditors, concluding that the interim results comply with applicable accounting principles, standards, and requirements[81](index=81&type=chunk) - The interim financial statements for the six months ended June 30, 2025, are unaudited but have been reviewed by the company's auditor, Ernst & Young, in accordance with Hong Kong Standard on Review Engagements 2410[81](index=81&type=chunk) [Securities Transactions and Investments](index=21&type=section&id=Securities%20Transactions%20and%20Investments) The company adopted the Model Code for directors' securities transactions, with all directors confirming compliance, and neither the company nor its subsidiaries purchased, sold, or redeemed any listed securities during the period - Following specific inquiries to all directors, all directors confirmed their compliance with the Model Code from the listing date up to the date of this report[79](index=79&type=chunk) - From the listing date up to the date of this interim report, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[82](index=82&type=chunk) - As of the report date, the Group has no material investment and capital asset plans other than those disclosed in the prospectus and the 'Use of Proceeds' section of this report[83](index=83&type=chunk) [Changes to Board and Directors' Information](index=21&type=section&id=Changes%20to%20Board%20and%20Directors'%20Information) Mr. Michael Wolff JENSEN and Mr. Jan Møller MIKKELSEN retired after the AGM on June 27, 2025, with Mr. FU Shan succeeding as Chairman, and Mr. Michael J. CHANG resigning as non-executive director, replaced by Mr. ZHANG Qing as independent non-executive director on August 27, 2025 - Mr. Michael Wolff JENSEN and Mr. Jan Møller MIKKELSEN retired after the company's Annual General Meeting held on **June 27, 2025**[84](index=84&type=chunk) - Mr. FU Shan was proposed and elected to succeed as Chairman of the Board, effective from the conclusion of the AGM[84](index=84&type=chunk) - Mr. Michael J. CHANG resigned as a non-executive director, effective **August 27, 2025**[84](index=84&type=chunk) - Mr. ZHANG Qing was appointed as an independent non-executive director, effective **August 27, 2025**[84](index=84&type=chunk) [Equity Disclosure](index=22&type=section&id=Equity%20Disclosure) This section discloses interests of directors, chief executives, and major shareholders in the company's shares, with Executive Director Mr. LU Anbang holding approximately 4.77% and major shareholders Ascendis Pharma A/S and Vivo Capital IX (Cayman), LLC. holding 36.11% and 32.62% respectively Interests of Directors and Chief Executive in the Company's Shares | Name of Director | Nature of Interest | Number of Shares (2) | Approximate Percentage of Shareholding (3) | | :--- | :--- | :--- | :--- | | Mr. LU Anbang | Beneficiary of trust / Settlor of discretionary trust | 5,435,000 (L) | 4.77% | Interests and Short Positions of Substantial Shareholders and Other Persons in the Company's Shares and Underlying Shares | Name of Shareholder | Capacity / Nature of Interest | Number of Shares (3) | Approximate Percentage of Shareholding (4) | | :--- | :--- | :--- | :--- | | Ascendis Pharma A/S (1) | Interest in controlled corporation | 41,136,364 (L) | 36.11% | | Vivo Capital IX (Cayman), LLC. (2) | Interest in controlled corporation | 37,167,064 (L) | 32.62% | - Ascendis Pharma A/S holds a total of **41,136,364 shares** through its wholly-owned subsidiaries Ascendis Pharma Endocrinology Division, Ascendis Pharma Growth Disorders, and Ascendis Pharma Bone Diseases[90](index=90&type=chunk) - Vivo Capital IX (Cayman), LLC. holds a total of **37,167,064 shares** through its controlled entities Vivo Capital Fund IX (Cayman), L.P. and Vivo Plenilune IX Limited[90](index=90&type=chunk) [Equity Incentive Plans](index=24&type=section&id=Equity%20Incentive%20Plans) The company has an equity incentive plan and a post-IPO share award scheme to incentivize and retain talent, with 8,845,500 unexercised restricted share units under the former and 435,000 award shares granted to Mr. LU Anbang under the latter - The equity incentive plan aims to help the company and its affiliates acquire and retain the services of eligible awardees, motivating them to contribute their utmost to the success of the company and its affiliates[92](index=92&type=chunk) - As of the date of this interim report, **8,845,500 unexercised restricted share units** equivalent to shares have been granted to **23 grantees** under the equity incentive plan, of which **5,000,000 shares** were granted to Mr. LU[93](index=93&type=chunk)[95](index=95&type=chunk) - The post-IPO share award scheme aims to align the interests of eligible participants with those of the Group through share ownership, dividends, other paid distributions related to shares, and/or share appreciation[97](index=97&type=chunk) - On **June 12, 2025**, the Board resolved to grant a total of **435,000 award shares** to Mr. LU Anbang, the company's Executive Director and CEO, under the post-IPO share award scheme, which was approved at the AGM on **June 27, 2025**[102](index=102&type=chunk)[104](index=104&type=chunk) - As of the date of this interim report, **1,964,500 new shares** remain available for grant under the post-IPO share award scheme[103](index=103&type=chunk) [Use of Proceeds from Global Offering](index=28&type=section&id=Use%20of%20Proceeds%20from%20Global%20Offering) The net proceeds from the global offering were approximately HK$672.3 million (RMB 620.2 million), with the company maintaining its planned use of proceeds as stipulated in the prospectus, having utilized RMB 44.8 million by June 30, 2025, primarily for lonapegsomatropin BLA registration and R&D - Net proceeds from the global offering (after full exercise of the over-allotment option) were approximately **HK$672.3 million** (equivalent to **RMB 620.2 million**)[106](index=106&type=chunk) - The company has not changed the planned use of proceeds as stipulated in the prospectus[106](index=106&type=chunk) Details of Use of Proceeds from Global Offering (As of June 30, 2025) | Purpose | Planned Net Proceeds (RMB million) | Actual Amount Utilized (RMB million) | Unutilized Amount (RMB million) | | :--- | :--- | :--- | :--- | | Import BLA registration for lonapegsomatropin | 43.4 | 18.3 | 25.1 | | R&D for locally manufactured lonapegsomatropin products | 126.5 | 9.7 | 116.8 | | R&D for new indication expansion of lonapegsomatropin | 196.6 | – | 196.6 | | Commercial supply of lonapegsomatropin | 154.4 | – | 154.4 | | R&D and regulatory application for palopegteriparatide | 47.1 | 8.0 | 39.1 | | R&D for China Phase 2 trial of navepegritide | 11.2 | 5.8 | 5.4 | | General working capital | 41.0 | 3.0 | 38.0 | | **Total** | **620.2** | **44.8** | **575.4** | [Events After Reporting Period](index=29&type=section&id=Events%20After%20Reporting%20Period) No significant events affecting the company occurred from the end of the reporting period up to the date of this interim report, other than those already disclosed - Other than those disclosed in this interim report, no significant events affecting the company occurred from the end of the reporting period up to the date of this interim report[109](index=109&type=chunk) [Independent Review Report](index=30&type=section&id=Independent%20Review%20Report) Ernst & Young reviewed Visen Pharmaceuticals' interim condensed consolidated financial information for the six months ended June 30, 2025, concluding it was prepared in all material respects according to IAS 34 - Ernst & Young has reviewed the condensed consolidated statement of financial position of Visen Pharmaceuticals and its subsidiaries as of **June 30, 2025**, and the related financial statements for the six-month period ended on that date[110](index=110&type=chunk) - A review is substantially less in scope than an audit conducted in accordance with Hong Kong Standards on Auditing, and consequently, no audit opinion is expressed[111](index=111&type=chunk) - Based on the review, nothing has come to the reviewer's attention that causes them to believe the interim financial information is not prepared, in all material respects, in accordance with International Accounting Standard 34[112](index=112&type=chunk) [Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=31&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2025, the company reported a loss for the period of RMB 118,020 thousand, an increase from RMB 83,471 thousand in the prior year, with basic and diluted loss per share at RMB 1.18 Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income | Metric | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | | :--- | :--- | :--- | | Other income | 5,301 | 7,248 | | Net other gains and losses | (7,062) | 1,582 | | Research and development costs | (46,621) | (38,917) | | Administrative expenses | (60,045) | (43,643) | | Finance costs | (39) | (90) | | Listing expenses | (9,554) | (9,651) | | Loss before tax | (118,020) | (83,471) | | Loss for the period | (118,020) | (83,471) | | Total comprehensive loss for the period | (117,891) | (83,645) | | Loss per share (basic and diluted) (RMB) | (1.18) | (0.89) | [Interim Condensed Consolidated Statement of Financial Position](index=32&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, the company's total assets increased to RMB 893,359 thousand, with cash and cash equivalents significantly rising to RMB 805,909 thousand, while total liabilities decreased and total equity grew substantially to RMB 855,552 thousand, indicating improved financial health Interim Condensed Consolidated Statement of Financial Position | Metric | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Total non-current assets | 24,105 | 71,250 | | Total current assets | 869,254 | 222,573 | | **Total assets** | **893,359** | **293,823** | | Total current liabilities | 37,807 | 52,188 | | Total non-current liabilities | – | 360 | | **Total liabilities** | **37,807** | **52,548** | | **Total equity** | **855,552** | **241,275** | - Net current assets increased from **RMB 170,385 thousand** as of December 31, 2024, to **RMB 831,437 thousand** as of June 30, 2025[116](index=116&type=chunk) [Interim Condensed Consolidated Statement of Changes in Equity](index=34&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Changes%20in%20Equity) For the six months ended June 30, 2025, total equity increased from RMB 241,275 thousand to RMB 855,552 thousand, primarily driven by RMB 697,863 thousand from shares issued in the IPO, despite a loss of RMB 118,020 thousand for the period Interim Condensed Consolidated Statement of Changes in Equity | Metric | As of January 1, 2025 (RMB '000) | Loss for the period (RMB '000) | Shares issued on initial public offering (RMB '000) | Equity-settled share-based payments (RMB '000) | As of June 30, 2025 (RMB '000) | | :--- | :--- | :--- | :--- | :--- | :--- | | Total | 241,275 | (118,020) | 697,863 | 34,305 | 855,552 | - Shares issued on initial public offering amounted to **RMB 697,863 thousand**, significantly increasing total equity[119](index=119&type=chunk) [Interim Condensed Consolidated Statement of Cash Flows](index=35&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash and cash equivalents increased by RMB 602,193 thousand, primarily due to net cash from financing activities of RMB 701,641 thousand (including share issuance proceeds), offsetting net cash used in operating activities of RMB 108,688 thousand Interim Condensed Consolidated Statement of Cash Flows | Cash Flow Category | Six Months Ended June 30, 2025 (RMB '000) | Six Months Ended June 30, 2024 (RMB '000) | | :--- | :--- | :--- | | Net cash flows used in operating activities | (108,688) | (69,305) | | Net cash flows from investing activities | 9,240 | – | | Net cash flows from financing activities | 701,641 | (1,984) | | Net increase in cash and cash equivalents | 602,193 | (71,289) | | Cash and cash equivalents at end of period | 805,909 | 276,319 | - Net cash flows from financing activities primarily resulted from proceeds from issuance of shares of **RMB 723,210 thousand**[121](index=121&type=chunk) [Notes to Interim Condensed Consolidated Financial Information](index=36&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Information) These notes detail the company's basic information, financial statement preparation, accounting policy changes, operating segments, income and expense breakdowns, taxes, dividends, EPS calculation, prepayments, cash, payables, share capital, commitments, related party transactions, and post-reporting period events [Company Information and Basis of Preparation](index=36&type=section&id=Company%20Information%20and%20Basis%20of%20Preparation) Visen Pharmaceuticals, incorporated in the Cayman Islands on November 1, 2018, focuses on developing and commercializing endocrine therapies, with its interim condensed consolidated financial information prepared according to IAS 34 and consistent accounting policies - The company was incorporated in the Cayman Islands on **November 1, 2018**, primarily engaged in the development and commercialization of endocrine therapies[122](index=122&type=chunk) - This interim condensed consolidated financial information has been prepared in accordance with International Accounting Standard 34 'Interim Financial Reporting' and should be read in conjunction with the Group's consolidated financial statements in the Accountants' Report set out in Appendix I to the company's prospectus[123](index=123&type=chunk) - The accounting policies adopted in the preparation of the interim condensed consolidated financial information are consistent with those applied in the preparation of the Accountants' Report[123](index=123&type=chunk) [Operating Segments and Geographical Information](index=37&type=section&id=Operating%20Segments%20and%20Geographical%20Information) The Group operates as a single reportable segment focused on developing and commercializing disruptive endocrine therapies, with no geographical segment information presented as almost all non-current assets are located in mainland China - For management purposes, the Group has only one reportable operating segment, which is the development and commercialization of disruptive endocrine therapies[127](index=127&type=chunk) - As almost all of the Group's non-current assets are located in mainland China, no geographical segment information is presented in accordance with IFRS 8 'Operating Segments'[128](index=128&type=chunk) [Other Income and Gains/Losses](index=37&type=section&id=Other%20Income%20and%20Gains%2FLosses) For the six months ended June 30, 2025, other income decreased by 26.9% to RMB 5,301 thousand due to reduced non-recurring government subsidies, while net other gains and losses shifted from a gain to a loss of RMB 7,062 thousand, primarily from unfavorable exchange rate fluctuations Other Income | Metric | Six Months Ended June 30 (RMB '000) | | :--- | :--- | | 2025 | 5,301 | | 2024 | 7,248 | - Other income decreased by **26.9%**, primarily due to a non-recurring government grant of **RMB 2.9 million** recognized in the six months ended June 30, 2024, partially offset by a **RMB 1.0 million** increase in bank interest income from higher average deposit balances post-listing[52](index=52&type=chunk)[129](index=129&type=chunk) Net Other Gains and Losses | Metric | Six Months Ended June 30 (RMB '000) | | :--- | :--- | | 2025 | (7,062) | | 2024 | 1,582 | - Net other gains and losses shifted from a gain of **RMB 1.6 million** for the six months ended June 30, 2024, to a loss of **RMB 7.1 million** for the six months ended June 30, 2025, primarily due to unfavorable exchange rate fluctuations during the reporting period[53](index=53&type=chunk)[130](index=130&type=chunk) [Loss Before Tax and Finance Costs](index=38&type=section&id=Loss%20Before%20Tax%20and%20Finance%20Costs) The company's loss before tax was influenced by depreciation, amortization, listing expenses, auditor's remuneration, short-term lease payments, and staff costs, including share-based payments, while finance costs were minimal, primarily from lease liabilities Components of Loss Before Tax | Expense Category | Six Months Ended June 30 (RMB '000) | | :--- | :--- | | Depreciation of property, plant and equipment | 148 | | Depreciation of right-of-use assets | 1,182 | | Amortization of intangible assets | 29 | | Listing expenses | 9,554 | | Auditor's remuneration | 1,228 | | Staff costs (including emoluments of directors, supervisors and chief executive) | 66,297 | | Of which: Share-based payment expenses | 34,305 | Finance Costs | Metric | Six Months Ended June 30 (RMB '000) | | :--- | :--- | | 2025 | 39 | | 2024 | 90 | - Finance costs represent interest on lease liabilities, amounting to **RMB 39 thousand** for the six months ended June 30, 2025[133](index=133&type=chunk) [Income Tax](index=39&type=section&id=Income%20Tax) Group entities pay income tax based on profits in their respective jurisdictions; no income tax in Cayman Islands and BVI, no profit tax provision in Hong Kong and Taiwan due to no assessable profits, and mainland China subsidiaries pay 25% corporate income tax with a 200% super deduction for qualified R&D expenses - Under current laws in the Cayman Islands and British Virgin Islands, the company and its BVI-incorporated subsidiaries are not subject to income or capital gains tax[135](index=135&type=chunk)[136](index=136&type=chunk) - No Hong Kong and Taiwan profits tax provision has been made as the Group did not generate any assessable profits in Hong Kong and Taiwan for the six months ended June 30, 2025[137](index=137&type=chunk)[139](index=139&type=chunk) - Subsidiaries operating in mainland China are subject to corporate income tax at a rate of **25%** on their taxable income and enjoy a **200% super deduction** for qualified research and development expenses[138](index=138&type=chunk) [Dividends and Loss Per Share](index=40&type=section&id=Dividends%20and%20Loss%20Per%20Share) For the six months ended June 30, 2025, the company neither paid nor declared any dividends, and basic and diluted loss per share expanded to RMB 1.18 from RMB 0.89 in the prior year - For the six months ended June 30, 2025, the company neither paid nor declared any dividends[140](index=140&type=chunk) Loss Per Share (Basic and Diluted) | Metric | Six Months Ended June 30 | | :--- | :--- | | 2025 (RMB '000) | (118,020) | | 2024 (RMB '000) | (83,471) | | Loss per share (basic and diluted) (RMB) | (1.18) | | 2024 (RMB) | (0.89) | - The weighted average number of ordinary shares outstanding during the period used in calculating basic and diluted loss per share was **100,052,220 shares** (2024: **93,636,364 shares**)[142](index=142&type=chunk) [Prepayments and Receivables](index=41&type=section&id=Prepayments%20and%20Receivables) As of June 30, 2025, non-current prepayments and other receivables totaled RMB 22,770 thousand, mainly comprising recoverable VAT and lease deposits, while current prepayments and other receivables totaled RMB 8,611 thousand, primarily for R&D services and accrued bank interest Prepayments and Other Receivables | Category | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Non-current: | 22,770 | 20,847 | | Current: | 8,611 | 11,184 | - Non-current prepayments and other receivables primarily include recoverable VAT of **RMB 22,455 thousand** and lease deposits of **RMB 315 thousand**[143](index=143&type=chunk) - Current prepayments and other receivables primarily include prepayments for research and development services of **RMB 3,537 thousand** and accrued bank interest of **RMB 2,470 thousand**[143](index=143&type=chunk) [Cash and Cash Equivalents](index=42&type=section&id=Cash%20and%20Cash%20Equivalents) As of June 30, 2025, cash and bank balances totaled RMB 805,909 thousand, primarily denominated in HKD (RMB 599,349 thousand) and RMB (RMB 166,299 thousand) Cash and Cash Equivalents by Currency | Currency | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | RMB | 166,299 | 138,106 | | USD | 39,206 | 62,258 | | NTD | 1,055 | 2,086 | | HKD | 599,349 | 1,137 | | **Total** | **805,909** | **203,587** | [Trade and Other Payables](index=42&type=section&id=Trade%20and%20Other%20Payables) As of June 30, 2025, trade and other payables totaled RMB 31,755 thousand, mainly comprising accrued R&D service expenses, salaries, and discretionary bonuses, with most trade payables to related parties due within three months Trade and Other Payables | Category | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Trade payables | 239 | 835 | | Accrued research and development service expenses | 20,653 | 9,316 | | Salaries and discretionary bonuses payable | 6,513 | 12,100 | | Other payables | 3,696 | 4,792 | | Accrued listing expenses | – | 9,075 | | Other taxes payable | 654 | 2,670 | | **Total** | **31,755** | **38,788** | - An aging analysis of trade payables and trade payables to related parties at the end of the reporting period shows that most are due within **three months**[145](index=145&type=chunk) [Share Capital and Treasury Shares](index=43&type=section&id=Share%20Capital%20and%20Treasury%20Shares) As of June 30, 2025, issued and fully paid share capital comprised 113,926,864 ordinary shares totaling RMB 78 thousand, an increase from year-end 2024 due to 11,385,000 ordinary shares issued in the IPO, with 8,905,500 treasury shares Issued and Fully Paid Share Capital | Metric | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | 113,926,864 (2024: 102,976,864) ordinary shares of US$0.0001 each | 78 | 70 | - Shares issued on initial public offering amounted to **11,385,000 ordinary shares**, with gross proceeds of **HK$783,288,000** (equivalent to **RMB 723,210,000**)[147](index=147&type=chunk) Treasury Shares | Metric | Number of Shares | | :--- | :--- | | As of June 30, 2025 | 8,905,500 | [Commitments and Contingent Liabilities](index=45&type=section&id=Commitments%20and%20Contingent%20Liabilities) As of the end of the reporting period, the Group had no material contractual commitments - As of the end of the reporting period, the Group had no material contractual commitments[148](index=148&type=chunk) [Related Party Transactions](index=45&type=section&id=Related%20Party%20Transactions) During the reporting period, the Group engaged in purchase transactions for goods and services with Ascendis Pharma and its subsidiaries, with amounts due to related parties of RMB 4,857 thousand and advances to related parties (current) of RMB 54,734 thousand as of June 30, 2025 Transactions with Related Parties | Type of Transaction | Six Months Ended June 30 (RMB '000) | | :--- | :--- | | Purchases of goods 2025 | 1,781 | | Purchases of goods 2024 | 1,664 | | Purchases of services 2025 | 6,872 | | Purchases of services 2024 | 9,084 | Outstanding Balances with Related Parties | Category | As of June 30, 2025 (RMB '000) | As of December 31, 2024 (RMB '000) | | :--- | :--- | :--- | | Amounts due to related parties | 4,857 | 11,403 | | Advances to related parties (current) | 54,734 | 7,802 | | Advances to related parties (non-current) | – | 39,193 | - Advances to related parties relate to prepayments for purchases of goods or services, are unsecured, and non-interest bearing[153](index=153&type=chunk) [Events After Reporting Period and Approval of Financial Statements](index=47&type=section&id=Events%20After%20Reporting%20Period%20and%20Approval%20of%20Financial%20Statements) No significant events occurred after the reporting period, other than those disclosed in this interim report, and the financial statements were approved and authorized for issue by the Board on August 27, 2025 - Other than those disclosed in this interim report, no significant events occurred after the reporting period[154](index=154&type=chunk) - The financial statements were approved and authorized for issue by the Board of Directors on **August 27, 2025**[155](index=155&type=chunk) [Definitions and Glossary](index=48&type=section&id=Definitions%20and%20Glossary) This section provides definitions for key terms and abbreviations used in the report, covering company, product, clinical trial stages, regulatory bodies, financial concepts, and other relevant industry terminology to ensure clear understanding - 'Achondroplasia' refers to a form of short-limbed dwarfism characterized by abnormal bone growth, where cartilage (especially in the long bones of the arms and legs) fails to convert into bone[156](index=156&type=chunk) - 'BLA' refers to a Biologics License Application, used to seek regulatory approval for the marketing and commercialization of a biologic product[156](index=156&type=chunk) - 'NMPA' refers to the National Medical Products Administration, a direct agency of the State Administration for Market Regulation, primarily responsible for the approval of INDs and NDAs[163](index=163&type=chunk)

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](