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鼻喷雾式/吸入型新冠疫苗
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掘金创新药丨双抗药物Ⅱ期赛跑 康宁杰瑞、康方生物谁能率先突围?
Mei Ri Jing Ji Xin Wen· 2025-11-24 07:53
Core Viewpoint - The article discusses recent developments in the pharmaceutical industry, particularly focusing on new drug applications and innovations in cancer treatment, highlighting the competitive landscape and market potential for various companies involved in drug development [5][12][20]. Group 1: New Drug Applications - From May 24 to May 30, the National Medical Products Administration received applications for 9 new chemical drugs and biological products from 6 listed companies [5]. - Companies such as Heng Rui Medicine, Hansoh Pharmaceutical, and Kangfang Biotech each submitted 2 clinical applications, while others like Canaan and Bai Jie Shen Zhou submitted 1 application each [6]. Group 2: Key Innovations in Cancer Treatment - Kangning Jereh's KN035, a subcutaneous PD-L1 inhibitor, has been submitted for clinical trials, potentially becoming the first of its kind globally. It targets multiple indications, with 3 applications already submitted and 7 ongoing clinical studies [12][13]. - KN035 offers advantages over traditional intravenous methods, including better patient compliance and reduced costs, which could enhance its market share [13]. - The competitive landscape includes existing PD-L1 inhibitors like Merck's Atezolizumab and AstraZeneca's Durvalumab, with KN035 targeting different cancer types [14]. Group 3: Dual Antibody Developments - Kangfang Biotech's AK104, a PD-1/CTLA-4 dual-specific antibody, has received approval for clinical trials, with 13 indications currently in phase II trials [17]. - The dual antibody approach is gaining traction due to the limitations of existing PD-1/L1 therapies, which have low efficacy rates in solid tumors [18]. - The market for dual antibodies is expected to grow significantly, with 217 candidates in various clinical stages globally [19]. Group 4: COVID-19 Vaccine Developments - CanSino's inhaled COVID-19 vaccine is in phase II trials and is applying for emergency use, which could enhance public acceptance due to its non-invasive administration method [20][21]. - Sinovac has expanded the emergency use of its vaccine to children aged 3 and above, with positive safety and efficacy results from clinical trials [24][25].