南财智讯1月29日电，泰恩康在投资者关系活动中表示，玫瑰痤疮适应症开发进度快于儿童白癜风，有 望成为CKBA首个提交注册申请的适应症；该适应症国内患者超5000万、支付意愿强，目前全球鲜有创 新药布局，若临床数据良好，获批后将成为国内首个该适应症的1类创新药，公司争取在2027年底前完 成III期临床。 ...

Group 1 - The core point of the news is that Green Leaf Pharmaceutical has received formal acceptance from the National Medical Products Administration of China 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] - Ruoxinlin® is expected to be the first SNDRI (serotonin, norepinephrine, and dopamine reuptake inhibitor) 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 that Ruoxinlin® can rapidly and comprehensively improve anxiety symptoms, with an efficacy rate exceeding 80% and a relief rate of approximately 50% [1] Group 2 - Anxiety disorders are the most common mental disorders in China, with approximately 58.67 million people affected, and generalized anxiety disorder has a lifetime prevalence rate of about 4.1%-6.6% among adults [2] - Current first-line treatments for generalized anxiety disorder, SSRIs and SNRIs, have limited efficacy, with a meta-analysis showing an overall efficacy rate of 67.7% and a relief rate of only 39.7% [2] - The market size for SSRIs and SNRIs is projected to be 4.83 billion yuan in 2024, with no innovative drugs approved in the last 20 years, highlighting a significant gap in the supply of innovative anti-anxiety treatments in China [2] Group 3 - Ruoxinlin® has served nearly 190,000 patients since its approval, gaining widespread recognition for its efficacy and safety, and is one of the fastest-growing antidepressants in China [3] - The drug is expected to be included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog by the end of 2024, further enhancing its accessibility [3] - The company has a long-term strategic focus on the central nervous system treatment field, with a diverse product portfolio that includes treatments for schizophrenia, bipolar disorder, and Alzheimer's disease, alongside ongoing development of next-generation innovative drugs [4]

Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the inclusion of 50 Class 1 innovative drugs in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1] - The drug Mesylate Prefofovir Tablets (brand name: Xinshi Mu) developed by Xi'an Xintong Pharmaceutical Research Co., Ltd. is the only Class 1 innovative drug from Shaanxi Province to be included, effective from January 1, 2026 [1] Group 1: Drug Details - Class 1 innovative drugs are defined as drugs that have not been marketed domestically or internationally, representing the highest level of drug innovation in China's registration classification [1] - Mesylate Prefofovir Tablets are indicated for the treatment of adult chronic hepatitis B, utilizing liver-targeted delivery technology to achieve precise release of active ingredients in the liver [1] - The drug significantly reduces the safety risks associated with kidneys and bones compared to conventional treatment options while effectively inhibiting hepatitis B virus replication [1] Group 2: Market Impact - Clinical research indicates that Mesylate Prefofovir Tablets excel in reducing hepatitis B surface antigen levels, which may enhance clinical cure rates and lower the long-term risks of cirrhosis and liver cancer [2] - The inclusion of this drug in the national medical insurance catalog is expected to rapidly increase its market availability, improving accessibility for a large number of chronic hepatitis B patients in China [2] - The influence of Shaanxi's listed backup enterprises in the capital market is anticipated to expand, with ongoing efforts to enhance support mechanisms for strategic emerging industries like biomedicine [2]

Core Viewpoint - The report from the National Medical Products Administration (NMPA) indicates a significant increase in new drug clinical trial registrations in China, highlighting a growing trend in the pharmaceutical industry towards innovative therapies, particularly in cell and gene therapy, as well as pediatric drug development [1][2]. Summary by Sections Clinical Trial Registration Growth - In 2024, the number of new drug clinical trial registrations reached a record high of 4,900, marking a 13.9% increase from the previous year [1][2]. - The efficiency of initiating clinical trials has improved, with over 60% of trials obtaining the first informed consent within six months, and 70.2% for biological products [1]. Regional Concentration of Trials - The report notes a concentration of clinical trials in specific regions, with six areas having over 2,000 participating units, an increase from three regions the previous year. Guangdong Province led with 2,892 participations [3]. Focus on Metabolic Drugs - The competition in the development of metabolic drugs is intensifying, driven by the rising prevalence of sub-health populations, diabetes, and obesity. In 2024, 86 clinical trials for the top 10 chemical drugs were registered, accounting for 6.1% of the total [4]. Pediatric Drug Development - The number of clinical trials targeting pediatric populations has been increasing, with a focus on respiratory diseases, allergies, and preventive vaccines. The NMPA has established a special group for pediatric drug review to address the shortage of medications for children [9][10]. Rare Disease Drug Trials - Clinical trials for rare disease medications are also on the rise, with a stable focus on blood system diseases, neurological disorders, and anti-tumor drugs. In 2024, trials for blood system disease drugs accounted for nearly 30% of the total rare disease clinical trials [10]. Advances in Cell and Gene Therapy - There has been a notable increase in clinical trials for cell and gene therapy products, with the NMPA moving towards a more open regulatory environment for advanced therapies. This includes the potential inclusion of CAR-T and tumor vaccines as advanced treatment drugs [11].