Core Insights - Ascletis Pharma Inc. has received acceptance for its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class oral fatty acid synthase inhibitor aimed at treating moderate-to-severe acne vulgaris, by the China National Medical Products Administration (NMPA) [2][3] - The Phase III clinical trial results demonstrated that denifanstat (ASC40) met all primary and secondary efficacy endpoints, showing significant improvement in acne vulgaris compared to placebo, with a favorable safety profile [4][5] Group 1 - The acceptance of the NDA is a significant milestone for Ascletis in its efforts to commercialize denifanstat (ASC40) [3] - Denifanstat (ASC40) has completed both Phase II and Phase III studies for the treatment of moderate-to-severe acne vulgaris [3][5] - The Phase III study results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2025, indicating the company's active engagement in scientific discourse [5] Group 2 - The Phase III study reported that all treatment-emergent adverse events (TEAEs) related to denifanstat (ASC40) were mild or moderate, with no severe adverse events observed [4] - Ascletis has licensed denifanstat (ASC40) from Sagimet Biosciences Inc. for exclusive rights in Greater China, highlighting strategic partnerships in drug development [5] - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced technologies in drug discovery [6]

Market Overview - The Hang Seng Index fell by 1.26%, down 340 points, closing at 26,732 points, while the Hang Seng Tech Index dropped by 2.20% [1] - Early trading volume in the Hong Kong stock market reached HKD 125 billion [1] Hydrogen Energy Sector - The hydrogen energy sector experienced significant gains following the National Energy Administration's encouragement of green hydrogen utilization in coal chemical projects [1] - Reshaping Energy (02570) surged over 55% [1] - Guofu Hydrogen Energy (02582) rose over 11% [1] - Guohong Hydrogen Energy (09663) increased by over 5% [1] - Yihua Tong (02402) saw a rise of 6.8% [1] Pharmaceutical Sector - Basestone Pharmaceuticals-B (02616) increased by over 14% as GIC continued to increase its stake, surpassing 7% ownership [1] - Gilead Sciences (01672) rose over 14%, marking five consecutive days of gains, as it develops ASC36 into a monthly therapy [1] - Laika Pharmaceuticals-B (02105) gained 11.96% after securing a significant BD order worth CNY 2.045 billion for a breast cancer target [1] - Yu Yuan Group (00551) rose over 4% due to an increase in shoe prices and potential market share expansion through overseas capacity growth [1] - JS Global Life (01691) increased by 3.5% as a new product from Joyoung became popular, leading to a two-day stock limit increase for Joyoung Co., Ltd. (002242.SZ) [1] - JD Health (06618) rose by 6.8% post-earnings, with a year-on-year operating profit increase of over 125% and strategic partnerships with several well-known pharmaceutical companies [1] Technology Sector - The Hang Seng Tech Index followed the Nasdaq's decline, dropping over 2% [1] - Alibaba fell by 3.46% [1] - Tencent dropped by 0.91% post-earnings [1] Cryptocurrency Sector - Cryptocurrency-related stocks declined, with Boya Interactive (00434) falling over 5% as Bitcoin dropped below the USD 100,000 mark [2]

Core Viewpoint - The stock of Gilead Pharmaceuticals (01672) has risen over 5%, marking a five-day consecutive increase, with a total weekly gain exceeding 30% [1] Group 1: Stock Performance - As of the report, Gilead Pharmaceuticals' stock is up 5.55%, trading at HKD 12.56, with a trading volume of HKD 18.19 million [1] Group 2: Clinical Development - Gilead Pharmaceuticals announced that its next-generation amylin receptor agonist ASC36 and next-generation GLP-1R/GIPR dual-target agonist ASC35 combination formulation have entered clinical development [1] - The company plans to submit a new drug clinical trial application for ASC36 and ASC35 for obesity treatment to the US FDA in the second quarter of 2026 [1] Group 3: Product Characteristics - ASC36 and ASC35 are proprietary ultra-long-acting combination formulations with superior physicochemical stability, showing no aggregation or precipitation at neutral pH levels [1] - Gilead aims to position ASC36 as a cornerstone for monthly therapy targeting cardiac metabolic diseases, including obesity [1] - ASC36 is expected to achieve better efficacy and tolerability compared to GLP-1 therapies and is an ideal candidate for both monotherapy and combination formulations with other long-acting agents like ASC35 or THRβ agonist ASC47 [1]

Core Viewpoint - The stock of Gilead Sciences (01672) has risen over 5%, marking five consecutive days of gains, with a cumulative increase of over 30% this week, currently trading at 12.56 HKD with a transaction volume of 18.19 million HKD [1] Group 1: Clinical Development - Gilead announced that its next-generation amylin receptor agonist ASC36 and next-generation GLP-1R/GIPR dual-target agonist ASC35 combination formulation have entered clinical development [1] - The company expects to submit a new drug clinical trial application for ASC36 and ASC35 for the treatment of obesity to the US FDA in the second quarter of 2026 [1] Group 2: Drug Characteristics - ASC36 and ASC35 are proprietary ultra-long-acting combination formulations with superior physicochemical stability, showing no aggregation or precipitation due to fibrosis at neutral pH [1] - Gilead aims to position ASC36 as a cornerstone for monthly therapies targeting cardiovascular metabolic diseases, including obesity [1] - ASC36 is anticipated to achieve better efficacy and tolerability compared to GLP-1 therapies, making it an ideal candidate for both monotherapy and combination formulations with other long-acting agents like ASC35 or THRβ agonist ASC47 [1]

Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]

Group 1 - Shimai Pharmaceutical plans to list on the Hong Kong Stock Exchange, having submitted its application with Huatai International as the sole sponsor [1] - Established in 2017, Shimai is a pioneer in next-generation T-cell engagers (TCE) aimed at utilizing the human immune system to combat cancer, with four self-developed clinical-stage candidates [1] - The company's core technology, the masking TCE, is designed for selective activation in tumors, focusing on solid tumors, which aligns with the growth trend in the TCE sector [1] Group 2 - Gilead Sciences announced the entry of its new generation of drugs ASC36 and ASC35 into clinical development, targeting obesity with a planned FDA submission in Q2 2026 [2] - ASC36 and ASC35 are proprietary long-acting combination formulations with superior physicochemical stability, designed to avoid aggregation and precipitation [2] - ASC36 is positioned as a cornerstone therapy for treating metabolic diseases, potentially offering better efficacy and tolerability compared to GLP-1 therapies [2] Group 3 - InnoCare Pharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors as an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of DB-1418 aims to address treatment bottlenecks in resistant solid tumors, enhancing the company's pipeline competitiveness [3] Group 4 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by the sales growth of its core product, BTK inhibitor Orelabrutinib [4] - Orelabrutinib's revenue increased by 45.8% year-on-year, surpassing last year's total revenue, while the company's losses narrowed by 74.8% to 70 million yuan [4] - The revenue growth and reduced losses indicate a potential profitability turning point, which may accelerate the advancement of the innovation pipeline and strengthen the company's position in the BTK field [4]

Core Insights - The company, Gilead Sciences, has announced the initiation of clinical development for its next-generation amylin receptor agonist ASC36 and the dual-target GLP-1R/GIPR agonist ASC35, both designed for monthly administration [1][2] - Gilead plans to submit an Investigational New Drug (IND) application to the FDA for ASC36 and ASC35 in the second quarter of 2026 for obesity treatment [1] Group 1 - ASC36 and ASC35 are developed using Gilead's AI-assisted drug discovery and ultra-long-acting drug development platforms, enabling proprietary formulations for monthly subcutaneous administration [2] - The formulations demonstrate superior physicochemical stability, avoiding aggregation and precipitation issues commonly seen with other amylin receptor agonists at neutral pH [2] Group 2 - In head-to-head studies, ASC36 showed a 32% greater weight loss effect compared to eloralintide in diet-induced obesity (DIO) rats, while ASC35 demonstrated a 71% greater effect compared to tirzepatide in DIO mice [3] - The combination of ASC36 and ASC35 resulted in a 51% greater weight loss effect compared to the combination of eloralintide and tirzepatide in DIO rat studies [3] - The CEO of Gilead expressed optimism about the potential of ASC36 and ASC35 to achieve more significant weight loss effects in obese populations compared to monotherapy, highlighting the company's capabilities in developing long-acting peptide therapies [3]

Core Insights - Ascletis Pharma Inc. has announced the co-formulation of ASC36, a once-monthly amylin receptor agonist, and ASC35, a once-monthly GLP-1R/GIPR dual agonist, for clinical development targeting obesity [5][6] Pharmacokinetics and Efficacy - The co-formulation of ASC36 and ASC35 demonstrated a comparable pharmacokinetic profile to the individual dosing of ASC36 and ASC35 in non-human primate studies, supporting once-monthly subcutaneous administration [7] - ASC36 monotherapy showed approximately 32% greater relative body weight reduction compared to eloralintide monotherapy in diet-induced obese (DIO) rat studies, while ASC35 monotherapy exhibited approximately 71% greater relative body weight reduction compared to tirzepatide monotherapy in DIO mouse studies [2][8] - The co-formulation of ASC36 and ASC35 resulted in approximately 51% greater relative body weight reduction compared to the co-formulation of eloralintide and tirzepatide in DIO rat studies [3][9] Stability and Formulation - The co-formulation of ASC36 and ASC35 exhibited excellent chemical and physical stability, with no aggregation or precipitation at neutral pH, which is crucial for maintaining potency and reducing immunogenicity risks [6][3] Regulatory and Future Plans - The company plans to submit an Investigational New Drug Application (IND) to the U.S. FDA for the co-formulation of ASC36 and ASC35 in the second quarter of 2026 [4][5] - A conference call is scheduled for November 13, 2025, to discuss further developments [12] Technological Advancements - Ascletis utilized its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies to develop ASC36 and ASC35, enabling the design of multiple once-monthly subcutaneous ultra-long-acting peptides [6][11]

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。 （股份代號：1672） 自願性公告 歌禮宣布每月一次新一代胰淀素受體激動劑ASC36和每月一次新一代 GLP-1R/GIPR雙靶點激動劑ASC35的複方製劑進入臨床開發階段 1 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） － 在非人靈長類動物的頭對頭研究中，每月一次皮下給藥的胰淀素(amylin)受 體激動劑多肽ASC36和每月一次皮下給藥的GLP-1R/GIPR雙靶點激動劑多肽 ASC35複方製劑的藥代動力學特徵與ASC36和ASC35單獨給藥時相當。該複 方製劑利用歌禮專有的超長效藥物開發平台(ULAP)技術開發而成。 － 在頭對頭飲食誘導肥胖 (DIO) 大鼠研究中，ASC36 單藥的減重效果較 eloralintide單藥相對提升約32%，而在頭對頭DIO小鼠研究中，ASC35單藥的 減重效果較替爾泊肽單藥相對提升約71%。 － 在頭對頭 DIO ...

Core Viewpoint - The company, Gilead Sciences-B (01672), has seen a significant stock increase of over 7% following the announcement of its potential "best-in-class" monthly subcutaneous injection amylin receptor agonist, ASC36, as a clinical development candidate [1] Group 1: Company Developments - Gilead has selected ASC36 as a candidate for clinical development, with plans to submit a new drug clinical trial application to the FDA in the second quarter of 2026 for obesity treatment [1] - ASC36 is designed to have a longer apparent half-life and higher bioavailability per milligram of peptide, enabling monthly subcutaneous administration [1] - The CEO, Dr. Wu Jinzi, indicated that ASC36's preclinical characteristics suggest it may achieve best-in-class efficacy and a more patient-friendly dosing titration scheme [1]