In the first three quarters of this year, 34 innovative drugs were approved, accounting for the highest proportion

category:Finance
 In the first three quarters of this year, 34 innovative drugs were approved, accounting for the highest proportion


Pratrazosin is a folic acid metabolism inhibitor. It was approved by the U.S. Food and Drug Administration (FDA) in September 2009 under the trade name of folotyn. Clinical trials have shown that folotyn is effective in reducing tumor size and prolonging patient survival. The approval of pratraxate will compete with sidabamine, which is independently developed by microchip. At present, citabine has been approved for the treatment of recurrent and refractory peripheral T-cell lymphoma and ER positive and HER2 negative advanced / metastatic breast cancer.

In addition, Zhengda Tianqing and Jiangsu Haosens pratrazoform have been approved for clinical application, and will become the competitors of Mengdi pharmaceutical in the future.

After the ice bucket challenge, the society pays more and more attention to rare diseases. In the first batch of clinical urgent overseas new drug list released in May 2018, a total of 23 varieties are listed. In the second batch of clinical urgent overseas new drug list published in March 2019, 17 clinically urgent drugs with 13 rare diseases were added to the list. These drugs are rare disease drugs with mature research abroad, which can simplify the procedures and speed up the listing process in China.

In 2019, 8 kinds of rare disease drugs were newly approved for marketing in China, and 6 kinds of rare disease drugs were approved for marketing from January to September this year. These six drugs are vidazol of Pfizer, sinimod of Novartis, deuterated butylbenzine of TIVA, laronidase of Sanofi, acarase u03b1 of baishen biotechnology and aido sulfatase u03b2 of Norai pharmaceutical / Beihai Kangcheng, respectively, aiming at the treatment of multiple neuropathy (attr-pn), multiple sclerosis, Huntingtons chorea and mucopolysaccharide Type I, Hunts syndrome (mucopolysaccharidosis type II) and Fabrys disease.

Among them, Sanofis laronidase (trade name elzan) is the first and only enzyme replacement therapy approved for the treatment of mucopolysaccharidosis type I in the world. It was approved in 2003 and was marketed in more than 70 countries and regions. Chinese patients have been looking forward to this specific drug for 17 years.

Three innovative traditional Chinese medicine drugs on the market

The research and development of innovative drugs is difficult, and the traditional Chinese medicine innovative drugs are dystocia because of the particularity of their products. In the 1-9 month of this year, a total of 3 innovative Chinese medicine drugs were approved to be listed, which were five and the total alkaloid tablets of the mulberry branch of Boao pharmaceutical company, the tibial pain relieving gel of Kang Yuan pharmaceutical company and the Lianhua light cough tablets of Yiling pharmaceutical company.

Among them, Sangzhi total alkaloid tablet has become the first approved new Chinese medicine drug for diabetes in China in recent ten years, and also the first original natural drug for hypoglycemia in China. The research and development lasted for 21 years. It has won the national and provincial level major foundations, such as the national major new drug creation technology special project, the national administration of traditional Chinese medicine development special project, Beijing ten diseases and ten drugs special project, Beijing new drug research and development special project Supported by Jin, it has been included in Zhongguancuns major frontier original high-end projects. The main component of the drug is the total alkaloids extracted from Ramulus Mori. The results of clinical trials showed that there was a significant difference between the two groups, which could effectively reduce the level of glycosylated hemoglobin (HbA1c) in subjects with type II diabetes mellitus. According to the State Food and drug administration, the new Chinese medicine is on the market, providing a new treatment for patients with type II diabetes. According to the data from the Internet, in the field of diabetes medication, in addition to the total alkaloid tablets of Sangzhi, five new Chinese medicine drugs have been accepted in recent 10 years, but the results are not satisfactory. Source: Zhang Mei, editor in charge of Beijing News_ NF2100

Among them, Sangzhi total alkaloid tablet has become the first approved new Chinese medicine drug for diabetes in China in recent ten years, and also the first original natural drug for hypoglycemia in China. The research and development lasted for 21 years. It has won the national and provincial level major foundations, such as the national major new drug creation technology special project, the national administration of traditional Chinese medicine development special project, Beijing ten diseases and ten drugs special project, Beijing new drug research and development special project Supported by Jin, it has been included in Zhongguancuns major frontier original high-end projects. The main component of the drug is the total alkaloids extracted from Ramulus Mori. The results of clinical trials showed that there was a significant difference between the two groups, which could effectively reduce the level of glycosylated hemoglobin (HbA1c) in subjects with type II diabetes mellitus. According to the State Food and drug administration, the new Chinese medicine is on the market, providing a new treatment for patients with type II diabetes.

According to the data from the Internet, in the field of diabetes medication, in addition to the total alkaloid tablets of Sangzhi, five new Chinese medicine drugs have been accepted in recent 10 years, but the results are not satisfactory.