Group 1 - The core point of the article is that Federal Pharmaceutical (03933) has seen a nearly 3% increase in its stock price following the announcement of successful Phase II clinical trials for its innovative drug TUL01101 for moderate to severe atopic dermatitis in adults [1] - The company reported that TUL01101 met its expected goals in the Phase II clinical study, which supports its progression to the next phase of clinical research [1] - Federal Pharmaceutical has completed communication with regulatory authorities regarding TUL01101's End of Phase 2 (EOP2) and is initiating Phase III clinical trials in China for moderate to severe atopic dermatitis patients [1]

Core Viewpoint - Federal Pharmaceutical (03933) has seen a nearly 3% increase in early trading, currently up 2.32% at HKD 12.8, with a trading volume of HKD 64.0646 million [1] Group 1: Clinical Research Progress - The company announced that its self-developed innovative drug TUL01101 has completed Phase II clinical trials in adult patients with moderate to severe atopic dermatitis in China [1] - TUL01101 met the expected goals in the Phase II clinical study, supporting its progression to the next stage of clinical research [1] - The company has completed communication with regulatory authorities regarding TUL01101's EOP2 and is initiating Phase III clinical trials in China for moderate to severe atopic dermatitis patients [1]

Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101 for moderate to severe atopic dermatitis in adults, demonstrating significant efficacy and safety [1][2] Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 participants [1] - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, with daily administration for 12 weeks [1] - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and the Investigator's Global Assessment (IGA) response [1] Group 2: Efficacy Results - Results showed significant efficacy across all dosage groups, with EASI scores decreasing notably from week 1 [2] - At week 12, the EASI score changes from baseline were -81.98% for the 20mg group, -79.87% for the 40mg group, and -87.85% for the 60mg group [2] - EASI75 response rates were 78.0%, 80.0%, and 84.0% for the respective dosage groups, while IGA response rates were 46.0%, 52.0%, and 68.0% [2] Group 3: Safety and Next Steps - The overall safety and tolerability of TUL01101 were good, with the most common adverse event being upper respiratory infection, mostly mild to moderate in severity [2] - No new safety signals were reported beyond those associated with similar products [2] - The successful completion of Phase II trials supports the initiation of Phase III clinical trials, which are currently being launched in China for moderate to severe atopic dermatitis [2]

Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II clinical study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, with treatment administered once daily for 12 weeks [1]. - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved EASI scores, with reductions of -81.98%, -79.87%, and -87.85% for the 20mg, 40mg, and 60mg groups, respectively, compared to baseline [2]. - EASI75 response rates were 78.0%, 80.0%, and 84.0% for the respective dosage groups, while IGA response rates were 46.0%, 52.0%, and 68.0% [2]. - The overall safety profile of TUL01101 was favorable, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].

Core Viewpoint - The company has successfully completed Phase II clinical trials for its innovative drug TUL01101, demonstrating significant efficacy and safety in treating moderate to severe atopic dermatitis in adults [1][2]. Group 1: Clinical Trial Details - The Phase II study was a multicenter, randomized, double-blind, parallel, placebo-controlled trial involving 201 adult participants with moderate to severe atopic dermatitis [1]. - Participants were randomly assigned to three different dosage groups (20mg, 40mg, 60mg) and a placebo group, receiving daily doses for 12 weeks [1]. - The primary efficacy endpoint was the change in the Eczema Area and Severity Index (EASI) score from baseline at week 12, with key secondary endpoints including the proportion of participants achieving EASI75 response and Investigator's Global Assessment (IGA) response [1]. Group 2: Trial Results - Results indicated that TUL01101 significantly improved skin lesions, reduced itching, and enhanced quality of life, with notable decreases in EASI scores observed as early as week 1 [2]. - By week 12, the EASI score changes from baseline for the 20mg, 40mg, and 60mg groups were -81.98%, -79.87%, and -87.85% respectively, with EASI75 response rates of 78.0%, 80.0%, and 84.0%, and IGA response rates of 46.0%, 52.0%, and 68.0% [2]. - The overall safety profile of TUL01101 was good, with the most common adverse event being upper respiratory tract infection, primarily mild to moderate in severity, and no new safety signals were identified [2]. Group 3: Future Development - TUL01101 is a highly selective JAK1 inhibitor, currently approved for clinical trials in atopic dermatitis and rheumatoid arthritis in China [3]. - The company plans to continue expanding clinical research for TUL01101 in the field of autoimmune diseases [3].

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 (於開曼群島成立之有限公司) (股份代號: 3933) 本集團產品 TUL01101 片臨床研究進展 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 公司自主研發的 1 類創新藥 TUL01101 片已完成在中國中重度特應性皮炎成人受試者 中的 II 期臨床研究。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 香港，二零二五年十一月十日 本研究採用多中心、隨機、雙盲、平行、安慰劑對照設計，共納入 201 例受試者，隨 機分配至 TUL01101 片三個不同劑量組（20 mg、40 mg、60 mg）及安慰劑組中，每 日給藥一次連續給藥 12 周，旨在評估 TUL01101 片在 ...

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1]. Core Views - The report highlights a positive change in the specialty raw materials sector, recommending companies such as Aorite and Prolo Pharmaceuticals [1]. - The report suggests that the Q3 performance of raw material pharmaceutical companies has reached a bottom, indicating potential recovery in profitability as high-cost inventory is consumed [19][20]. Summary by Sections Investment Highlights - The recommended sub-industry rankings are: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12]. - Specific stock recommendations include: - From raw materials: Aorite, Qianhong Pharmaceutical - From Traditional Chinese Medicine: Zorui Pharmaceutical, Fangsheng Pharmaceutical, Dong'e Ejiao - From medical devices: United Imaging Healthcare, Yuyue Medical - From AI pharmaceuticals: Jingtai Holdings - From GLP-1 sector: Lianbang Pharmaceutical, Borui Pharmaceutical, Zhongsheng Pharmaceutical, and Innovent Biologics - From PD-1/VEGF dual antibodies: Sanofi Biopharmaceuticals, Kangfang Biologics, and Rongchang Biopharmaceuticals - From innovative drugs: Innovent Biologics, BeiGene, HengRui Medicine, Zai Lab, Baillie Tianheng, Kelun Pharmaceutical, Dize Pharmaceutical, and Haizheng Pharmaceutical [3][15]. Industry Trends - The A-share pharmaceutical index has seen a year-to-date increase of 18.2%, while the Hang Seng Biotechnology Index has increased by 76.6% [6][11]. - The report notes that the raw material pharmaceutical sector is under pressure due to high base effects and declining prices, with significant revenue impacts [19][20]. R&D Progress and Company Dynamics - Recent approvals include Novartis' radioligand therapy drug, which received dual indications for prostate cancer treatment [2]. - The report provides an overview of ongoing clinical trials and drug approvals, emphasizing the importance of innovation in the pharmaceutical sector [30]. Market Performance - The report indicates that the pharmaceutical sector has experienced adjustments, with notable stock performances including significant gains for companies like Hezhong China (+61%) and Wanze Shares (+30%) [11]. - The report also highlights the performance of various pharmaceutical stocks, noting both gains and losses in the market [16][17]. Raw Material Pricing Trends - The price of 6-APA has dropped significantly, from 370 RMB/kg in 2022 to 180 RMB/kg in October 2025, a decrease of 51% [23]. - The price of Amoxicillin has also decreased from 320 RMB/kg in January 2023 to 190 RMB/kg in October 2025, a decline of 41% [23]. Conclusion - The report suggests that as high-cost inventory is depleted, the gross margins for raw material producers are expected to improve, indicating a potential recovery in profitability for companies like Fuxiang Pharmaceutical and Lukang Pharmaceutical [19][23].

Core Viewpoint - Federal Pharmaceutical (03933) announced the purchase of 3.5 million shares of reward stock at an average price of HKD 12.905 per share, to fulfill its obligation to the beneficiaries who have met the 2024 performance targets by November 13, 2025 [1] Group 1 - The trustee has acquired the shares through market transactions [1] - The trustee will continue to purchase the relevant number of reward shares depending on market conditions [1] - The reward shares will be held in trust until they vest and are delivered to the beneficiaries according to the terms of the share award plan [1]

Core Viewpoint - The company announced the purchase of 3.5 million shares at an average price of HKD 12.905 per share to fulfill its obligations under the share award plan for achieving 2024 performance targets [1] Group 1 - The trustee has acquired 3.5 million shares through market transactions [1] - The average purchase price per share was HKD 12.905 [1] - The shares will be held in trust until they vest to the relevant award recipients according to the terms of the share award plan [1] Group 2 - The trustee will continue to purchase additional shares depending on market conditions [1] - The shares are intended for individuals who have met the performance targets set for 2024 [1]

Core Viewpoint - The company, 联邦制药 (03933.HK), announced the purchase of 3.5 million reward shares at an average price of HKD 12.905 per share to fulfill its obligation to the beneficiaries who met the 2024 performance targets by November 13, 2025 [1] Group 1 - The trustee has acquired 3.5 million reward shares through market transactions [1] - The average purchase price for the shares was HKD 12.905 each [1] - The trustee will continue to purchase additional reward shares depending on market conditions until the shares are vested to the beneficiaries [1]