02期 总163期 2026年01月03日—2026年01月09日 药渡全球药物研发进展报告 ⸺仿制药篇 加入群聊 联系客服 www.pharmacodia.com 扫码试用 | ★本周渡选★ 2 | | | --- | --- | | 一、 | 国内仿制药研发批准动态 4 | | 首家仿制药品种批准上市情况 4 | 1.1 | | 新注册分类品种批准上市情况 4 | 1.1.1 | | 一致性评价品种批准上市情况 7 | 1.1.2 | | 其他仿制药品种批准上市情况 8 | 1.2 | | 新注册分类品种批准上市情况 8 | 1.2.1 | | 一致性评价品种批准上市情况 16 | 1.2.2 | | 仿制药品种批准临床情况 17 | 1.3 | | 仿制药品种拒绝批准/主动撤回情况 17 | 1.4 | | 二、 | 国内仿制药研发申报动态 18 | | 新注册分类品种申报上市情况 18 | 2.1 | | 一致性评价品种申报上市情况 27 | 2.2 | | 仿制药补充申请情况 28 | 2.3 | | 仿制药申报上市专利声明信息 29 | 2.4 | | 三、 | 国内仿制药研发领域热点聚焦 36 ...

中国人寿 紫金矿业 中芯国际 中国移动 华虹公司 中国人寿 分时图 日K线 周K线 月K线 48.34 -1.38 -2.78% 3.40% 2.27% 1.13% 0.00% 1.13% 2.27% 3.40% 48.03 48.59 49.16 49.72 50.28 50.85 51.41 09:30 10:30 11:30/13:00 14:00 15:00 0 21万 41万 62万 2月2日港股市场，北水成交净买入19.07亿港元，其中港股通(沪)成交净买入27.38亿港元，港股通(深)成交净卖出8.3亿港元。 北水净买入最多的个股是腾讯(00700)、小米集团-W(01810)、中国人寿（601628）(02628)。北水净卖出最多的个股是华虹半 导体(01347)、紫金矿业（601899）(02899)、石药集团(01093)。 | 股票名称 | 买入额 | 卖出额 | 买卖总额 | | --- | --- | --- | --- | | | | | 净流入 | | 阿里巴巴-W | 26.52 乙 | 34.69 Z | 61.21亿 | | HK 09988 | | | -8.16 亿 | ...

恒生医疗低开低走三连跌，截至收盘下跌3.62%。 其中康方生物大跌8.61%，中国生物下跌5.27%，石药 集团下跌4.69%，百济神州下跌4.11%，京东健康、翰森制药、药明生物等股跌幅均在3%上方。 恒生银行探底回升，盘中一度大跌1.84%，截至收盘下跌1.05%。其中大新金融下跌3.54%，大新银行下 跌2.33%，重庆银行下跌2.29%，中银香港下跌2.04%，郑州银行、渣打银行、汇丰控股等超10只个股跌 幅在1%上方。 开盘后直线跳水，随后全天弱势，截至收盘大跌2.23%。恒生科技跌幅居前，互联网、恒生医疗、大消 费等紧随其后；恒生银行相对抗跌。 恒生科技低开低走大跳水，截至收盘下跌3.99%。比亚迪股份大跌6.91%，中芯国际下跌4.24%，百度集 团下跌3.99%，快手下跌3.93%，阿里巴巴下跌3.49%，网易下跌3.46%。 内容只是个人观点，仅供参考，不作为投资依据！欢迎关注交流，互相学习、共同探讨！ ...

Core Viewpoint - On January 30, 2023, the company signed a strategic research and development cooperation and licensing agreement with AstraZeneca, leveraging its sustained-release drug delivery technology platform and peptide drug AI discovery platform to develop innovative long-acting peptide drugs, with a total potential transaction value of up to $18.5 billion, including $1.2 billion in upfront payments, up to $3.5 billion in research milestones, and up to $13.8 billion in sales milestones along with double-digit sales royalties, showcasing the company's global leading position in long-acting peptide and AI drug development [1][2] Event - The company announced the signing of a strategic R&D cooperation and licensing agreement with AstraZeneca to utilize its proprietary sustained-release drug delivery technology platform and peptide drug AI discovery platform to develop innovative long-acting peptide drugs, including a clinical-ready project SYH2082 (long-acting GLP1R/GIPR agonist) currently advancing to Phase I clinical trials, along with three preclinical projects with different mechanisms of action [1][2] Product Development - SYH2082 is a long-acting GLP1R/GIPR dual receptor agonist, designed for monthly administration, utilizing the sustained-release drug delivery technology platform and peptide drug AI discovery platform to achieve weight loss and metabolic improvement for obesity and weight management indications [2] - The company's sustained-release drug delivery technology platform (LiquidGel long-acting sustained-release system) employs innovative gel matrix and microsphere preparation technology to achieve stable sustained release of peptide drugs, significantly improving safety and tolerability [2] Pipeline and Collaboration - The company continues to advance its innovative drug pipeline, with multiple clinical products showing significant potential for external licensing, supported by diversified technology platforms and global strategic layout [2] - In 2025, the company successfully licensed several core products and innovative technology platforms, including ROR1 ADC (SYS6005) licensed to Radiance Biopharma with an upfront payment of $15 million and potential development, regulatory, and sales milestone amounts totaling up to $1.225 billion, and the oral small molecule GLP-1 receptor agonist SYH2086 licensed globally to Madrigal Pharmaceuticals with an upfront payment of $120 million and potential total collaboration value of up to $2.075 billion [2] Financial Forecast - The company forecasts revenues of 27.335 billion yuan, 28.333 billion yuan, and 30.047 billion yuan for 2025-2027, with net profits attributable to the parent company of 4.924 billion yuan, 5.086 billion yuan, and 5.416 billion yuan, corresponding to PE ratios of 25, 24, and 23, maintaining a "buy" rating [3]

Major Events - Singularity Guofeng (01280) sold all shares of China Silver Ray (Hong Kong) Investment Holdings Limited at zero cost [1] - ZTE Corporation (00763) plans to invest 117 million yuan to subscribe to Jianxing Zhanlu Fund shares [1] - Cloud Factory (02512) subsidiary won the bid for the second phase of the artificial intelligence industry base project [1] - CSPC Pharmaceutical Group (01093) received drug registration approval for Chlorpheniramine Lactate Injection [1] - Derin Holdings (01709) reported a Bitcoin balance of 84.555 BTC as of January 31 [1] - Baiguoyuan Group (02411) diluted its stake in Baiguoyuan Commercial Management to 51.02%, with core management investing to enhance new business layout [1] Operating Performance - XPeng Motors-W (09868) delivered 20,011 new vehicles in January [1] - Ruipulan Jun (00666) issued a profit warning, expecting a net profit of approximately 630 million to 730 million yuan in 2025, turning from loss to profit [1] - China Merchants Jinling (00978) projected a total contract sales amount of approximately 32.308 billion yuan in 2025, a year-on-year decrease of 23.91% [1] - China National Building Material (03323) issued a profit warning, expecting a shareholder loss of approximately 2.3 billion to 4 billion yuan in 2025, turning from profit to loss [1]

Group 1 - The Hong Kong Dividend ETF (ICBC, 159691) closed down 3.71% on February 2, with a trading volume of 472 million yuan [1] - The fund was established on March 30, 2023, with an annual management fee of 0.45% and a custody fee of 0.07% [1] - As of January 30, 2024, the fund's latest share count was 6.306 billion, with a total size of 8.691 billion yuan, reflecting a 3.43% decrease in shares and a 3.03% increase in size since December 31, 2025 [1] Group 2 - The current fund managers are Liu Weilin and He Shun, with Liu managing since March 30, 2023, achieving a return of 39.18%, while He is set to manage from May 30, 2024, with a return of 16.38% [2] - The fund's top holdings include China National Offshore Oil Corporation (14.55%), China Shenhua Energy (9.65%), and China Pacific Insurance (8.90%), among others [2][3]

Core Viewpoint - The announcement highlights that CSPC Pharmaceutical Group has received drug registration approval from the National Medical Products Administration of China for its Lercanidipine injection, which is a rapid-acting intravenous antihypertensive medication designed for patients who cannot take oral medications effectively [1] Group 1: Product Details - The Lercanidipine injection is classified as a dihydropyridine calcium channel blocker and is intended for the treatment of hypertension [1] - The product is available in two formulations: 25mg in a 50ml vial and 50mg in a 100ml vial [1] Group 2: Advantages - The product offers significant advantages over commonly used medications, including faster onset of action and the ability to achieve rapid, real-time, and precise blood pressure control [1] - It is particularly suitable for patients with liver and kidney dysfunction, as dosage adjustments are not required during treatment [1] - The formulation does not require dilution, which can significantly benefit patients at risk of fluid overload [1] Group 3: Market Impact - The approval of this product will enhance CSPC's product pipeline in the cardiovascular disease treatment sector, increasing its competitiveness in this field [1] - The product is expected to address the clinical demand gap for emergency hypertension medications [1]

Core Viewpoint - The approval of Chloride Dihydropyridine Injection by the National Medical Products Administration of China represents a significant advancement for the company in the cardiovascular treatment sector, addressing an unmet clinical need for emergency hypertension medications [1] Company Summary - The product is a dihydropyridine calcium channel blocker, classified as a rapid-acting intravenous antihypertensive drug, suitable for patients who cannot take oral medications or have poor expected responses to oral treatments [1] - The injection comes in two formulations: 50ml with 25mg and 100ml with 50mg [1] - The approval enhances the company's product pipeline in the cardiovascular disease treatment area, increasing its competitiveness in this field [1] Product Advantages - The product offers significant advantages over commonly used clinical medications, including faster onset of action, allowing for rapid, real-time, and precise blood pressure control [1] - It is particularly suitable for patients with liver and kidney dysfunction, as dosage adjustments are not required during treatment [1] - The product does not require dilution or preparation, which can significantly benefit patients at risk of fluid overload [1] Market Implications - The approval is expected to fill a clinical demand gap for emergency hypertension medications, thereby potentially increasing market share and revenue for the company in the cardiovascular sector [1]

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1月31日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 石藥集團有限公司 | | | | 呈交日期: | 2026年2月2日 | | | | I. 法定/註冊股本變動 不適用 | | | | FF301 第 1 頁 共 10 頁 v 1.2.0 FF301 II. 已發行股份及/或庫存股份變動及足夠公眾持股量的確認 1. 股份分類 普通股 股份類別 不適用 於香港聯交所上市 (註1) 是 證券代號 (如上市) 01093 說明 已發行股份（不包括庫存股份）數目 庫存股份數目 已發行股份總數 上月底結存 11,522,451,732 0 11,522,451,732 增加 / 減少 (-) 0 0 本月底結存 11,522,451,732 0 11,522,451,732 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 ...

Core Viewpoint - The approval of Chloride Dihydropyridine Injection by the National Medical Products Administration of China represents a significant advancement for the company in the treatment of hypertension, particularly for patients who cannot take oral medications [1] Group 1: Product Details - The product is a dihydropyridine calcium channel blocker, classified as a rapid-acting intravenous antihypertensive drug [1] - It is specifically designed for patients who are unsuitable for oral medication or have poor expected outcomes from oral treatments [1] Group 2: Advantages - The injection has notable advantages over commonly used clinical medications, including faster onset of action and the ability to achieve rapid, real-time, and precise blood pressure control [1] - It is particularly suitable for patients with liver and kidney dysfunction, as dosage adjustments are not required during treatment [1] - The product does not require dilution or preparation, which significantly benefits patients at risk of fluid overload [1] Group 3: Market Impact - The approval will enhance the company's product pipeline in the cardiovascular disease treatment sector, increasing its competitiveness in this field [1] - It is expected to address the clinical demand gap for emergency hypertension medications [1]