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The number of innovative drugs approved for market in China has increased by nearly 20% year-on-year


Time:2024-09-13 11:02:24  Source:  Author:

 

In recent years, the vitality of pharmaceutical innovation in China has continued to increase, and the pace of innovative product launches has been accelerating. Data shows that from January to August 2024, the National Medical Products Administration approved 31 innovative drugs and 46 innovative medical devices, an increase of 19.23% and 12.19% respectively compared to the same period last year.

 
 
 
Among them, in terms of innovative drugs, Xinda Biotechnology's Class 1 innovative drug, Fluzelese Tablets (trade name: Dabert), has been approved by the National Medical Products Administration for marketing. It is suitable for adult patients with advanced non-small cell lung cancer (NSCLC) who have received at least one systemic treatment for the G12C mutation of the murine sarcoma virus oncogene (KRAS), providing patients with a new treatment option.
 
 
 
Baiaotai's Class 1 innovative drug, Betadine Citrate Injection (trade name: Betadine), has been approved for marketing and is suitable for patients with acute coronary syndrome undergoing percutaneous coronary intervention (including coronary stent implantation) to reduce the risk of acute occlusion, stent thrombosis, no reflow, and slow blood flow. Its listing provides a new antithrombotic treatment option for patients with acute coronary syndrome who require PCI treatment.
 
 
 
The first class innovative drug of Sinritai Pharmaceutical, Fugliptin Benzoate Tablets (trade name: Sinritin), and the first class innovative drug of Hisco Cogliptin Tablets (trade name: Beichangping) were approved for marketing, providing new treatment options for adult patients with type 2 diabetes. Dizhe (Jiangsu) Pharmaceutical's Class 1 innovative drug, golixitinib capsules (trade name: Gao Ruizhe), has been approved for marketing, providing a new treatment option for adult patients with peripheral T-cell lymphoma. Zhengda Tianqing Pharmaceutical's Class 1 innovative drug, Yifeng Ak Capsules Citrate (trade name: Anluoqing), has been approved for market, providing a new treatment option for non-small cell lung cancer patients.
 
 
 
Kangfang Sainuo Pharmaceutical's Ivoxidan Anti Injection (trade name: Yida Fang) has also been approved for marketing. Its combination with pemetrexed and carboplatin is used for the treatment of locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC) patients with EGFR gene mutation positive progression after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy
 
 
 
In terms of innovative medical devices, Beijing Bairen Medical's "Transcatheter Aortic Valve System" innovative product has been approved for market launch. It is suitable for patients aged 70 years or older who have been assessed by the cardiac team and scoring system as having symptomatic, calcified, severe degenerative aortic valve stenosis and are not suitable for routine surgical valve replacement.
 
 
 
The innovative product of Shanghai Blue Vein Medical's "venous stent system" has been approved for sale, used for the treatment of non thrombotic iliac vein compression syndrome, deep vein thrombosis, and post deep vein thrombosis syndrome. Among them, the stent adopts an integrated weaving method with different mesh densities, and the design of combining sparse and dense mesh holes can effectively meet the support and flexibility requirements of the stent in clinical practice.
 
 
 
The innovative product of Shanghai Minimally Invasive Medical's "Bioabsorbable Rapamycin Eluting Coronary Stent System" has been approved for market launch. The product is sterilized by irradiation, disposable, improves the diameter of the coronary artery lumen, and is suitable for patients with ischemic heart disease caused by primary coronary artery lesions
 
 
 
The industry has stated that ensuring the safety of people's medication and promoting the improvement of drug quality rely crucially on the high-quality development of the pharmaceutical industry. It is reported that in recent years, with the deepening of the review and approval system reform by the National Medical Products Administration, the pace of domestic innovative drugs and medical devices being launched has further accelerated. At the same time, significant progress has been made in the "going global" of innovative drugs such as small molecule targeted therapy, immunotherapy, and cell therapy, and the global market's recognition of Chinese innovative drugs is constantly increasing.

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