联邦制药(03933)发布公告，于2026年1月28日，由公司全资附属公司珠海联邦制药股份有限公司自主研 发的1类创新药注射用TUL108的新药临床试验注册申请(IND)获美国食品药品监督管理局(FDA)批准， IND编号为178724。 注射用TUL108的研发将强化公司于抗感染领域的优势地位。未来，公司将继续致力于新产品研发，持 续提升于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。 注射用TUL108是由公司自主设计并研发的一种新型超广谱β-内醯胺酶抑制剂，拟用于治疗由革兰氏阴 性菌或革兰氏阳性菌所引起的感染，包括复杂性尿路感染(cUTI)、复杂性腹腔感染(cIAI)及肺部感染和 血流感染。TUL108联合美罗培南对碳青霉烯类耐药大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌及鲍曼 不动杆菌等均具有高度敏感性，针对临床极待解决的对碳青霉烯耐药的革兰阴性菌可实现全覆盖。 ...

格隆汇1月28日丨联邦制药(03933.HK)公布，于2026年1月28日，由公司全资附属公司珠海联邦制药股份 有限公司自主研发的1类创新药注射用TUL108的新药临床试验注册申请(「IND」)获美国食品药品监督 管理局(「FDA」)批准，IND编号为178724。 注射用TUL108是由公司自主设计并研发的一种新型超广谱β-内醯胺酶抑制剂，拟用于治疗由革兰氏阴 性菌或革兰氏阳性菌所引起的感染，包括复杂性尿路感染(cUTI)、复杂性腹腔感染(cIAI)及肺部感染和 血流感染。TUL108联合美罗培南对碳青霉烯类耐药大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌及鲍曼 不动杆菌等均具有高度敏感性，针对临床极待解决的对碳青霉烯耐药的革兰阴性菌可实现全覆盖。 注射用TUL108的研发将强化公司于抗感染领域的优势地位。未来，公司将继续致力于新产品研发，持 续提升于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。 ...

智通财经APP讯，联邦制药(03933)发布公告，于2026年1月28日，由公司全资附属公司珠海联邦制药股 份有限公司自主研发的1类创新药注射用TUL108的新药临床试验注册申请(IND)获美国食品药品监督管 理局(FDA)批准，IND编号为178724。 注射用TUL108是由公司自主设计并研发的一种新型超广谱β-内醯胺酶抑制剂，拟用于治疗由革兰氏阴 性菌或革兰氏阳性菌所引起的感染，包括复杂性尿路感染(cUTI)、复杂性腹腔感染(cIAI)及肺部感染和 血流感染。TUL108联合美罗培南对碳青霉烯类耐药大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌及鲍曼 不动杆菌等均具有高度敏感性，针对临床极待解决的对碳青霉烯耐药的革兰阴性菌可实现全覆盖。 注射用TUL108的研发将强化公司于抗感染领域的优势地位。未来，公司将继续致力于新产品研发，持 续提升于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。 ...

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。 注射用 TUL108 是由本公司自主設計並研發的一種新型超廣譜 β-內醯胺酶抑制劑，擬 用於治療由革蘭氏陰性菌或革蘭氏陽性菌所引起的感染，包括複雜性尿路感染（cUTI）、 複雜性腹腔感染（cIAI）及肺部感染和血流感染。TUL108 聯合美羅培南對碳青霉烯 類耐藥大腸埃希菌、肺炎克雷伯菌、銅綠假單胞菌及鮑曼不動桿菌等均具有高度敏感 性，針對臨床極待解决的對碳青霉烯耐藥的革蘭陰性菌可實現全覆蓋。 注射用 TUL108 的研發將強化本公司於抗感染領域的優勢地位。未來，本公司將繼續 致力於新產品研發，持續提升於醫藥行業的競爭力及創造力，預期將為本公司及其股 東創造更大收益。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3 ...

Core Viewpoint - The global GLP-1 market is shifting, with multinational pharmaceutical companies increasingly focusing on Chinese biopharmaceutical assets, a trend expected to peak in 2025 and be confirmed in early 2026 [5] Group 1: Market Dynamics - The competition in the weight loss and metabolic disease market is evolving from single product competition to a comprehensive contest involving multiple mechanisms, indications, and long-term medication [5] - Multinational pharmaceutical companies are experiencing anxiety regarding pipeline breadth and technological reserves, with China emerging as a key source for supplementing GLP-1 pipelines [5] - Over the past decade, the role of Chinese innovative drug companies has shifted from introducing overseas technology to exporting self-developed assets [5] Group 2: Asset Development - Chinese companies have accumulated a number of candidates in the GLP-1 field, particularly in dual-target, triple-target, and oral formulations, with several in Phase II and III [5] - These assets are characterized by preliminary validation of scientific pathways and identifiable clinical risks, making them valuable for multinational companies to quickly fill their pipelines through licensing or acquisition [5] Group 3: Transaction Highlights - Novo Nordisk made a significant move by securing rights to a triple-target agonist, UBT251, with a payment structure of $200 million upfront and up to $1.8 billion in milestone payments, reflecting a strategic choice to rebuild its next-generation weight loss product lineup [7] - Regeneron entered a licensing agreement with Hansoh Pharma worth over $2 billion for a GLP-1/GIP dual-target agonist in Phase III, aiming to strengthen its position in the metabolic disease field [7] - Pfizer, after terminating two late-stage oral GLP-1 candidates due to safety issues, acquired Metsera for nearly $10 billion and entered a licensing agreement with YaoPharma for an early-stage oral GLP-1 candidate, demonstrating a cautious approach to re-entering the oral weight loss drug market [7] Group 4: Strategic Implications - These transactions signal that multinational pharmaceutical companies are preparing for the second phase of competition in the GLP-1 market, focusing on efficacy limits, medication convenience, long-term safety, and combination therapy potential [8] - The shift indicates a structural adjustment in the global pharmaceutical industry, with China transitioning from merely a clinical trial and production base to a significant technology supplier in key therapeutic areas [8]

Investment Rating - The report indicates a significant acceleration in BD (Business Development) overseas for Chinese innovative drugs, suggesting a positive investment outlook for the industry [3]. Core Insights - The number of BD projects, upfront payments, and total amounts for Chinese pharmaceutical companies significantly increased in 2025, with 165 projects, over $7.03 billion in upfront payments (up 226.8% year-on-year), and a total amount of $136.68 billion (up 192.2% year-on-year) [2][7]. - The report highlights a focus on dual antibodies (双抗), antibody-drug conjugates (ADC), GLP-1 receptor agonists (GLP1RA), and small nucleic acids as key areas for BD overseas [2][3]. Summary by Sections BD Project Growth - In 2025, the quarterly breakdown of BD projects shows 41, 43, 30, and 51 projects in Q1, Q2, Q3, and Q4 respectively, with significant year-on-year increases [2][7]. - Upfront payments for each quarter were $0.9 billion, $2.0 billion, $1.86 billion, and $2.27 billion, reflecting substantial growth rates [2][7]. Outbound BD Models - The predominant model for BD remains license in/out, while the NewCo/Co-CoJV model is gaining attention, with limited successful cases of independent commercialization [2][12][13]. - In 2025, MNCs (Multinational Corporations) accounted for $4.71 billion in upfront payments, representing 67% of total BD upfront payments [12]. Key Drug Categories - Dual antibodies saw a remarkable increase, with $3.5 billion in upfront payments (up 414.7%) and a total amount of $21.85 billion (up 361.5%) in 2025 [2][18]. - ADCs emerged as a significant focus, with $1.63 billion in upfront payments (up 676.2%) and a total amount of $21.13 billion (up 390.6%) [2][26]. - GLP-1RA projects achieved $470 million in upfront payments, marking a 109.8% increase, with a total amount of $9.6 billion [2]. NewCo Model - The NewCo model has facilitated overseas BD, with a total of $350 million in upfront payments and $13.74 billion in potential total amounts from 2023 to 2025 [17]. - In 2025, NewCo projects secured $110 million in upfront payments and $4.76 billion in potential total amounts [17]. Clinical Development Stages - Approximately 62% of molecules were in early clinical stages (pre-clinical to before Phase II) at the time of BD, indicating a trend towards early-stage licensing [8][9].

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12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: 聯邦制藥國際控股有限公司 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 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 ...

Core Viewpoint - The Hong Kong stock market has seen a surge in refinancing activities this year, with placements becoming the preferred method for companies due to their efficiency, flexibility, and cost advantages [1][3]. Group 1: Market Activity - Hong Kong listed companies have raised nearly 350 billion HKD through placements, rights issues, and consideration issues this year, with placements accounting for almost 90% of the total [1][3]. - The total amount raised through placements alone reached approximately 312.4 billion HKD, representing 89.61% of the total refinancing [3][7]. Group 2: Industry Insights - Key industries leading the placements include hardware equipment, automotive and parts, biomedicine, and software services, with hardware equipment raising 600.07 billion HKD [4][5]. - Notable contributions from specific companies include Xiaomi Group raising 426 billion HKD in the hardware sector and BYD raising 435.09 billion HKD in the automotive sector [4][7]. Group 3: Fund Utilization - The funds raised through placements are primarily allocated for research and development, business expansion, international market development, and optimizing capital structure [9]. - Companies like SenseTime and BYD have specified that their raised funds will support core business development, AI infrastructure, and overseas market expansion [9]. Group 4: Market Conditions - The active refinancing in the Hong Kong market is attributed to increased market activity, rising trading volumes, and valuation recovery, providing an excellent window for companies to refinance [10]. - Analysts predict that the liquidity in the Hong Kong market will continue to improve, driven by the "wealth effect" and increasing participation from mainland investors [10].

Group 1 - The report highlights the recent performance of various industries, with notable gains in sectors such as non-ferrous metals, electronics, and power equipment, while retail and real estate sectors faced declines [1][1][1] - The central economic work conference emphasized the importance of technological breakthroughs and supply-demand optimization, indicating a shift towards quality improvement in economic growth [11][12][19] - The commercial aerospace sector is experiencing significant growth, with the establishment of a dedicated regulatory body and a notable increase in the commercial aerospace index, which has risen by 46.52% since April 7 [47][48] Group 2 - The report indicates a seasonal recovery in social financing, with November seeing an increase of 24,885 billion yuan, driven primarily by government bond issuance [4][7] - The credit environment is showing signs of marginal improvement, particularly in corporate loans, which increased by 6,100 billion yuan in November, reflecting a recovery in demand [5][6] - The report notes that the retail sector is undergoing a transformation, with a focus on quality, as highlighted by the Ministry of Commerce's emphasis on retail quality upgrades [1][1][1] Group 3 - The report discusses the rising interest in inquiry transfers, which have seen a significant increase in both project numbers and transfer scale, indicating a growing trend in the market [51][52] - The technology sector is expected to remain a key focus, with upcoming events such as the Volcano Engine FORCE conference anticipated to showcase advancements in AI and cloud services [56]

Major Events - HASHKEY HLDGS (03887) plans to conduct an IPO from December 9 to December 12, aiming to globally offer 241 million shares and has secured cornerstone investors including UBS AM Singapore [1] - Tuda Tong (02665) is set to list on December 10 with a share price of HKD 10 [1] - Federated Pharmaceuticals (03933) has received approval from the National Medical Products Administration for its moxifloxacin hydrochloride eye drops [1] - Shou Cheng Holdings (00697) has attracted investments from Beijing Robotics Fund and Shou Bao Fund for its subsidiary Yun Shen Chu Technology [1] - Botai Vehicle Link (02889) has been selected by a leading OEM in the new energy vehicle sector as a supplier for the next-generation smart car cockpit project [1] - Guangdong-Hong Kong-Macau Holdings (01396) subsidiary Tiandun Data has signed a strategic cooperation agreement with Huagong Technology (000988.SZ) [1] Operating Performance - China Life Insurance (02628) reported total premiums exceeding CNY 700 billion by the end of November [1] - Datang Renewable (01798) achieved a cumulative power generation of approximately 31.6521 million MWh in the first 11 months, representing a year-on-year increase of 10.58% [1] - Longfor Group (00960) recorded total contract sales of CNY 59.39 billion in the first 11 months [1] - China Jinmao (00817) reported a cumulative contracted sales amount of CNY 100.679 billion in the first 11 months, reflecting a year-on-year growth of 21.3% [1] - New Town Development (01030) reported a cumulative contract sales amount of approximately CNY 17.917 billion in the first 11 months, a year-on-year decrease of 51.53% [1] - CIFI Holdings Group (00884) achieved a cumulative contract sales amount of approximately CNY 15.1 billion in the first 11 months [1]