Tiger pharmaceutical has not been approved to provide cro service for qsymia clinical trial of vivus

Qsymia (general name: fentanyl topiramate sustained release capsule) of vivus was notified to supplement materials before import registration of clinical trials in China The second application was accepted in mid June this year, and it is expected that it will be difficult to obtain approval within this year In July last year, tag Pharma signed an intentional agreement and the first phase of work order with vivus to provide cro services for the qsymia clinical trial of vivus Tiger pharmaceutical is mainly engaged in clinical cro, and the cooperation with vivus is one of the company's potential large orders, which has attracted the attention of the capital market However, qsymia has not been approved to carry out clinical trials so far, resulting in the failure to sign the subsequent order of the cooperation According to CFDA website, tag has applied for import registration of fentanyl topiramate sustained-release capsules twice The first declaration was made in August last year, and the certificate preparation was completed on July 10 this year The second declaration is on June 20 this year, just entering the review stage The above-mentioned company pointed out that after the first declaration, CFDA required the company to supplement information, which is expected to take 8 months from CFDA acceptance to approval "It was only accepted in the middle of June It should not be approved in this year." She also said that since the company and vivus have signed an intentional agreement, the company will still be the cro service provider of qsymia clinical trial after the drug is approved However, she also pointed out that it is not excluded that vivus company reduces the number of domestic clinical trials or even cancels the risk of clinical trials in China due to the slow progress of domestic reviews According to CSCI, vivus has 3600 patients in China and 16000 in the world Considering the "customer unit price", the R & D cost of this product in China accounts for about 10-20% of the world's total, while vivus estimates that the total R & D cost of this product is US $150-250 million In 2013, tag pharmaceutical achieved an operating revenue of 337 million yuan On July 17, 2012, the U.S FDA approved qsyma (phentermine plus extended release topiramate) as an additional measure of low calorie diet and physical exercise for long-term weight control in obese patients The drug is suitable for adults with a body mass index (BMI) of 30 or more, or a BMI of 27 or more, with at least one weight-related condition, such as high blood pressure, type II diabetes, and high cholesterol (dyslipidemia) BMI measures a person's body fat based on weight and height to define obesity and overweight categories More than a third of adults in the United States are obese, according to the Centers for Disease Control and prevention Obesity threatens the overall interests of patients and is a major public health problem Dr Janet Woodcock, director of FDA's Center for drug evaluation and research, said: "qsyma, combined with a healthy lifestyle, including calorie reducing diet and exercise, is a new option for obese or overweight patients with at least one weight-related comorbidity for long-term treatment." Qsymia is a sustained-release formulation combination of two drugs approved by FDA, i.e phentermine and topiramate Fentamine is suitable for short-term treatment of overweight or obese adults, combined with exercise and calorie reduction diet Topiramate was used to treat some types of epilepsy and prevent migraine Qsymia should not be used during pregnancy as it may be harmful to the fetus Data showed that in the first three months of pregnancy, the risk of cleft lip and palate (cleft lip or palate) was increased when the fetus was exposed to topiramate, one of the components of qsyma Pregnant women with reproductive ability were tested monthly before and during the treatment of qsymia, and contraceptive measures were taken.