Workflow
康方生物卡度尼利单抗
icon
Search documents
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].