For the first time in 15 years! Mercadon anti-infection new drug declared on the market in China

On November 18, China's State Drug Administration's Drug Review Center (CDE) announced that the MSD antiviral drug letermovir submitted four applications for market and received four new drugs, including injections and tablets.
noted that the drug was approved by the FDA in November 2017 to prevent cytocellular virus (CMV) infections and related diseases.
, according to an earlier press release from Mercedon, is the first new drug approved in the United States in 15 years to treat CMV infection.
screenshot Source: CDE.com Cytovirus is a common virus that infects people of all ages.
, people with normal immune systems rarely have CMV symptoms after their initial infection, and the virus usually remains inactive or lurks in the body for a lifetime.
, however, may reactivate the virus when the body's immunity decreases, leading to symptomatic diseases or secondary infections caused by other pathogens.
clinically, CMV infection is one of the most common complications in patients with hematopoietic stem cell transplantation (HSCT), which can lead to gastrointestinal diseases, pneumonia or retinitis, increasing the risk of failure and death.
temove is a new type of non-nucleoside CMV inhibitor (3,4-hydroquinone).
public information shows that the product has a new anti-CMV effect, by inhibiting the activity of the end-of-cytoviral enzyme complex, to prevent the processing and packaging of viral DNA, thereby playing an anti-viral role.
it differs from DNA polymerase inhibitors such as more silovir and sodium potassium phosphate in that lymovir is more selective to CMV and has significantly higher intensity of action.
's molecular structure (Photo: Wikipedia) In China, Lemowe obtained implicit permission from four clinical trials of CDE in June this year to develop an adaptation to prevent CMV reactivation and disease in adult recipients who are seropositive for hematopoietic stem cell transplantation.
in the United States, the European Union and Japan, Lythmowe was granted orphan drug eligibility to prevent cytovirus disease.
November 2017, the FDA approved temove oral tablets and intravenous fluids that can be used to prevent CMV infections and related diseases in adult patients who test positive for CMV serum after receiving a hematopoietic stem cell transplant.
Based on a multi-center, double-blind, placebo-controlled Phase 3 clinical trial conducted in adult transplant patients with cmV serum-positive isogen HSCT, the main therapeutic endpoint was the clinically significant rate of CMV infection in week 24 after transplantation.
results showed that among 565 patients treated, the proportion of patients in the trial group with clinically significant CMV infection was 18 percent (vs 42 percent) at the 24th week after transplantation, compared to the placebo group.
14 weeks after the transplant, the figure was 8% (vs 39%).
in high-risk and low-risk populations with CMV reactivation, the results were consistent.
, the total cause mortality rates were 12 percent and 17 percent, respectively, in the trial and placebo groups.
, according to an earlier press release issued by Mercadon, the results showed that lytemove had prevented clinically significant cytocytovirus infections in susceptible patients and had made significant progress in reducing mortality.
merck Research Laboratories executives have pointed out that Lythmoway is the first new CMV infection drug approved in the United States in 15 years, continuing Mercedon's long tradition of providing important new treatments to address serious infectious diseases.