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 ...