创新药研发
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汇宇制药(688553.SH):与阿斯利康达成临床研究合作
Xin Lang Cai Jing· 2026-01-09 09:24
Core Viewpoint - The company has signed a clinical trial cooperation agreement with AstraZeneca to explore the combination therapy of its innovative drug HYP-6589 with AstraZeneca's Osimertinib for specific types of non-small cell lung cancer [1] Group 1: Clinical Collaboration - The collaboration aims to conduct clinical trials to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HYP-6589 both as a monotherapy and in combination with Osimertinib [1] - This partnership is expected to accelerate the clinical trial process for the company's innovative drugs, enhancing research and development efficiency [1] Group 2: R&D Strategy - The company is committed to embracing innovation in the field of anti-tumor treatments, with a pipeline of 14 class I innovative drugs, including multi-specific antibodies and antibody-drug conjugates [1] - Five of these class I innovative drug pipelines have already entered clinical research, indicating a strong focus on advancing drug development [1] Group 3: Financial Impact - The clinical research collaboration is not expected to have a significant impact on the company's financial status and operating results [1]
汇宇制药子公司与阿斯利康达成临床研究合作
Zhi Tong Cai Jing· 2026-01-09 08:35
Core Viewpoint - The company has signed a clinical trial cooperation agreement with AstraZeneca to explore the combination therapy of its innovative drug HYP-6589 with AstraZeneca's drug Osimertinib for the treatment of specific types of non-small cell lung cancer [1][2] Group 1: Clinical Collaboration - The collaboration aims to conduct clinical trials to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HYP-6589 both as a monotherapy and in combination with Osimertinib [1] - This partnership is expected to accelerate the clinical trial process for the company's innovative drugs, enhancing research and development efficiency [2] Group 2: R&D Strategy - The company is committed to embracing innovation in the field of anti-tumor treatments, with a pipeline of 14 class I innovative drugs, including multi-specific antibodies and antibody-drug conjugates [2] - Five of these class I innovative drug pipelines have entered clinical research, indicating a robust R&D capability [2] - The collaboration with AstraZeneca is anticipated to expand the company's new drug development capabilities and potentially reduce the time and costs associated with clinical trials [2]
汇宇制药(688553.SH)子公司与阿斯利康达成临床研究合作
智通财经网· 2026-01-09 08:33
Core Viewpoint - The company has signed a clinical trial cooperation agreement with AstraZeneca to explore the combination therapy of its innovative drug HYP-6589 with AstraZeneca's drug Osimertinib for specific types of non-small cell lung cancer [1][2] Group 1: Clinical Collaboration - The collaboration aims to conduct clinical trials to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HYP-6589 both as a monotherapy and in combination with Osimertinib [1] - This partnership is expected to accelerate the clinical trial process for the company's innovative drugs, enhancing research and development efficiency [2] Group 2: R&D Strategy - The company is committed to embracing innovation in the field of anti-tumor treatments, with a pipeline of 14 class I innovative drugs, including multi-specific antibodies and antibody-drug conjugates [2] - Five of these class I innovative drug pipelines have entered clinical research, indicating a robust development strategy [2] - The collaboration with AstraZeneca is anticipated to expand the company's new drug development capabilities and potentially reduce the time and costs associated with clinical trials [2]
海外消费周报:澳门博彩收入维持双位数增长,元旦访客量数据创新高-20260109
Shenwan Hongyuan Securities· 2026-01-09 08:14
Group 1: Overseas Social Services - The investment rating for the overseas social services sector is positive, with a focus on Macau's gaming revenue maintaining double-digit growth and record visitor numbers during New Year's [1][4]. - In December, Macau's gross gaming revenue reached 20.9 billion MOP, representing a year-on-year increase of 14.8%, and recovering to 91% compared to the same period in 2019. The total gross gaming revenue is expected to grow by 9.1% in 2025 [4]. - The total number of visitors to Macau in 2025 is projected to be 40.06 million, a year-on-year increase of 14.7%, marking a historical high. On New Year's Day 2026, the number of visitors reached 188,000, the highest ever for that day [4]. Group 2: Overseas Pharmaceuticals - The investment rating for the overseas pharmaceuticals sector is also positive, with significant developments in drug approvals and clinical trials [2][7]. - BeiGene's BCL2 inhibitor received conditional approval in China for treating chronic lymphocytic leukemia and mantle cell lymphoma, marking it as the first and only BCL2 inhibitor approved for MCL in the country [8][9]. - The Hang Seng Healthcare Index rose by 11.15%, outperforming the Hang Seng Index by 9.12 percentage points, indicating strong market performance [7]. Group 3: Overseas Education - The investment rating for the overseas education sector is favorable, with a focus on vocational education and training [3][14]. - The education index increased by 2.7%, outperforming the Hang Seng Index by 1.3 percentage points, indicating a positive market trend [14]. - The report suggests focusing on Hong Kong vocational education companies, particularly China Oriental Education, which is expected to see enrollment growth due to strategic adjustments in response to market demand [16].
昭衍新药涨超7% 近一月股价累涨近六成 公司有望受益猴价公允价值收益
Zhi Tong Cai Jing· 2026-01-09 07:02
昭衍新药(603127)(06127)再涨超7%,近一月股价累涨近六成。截至发稿,涨7.02%,报25.92港元, 成交额2.03亿港元。 据方正证券测算,以昭衍新药为例,假设按照2024年实验猴均价计入公允价值8.49万/只,2025Q4价格 提升至14万/只,假设猴场出栏率为17%,按照已知23200只猴测算,毛估计(不考虑新补进猴子及未成年 &老龄猴的影响)2025年新增公允价值约2.2亿。 消息面上,国海证券指出,安评阶段,大分子(多抗、ADC)、小核酸、多肽、细胞基因疗法等新技术平 台均需要食蟹猴模拟人体进行安评试验检测药物安全性数据,目前3-5岁左右是食蟹猴已涨到14万元一 只,年内已出现供不应求的局面,进一步佐证国内创新药研发景气度恢复,并且猴价上涨带来的公允价 值变动也会直接贡献利润。 ...
港股异动 | 昭衍新药(06127)涨超7% 近一月股价累涨近六成 公司有望受益猴价公允价值收益
智通财经网· 2026-01-09 06:58
智通财经APP获悉,昭衍新药(06127)再涨超7%,近一月股价累涨近六成。截至发稿,涨7.02%,报 25.92港元,成交额2.03亿港元。 消息面上,国海证券指出,安评阶段,大分子(多抗、ADC)、小核酸、多肽、细胞基因疗法等新技 术平台均需要食蟹猴模拟人体进行安评试验检测药物安全性数据,目前3-5岁左右是食蟹猴已涨到14万 元一只,年内已出现供不应求的局面,进一步佐证国内创新药研发景气度恢复,并且猴价上涨带来的公 允价值变动也会直接贡献利润。 据方正证券测算,以昭衍新药为例,假设按照2024年实验猴均价计入公允价值8.49万/只,2025Q4价格 提升至14万/只,假设猴场出栏率为17%,按照已知23200只猴测算,毛估计(不考虑新补进猴子及未成 年&老龄猴的影响)2025年新增公允价值约2.2亿。 ...
江苏亚虹医药科技股份有限公司自愿披露关于APL-2401完成I期临床试验首例受试者入组公告
Shang Hai Zheng Quan Bao· 2026-01-08 18:02
自愿披露关于APL-2401完成I期临床试验 首例受试者入组公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性依法承担法律责任。 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:688176 证券简称:亚虹医药 公告编号:2026-001 江苏亚虹医药科技股份有限公司 二、该药品研发及其他相关情况 APL-2401为全球同步研发的1类创新药,其国际多中心临床试验设计及申报资料符合国际临床试验技术 标准体系要求,成功纳入国家药监局于2025年9月12日发布的《关于优化创新药临床试验审评审批有关 事项的公告(2025年第86号)》规定的"30日通道",并以仅22个工作日获得批准,成为全国首批获得此 项新政审批通过的项目之一,具体内容详见公司披露于上海证券交易所网站(www.sse.com.cn)的《江 苏亚虹医药科技股份有限自愿披露关于APL-2401临床试验申请获得国家药品监督管理局批准的公告》 (公告编号:2025-046)。该研究已于近日成功完成I期临床首例受试者给药,自获批后仅15个工作日 即实现首例给药,成为新政下首批临 ...
亚太药业控股权过户完成 实际控制人变更为邱中勋
Zheng Quan Ri Bao Zhi Sheng· 2026-01-08 13:38
Group 1 - Zhejiang Apac Pharmaceutical Co., Ltd. announced the completion of the transfer of control to Xinghao Holdings, marking the end of a three-month control change process [1] - The transfer involved a share transfer at a price of 8.26 yuan per share, totaling 900 million yuan for a 14.61% stake, representing a 45.68% premium over the pre-suspension price of 5.67 yuan [1] - Apac Pharmaceutical plans to raise up to 700 million yuan through a private placement to fund new drug research and development, further consolidating Xinghao Holdings' control [1] Group 2 - Xinghao Holdings has signed a technology development contract with Beijing Sunshine Nuohuo Pharmaceutical Research Co., Ltd. for the domestic rights transfer of the innovative drug STC008, targeting late-stage non-small cell lung cancer [2] - The change in control signifies a new era for Apac Pharmaceutical under the leadership of Qiu Zhongxun, who is expected to integrate digital ecosystems with the company's R&D capabilities [2] - The market anticipates that Qiu Zhongxun will lead the revival and new achievements of this established pharmaceutical company [2]
泽璟制药上市6年未盈利:左手赴港募资出海,右手注销海外子公司
Xin Lang Cai Jing· 2026-01-08 12:45
Core Viewpoint - Zai Jing Pharmaceutical, the first innovative drug company to list on the STAR Market under the "Fifth Set of Standards," has struggled to achieve profitability since its IPO in 2020, despite launching several products and transitioning from a clinical biotech firm to a commercial pharmaceutical company [4][6][9]. Financial Performance - Since its listing, Zai Jing Pharmaceutical has reported continuous losses, with a net loss of 1.5 billion RMB in 2024 and a net loss of 1.38 billion RMB [6][10]. - As of the end of Q3 2025, the company reported revenues of 5.93 billion RMB, surpassing the total revenue for 2024 [10][11]. - The company's debt ratio exceeded 60% by Q3 2025, with total liabilities reaching 18.64 billion RMB, primarily driven by short-term debts [17][18]. Product Development and Sales - Zai Jing Pharmaceutical's product portfolio includes multiple drugs, with its main revenue source being Donafenib, which has been approved for use in over 2,200 hospitals [20][21]. - The company has launched several products, including Donafenib, Recombinant Human Thrombin, and JAK inhibitor Gika Xitini, with the latter expected to enter the national medical insurance directory in January 2026 [8][21]. - Despite revenue growth, the company faces high sales and distribution expenses, which reached 3.32 billion RMB in the first three quarters of 2025, indicating a sales expense ratio of over 56% [9][21]. Strategic Moves - Zai Jing Pharmaceutical is pursuing a dual listing on the Hong Kong Stock Exchange to raise funds for international expansion and brand establishment [11][12]. - The company recently announced a licensing deal with AbbVie for its drug ZG006, which could provide up to 1 billion USD in milestone payments, marking its first overseas licensing agreement [16][24]. - The cancellation of its U.S. subsidiary, Gensun Biopharma, was aimed at optimizing resource allocation and enhancing R&D efficiency, although it raised questions about the rationale behind the acquisition of a loss-making asset [12][15]. Market Sentiment - The stock price of Zai Jing Pharmaceutical saw a nearly 50% increase in the first half of 2025, but market sentiment has shifted, with concerns about the company's ability to achieve profitability and manage high sales expenses [22][23]. - As of January 8, 2026, the stock price was reported at 97.25 RMB per share, reflecting a decline, indicating market skepticism regarding the company's future performance [23][24].
绿叶制药(02186):1类创新药若欣林用于治疗广泛性焦虑障碍的新适应症中国上市申请获得受理
智通财经网· 2026-01-08 11:12
Core Viewpoint - Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration for the new indication application of its innovative drug Ruoxinlin® for the treatment of generalized anxiety disorder, marking a significant milestone since its approval for depression treatment in November 2022 [1] Group 1: Product Development and Clinical Research - Ruoxinlin® is expected to be the first SNDRI in China for treating generalized anxiety disorder, potentially benefiting a larger patient population [1] - The new indication application is based on a Phase III clinical study involving 555 patients, demonstrating an efficacy rate exceeding 80% and a remission rate of approximately 50% [1] - The safety profile of Ruoxinlin® is favorable, with low incidences of adverse reactions such as drowsiness and sexual dysfunction, and no significant impact on weight or glucose-lipid metabolism [1] Group 2: Market Context and Demand - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million affected individuals, and the lifetime prevalence of generalized anxiety disorder in adults is estimated at 4.1%-6.6% [2] - Current first-line treatments, SSRIs and SNRIs, have limited efficacy, with overall effectiveness rates of 67.7% and remission rates of only 39.7%, alongside common adverse effects that affect patient compliance [2] - The market for SSRIs and SNRIs is projected to reach 4.83 billion yuan in 2024, with no new innovative drugs approved in the last 20 years, highlighting a significant gap in the treatment landscape [2] Group 3: Company Strategy and Product Portfolio - The central nervous system treatment area, including depression and anxiety, is a core strategic focus for the company, which has developed a differentiated product portfolio addressing various mental health conditions [4] - In addition to Ruoxinlin®, the company’s portfolio includes other approved products such as Erzofri® and Rykindo®, and it is actively developing next-generation innovative drugs targeting multiple mechanisms [4] - Ruoxinlin® has served nearly 190,000 patients since its launch, gaining recognition for its efficacy and safety, and is expected to further enhance accessibility with its new indication [3]