Topic: Summary of China's Class I New Drugs
★Bisinol
Introducing some of the Class I new drugs that have been researched and developed in China, and there are more than 20 types of drugs currently under development. New drugs in clinical trials, (NCE or traditional Chinese medicine), I hope you can add other new drug information.
★Bicyclol tablets (Bicol)
The trade name is "Bisinol". The product developed by the Chinese Academy of Medical Sciences and the Institute of Medicine of China Union Medical College is my country's first class of synthetic innovative anti-hepatitis drug with independent intellectual property rights.
In December 1996, it was approved by the Ministry of Health to enter clinical trials. In September 2001, it obtained the new drug certificate and production approval document issued by the original SDA, and was produced and marketed by Peking Union Medical College. At present, it has obtained 20-year invention patent protection in 16 countries and regions around the world, and enjoys a 12-year administrative protection period in China.
This product is a chemically synthesized and screened drug based on the enzyme-lowering drugs diphenyl diester and Schisandra chinensis. It has a good dual mechanism that can scavenge free radicals to protect cell membranes and protect the nucleus of liver cells. DNA immunity is damaged and the occurrence of cell apoptosis is reduced. Clinically shown to have a good inhibitory effect on hepatitis B virus, good safety, low toxicity, no mutagenic adverse reactions, and suitable for mild and moderate chronic hepatitis. Clinical studies have shown that the long-term efficacy is better than that of diphenyl diester, and it has become one of the first-choice drugs against chronic viral hepatitis.
★Aprelite
Aprelite is a new type of 5α-reductase selective inhibitor. In July 1993, it was approved by China Pharmaceutical University and Chinese Academy of Sciences Shanghai Organic Research Institute. It was jointly developed by the Institute of Chemistry and Yangzhou Pharmaceutical Factory. In 1996, it was listed as a key scientific and technological research project in the “Ninth Five-Year Plan” by the state.
In 1996, Aiplite was approved to enter the clinical research stage. In August 1999, it obtained the new drug certificate and production approval document for raw materials and tablets issued by the former SDA. It was converted into a regular company in 2001 and has now become the leading product of Lianhuan Pharmaceutical, enjoying a 12-year exclusive production protection period.
This drug can inhibit the conversion process of testosterone, reduce the content of dihydrotestosterone in the prostate, and cause the proliferated prostate to shrink, thereby improving symptoms such as difficulty urinating in patients with benign prostatic hyperplasia. It is safe and reliable. According to the requirements of the national first-class new drugs, the drug has achieved satisfactory efficacy in the open phase IV clinical study. The drug has been included in the "National Basic Medical Insurance Drug Catalog". Aprelite products are in their infancy after being launched on the market. In the rising stage, market share will gradually increase.
Aprelate can selectively inhibit 5α-reductase. Its inhibitory effect is more selective than finasteride and has few adverse reactions. It is a safe and effective drug and a highly competitive treatment. drug.
★Enbipu
The main ingredient of "Enbipu" is butylphthalide, which was jointly developed by the Institute of Materia Medica, Chinese Academy of Medical Sciences and Shijiazhuang Pharmaceutical Group Co., Ltd. is my country’s first class-one new drug with independent intellectual property rights in the field of cardiovascular and cerebrovascular diseases, and has obtained two national patents.
"Enbipu" is suitable for the treatment of ischemic stroke (commonly known as cerebral apoplexy). Its main component is butylphthalide, which has the same structure as apigenin A extracted from celery seeds. The launch of this product will become a new profit growth point for CSPC Pharmaceutical Group.
★Hematoporphyrin injection
Hematoporphyrin is a photosensitizer pioneered in my country. It belongs to a class of new drugs and is a new drug for the treatment of malignant tumors. It is known as the "photochemical missile". Chongqing Huading Modern Biopharmaceutical obtained the production approval issued by the original SDA in 2003, and exclusively produced and launched it under the trade name "Xibofen".
After the drug enters the human body through intravenous drip, it reaches the malignant tumor tissue along with the blood circulation, and accumulates and is retained inside. Subsequently, when these tumors are irradiated with laser light of a specific wavelength, the drug undergoes a photochemical reaction, producing a type of monovalent oxygen that directly kills malignant tumor tissue without causing any damage to normal human tissue.
Regardless of whether it is a primary cancer or a recurrent cancer, it can achieve the purpose of cure or improvement, and at the same time reduce the patient's pain and disability.
At the same time, the drug is also used for the localization diagnosis and treatment of cancer, and is highly selective. It has the characteristics of basically no damage to normal tissues and small side effects. It can be used clinically to locate and diagnose cancer with a rate of 91%.
★Glycindiazole sodium
The first-class new drug anti-cancer sensitizer glycididazole sodium (CMNa) is an innovative drug independently designed and developed in my country with independent intellectual property rights. In 2002, Guangzhou Laitai Pharmaceutical obtained the Class I new drug certificate and production approval issued by the original SDA, and exclusively produced and launched it under the trade name "Ximeina".
Glycididazole sodium is an innovative chemically synthesized drug and the only low-toxicity and high-efficiency chemotherapy sensitizer currently on the market in the world. The drug was researched by the Radiology Research Office of the Second Military Medical University in 1983. In September 1993, it was granted an invention patent by the State Patent Office. In early 2000, the patent was awarded the Invention Gold Medal by the State Intellectual Property Office and the World Intellectual Property Organization.
Clinical studies have shown that glycididazole sodium has a good therapeutic effect in anti-cancer treatment and has broad market prospects.
★Naxos (rmhTNF)
Recombinant human tumor necrosis factor for injection (rmhTNF) is a recombinant human tumor necrosis factor for injection developed and produced by Shanghai Saida Biopharmaceutical Co., Ltd. Human tumor necrosis factor, trade name "Nax", obtained a Class I new drug certificate on April 24, 2003. It is the world's first alloform of tumor necrosis factor approved for systemic application.
Naxos is called by experts the most inspiring anti-tumor drug currently discovered. This product has significant effects on a variety of malignant tumors, especially malignant tumors of the respiratory system. Its main mechanism of action is: direct Kill tumor cells; destroy the blood supply of tumor tissue; mediate the body's immune regulation; enhance radio/chemotherapy sensitivity. This product is expected to achieve better economic benefits after being put on the market.
★Pioglitazone
Insulin resistance refers to the insensitivity or reduced sensitivity of human insulin-responsive tissues to insulin. It is considered to be the fundamental cause of type 2 diabetes and its complications. Pioglitazone hydrochloride is a new generation of insulin sensitizer. Its mechanism of action is to enhance the sensitivity of peripheral tissues to insulin, reduce insulin resistance, and thereby lower blood sugar. It is the only drug approved by the US FDA that can be combined with insulin and sulfonylurea for treatment. Ketogenic drugs.
At present, there are pioglitazone hydrochloride raw materials and tablets (trade name: Aitin) jointly developed by China Pharmaceutical Research and Development Center and Beijing Taiyang Pharmaceutical Co., Ltd. in China; Dalian Yuanda Pharmaceutical, Jiangsu Emperor APIs and tablets from Yi Pharmaceutical, Libao Biopharmaceutical, Beijing Xinghao Modern, Shanghai Fosun Zhaohui, Shanghai Medical Institute, Jiangsu Hengrui Pharmaceutical, Henan Xinxiang Lianyi Pharmaceutical; Shandong Zibo Xinda Pharmaceutical Co., Ltd., Li Capsules from Bao Biopharmaceutical, Beijing Xinghao Modern, and Shenyang Jinlong; tablets (trade name: Ruitong) from Jiangsu Hengrui Medicine and Shanghai Institute of Pharmaceutical Industry have all obtained national Class I new drug certificates and have been fully entered into clinical use.
★Nafedil Tablets
Nafedil Tablets were first independently developed by Guizhou Yikang Pharmaceutical Group over a period of 8 years and have independent intellectual property rights in my country. A new class of antihypertensive chemically synthesized drug (trade name: Bodi), launched in May 2001. It is said to be my country's first chemically synthesized Class 1 new drug, thus ending the history of domestically produced antihypertensive chemically synthesized drugs without Class 1 new drugs.
Nafedil tablets have its own unique advantages in the treatment of hypertension: the drug is an ultra-highly selective α1-adrenergic receptor blocker and a 5-HT1A receptor agonist. and Ca2+ channel antagonist; it has multiple antihypertensive mechanisms. While effectively controlling blood pressure, it can avoid adverse reactions such as "first dose effect" orthostatic hypotension and reflex tachycardia, and has a benign effect on blood lipids and blood sugar metabolism. It can improve urination difficulties caused by prostatic hypertrophy and is a safe and effective new drug for the long-term treatment of hypertension.
At present, in terms of domestic research and development of naphpidil tablets, Nanjing Second Pharmaceutical Factory, Nanjing Meirui Pharmaceutical (trade name: Natuo), and Hainan Haifu Pharmaceutical have also successively obtained raw materials or tablets. Category I new drug approval document.
★Artemisinin
The research results are a successful example of promoting my country’s treasure house of traditional Chinese medicine. They are also a successful example of researchers from the Chinese Academy of Sciences carrying out scientific research and daring to innovate in response to major national needs. At present, the relevant scientific researchers of the Institute of Drug Research have applied to the Ministry of Science and Technology for research projects on artemisinin-based anti-bloodworm and anti-cancer drugs, and are working hard to conduct further research on artemisinin.
★Boanmycin
Boanmycin is a new class of anti-tumor antibiotic drug—Boanmycin is the first class of new anti-tumor antibiotic drug developed in my country. Boanmycin, formerly known as Zhengguangmycin A6, is produced by Streptomyces vericilus Var. Pingyangensis n.sp. and belongs to the B1eomycin family. Boanmycin In addition to having the same anti-tumor spectrum as B1eomycin, it also has a high inhibitory ability against liver cancer, gastric cancer, lung cancer, and colon cancer, and its lung toxicity is significantly lower than other similar products. After nearly two decades of hard work, it has passed the review by the New Drug Evaluation Center and experts of the State Food and Drug Administration and obtained a Class I new drug certificate.
★Retinoic acid treats leukemia (APL)
★Arsenic trioxide treats leukemia (APL, MDS, MM)
★Enjingfu (NOBEX)
The ingredient is mouse nerve growth factor (mNGF), which was supported by the "Ninth Five-Year Plan" National Key Science and Technology Research Plan, was listed as a high-tech industrialization demonstration project of the State Planning Commission, and was also a national torch in 2002 A planned project, it is a national first-class new drug (biological drug) jointly developed by Xiamen Peking University Road Bioengineering Co., Ltd. and the Lanzhou Institute of Biological Products of the Ministry of Health. The indication developed is cyclohexane toxic neurological injury. Used to treat various nerve injuries.