摩·咨询 查数据·找摩熵 摩炳咨询 医药行业观察周报 2026.03.09-2026.03.15 摩熵·咨询 摩咨询一医药行业观察周报 查数据·找摩 目录 | 本周国内创新药/改良型新药申请临床/获批临床/申请上市/获批上市数据分析。 | | | --- | --- | | 1.1总体概况 | | | 1.2本周获批临床创新药/改良型新药信息速览(不含补充申请) | | | 1.3本周获批上市创新药信息速览 | 10 | | 、本周国内仿制药/生物类似物申报/审批数据分析。 | 10 | | 2.1总体概况， | 10 | | 2.2本周通过/视同通过一致性评价全局分析. | 11 | | 2.3本周首次过评/视同过评、过评/视同过评达7 家品种盘点 | 12 | | 三、本周国内医药大健康行业政策法规汇总 | 13 | | 3.1本周国内医药大健康行业政策法规速览 | .13 | | 3.2本周重点行业政策详细说明， | .14 | | 》国家药监局综合司关于学习宣传贯彻《中华人民共和国药品管理法实施条例》的通知 | .14 | | 四、本周全球创新药研发概览 | .14 | | 4.1本周全球TOP10创 ...

Core Viewpoint - The article highlights the positive results of the Phase II 24-week study of ASC30, a subcutaneous depot formulation of a small molecule GLP-1 receptor agonist developed by Gilead Sciences, demonstrating significant weight loss and safety in obese patients with related comorbidities [6][7]. Group 1: Study Results - The study involved 65 participants and aimed to assess the safety, tolerability, and efficacy of ASC30 in the target population [6]. - Patients receiving three doses of ASC30 showed an average weight reduction of 6.3% by week 12, increasing to 7.5% by week 16, indicating significant efficacy for weight loss [6]. - The monthly administration of ASC30 proved effective in maintaining weight loss, suggesting its potential as a long-term maintenance therapy [6]. Group 2: Safety and Tolerability - ASC30 exhibited good safety and tolerability profiles, comparable to common GLP-1 class medications [7]. - No patients discontinued the treatment due to adverse events, and gastrointestinal side effects were mild, with no serious safety signals identified [7]. - The successful outcomes of this study provide strong support for further clinical development of ASC30 and open new avenues for the future application of GLP-1 class weight loss medications [7].

Investment Rating - The industry investment rating is "Overweight" indicating that the industry is expected to outperform the overall market [2][6]. Core Insights - Recent adjustments to the Hong Kong Stock Connect list include companies such as Weili Zhibo and Jinfang Pharmaceutical, effective from March 9. Kangfang Biologics has received clinical approval for its first tri-antibody [2][3]. - Kingsray Biotech anticipates an adjusted net profit of USD 207-242 million for 2025, representing a year-on-year growth of approximately 246.5%-304.3%, primarily due to licensing revenue increasing from USD 2.4 million in 2024 to USD 256-299 million [2][7]. - The Hang Seng Healthcare Index rose by 2.58%, outperforming the Hang Seng Index by 1.02 percentage points [6]. Summary by Sections 1. Overseas Pharmaceuticals - Companies like Weili Zhibo, Jinfang Pharmaceutical, and others have been included in the Hong Kong Stock Connect list since March 9. Kangfang Biologics' AK150 has received clinical trial approval for treating advanced malignant solid tumors [3][8]. - Alnylam has initiated a clinical trial for ALN-2232 (ALK7 siRNA) aimed at obesity, with an expected completion date in March 2028 [4][9]. - Agilent Technologies has agreed to acquire Biocare Medical for USD 950 million, enhancing its capabilities in clinical pathology [4][9]. 2. Performance Updates - Kingsray Biotech expects a significant increase in net profit for 2025, while Lepu Biotech anticipates a net profit of no less than RMB 200 million, marking a turnaround [7][8]. - The revenue forecast for Jike Si is projected to decline by 65.6% in 2025, with a net loss of RMB 146 million [7][8]. 3. Recommendations - Focus on innovative drugs with ongoing commercialization and active overseas transactions, particularly companies like BeiGene, Innovent Biologics, and Kangfang Biologics [12]. - In the Pharma sector, companies like 3SBio and Hansoh Pharmaceutical are making strides in their innovative pipelines [12]. 4. Education Sector - The education index increased by 3.1%, outperforming the Hang Seng Index by 0.3 percentage points [14]. - China Oriental Education is recommended due to its strong growth prospects and strategic adjustments in response to vocational training demand [17]. 5. Social Services - Macau's visitor numbers during the Spring Festival reached historical highs, with total inbound travelers at 1.554 million and an average daily visitor count of 173,000, reflecting a year-on-year growth of 5.5% [19].

Core Insights - Ascletis Pharma Inc. announced positive topline results from a U.S. Phase II, 24-week study for its ASC30 subcutaneous depot formulation, achieving a statistically significant and clinically meaningful placebo-adjusted mean weight loss of 7.5% at week 16 after three monthly doses [1] Group 1: Study Results - The Phase II study involved 65 participants with obesity or overweight, achieving its primary endpoint with a mean weight loss of 6.3% at week 12 and 7.5% at week 16 for the ASC30 SQ depot formulation A1 [1] - The study demonstrated that ASC30 maintained weight loss for four months following the last dose, indicating potential for quarterly dosing as a maintenance therapy [1] - ASC30 SQ depot formulation A1 showed a safety and tolerability profile consistent with the GLP-1 drug class, with no discontinuations due to adverse events [1] Group 2: Formulation Details - ASC30 SQ depot formulation A1 was administered in three doses of 400 mg each, achieving placebo-adjusted mean body weight loss of 2.7%, 5.5%, 6.3%, and 7.5% at weeks 4, 8, 12, and 16 respectively [1] - The formulation demonstrated therapeutic drug exposures over a 16-week maintenance period, with mean weight loss of 5.5% at week 8, 6.4% at week 20, and 5.8% at week 24 [1] - ASC30 is the first GLP-1 to achieve effective weight loss with once-monthly injection without requiring lead-in weekly injections [1] Group 3: Company Overview - Ascletis Pharma Inc. is focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary technologies such as Artificial Intelligence-assisted Structure-Based Drug Discovery and Ultra-Long-Acting Platform [2] - ASC30 is a new chemical entity with U.S. and global patent protection through 2044, designed for both oral and subcutaneous administration [2] - The company is listed on the Hong Kong Stock Exchange and has developed multiple drug candidates for chronic weight management [2]

消息面上，GIC在歌礼制药最新一轮配售中获得头部分配额度，将助力ASC30加速全球III期临床推进。 2月6日，港交所披露的信息显示，新加坡政府投资基金(GIC)以每股均价12.18港元的价格，斥资约7.81 亿港元买入歌礼制药6412.8万股新股。交易完成后，GIC持有歌礼制药6.42%股权。 东方证券表示，ASC30减重数据优越，安全性良好，且分子专利已获美国授权，BD潜力较大。此外， 歌礼制药基于超长效药物开发平台(ULAP)开发的用于减重和维持治疗的ASC30皮下注射剂型，表观半 衰期分别长达46天和75天，远超其他超长效GLP-1药物，同时安全性占优。 智通财经APP获悉，歌礼制药-B(01672)再涨超6%，截至发稿，涨5.52%，报17.2港元，成交额6945.8万 港元。 ...

歌礼制药-B(01672)再涨超6%，截至发稿，涨5.52%，报17.2港元，成交额6945.8万港元。 东方证券表示，ASC30减重数据优越，安全性良好，且分子专利已获美国授权，BD潜力较大。此外， 歌礼制药基于超长效药物开发平台(ULAP)开发的用于减重和维持治疗的ASC30皮下注射剂型，表观半 衰期分别长达46天和75天，远超其他超长效GLP-1药物，同时安全性占优。 消息面上，GIC在歌礼制药最新一轮配售中获得头部分配额度，将助力ASC30加速全球III期临床推进。 2月6日，港交所披露的信息显示，新加坡政府投资基金(GIC)以每股均价12.18港元的价格，斥资约7.81 亿港元买入歌礼制药6412.8万股新股。交易完成后，GIC持有歌礼制药6.42%股权。 ...

Core Viewpoint - Ascletis Pharma Inc. announced positive topline results from a Phase III open-label study of denifanstat (ASC40), a first-in-class oral fatty acid synthase (FASN) inhibitor for treating moderate-to-severe acne vulgaris, indicating a potential breakthrough in acne treatment [1] Group 1: Study Results - Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile in a Phase III open-label study involving 240 patients, with most treatment-emergent adverse events (TEAEs) being mild (grade 1) or moderate (grade 2) [1] - No grade 3 or 4 adverse events or serious adverse events (SAEs) related to denifanstat (ASC40) were reported, and no deaths occurred during the study [1] Group 2: Mechanism of Action - The mechanism of action for denifanstat (ASC40) includes direct inhibition of sebum production by inhibiting de novo lipogenesis (DNL) in human sebocytes and reducing inflammation by decreasing cytokine secretion and Th17 differentiation [1] - This unique mechanism sets denifanstat (ASC40) apart from most other acne treatments, which do not address the underlying cause of acne [1] Group 3: Regulatory Progress - The New Drug Application for denifanstat (ASC40) for acne has been accepted by the China National Medical Products Administration, indicating progress towards commercialization [1] Group 4: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing potential best-in-class and first-in-class therapeutics for metabolic diseases [1] - The company utilizes proprietary technologies such as Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) to develop multiple drug candidates, including small molecules and peptides [1]

Core Viewpoint - The stock of Gilead Sciences-B (01672) rose over 4% in the afternoon, currently up 3.85% at HKD 13.76, with a trading volume of HKD 12.1855 million. The company announced the completion of the first patient dosing in a Phase II clinical trial in the U.S. for its oral GLP-1 receptor agonist ASC30, aimed at treating type 2 diabetes, with plans to recruit approximately 100 patients across multiple centers in the U.S. The primary data from this 13-week study is expected to be released in Q3 2026 [1]. Group 1 - Gilead Sciences has initiated a Phase II clinical trial for ASC30, targeting type 2 diabetes treatment [1]. - The trial will involve around 100 patients and is set to take place in multiple centers across the U.S. [1]. - The company plans to announce the primary data from the trial in Q3 2026 [1]. Group 2 - The CEO of Gilead Sciences, Dr. Wu Jinzi, emphasized the strategic expansion into the diabetes treatment market with ASC30 [1]. - The company aims to showcase ASC30 as a potential best-in-class oral treatment option, administered once daily [1]. - The upcoming trial results are anticipated to provide significant insights into the efficacy of ASC30 for diabetes patients [1].

Core Viewpoint - The announcement of the completion of the first patient dosing in the Phase II clinical trial of ASC30 for type 2 diabetes treatment has positively impacted the stock price of the company, leading to a rise of over 4% [1] Company Developments - The company, Songlei Pharmaceutical, has initiated a Phase II clinical trial in the United States for its oral small molecule GLP-1 receptor agonist ASC30, targeting approximately 100 type 2 diabetes patients across multiple centers [1] - The primary data from this 13-week Phase II study is expected to be released in the third quarter of 2026 [1] - The founder and CEO, Dr. Wu Jinzi, emphasized the strategic importance of expanding ASC30's clinical development into the large diabetes treatment market, highlighting its potential as a best-in-class oral treatment option [1]

在肥胖或超重受试者中开展的13周研究显示，ASC30的经安慰剂校正后的体重下降高达7.7%，且胃肠 道耐受性更佳，未观察到肝脏安全性信号。该研究共入组125例肥胖受试者或伴有至少一种体重相关合 并症的超重受试者。 在第13周的主要终点上，ASC30片的每日一次20毫克、40毫克和60毫克分别实现了5.4%、7.0%和7.7% 的体重下降，且体重下降具有统计学显著性和临床意义。因不良事件导致的总停药率为4.8%。 1月26日，歌礼制药发布公告称，公司完成了口服小分子GLP-1R激动剂ASC30治疗糖尿病的美国II期研 究首批受试者给药。预计将于2026年第三季度获得该项研究的顶线数据。 ...