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 ...

董事會會議通告 歌禮製藥有限公司（「本公司」）董事會（「董事會」）謹此宣佈，董事會會議將於二 零二六年三月三十一日（星期二）舉行，藉以（其中包括）考慮及批准本公司及其附 屬公司截至二零二五年十二月三十一日止年度業績及其發佈，並考慮建議派發末 期股息（如有）。 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之內容概不負責，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倚 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） 承董事會命 歌禮製藥有限公司 主席 吳勁梓 香港 二零二六年三月十八日 於本公告日期，本公司董事會包括執行董事吳勁梓博士及何淨島女士；及獨立非 執行董事魏以楨博士、顧炯先生及華林女士。 ...

Performance Summary - Fuyao Glass (03606.HK) reported a revenue of approximately 45.787 billion yuan for 2025, representing a year-on-year increase of 16.65%, with a net profit of about 9.312 billion yuan, up 24.2% [1] - Hengan International (01044.HK) achieved a revenue of 23.069 billion yuan in 2025, a 1.8% increase year-on-year, and a net profit of 2.535 billion yuan, up 10.3%. E-commerce and new retail sales revenue grew by 10.1%, with an annual gross margin improvement to approximately 33.8% [1] - Sunac China (01918.HK) expects a loss between 12 billion to 13 billion yuan for 2025, a reduction compared to the previous year, primarily due to gains from overseas debt restructuring [1] - Tencent Music (01698.HK) reported total revenue of 32.9 billion yuan for 2025, a 15.8% year-on-year increase, with a net profit of 11.06 billion yuan, up 66.4% [2] - China Eastern Education (00667.HK) achieved a revenue of 4.616 billion yuan in 2025, a 12.1% increase, with adjusted net profit of 792 million yuan, up 50.9% [4] - Hong Kong Electric (02638.HK) reported a revenue of 12.125 billion yuan for 2025, a 0.6% increase, and a net profit of 3.149 billion yuan, up 1.2% [5] - Longjiang Life Science (00775.HK) reported a revenue of 5.41 billion HKD, a 2% decrease, with a net loss of 187 million HKD, an increase of 47.61% year-on-year [3] Company News - Weisheng Holdings (03393.HK) won a supply contract for reclosers from CEMIG, Brazil's largest power company, valued at 138 million Brazilian Reais (approximately 182 million yuan or 206 million HKD), to be delivered in batches over the next two years [9] - Hong Kong International Holdings (00480.HK) partnered with Jiaxing Xiutuo Construction Investment Group to acquire a commercial land plot in Jiaxing for approximately 216.4 million yuan, planning to develop a shopping center [9] Financing and Buyback Activities - Xindong Company (02400.HK) repurchased 108,000 shares at a cost of approximately 7.911 million HKD, with prices ranging from 72.00 to 75.05 HKD [16] - Yum China (09987.HK) repurchased 18,500 shares for about 7.714 million HKD, with prices between 414.8 and 420.6 HKD [16] - CNOOC Oilfield Services (02883.HK) completed the issuance of 5 billion yuan in bonds through its wholly-owned overseas subsidiary [17]

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） ASC39具有獨特的化學骨架，該化學骨架是利用歌禮基於結構的AI輔助藥物發 現（Artificial Intelligence-assisted Structure-Based Drug Discovery，AISBDD）技 術自主發現的。在ASC39與eloralintide的頭對頭環磷酸腺苷(cAMP)激活實驗中， ASC39與eloralintide（胰淀素多肽類似物）對人胰淀素1型受體(hAMY1R)的EC50 （半數最大有效濃度）分別為21.4 pM和21.2 pM。ASC39與eloralintide對人降鈣素 受體(hCTR)的EC50分別為846.1 pM和1,350.8 pM。這些數據表明，相較於hCTR， ASC39對hAMY1R具有高度選擇性，且ASC39對hAMY ...

Investment Rating - The report maintains an "Overweight" rating for the overseas pharmaceutical industry, indicating a positive outlook compared to the overall market performance [6][11]. Core Insights - Recent adjustments to the Hong Kong Stock Connect list include companies like Weili Zhibo and Jinfang Pharmaceutical, effective from March 9, 2026. Additionally, Kangfang Biotech's first tri-antibody has received clinical trial approval [2][3]. - Kingsray Biotech expects an adjusted net profit of USD 207-242 million for 2025, representing a year-on-year growth of approximately 246.5%-304.3%, primarily driven by licensing revenue growth 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 and Jinfang Pharmaceutical have been included in the Hong Kong Stock Connect list, effective March 9, 2026. Kangfang Biotech's AK150 has received clinical trial approval for treating advanced malignant solid tumors [3][8]. - Songli Pharmaceutical's small molecule GLP-1R agonist ASC30 achieved statistically significant weight loss results in a U.S. Phase II trial, with an average weight reduction of 7.5% after three monthly doses [3][8]. 2. Performance Updates - Kingsray Biotech anticipates a significant increase in net profit for 2025, while Lepu Biotech expects to achieve a net profit of no less than RMB 200 million, marking a turnaround from losses [2][7]. - Jike Si's revenue is projected to decline by 65.6% in 2025, with a net loss of RMB 146 million [2][7]. 3. Recommendations - The report suggests focusing on innovative drugs with ongoing commercialization and business development opportunities, particularly companies like Baijie Shenzhou, Xinda Biotech, and Kangfang Biotech [11]. - In the pharmaceutical sector, companies like Sanofi and China Biopharmaceutical are highlighted for their progressive innovation pipelines [11]. 4. Overseas Education - The education index increased by 3.1%, outperforming the Hang Seng China Enterprises Index by 0.3 percentage points [13]. - The report recommends focusing on Chinese Oriental Education, which is expected to see accelerated enrollment growth due to rising demand for vocational training [15]. 5. Overseas Social Services - Macau's total visitor numbers during the Spring Festival reached a record high, with 1.554 million visitors and an average daily visitor count of 173,000, reflecting a year-on-year growth of 5.5% [17].

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].

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 歌禮宣佈其小分子GLP-1R激動劑ASC30的超長效 皮下儲庫型製劑針對肥胖適應症的美國II期24周研究獲積極頂線結果 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。 該II期研究同時評估了ASC30皮下儲庫型製劑A1作為維持療法的潛力。在第8周 完成末次給藥後，對在患者中的療效持續時間進行了為期16周的評估。ASC30皮 下儲庫型製劑A1在末次給藥後的16周維持期內均達到了治療性藥物暴露水平。 經安慰劑校正後的平均體重下降在第8周為5.5%，第20周（末次給藥後3個月）為 6.4%，第24周（末次給藥後4個月）為5.8%。這些結果顯示ASC30皮下儲庫型製劑 A1有望成為每季度給 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | | --- | | 2026年2月28日 | | 狀態: | | 新提交 | 致：香港交易及結算所有限公司 公司名稱: 歌禮製藥有限公司 呈交日期: 2026年3月3日 I. 法定/註冊股本變動 足夠公眾持股量的確認(註4) | 根據《主板上市規則》第13.32D(1)條或第19A.28D(1)條 / 《GEM上市規則》第17.37D(1)條或第25.21D(1)條，我們在此確認，就上述所列股份類別而言，截至本月底: | | --- | | ✔ 已符合適用的公眾持股量要求（見下方） | | 未符合適用的公眾持股量要求（見下方） | | 根據《主板上市規則》第13.32B條或第19A.28B條 / 《GEM上市規則》第17.37B條或第25.21B條（視情況而定）所載的有關股份類別的最低公眾持股量要求為： | | 適用的公眾持股量門檻 初始指定門檻 - 上市股份所屬類別的已發行股份總數(不包括庫存股份)的25% | | 額外信息 | 第 2 頁 共 10 頁 v 1.2.0 FF301 | 1. 股份分類 | 普 ...

Group 1 - The pharmaceutical stocks have shown a general upward trend, with notable increases in companies such as Genscript Biotech (up 6.33%), Kintor Pharmaceutical (up 5.23%), and Junshi Biosciences (up 4.39%) [1] - The Chinese innovative drug licensing market has continued its strong growth into 2026, with total transaction amounts exceeding $33.28 billion in the first quarter, surpassing the highest quarterly upfront payment levels of 2025 [1] - According to Open Source Securities, the innovative drug sector has experienced a correction over the past two quarters, but long-term prospects for quality stocks are favorable, suggesting an increase in sector allocation focusing on companies with established overseas opportunities and high clinical data performance [1] Group 2 - Donghai Securities previously indicated that the innovative drug sector is entering a phase of accelerated profit realization by 2025, with companies like Innovent Biologics and Rongchang Biopharmaceutical achieving profitability, while others like 3SBio and Shanghai Yizhong are expected to see significant performance increases [2] - The strong performance of the innovative drug sector validates the effectiveness of the domestic innovative drug business model, with core product volume growth supported by medical insurance becoming the foundation for performance growth, while external collaborations such as BD are crucial for enhancing earnings [2]