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[Pharmaceutical Network Industry News] With the fierce homogeneity competition in the domestic pharmaceutical market and the promotion of the centralized procurement policy, more and more powerful domestic pharmaceutical companies are heading oversea.
Among them, the North American market has become the main destination for many local pharmaceutical companies to go overseas due to its strong market shar.
Pharmaceutical companies only need to pass FDA approval to be eligible for commercial clinical applications in the US marke.
Pharmaceutical industry (Source: Pharmaceutical Network) According to incomplete statistics, in the past three months (May 10-August 30), 18 pharmaceutical companies in Shanghai and Shenzhen have obtained news from the FDA, which is related to product acquisitio.
In terms of FDA's implied license for clinical trials of drugs, obtaining drug registration approval documents, and obtaining approval numbers, a large number of domestic drugs have now obtained FDA certificatio.
For example, Jianyou shares frequently reported good new.
On August 3, the company announced that its abbreviated new drug application (ANDA, US generic drug application) for vancomycin hydrochloride for injection 500mg/bottle and 1g/bottle has been approved by the United States in July 202 FDA-approved for serious infections caused by methicillin-resistant Staphylococcus and other bacteria; on June 8, Jianyou shares announced that its subsidiary Hong Kong Jianyou's Ganirelix acetate injection 250 mcg/5 mL was approved by the US FDA Approved, this product is used in women with controlled ovarian stimulation (COS) program to prevent premature luteinizing hormone (LH) peak; FDA-approved for the treatment of the following fungal infections in adults and children 2 years of age and olde.
Huahai Pharmaceutical is also accelerating the process of going oversea.
On July 11, Huahai Pharmaceutical announced that the company's enalapril maleate tablet ANDA for the treatment of hypertension has been approved by the FDA, which means that the product can be produced and sold in the US marke.
On May 12, the company announced that the ANDA of ropinirole hydrochloride extended-release tablets submitted by the company to the US FDA has been approved for the treatment of symptoms and signs of Parkinson's diseas.
The day before, the company announced that the FDA has approved a new drug brief application for roflumilast tablets for the treatment of bronchitis-related cough and excessive mucus symptoms in patients with severe COP.
Hengrui Medicine announced on May 25 that the ANDA application for iodixanol injection submitted by the company to the US FDA was reviewed and approved by the US FD.
The drug is suitable for arterial digital subtraction angiography, cardiovascular angiography, peripheral Arterial and venous angiography, visceral arteriography, cerebral arteriography, head and body CT imaging, excretory urography, coronary CT angiography (CCTA.
Global sales of iodixanol-related dosage forms in 2021 will be approximately US$873 millio.
At present, no similar generic drug products have been approved for marketing abroa.
In addition to the above-mentioned pharmaceutical companies, a large number of pharmaceutical companies have obtained FDA approval for clinical trials of their product.
For example, the new drug of recombinant herpes zoster vaccine (LZ901), a joint-stock company of Saisheng Pharmaceutical C.
, Lt.
, was approved by the US FDA to enter clinical research, and Guilin Sanjin Holdings Sun C.
, Lt.
The application for clinical trials of BC007 antibody injection for the treatment of advanced solid tumors was approved by the FDA, Genalizumab for injection of Changchun Hi-Tech Holdings' subsidiary was approved by the FDA for clinical trials, and GZR4 of Gan & Lee Pharmaceutical's US subsidiary was approved by the FD.
The clinical trial has implied permission to carry out this phase I clinical trial in the United State.
.
It can be said that domestic drugs are ready to go oversea.
For a drug manufacturer approved by the FDA, it means that the newly approved product is qualified to sell the drug in the .
.
market, and the drug company will have a broader market, which is expected to have a positive impact on the operating performance of related companie.
In recent years, local pharmaceutical companies have been actively deploying overseas clinical trials, relying on the advantages of APIs and quality to allow a large number of generic drugs to "go out" and enhance their competitiveness in the international marke.
At the same time, some domestic innovative drug companies are also accelerating the research and development of innovative drugs, and speeding up "going overseas" through modes such as license ou.
The industry expects that the proportion of domestic generic drugs, including high-end generic drugs, in the international market will continue to increase in the futur.
There is great potential for medicine to go out to se.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.
Among them, the North American market has become the main destination for many local pharmaceutical companies to go overseas due to its strong market shar.
Pharmaceutical companies only need to pass FDA approval to be eligible for commercial clinical applications in the US marke.
Pharmaceutical industry (Source: Pharmaceutical Network) According to incomplete statistics, in the past three months (May 10-August 30), 18 pharmaceutical companies in Shanghai and Shenzhen have obtained news from the FDA, which is related to product acquisitio.
In terms of FDA's implied license for clinical trials of drugs, obtaining drug registration approval documents, and obtaining approval numbers, a large number of domestic drugs have now obtained FDA certificatio.
For example, Jianyou shares frequently reported good new.
On August 3, the company announced that its abbreviated new drug application (ANDA, US generic drug application) for vancomycin hydrochloride for injection 500mg/bottle and 1g/bottle has been approved by the United States in July 202 FDA-approved for serious infections caused by methicillin-resistant Staphylococcus and other bacteria; on June 8, Jianyou shares announced that its subsidiary Hong Kong Jianyou's Ganirelix acetate injection 250 mcg/5 mL was approved by the US FDA Approved, this product is used in women with controlled ovarian stimulation (COS) program to prevent premature luteinizing hormone (LH) peak; FDA-approved for the treatment of the following fungal infections in adults and children 2 years of age and olde.
Huahai Pharmaceutical is also accelerating the process of going oversea.
On July 11, Huahai Pharmaceutical announced that the company's enalapril maleate tablet ANDA for the treatment of hypertension has been approved by the FDA, which means that the product can be produced and sold in the US marke.
On May 12, the company announced that the ANDA of ropinirole hydrochloride extended-release tablets submitted by the company to the US FDA has been approved for the treatment of symptoms and signs of Parkinson's diseas.
The day before, the company announced that the FDA has approved a new drug brief application for roflumilast tablets for the treatment of bronchitis-related cough and excessive mucus symptoms in patients with severe COP.
Hengrui Medicine announced on May 25 that the ANDA application for iodixanol injection submitted by the company to the US FDA was reviewed and approved by the US FD.
The drug is suitable for arterial digital subtraction angiography, cardiovascular angiography, peripheral Arterial and venous angiography, visceral arteriography, cerebral arteriography, head and body CT imaging, excretory urography, coronary CT angiography (CCTA.
Global sales of iodixanol-related dosage forms in 2021 will be approximately US$873 millio.
At present, no similar generic drug products have been approved for marketing abroa.
In addition to the above-mentioned pharmaceutical companies, a large number of pharmaceutical companies have obtained FDA approval for clinical trials of their product.
For example, the new drug of recombinant herpes zoster vaccine (LZ901), a joint-stock company of Saisheng Pharmaceutical C.
, Lt.
, was approved by the US FDA to enter clinical research, and Guilin Sanjin Holdings Sun C.
, Lt.
The application for clinical trials of BC007 antibody injection for the treatment of advanced solid tumors was approved by the FDA, Genalizumab for injection of Changchun Hi-Tech Holdings' subsidiary was approved by the FDA for clinical trials, and GZR4 of Gan & Lee Pharmaceutical's US subsidiary was approved by the FD.
The clinical trial has implied permission to carry out this phase I clinical trial in the United State.
.
It can be said that domestic drugs are ready to go oversea.
For a drug manufacturer approved by the FDA, it means that the newly approved product is qualified to sell the drug in the .
.
market, and the drug company will have a broader market, which is expected to have a positive impact on the operating performance of related companie.
In recent years, local pharmaceutical companies have been actively deploying overseas clinical trials, relying on the advantages of APIs and quality to allow a large number of generic drugs to "go out" and enhance their competitiveness in the international marke.
At the same time, some domestic innovative drug companies are also accelerating the research and development of innovative drugs, and speeding up "going overseas" through modes such as license ou.
The industry expects that the proportion of domestic generic drugs, including high-end generic drugs, in the international market will continue to increase in the futur.
There is great potential for medicine to go out to se.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyon.
