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联邦制药(03933) - 截至2025年9月30日止月份之股份发行人的证券变动月报表
2025-10-02 12:19
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 ...
联邦制药(03933.HK):注射用UBT37034超重或肥胖适应症获临床试验默示许可
Ge Long Hui· 2025-09-30 08:57
UBT37034是一款新型多肽类受体激动剂,可通过选择性作用于神经肽Y2受体减轻体重。临床前多种动 物模型研究结果显示,UBT37034与GLP-1类似物联用能够显著降低体重。此外,UBT37034注射液关于 超重或肥胖适应症的新药临床试验申请("IND")已于2025年7月获得美国食品药品监督管理局批准,IND 编号为175188。未来,公司将持续致力于新产品研发,并重点提升在生物医药行业的竞争力及创造力, 预期将为公司及其股东创造更大收益。 格隆汇9月30日丨联邦制药(03933.HK)发布公告,2025年9月29日,公司全资附属公司联邦生物科技(珠 海横琴)有限公司自主研发的1类创新药注射用UBT37034关于超重或肥胖适应症的临床试验注册申请获 得中国国家药品监督管理局临床试验默示许可,受理号为CXHL2500772。 ...
联邦制药(03933):注射用UBT37034超重或肥胖适应症获临床试验默示许可
Zhi Tong Cai Jing· 2025-09-30 08:52
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]
联邦制药:注射用UBT37034超重或肥胖适应症获临床试验默示许可
Zhi Tong Cai Jing· 2025-09-30 08:41
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]
联邦制药(03933) - 注射用UBT37034超重或肥胖适应症获临床试验默示许可
2025-09-30 08:32
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 ...
联邦制药(03933) - 致非登记股东通知信函及回条
2025-09-29 12:45
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 ...
联邦制药(03933) - 致股东通知信函及回条
2025-09-29 12:42
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 ...
联邦制药(03933) - 2025 - 中期财报
2025-09-29 12:33
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]
行业深度报告:原料药公司加速创新药布局,AI+医疗布局逐步深化
KAIYUAN SECURITIES· 2025-09-24 12:43
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The industry is entering a new development phase driven by optimized procurement and innovation [3] - The raw material pharmaceutical sector is at a cyclical bottom, with companies actively transitioning to innovative drug development [5][8] - The vaccine sector is experiencing a decline in performance but is accelerating the layout of new technologies and products [6] - The medical services sector is leveraging AI technology to enhance efficiency and quality [7] Summary by Sections Raw Material Pharmaceutical Sector - The raw material pharmaceutical industry has faced a downturn for nearly four years, with prices of various products, such as sartans and heparins, reaching historical lows [5] - Revenue and net profit in the raw material pharmaceutical sector showed a downward trend in the first half of 2025 due to significant price drops in anti-infective products and increased R&D investments [5] - Companies like Huahai Pharmaceutical and Borui Pharmaceutical are focusing on innovative drug development, with several products in various clinical trial phases [5][68] Vaccine and Blood Products Sector - The vaccine industry is facing continuous performance decline due to a decrease in newborn numbers and changing competitive dynamics, although some companies are introducing new technologies and products [6] - The blood products sector is also experiencing a downturn, with revenue and net profit declining due to high inventory levels and suppressed demand from medical insurance [6][75] - The industry is expected to see increased consolidation as leading companies accelerate mergers and acquisitions [6][8] Medical Services Sector - The medical services sector's performance has declined due to DRGs and the consumption environment, but the application of AI technology is expected to enhance service quality and efficiency [7] - The core competitiveness of the medical services industry lies in acquiring and training quality doctors and hospital management [7] Investment Recommendations - The report suggests that companies in the raw material pharmaceutical sector are likely to enter a harvest period as they transition to innovative drugs [8] - The blood products sector is anticipated to accelerate consolidation, with significant mergers expected in the near future [8] - Recommended stocks include Federal Pharmaceutical, Pro Pharmaceutical, Guobang Pharmaceutical, and others, while benefiting stocks include Tianyu Co., Meinuo Pharma, and others [8]
联邦制药20250923
2025-09-24 09:35
Summary of Federal Pharmaceutical Conference Call Company Overview - Federal Pharmaceutical's market value growth is closely linked to its product line, including the rise in prices of intermediates and active pharmaceutical ingredients, the launch of insulin products, and the BD agreement for the tri-target GLP-1 product, all contributing to stock price and market value changes [2][4][23] Core Business Segments - The main business segments include: - Antibiotic raw materials - Intermediates - Human antibiotics - Insulin preparations - Active expansion of innovative pipelines [6][5] Market Trends and Opportunities - The global diabetes and obesity issues are worsening, with the GLP-1 drug market showing significant potential. Sales of Semaglutide reached 21 billion yuan in 2023, with Goldman Sachs predicting a market size of $130 billion by 2030 [2][7] - The UBT 251, a tri-target GLP-1 receptor agonist, shows superior weight loss effects compared to Liraglutide, with clinical trials indicating a weight reduction of 15.1% over 12 weeks [9][10] Product Pipeline and Innovations - Federal Pharmaceutical has multiple products in the GLP-1 drug field, including oral GLP-1 small molecule formulations and UBT 37,034 injections. Liraglutide has been approved for market entry, while Semaglutide is expected to launch in 2026 [11][12] - The company is also focusing on metabolic disorders beyond obesity, including fatty liver and chronic kidney disease, with UBT 251 projected to peak at $5.2 billion domestically and $8.547 billion overseas by 2030 or 2031 [10][2] Financial Performance and Projections - The company anticipates a net profit of 2.76 billion yuan in 2025, with a slight decrease to around 2.6 billion yuan in 2026 due to reduced upfront payments [21][24] - The animal health business is expected to contribute 15%-20% of total revenue, with a compound annual growth rate of 75% from 2020 to 2023 [14] Competitive Landscape - Federal Pharmaceutical holds a significant position in the intermediate raw material market, particularly in 6-APA, with a global market share of 60%-70%. The industry is becoming more concentrated, with major production held by Federal, Sinopharm Weichida, and Chuan Ning Bio [19][20] Regulatory and Market Challenges - The company faces challenges from price pressures in the antibiotic sector due to centralized procurement and market demand slowdowns, impacting sales of key products [16][18] - Despite concerns about Indian competitors releasing capacity, the actual competitive pressure remains low due to production delays and government policy uncertainties in India [22] Future Outlook - Federal Pharmaceutical's innovative pipeline and the potential for increased valuation present significant growth opportunities. The company is currently valued below industry averages, but rapid advancements in its pipeline could enhance overall valuation multiples [23][24]