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: 聯邦制藥國際控股有限公司 呈交日期: 2025年10月2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) | 03933 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 3,800,000,000 | HKD | | 0.01 | HKD | | 38,000,000 | | 增加 / 減少 (-) | | | | | | | HKD | | | | 本月底結存 | | | 3,800,000,000 | HKD | | 0.01 | HKD | | 38,000,000 | 本月底法定/註冊股本總額： HKD 38,000,000 股份發行人及根據《上市規則》第十九B ...

Core Viewpoint - The announcement highlights the approval of a clinical trial application for UBT37034, a novel peptide receptor agonist targeting overweight or obesity, indicating a significant advancement in the company's product pipeline and potential market competitiveness [1] Group 1: Clinical Trial Approval - The clinical trial registration application for UBT37034 received implied approval from the National Medical Products Administration of China, with acceptance number CXHL2500772 [1] - UBT37034 is designed to selectively act on the neuropeptide Y2 receptor to aid in weight reduction [1] Group 2: Preclinical and Regulatory Milestones - Preclinical studies in various animal models demonstrated that UBT37034, in combination with GLP-1 analogs, can significantly reduce body weight [1] - The Investigational New Drug (IND) application for UBT37034 was approved by the U.S. Food and Drug Administration on July 2025, with IND number 175188 [1] Group 3: Future Outlook - The company aims to continue its focus on new product development to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - There is an expectation that these advancements will generate greater returns for the company and its shareholders [1]

Core Viewpoint - Federal Pharmaceutical (03933) has received implied approval for clinical trials of its injectable drug UBT37034 for overweight or obesity indications from the National Medical Products Administration of China [1] Group 1: Drug Development - UBT37034 is a novel peptide receptor agonist that selectively targets neuropeptide Y2 receptors to aid in weight loss [1] - Preclinical studies in various animal models indicate that UBT37034, when used in conjunction with GLP-1 analogs, significantly reduces body weight [1] - The new drug clinical trial application (IND) for UBT37034 regarding overweight or obesity indications was approved by the U.S. Food and Drug Administration on July 2025, with IND number 175188 [1] Group 2: Future Outlook - The company will continue to focus on new product development and aims to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - The anticipated advancements are expected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - Federal Pharmaceutical (03933) announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., received implicit approval from the National Medical Products Administration of China for the clinical trial registration application of its innovative drug UBT37034 for overweight or obesity indications [1] Group 1: Product Development - UBT37034 is a novel peptide receptor agonist that selectively targets neuropeptide Y2 receptors to aid in weight reduction [1] - Preclinical studies in various animal models indicate that UBT37034, when used in conjunction with GLP-1 analogs, significantly reduces body weight [1] - The new drug clinical trial application (IND) for UBT37034 regarding overweight or obesity indications was approved by the U.S. Food and Drug Administration in July 2025, with IND number 175188 [1] Group 2: Future Outlook - The company will continue to focus on new product development and aims to enhance its competitiveness and creativity in the biopharmaceutical industry [1] - The anticipated advancements in product development are expected to generate greater returns for the company and its shareholders [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，概不對因本公告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。 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 本公告乃由聯邦制藥國際控股有限公司（「本公司」）自願發出。 本公司董事會欣然公佈，於二零二五年九月二十九日，本公司全資附屬公司聯邦生物科技 （珠海橫琴）有限公司自主研發的 1 類創新藥注射用 UBT37034 關於超重或肥胖適應症的 臨 床 試 驗 註 冊 申 請 獲 得 中 國 國 家 藥 品 監 督 管 理 局 臨 床 試 驗 默 示 許 可 ， 受 理 號 為 CXHL2500772。 UBT37034 是一款新型多肽類受體激動劑，可通過選擇性作用於神經肽 Y2 受體減輕體重。 臨床前多種動物模型研究結果顯示，UBT37034 與 GLP-1 類似物聯用能夠顯著降低體重。 此外，UBT37034 注射液關於超重或肥胖適應症的新藥臨床試驗申請（「IND」）已於二零二 ...

The United Laboratories International Holdings Limited 聯 邦 制 藥 國 際 控 股 有 限 公 司 (Incorporated in the Cayman Islands with limited liability) （於開曼群島成立之有限公司） (Stock code 股份代號: 3933) NOTIFICATION LETTER 通知信函 Dear Non-registered holder(Note 1) , The English and Chinese versions of the Company's Current Corporate Communication are available on the Company's website at www.tul.com.hk and the HKExnews' website at www.hkexnews.hk, or the arranged printed form(s) of Current Corporate Communication is enclosed (if appl ...

The United Laboratories International Holdings Limited 聯 邦 制 藥 國 際 控 股 有 限 公 司 Dear Shareholder, 30 September 2025 The United Laboratories International Holdings Limited (the "Company") Notice of Publication of 2025 Interim Report ("Current Corporate Communication") The English and Chinese versions of the Company's Current Corporate Communication are available on the Company's website at www.tul.com.hk and the HKExnews' website at www.hkexnews.hk, or the arranged printed form(s) of Current Corporate Communi ...

Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 7,518,683, an increase of 4.8% compared to RMB 7,175,804 in 2024[4] - EBITDA for the same period was RMB 2,752,120, reflecting a growth of 23.3% from RMB 2,231,943 in 2024[4] - Profit before tax increased by 27.2% to RMB 2,419,651 from RMB 1,901,702 in the previous year[4] - Net profit attributable to the company's owners rose by 27.0% to RMB 1,894,314, compared to RMB 1,491,404 in 2024[4] - Basic earnings per share increased to RMB 104.26, up 27.0% from RMB 82.08 in the prior year[4] - Total comprehensive income for the period was RMB 1,892,823, compared to RMB 1,491,641 in 2024, showing overall growth[12] Expenses and Costs - Research and development expenses were RMB 498,941, an increase from RMB 446,800 in the previous year, highlighting ongoing investment in innovation[12] - The company reported a decrease in sales and distribution expenses to RMB 682,161 from RMB 706,651, indicating improved cost management[12] - The total employee costs for the six months ended June 30, 2025, amounted to RMB 1,112,645,000, up from RMB 1,035,973,000 in 2024, reflecting an increase of about 7.4%[55] - The company’s financial costs decreased to RMB 20,797 thousand in 2025 from RMB 25,172 thousand in 2024, a reduction of approximately 17.5%[45] Assets and Liabilities - As of June 30, 2025, total non-current assets increased to RMB 11,131,383 thousand from RMB 9,762,356 thousand, representing a growth of approximately 14.0% year-over-year[14] - Current assets rose to RMB 18,303,138 thousand, up from RMB 16,070,696 thousand, indicating an increase of about 13.6% compared to the previous year[14] - Total liabilities increased to RMB 4,115,975 thousand, compared to RMB 2,625,263 thousand, marking a significant rise of approximately 56.7%[15] - The total equity attributable to owners of the company increased to RMB 15,566,827 thousand from RMB 14,388,283 thousand, reflecting a growth of about 8.2%[15] Cash Flow and Investments - Operating cash flow for the six months ended June 30, 2025, was RMB 1,997,122 thousand, compared to RMB 1,845,577 thousand, showing an increase of 8.2% year-over-year[20] - The net cash used in investing activities for the six months ended June 30, 2025, was RMB (1,313,174,000), compared to RMB (523,670,000) in the same period of 2024, indicating a significant increase in investment outflows[22]. - Cash and cash equivalents increased by RMB 2,685,387,000 for the six months ended June 30, 2025, compared to an increase of RMB 2,292,276,000 for the same period in 2024[22]. Revenue Segmentation - Revenue from intermediates was RMB 1,010,665,000, while raw materials and formulation products generated RMB 2,529,547,000 and RMB 3,978,471,000 respectively, contributing to a total segment revenue of RMB 9,282,096,000[27]. - The revenue from the formulation products segment reached RMB 3,978,500,000, a significant increase of 65.9% year-on-year, accounting for 52.9% of total revenue[85] - The company achieved sales revenue of RMB 966,100,000 from diabetes products, marking a 75.5% increase year-on-year[86] - The animal health business recorded sales revenue of RMB 564,600,000, a decrease of 15.9% year-on-year[91] Market Performance - Revenue from the Chinese market (including Hong Kong) was RMB 4,725,243,000, a decrease of 17.7% from RMB 5,748,478,000 in the previous year[30]. - The company’s revenue from Europe increased significantly to RMB 1,741,465,000 from RMB 411,566,000, indicating a strong market expansion in that region[30]. Shareholder Information - The company maintained an interim dividend of RMB 16.0 per share, unchanged from the previous year[4] - The interim dividend declared was RMB 0.16 per share, maintaining the same level as the previous year, with a payout ratio of 16.7%[82] - The group recognized a total of RMB 726,811,000 in dividends for the year-end 2024, consistent with the previous year[60] Corporate Governance and Management - The company adopted a share incentive plan on October 26, 2023, allowing for the issuance of up to 181,702,650 shares, which is 10% of the total issued shares as of that date[119] - The company currently does not have a Chief Executive Officer, and plans to appoint one at an appropriate time[127] - The audit committee consists of three independent non-executive directors: Mr. Zhang Pinwen, Professor Song Min, and Dr. Fu Qiushi, who reviewed the unaudited condensed consolidated financial report for the six months ending June 30, 2025[128] Future Plans and Developments - The company plans to expand its formulation exports and deepen its global market layout, focusing on the "Belt and Road" initiative[85] - The group aims to accelerate overseas registration and licensing of key products while enhancing its international competitiveness in production, R&D, and commercialization[108] - The group has 43 new human drug products in development, including 22 first-class new drugs focusing on endocrine, metabolism, autoimmune, ophthalmology, and anti-infection fields[92] Legal and Compliance - The group is involved in litigation to recover approximately RMB 340 million from Chengdu Evergrande, with a court ruling in June 2024 ordering a payment of approximately RMB 136.3 million[106] - The company has not disclosed any other significant litigation during the reporting period[107]

Investment Rating - The industry investment rating is "Strong Outperform" [2] Core Insights - The report emphasizes the potential of TSLP-targeted bispecific antibodies in addressing unmet needs in the autoimmune sector, particularly in asthma and atopic dermatitis [4][6] - The success of Dupilumab (Dupi) illustrates the demand for long-acting, multi-indication therapies in a market characterized by high patient numbers and chronic conditions [5][15] - The report identifies a significant market opportunity driven by high disease prevalence and the need for new therapeutic options [5][15] Summary by Sections High Disease Prevalence Creates Market Opportunities - The report highlights the large patient populations for conditions like asthma and atopic dermatitis, with millions affected, indicating a substantial market for new treatments [14][15] - Existing therapies have unmet needs, particularly in terms of long-acting formulations and improved efficacy [18][19] Focus on Bispecific Antibodies - The report suggests prioritizing bispecific antibodies that target TSLP and IL-13, as they have shown clinical promise in enhancing efficacy and expanding patient populations [6][22] - Companies such as 康诺亚, 信达生物, 荃信生物, and 联邦制药 are identified as key players in this space [6] Respiratory Diseases and Bispecific Antibodies - In the respiratory disease sector, particularly asthma and COPD, the report notes the need for long-term management and the potential of bispecific antibodies to address this challenge [25][37] - The market for asthma biologics is projected to reach approximately $7.5 billion by 2023, with significant growth expected [25][28] Clinical Data and Efficacy - The report discusses the clinical efficacy of various biologics, noting that Dupilumab and Tezepelumab have shown significant improvements in asthma control and quality of life [34][35] - The combination of TSLP and IL-4R is highlighted as a promising therapeutic strategy, with early clinical data supporting its potential [37][47]

Core Viewpoint - The conference on cutting-edge technologies in cell and gene therapy highlighted the industry's innovative development paths and trends, emphasizing the potential of these therapies in treating tumors and rare diseases, positioning them as a key engine for the future of biomedicine [1][4]. Group 1: Industry Trends and Developments - The conference featured discussions on the advancements in stem cell drug development, particularly in applications for osteoarthritis, graft-versus-host disease, and Crohn's disease, indicating a shift from basic research to industrial application [3]. - mRNA nucleic acid drugs were identified as a breakthrough approach for personalized treatment, with significant advantages in oncology and neurodegenerative diseases, alongside a vision for AI-driven automated mRNA drug manufacturing [3]. - The integration of artificial intelligence into life sciences is expected to broaden market prospects for advanced therapies, as highlighted by experts analyzing the domestic and international development of cell and gene therapies [3][4]. Group 2: Regional Industry Growth - Zhuhai has over 380 biopharmaceutical companies, including 116 large-scale enterprises and 9 listed companies, indicating a robust industry presence [5]. - The biopharmaceutical industry in Zhuhai is projected to exceed 30 billion yuan in 2024, with notable companies in the cell and gene therapy sector, such as Chengnuo Regeneration and Aimsitan, showcasing strong competitive innovation [5]. - The conference served as a platform for fostering collaboration across the industry chain, promoting innovation and development in Zhuhai's biopharmaceutical sector [4].