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 Insights - The article highlights the transformative journey of Gilead Sciences (1672.HK) in the Chinese biotech industry, showcasing its resilience and strategic decision-making in the face of challenges [2][11] - Gilead's shift towards a differentiated pipeline in weight loss drugs has led to a significant market re-evaluation and recovery in its stock price [4][9] Group 1: Company Development - Gilead Sciences was listed on the Hong Kong Stock Exchange in August 2018 at an initial price of 14 HKD, reaching a market capitalization of 16 billion HKD, but faced a decline due to setbacks in its core hepatitis C drug [3][4] - By August 2024, the company's stock price had plummeted to 0.76 HKD, resulting in a market value reduction of over 95% [3][4] - The founder, Dr. Wu Jinzi, demonstrated strategic foresight by pivoting the company's focus to the metabolic disease sector, particularly the weight loss drug market, starting in 2022 [3][5] Group 2: Strategic Shift and Market Response - Following the strategic shift, Gilead's stock price surged from 0.76 HKD in August 2024 to 18.75 HKD by August 2025, representing an increase of over 20 times and restoring its market capitalization to the billion HKD level [4][9] - The market's positive response reflects recognition of Gilead's research team's capabilities and strategic execution [4][9] Group 3: R&D and Competitive Advantage - Gilead has adopted a differentiated approach in drug development, focusing on oral small molecule GLP-1 receptor agonists and ultra-long-acting formulations, rather than following mainstream peptide drug development paths [5][8] - The core pipeline, ASC30, has shown promising clinical results, with a maximum weight reduction of 6.5% in U.S. Phase Ib trials, and is expected to complete Phase IIa trials by the end of the year [5][6] - Gilead is also developing ASC35 and ASC36, which are expected to provide significant advantages in terms of dosing frequency and efficacy compared to existing treatments [6][7] Group 4: Global Competitiveness and Valuation - Despite the stock price recovery, Gilead's current market capitalization is still considered undervalued compared to global peers, as evidenced by recent acquisition bids for similar companies [9][10] - Gilead's diverse pipeline, including multiple formulations with the potential for monthly and quarterly dosing, positions it favorably in the competitive landscape [9][10] Group 5: Lessons and Implications for the Industry - Gilead's successful transformation underscores the importance of strong R&D leadership and strategic vision in navigating industry challenges [11] - The case of Gilead serves as a valuable reference for other Chinese biotech companies seeking to innovate and compete on a global scale [11]

Core Insights - Ascletis Pharma Inc. has selected ASC36 as a clinical development candidate for obesity treatment, with an Investigational New Drug Application (IND) submission expected in Q2 2026 [3][4][7] Group 1: Drug Development and Efficacy - ASC36 is a once-monthly, subcutaneously administered amylin receptor agonist, demonstrating a half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide [1][4] - In a diet-induced obese rat study, ASC36 achieved a body weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% greater relative efficacy [5][6] - The drug's formulation allows for co-formulation with other peptides, such as ASC35, enhancing its therapeutic potential [2][7] Group 2: Technological Advancements - ASC36 was developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which facilitate the design of ultra-long-acting peptides [4][9] - The engineered properties of ASC36 support scalability advantages in manufacturing, contributing to its potential as a best-in-class treatment for obesity [5][7] Group 3: Company Strategy and Future Plans - Ascletis aims to develop ASC36 as a cornerstone therapy for cardio-metabolic diseases, with plans for combination therapies involving ASC35 [8] - A conference call is scheduled for October 30, 2025, to discuss further developments [10]

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 歌禮選定同類最佳每月一次皮下注射胰淀素受體激動劑 ASC36進入臨床開發階段 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，已選定一款有望成為同類最佳每月一 次皮下注射胰淀素(amylin)受體激動劑ASC36作為臨床開發候選藥物。歌禮預計 將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC36治療肥胖症的 新藥臨床試驗申請(IND)。 | 組別 | 給藥方案 | 相對基線的 | 較petrelintide的 | | --- | --- | --- | --- | | | | 總體重變化 | 減重效果相對提升 | | 服 ...