The sword refers to Merck Prevymis, Nanjing Chia Tai Tianqing Class 4 generic drug "Letemovir Tablets" reported production

Recently, the registration application for Class 4 generic drugs of "Letemovir tablets" submitted by Nanjing Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
was accepted by CDE, which means that the first domestic letimovir tablets were reported for production
.

Letermovir is a novel non-nucleoside cytomegalovirus (CMV) inhibitor (3,4-dihydroquinazoline) with novel anti-CMV effects, which exerts an antiviral effect
by inhibiting the activity of cytomegalovirus terminal enzyme complexes and preventing the processing and packaging of viral DNA.
Unlike DNA polymerase inhibitors, letemovir is more selective for CMV and has a significantly higher
intensity of action.

Since 2017, Temovir tablets and intravenous formulations have been approved by the FDA for use in adult recipients of CMV-seropositive allogeneic hematopoietic stem cell transplantation (allo-HSCT) for the prevention of CMV infection, and the trade name is Prevymis
.
It is reported that Prevymis was initially priced in the United States at $270 per day for injections and $195 per day for tablets, with a course of
100 days.
As the first new drug approved for CMV infection in the U.
S.
market in the past 15 years, Prevymis had sales of $281 million in 2020 and $370 million
in 2021.

In China, the original Ritemovir tablet was first approved by the NMPA in January 2022 for the use of CMV-seropositive adult recipients of allogeneic hematopoietic stem cell transplantation (Allo-HSCT) to prevent CMV reactivation and disease, and the trade name is prelimin
.
In May 2022, letemovir injection was approved
in China.

It is reported that AiCuris is the holder of the Letamovir composite patent in the United States, which has been licensed to Merck and the patent is expected to expire
in 2024.
In China, according to public information, only Nanjing Zhengda Tianqing announced the layout of the Temovir generic drug market
.
The domestic production of letemovir tablets in China is expected to accelerate the accessibility of
letemovir in the domestic market.

Cytomegalovirus (CMV) is a herpesvirus-group DNA virus
.
CMV infection is a serious, life-threatening disease in immunocompromised patients, especially in allogeneic hematopoietic cell transplant recipients, with a high incidence of CMVEMIA of 50% to 60%.

CMV infection is a common complication after allogeneic hematopoietic stem cell transplantation, which seriously affects the quality of life and life
of transplant recipients.
The standard treatment strategy for CMV infection is preemptive treatment, but this strategy has many limitations, such as uneven therapeutic drug thresholds, adverse reactions such as bone marrow suppression and renal toxicity, and the risk of cross-resistance
.

In addition to letemovir, the FDA has recently approved a new drug for CMV infection, Takeda's Livtencity (TAK-620).

The drug, a class of drugs called benzimidazole riboside, targets the pUL97 protein kinase that inhibits CMV, potentially affecting several key processes of CMV replication, including viral DNA replication, viral gene expression, capsidization, and escape of mature capsids from the nucleus of infected cells
.

In November 2021, Maribavir was approved by the FDA for the treatment of post-transplant cytomegalovirus (CMV) infection in transplant recipients refractory to conventional antiviral therapy (with or without genotype resistance) for adult and pediatric patients (age ≥ 12 years, weight ≥ 35 kg) undergoing solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT), for the treatment of ganciclovir [ganciclovir], valganciclovir [ Valganciclovir], foscarnet, cidofovir [cidofovir] refractory (with or without genotype resistance) post-transplant CMV infection
.

In China, Maribavir was approved for clinical trials in China in May 2020 for the treatment of CMV infection or disease
.
In January 2021, the drug was included in the CDE breakthrough therapy variety for the treatment of cytomegalovirus infection or disease that occurs after transplantation, including refractory and drug-resistant infections
with ganciclovir, valganciclovir, cidofovir and foscarnet.