Core Viewpoint - The company, Gilead Sciences-B (01672.HK), announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, denifasertib (ASC40), in patients with moderate to severe acne vulgaris [1] Group 1: Study Overview - The Phase III study was conducted in China and involved 240 patients with moderate to severe acne vulgaris [1] - The study aimed to evaluate the long-term safety of denifasertib (ASC40) over a 40-week treatment period, following a 12-week treatment with either denifasertib (ASC40) or placebo [1] Group 2: Safety and Tolerability - Key endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events (AEs) [1] - Denifasertib (ASC40) demonstrated good safety and tolerability, with most adverse events being mild (Grade 1) or moderate (Grade 2) [1] - No Grade 3 or 4 adverse events or serious adverse events related to denifasertib (ASC40) were reported, and there were no reported deaths [1]

Core Insights - The company has announced positive topline results from a Phase III open-label study of its first-in-class oral small molecule FASN inhibitor, ASC40, for moderate to severe acne patients [1] - ASC40 demonstrated good safety and tolerability, with most adverse events being mild to moderate, and no severe adverse events reported [1] - The company has also achieved all primary and key secondary endpoints in a randomized, double-blind, placebo-controlled Phase III clinical study involving 480 patients [2] Group 1 - ASC40 was evaluated in a Phase III open-label study involving 240 moderate to severe acne patients, focusing on long-term safety [1] - The primary endpoints included the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and the rate of discontinuation due to adverse events [1] - The study showed that there were no grade 3 or 4 adverse events related to ASC40, and no deaths were reported [1] Group 2 - The mechanism of action for ASC40 involves inhibiting de novo lipogenesis (DNL) in human sebocytes, directly reducing sebum production and inflammation [2] - Excessive sebum production is a major cause of acne, and ASC40's unique mechanism sets it apart from other acne treatments that do not address the root cause [2] - The company has obtained exclusive rights for ASC40 in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The announcement of the New Drug Application (NDA) acceptance for denifanstat (ASC40), a first-in-class oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate to severe acne, marks a significant milestone for the company in providing a potentially groundbreaking therapy for acne treatment [1][2]. Group 1 - The NDA for denifanstat (ASC40) has been accepted by the National Medical Products Administration (NMPA) of China [1]. - The company has completed Phase II (NCT05104125) and Phase III (NCT06192264) studies for denifanstat (ASC40) in treating moderate to severe acne [1]. - The Phase III study demonstrated that denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints, significantly improving moderate to severe acne compared to placebo [2]. Group 2 - Denifanstat (ASC40) exhibited good safety and tolerability, with all treatment-emergent adverse events (TEAEs) being mild (Grade 1) or moderate (Grade 2) [2]. - There were no Grade 3 or 4 TEAEs related to denifanstat (ASC40), nor were there any serious adverse events (SAEs) associated with the treatment [2]. - The company has received positive feedback from the NMPA following recent pre-NDA communications regarding the new drug application for denifanstat (ASC40) [2]. Group 3 - The company has obtained exclusive rights for denifanstat (ASC40) in the Greater China region from Sagimet Biosciences Inc. (NASDAQ: SGMT) [2]. - The results of the Phase III study were presented orally at the 2025 European Academy of Dermatology and Venereology (EADV) annual meeting held in Paris [2].

Core Viewpoint - The announcement of the acceptance of the New Drug Application (NDA) for the first-in-class oral small molecule fatty acid synthase (FASN) inhibitor, ASC40, by the National Medical Products Administration (NMPA) of China marks a significant milestone in providing a potential groundbreaking therapy for moderate to severe acne [1] Company Summary - The company, Gilead Sciences-B (01672.HK), is advancing its innovative treatment for moderate to severe acne with the drug ASC40, which is a first-in-class FASN inhibitor [1] - The CEO, Dr. Wu Jinzi, expressed excitement about the NDA acceptance, indicating that ASC40 is just one step away from commercialization [1]

Core Insights - The company reported significant results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne at the 2025 EADV annual meeting in Paris, highlighting its innovative mechanism of action and clinical significance [1] - Denifanstat (ASC40) demonstrated statistically significant improvements in all primary and secondary endpoints compared to placebo, along with good safety and tolerability profiles [1] - The company is in communication with the National Medical Products Administration (NMPA) in China regarding the pre-New Drug Application (Pre-NDA) process, with positive feedback received [1] Company Developments - The company has obtained exclusive rights for denifanstat (ASC40) in Greater China from Sagimet Biosciences Inc. [2]

Core Viewpoint - The company reported positive results from the Phase III study of denifanstat (ASC40) for the treatment of moderate to severe acne, demonstrating significant efficacy compared to placebo and good safety and tolerability profiles [1] Group 1: Study Results - Denifanstat (ASC40) achieved all primary, key secondary, and secondary efficacy endpoints in the intent-to-treat (ITT) analysis, showing significant improvement in moderate to severe acne compared to placebo [1] - The incidence of treatment-emergent adverse events (TEAEs) was comparable between the denifanstat (ASC40) group and the placebo group, at 58.6% versus 56.3% respectively [1] - Most TEAEs were mild (Grade 1) or moderate (Grade 2) [1] Group 2: Regulatory Communication - The company is in pre-New Drug Application (Pre-NDA) communication with the National Medical Products Administration (NMPA) in China regarding denifanstat (ASC40) [1] - Feedback from the NMPA has been positive, and the company plans to submit a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne following the completion of pre-application communications [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，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮在2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場 報告了同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他(ASC40) 治療痤瘡的III期研究結果 本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集 團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。 本公司董事（「董事」）會（「董事會」）宣佈，在2025年9月17日於法國巴黎舉 行的2025年歐洲皮膚病與性病學會(EADV)年會最新突破性研究專場上口頭 報告了地尼法司他（denifanstat，ASC40）治療中重度尋常性痤瘡的III期研究 (NCT06192264)結果。 口頭報告細節 標題：同類首創脂肪酸合成酶(FASN)抑制劑地尼法司他治療尋常性痤瘡達到所有 ...

Group 1 - Company Gilead Sciences-B (01672) saw a significant stock increase of over 18%, currently trading at 10.96 HKD with a transaction volume of 79.907 million HKD [1] - Gilead announced that its oral small molecule fatty acid synthase (FASN) inhibitor, ASC40, achieved all primary, key secondary, and secondary endpoints in a Phase III clinical trial for moderate to severe acne [1] - Dongwu Securities highlighted that ASC40's clinical trial results are promising, indicating it may become an effective, patient-compliant, and safe treatment for acne, with plans to submit for regulatory approval in 2025 and potential revenue contribution in 2026 [1] Group 2 - Gilead will present early research data on its oral small molecule GLP-1 receptor agonist ASC30 and fat-targeting weight loss candidate ASC47 at the 85th American Diabetes Association (ADA) Scientific Sessions in Chicago [2] - ASC30 is noted as the only GLP-1 small molecule that can be administered both orally daily and via monthly subcutaneous injection, catering to diverse market needs [2] - ASC47 targets the THRβ receptor in fat cells and has potential for fat loss without muscle loss, being the first small molecule weight loss drug targeting THRβ, with Phase I SAD study data already released [2]