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Home News Cosunter Obtains 1st Approval for Production of TDF for HBV Indications

Cosunter Obtains 1st Approval for Production of TDF for HBV Indications

Published:2017-05-25 | Source:Cosunter | Visited:413

All efforts will be paid off some day.

On May 18, the important medicine of Fujian Cosunter Pharmaceutical Co., Ltd., “Fuganding-Tenofovir Disoproxil Fumarate Capsules (Approval No.:SFDA 2017H0005) is successfully approved, representing the first approval for TDF for HBV Indications is given to Fujian Province in China.

As a new generation of anti-HBV medicine, TDF is recommended as the best choice for chronic hepatitis B (CHB) treatment in the CHB prevention guides of all countries, due to its powerful effect, relative safety and no drug tolerance in eight consecutive years.

In 2007, Consunter took the lead in China to begin the research of TDF and won extensive support from the major special scientific projects for the “11th Five-Year Plan” and “12th Five-Year Plan” of Fujian Province. Thanks to ten years of efforts and a cost of about RMB 50 million, it managed to complete the first multi-centered clinical and experimental study to non-inferiority of two priority medicines TDF-ETV across the globe. Given the achievement, it won the first approval for production of TDF for HBV indications in China, thus posing a challenge to foreign enterprises, breaking the high-priced monopoly of imported medicines. All these promote production of anti-HBV medicines in China for the great benefit of Chinese hepatitis-B patients.

Hepatitis B tops among the four infectious diseases under major prevention and control in China, great attention is paid to treatment of Hepatitis B. TDF has been listed into the National Reimbursement Drug List (NRDL) in 2017.

Approval of TDF bulk drug and capsules helps Cosunter become the only enterprise to have the two priority anti-HBV medicines of TDF and ETV, with the most complete production line in the anti-HBV field in China, so that it leads in the China’s market for anti-HBV medicines.