新药研发

Search documents
新药周观点:25年医保调整工作启动,多个新药有望参与谈判-20250706
Guotou Securities· 2025-07-06 07:35
Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [7]. Core Insights - The National Healthcare Security Administration has initiated the adjustment work for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, which is expected to include multiple new drugs for negotiation [2]. - From July 1, 2024, to June 30, 2025, approximately 19 oncology drugs and 23 non-oncology drugs are anticipated to be approved and may participate in the 2025 medical insurance negotiations [2]. Summary by Sections 1. Weekly New Drug Market Review - From June 30, 2025, to July 4, 2025, the top five companies in the new drug sector by stock price increase were: - Zai Lab (45.00%) - Sanofi (36.30%) - Frontier Biopharma (30.60%) - Micron Biomedicine (30.50%) - Kangfang Biopharma (25.50%) - The top five companies with the largest declines were: - Oconview (-12.90%) - Kexin Pharmaceuticals (-9.10%) - Dongyao Pharmaceuticals (-6.70%) - Lepu Biopharma (-6.40%) - Yifang Biopharma (-3.60%) [1][16]. 2. Weekly New Drug Industry Analysis - The adjustment work for the 2025 medical insurance catalog has begun, allowing new generic drugs approved between January 1, 2020, and June 30, 2025, to apply for inclusion [2]. - The expected new drugs for negotiation in 2025 will primarily be those approved between July 1, 2024, and June 30, 2025 [2]. 3. Weekly New Drug Approval & Acceptance Status - This week, 22 new drugs or new indications received approval for market entry, while one new drug application was accepted [3][26]. 4. Weekly New Drug Clinical Application Approval & Acceptance Status - A total of 46 new drug clinical applications were approved this week, and 31 new drug clinical applications were accepted [4][32]. 5. Key Domestic Market Events - Key events included the approval of a MET inhibitor by Hutchison China MediTech for treating advanced non-squamous non-small cell lung cancer and the approval of an anti-IL-1β monoclonal antibody by Junshi Biosciences for treating acute attacks of gouty arthritis [5][12]. 6. Key Overseas Market Events - Notable overseas events included Moderna's positive progress in its seasonal flu mRNA vaccine study, Regeneron's accelerated approval of a dual antibody for multiple myeloma, and Pfizer's announcement of a significant reduction in bleeding rates in hemophilia patients [13].
新药周观点:创新药4月进院数据更新,多个新纳入医保创新药快速进院-20250615
Guotou Securities· 2025-06-15 09:02
Investment Rating - The report maintains an investment rating of "Outperform-A" for the biopharmaceutical sector [6]. Core Insights - The biopharmaceutical sector is experiencing rapid growth, particularly with the inclusion of several innovative drugs into the national medical insurance directory, leading to increased hospital admissions [2][19]. - Notable increases in hospital admissions for specific drugs have been observed, such as the rapid uptake of drugs like Budesonide enteric-coated capsules and monoclonal antibodies from Kangfang Biotech [2][19]. - The report highlights significant clinical approvals and applications for new drugs, indicating a robust pipeline and ongoing innovation within the industry [3][4][23]. Summary by Sections 1. Weekly New Drug Market Review - From June 9 to June 13, 2025, the top five companies in the new drug sector by stock price increase were Beihai Kangcheng-B (up 118.12%), Oconview Biotech-B (up 28.59%), Junshengtai Pharmaceutical-B (up 23.75%), WuXi AppTec-B (up 23.63%), and Gilead Sciences-B (up 23.40%) [1][13]. - The top five companies with stock price declines included Sangamo Therapeutics (-7.41%), Nossland (-7.14%), Yiming Oncology-B (-6.10%), Hualing Pharmaceutical-B (-4.38%), and Yongtai Biotech-B (-3.48%) [1][13]. 2. Key Industry Analysis - The National Healthcare Security Administration updated the hospital admission data for innovative drugs included in the medical insurance directory as of April 2025, showing rapid hospital admissions for several newly included domestic innovative drugs [2][19]. - The drugs with the fastest growth in hospital admissions compared to March 2025 include Budesonide enteric-coated capsules, Kangfang Biotech's monoclonal antibodies, and others [2][19]. 3. New Drug Application Approvals & Acceptances - Two new drug or new indication applications were approved this week, including the inhalation solution of Revinase and the injection of Pembrolizumab [23][24]. - Nine new drug applications were accepted, including Bevacizumab intravitreal injection and various insulin formulations [23][24]. 4. New Drug Clinical Application Approvals & Acceptances - A total of 45 new drug clinical applications were approved this week, with six new drug clinical applications accepted [4]. 5. Domestic Market Key Events TOP3 - Lepu Biotech's new drug MRG007 was approved for clinical trials, targeting locally advanced or metastatic solid tumors [5]. - Nocera Biotech presented multiple drug research data at the European Hematology Association annual meeting, showing significant efficacy in treating various blood diseases [5][9]. 6. Overseas Market Key Events TOP3 - Bristol-Myers Squibb announced positive results for Deucravacitinib in a Phase III trial for psoriatic arthritis, significantly improving patient symptoms [10]. - Nuvation Bio's Ibtrozi received FDA approval for treating ROS1-positive non-small cell lung cancer, demonstrating high response rates and good tolerability [10]. - Merck's enlictide decanoate showed positive results in two Phase III trials, potentially becoming the first oral PCSK9 inhibitor approved in the U.S. [10].
32个高校项目比拼“产品力”
Su Zhou Ri Bao· 2025-06-12 00:26
Group 1 - The core viewpoint of the news is the acceleration of the transformation of biomedical technology achievements from universities in Suzhou Industrial Park, promoting deep integration of industry, academia, and research [1] - The "BioMatch" series of events is organized to showcase projects from 23 universities, with 32 projects participating in the semi-annual roadshow, which aims to validate the "product strength" of innovative entrepreneurial ideas [1][2] - Award-winning projects can receive up to 200 square meters of free office space for three years and up to 500,000 yuan in concept verification funding, with additional support for top projects [1] Group 2 - The Suzhou Biomedical Sub-center aims to bridge the gap between industry and academia by organizing events that facilitate deep and efficient connections among universities, enterprises, and investment institutions [2] - Approximately 1,700 university achievements have been collected, with six roadshows organized, inviting over 80 quality university projects, and 165 projects have entered the concept verification database [2] - A reward mechanism has been established to promote the transfer and transformation of achievements, including rent-free office space, youth talent subsidies, and concept verification support [2]
药明康德: 关于参股公司股票上市的公告
Zheng Quan Zhi Xing· 2025-05-18 09:13
Group 1 - The core point of the announcement is that Wuxi AppTec's subsidiary, Jiangsu Hanbang Technology Co., Ltd., was listed on the Shanghai Stock Exchange on May 16, 2025 [1] - Wuxi AppTec indirectly holds 5,313,131 shares of Hanbang Technology, representing 6.04% of its total share capital after the IPO [1] - The investment is classified as a financial asset measured at fair value with changes recognized in profit or loss, and it is reported under "other non-current financial assets" [1] Group 2 - The fair value of this investment is less than 0.5% of Wuxi AppTec's audited net assets attributable to shareholders for the year 2024, and it does not have a significant impact on the profit for the year 2025 [1] - The company anticipates no significant changes in the accounting treatment of this investment in the future [2] - The fair value of the investment may fluctuate due to stock market price changes, leading to uncertain impacts on the company's performance [2]
新药周观点:ASCO2025多个国产创新药获口头报告,数据披露值得期待-20250427
Guotou Securities· 2025-04-27 09:13
Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [6]. Core Insights - The ASCO 2025 conference is set to take place from May 30 to June 3, 2025, and several domestic pharmaceutical companies are expected to present new clinical data, with potential for exceeding expectations [2][14]. - A total of 13 new drugs or new indications were approved for market launch in the past week, alongside 50 new drug IND approvals and 27 IND applications accepted [3][17]. Weekly New Drug Market Review - From April 21 to April 27, 2025, the top five companies in the new drug sector by stock price increase were: - Yiming Oncology: +40.20% - Ascentage Pharma: +38.63% - Genscript Biotech: +27.13% - JACOB: +24.52% - Kedi: +24.02% - The top five companies by stock price decrease were: - Boan Biotech: -23.11% - ZhiXiang JinTai: -7.30% - Maibo Pharmaceutical: -7.07% - Aidi Pharmaceutical: -6.30% - Haizhi Pharmaceutical: -3.76% [10][11]. Weekly New Drug Industry Key Analysis - The ASCO 2025 conference will feature multiple oral presentations from domestic companies, including: - Innovent Biologics: PD-1/IL-2 dual antibody with three oral reports and Claudin18.2 ADC with one oral report. - Other companies such as Kelun Biotech, BaiLi TianHeng, and Hengrui Medicine are also expected to present various new drugs and indications [2][14][15]. Weekly New Drug Approvals & Acceptance - The report highlights the approval of 13 new drugs or new indications, including: - Canfuo Biotech's PD-1/VEGF dual-specificity tumor immunotherapy drug approved for new indications. - AstraZeneca's Dupixent for chronic spontaneous urticaria in patients aged 12 and older [4][18]. - Additionally, 50 new drug INDs were approved, and 27 IND applications were accepted [3][17]. Domestic New Drug Industry Focus - Key highlights include: - Canfuo Biotech's PD-1 monoclonal antibody approved by the FDA for metastatic nasopharyngeal carcinoma. - Canfuo Biotech's new indication for its PD-1/VEGF dual-specificity drug approved by NMPA for non-small cell lung cancer. - Novartis' BTK inhibitor approved for chronic lymphocytic leukemia [4][18]. Overseas New Drug Industry Focus - Notable developments include: - Sanofi's Dupixent for chronic spontaneous urticaria approved by the FDA. - AstraZeneca's Enhertu showing positive results in clinical trials for HER2-positive metastatic breast cancer. - Gilead Sciences' Trodelvy achieving positive results in clinical studies [5][7].
新药周观点:映恩生物IPO在即,多个ADC进展值得关注-20250413
Guotou Securities· 2025-04-13 13:03
2025 年 04 月 13 日 生物医药Ⅱ 新药周观点:映恩生物 IPO 在即,多个 ADC 进展值得关注 本周新药行情回顾: 2025 年 4 月 7 日-2025 年 4 月 13 日,新药板块涨幅前 5 企业:北海 康成(21.53%)、海思科(11.07%)、乐普生物(6.28%)、艾迪药 业(6.24%)、智翔金泰(6.18%),跌幅前 5 企业:再鼎医药(-22.92%)、 科笛(-22.51%)、基石药业(-22.40%)、宜明昂科(-20.79%)、 康宁杰瑞(-19.47%)。 本周新药行业重点分析: 映恩生物即将于 2025 年 4 月 15 日在香港联交所主板挂牌上市,作 为国内抗体偶联药物(ADC)领域明星企业之一,其上市引发市场广 泛关注。目前公司创新药管线共有约 7 款 ADC 药物进入临床开发阶 段,包括 HER2 ADC DB-1303/BNT323、B7H3 ADC DB-1311/BNT324、 TROP2 ADC DB-1305 /BNT325、HER3 ADC DB-1310、B7H4 ADC DB- 1312/BG-C9074、B7H3/PD-L1 双抗 ADC D ...