Core Viewpoint - The company has successfully passed the consistency evaluation for the generic drug Roxithromycin capsules (150mg) through the National Medical Products Administration of China, reinforcing its competitive position in the anti-infection sector [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for Roxithromycin capsules, marking it as the first enterprise to pass the consistency evaluation for this formulation [1] - Roxithromycin is a second-generation macrolide antibiotic known for its acid resistance, broad antibacterial spectrum, strong tissue penetration, and low incidence of adverse reactions [1] Group 2: Clinical Applications - Roxithromycin capsules are clinically applicable for treating infections caused by Roxithromycin-sensitive pathogens, including those affecting the ear, nose, throat, respiratory tract, skin, soft tissues, and urogenital tract [1] Group 3: Market Position and Future Outlook - The product is listed as a Class B drug in the National Medical Insurance Directory (2025 version), which is expected to enhance the company's market position in the anti-infection field [1] - The company aims to continue its commitment to new product development, anticipating greater returns for itself and its shareholders [1]

Core Viewpoint - The approval of the roxithromycin capsules by the National Medical Products Administration of China enhances the company's competitive position in the anti-infection sector and is expected to generate greater returns for the company and its shareholders [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation of the roxithromycin capsules (150mg) [1] - Roxithromycin capsules are a second-generation macrolide antibiotic known for their acid resistance, broad antibacterial spectrum, strong tissue penetration, and low incidence of adverse reactions [1] - The product is currently listed as a Class B drug in the National Medical Insurance Directory (2025 version) [1] Group 2: Market Position and Future Prospects - The company is the first to pass the consistency evaluation for the roxithromycin capsule formulation [1] - This approval will further help the company consolidate its advantageous position in the anti-infection field [1] - The company is committed to ongoing new product development, which is anticipated to create greater benefits 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。 本次獲批將進一步有助於本公司鞏固於抗感染領域的優勢地位。本公司將持續致力於 新產品研發，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: 3933) 本集團產品羅紅霉素膠囊通過一致性評價 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（「董事會」）欣然公佈，本公司全資附屬公司珠海聯邦制藥股份有限公 司中山分公司申報的羅紅霉素膠囊（規格：150mg）通過中國國家藥品監督管理局仿 製藥質量和療效一致性評價（「一致性評價」）。 羅紅霉素膠囊是第二代大環內酯類抗生素，具有耐酸性好、抗菌譜廣、組織穿透性強、 不良反應發生率較低等顯著抗感染優勢。臨床適用於治療由羅紅霉素 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry [3] Core Insights - The commercialization of ADC (Antibody-Drug Conjugates) is accelerating, with 20 ADC drugs approved globally, and 6 of them have been in the "billion-dollar club" for two consecutive years [30][31] - The report highlights the increasing competition in the ADC sector, with approximately 60 ADC drugs currently in clinical phase 3 and application stages [30] - Domestic innovative pharmaceutical companies are adopting various strategies for ADC capacity layout, with companies like Rongchang Biopharma transitioning from outsourcing to in-house production, while others like Kelong Biotechnology are building their own production bases [31][32] Summary by Sections Market Review - The pharmaceutical index rose by 0.14% this week, outperforming the CSI 300 index by 1.47 percentage points, ranking 15th in industry performance [10] - Year-to-date, the pharmaceutical index has increased by 3.28%, also outperforming the CSI 300 index by 2.99 percentage points, ranking 23rd [10] Individual Stock Performance - In the A-share market, 255 out of 479 pharmaceutical stocks rose, with the top five performers being Guangshengtang (+29.83%), Haixiang Pharmaceutical (+18.64%), and Meidixi (+18.04%) [20] - In the Hong Kong market, 38 out of 116 pharmaceutical stocks rose, with the top performers including Yiteng Jiahe (+14%) and Kedi-B (+9.96%) [24] Industry News and Policies - The newly revised "Regulations on the Implementation of the Drug Administration Law" supports segmented contract manufacturing and commercial-scale drug sales, providing a foundation for ADC commercialization cooperation [32] - Notable industry developments include Novartis's application for Ianalumab in China and Johnson & Johnson's approval of Daratumumab injection for multiple myeloma treatment [27][28] Weekly Insights - The ADC commercialization battle has begun, with a significant increase in demand for ADC production capacity, leading to a supply-demand imbalance [30] - Major CXO companies are expanding ADC production capacity, with companies like WuXi AppTec acquiring East Yao Pharmaceutical to meet rising orders [31]

Group 1 - The stock of United Pharmaceuticals (03933.HK) has increased by over 7%, currently up by 6.1% at HKD 13.39 [1] - The trading volume reached HKD 80.98 million [1]

Core Viewpoint - Federal Pharmaceutical (03933) has seen a significant stock increase, attributed to the announcement of its innovative drug UBT251 receiving clinical trial approval for obesity-related moderate to severe obstructive sleep apnea (OSA) from the National Medical Products Administration of China [1] Group 1: Company Developments - Federal Pharmaceutical's wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., has developed UBT251, which is the first chemical-synthetic GLP-1/GIP/GCG tri-target receptor agonist new drug in China [1] - The company has established a strong position in the research field of this type of medication, enhancing its competitive edge [1] Group 2: Financial Insights - UBS has released a report stating that Federal Pharmaceutical is a leading drug manufacturer in China, with an integrated business line covering intermediate products, active pharmaceutical ingredients, and formulation products [1] - The company has a strong research and development background in metabolic diseases, which has led to promising early clinical results for UBT251 [1] - In March of the previous year, the company licensed the rights for UBT251 outside of China to Novo Nordisk (NVO.US), which included a $200 million upfront payment, up to $1.8 billion in milestone payments, and tiered royalties on sales [1] Group 3: Market Potential - UBS believes that the market has underestimated the sales potential of UBT251 and the broader innovative research and development pipeline of the company [1]

Core Viewpoint - Federal Pharmaceutical (03933) has seen a significant stock increase of over 7%, currently trading at HKD 13.39, with a transaction volume of HKD 80.98 million, following the announcement of its innovative drug UBT251 receiving clinical trial approval for obesity-related moderate to severe obstructive sleep apnea (OSA) from the National Medical Products Administration of China [1] Group 1: Company Developments - Federal Pharmaceutical's wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., has independently developed the innovative drug UBT251 injection, marking it as China's first chemical-synthesized GLP-1/GIP/GCG tri-target receptor agonist [1] - The company has established a significant position in the research field of this type of medication, enhancing its competitive edge in the pharmaceutical industry [1] Group 2: Market Analysis - UBS has released a report stating that Federal Pharmaceutical is a leading drug manufacturer in China, with an integrated business line that includes intermediate products, active pharmaceutical ingredients, and formulation products [1] - The report highlights that the market may be underestimating the sales potential of UBT251 and the broader innovative research pipeline of the company [1] - Last year, the company licensed the rights of UBT251 outside of China to Novo Nordisk (NVO.US), which included an upfront payment of USD 200 million, potential milestone payments of up to USD 1.8 billion, and tiered royalties on sales [1]

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: 2026年1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2月5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 ...

Core Viewpoint - Federal Pharmaceutical (03933) shares increased by nearly 3%, currently up 2.7% at HKD 12.17, with a trading volume of HKD 54.12 million [1] Group 1: Company Developments - Federal Pharmaceutical announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., received implied approval from the National Medical Products Administration of China for clinical trials of its self-developed innovative drug UBT251 injection for the indication of moderate to severe obstructive sleep apnea (OSA) [1] - UBT251 is the first chemical-synthesized GLP-1/GIP/GCG tri-target receptor agonist new drug in China, positioning the company significantly in the research field of this type of medication [1] - The company aims to continue focusing on new product development, enhancing its competitiveness and creativity in the biopharmaceutical industry, which is expected to generate greater returns for the company and its shareholders [1]

Core Viewpoint - Federal Pharmaceutical (03933) shares increased by nearly 3%, currently trading at HKD 12.17 with a transaction volume of HKD 54.12 million, following the announcement of a significant regulatory milestone for its innovative drug UBT251 [1] Group 1: Company Developments - Federal Pharmaceutical announced that its wholly-owned subsidiary, Federal Biotech (Zhuhai Hengqin) Co., Ltd., received implied clinical trial approval from the National Medical Products Administration of China for UBT251 injection, targeting moderate to severe obstructive sleep apnea (OSA) associated with obesity, effective February 2, 2026 [1] - UBT251 is recognized as China's first chemically synthesized GLP-1/GIP/GCG tri-target receptor agonist new drug, positioning the company prominently in the research field of this category of drugs [1] - The company aims to continue its focus on new product development, enhancing its competitiveness and creativity in the biopharmaceutical industry, which is expected to generate greater returns for the company and its shareholders [1]