Merck and Sinopharm Group, the world’s first oral drug for COVID-19 monogravir to accelerate the process of entering China

MSD and China National Pharmaceutical Group Co., Ltd. (“Sinopharm”) signed a cooperation framework agreement in Beijing today, Merck will use the anti-coronavirus oral drug developed by it and Ridgeback to The distribution rights and exclusive import rights of noravir (molnupiravir) in China have been granted to Sinopharm Group Sino Bio. At the same time, the two parties will evaluate the feasibility of technology transfer so that the drug can be produced, supplied and commercialized in China for the benefit of Chinese patients.

△On September 28, 2022, Merck and Sinopharm signed a cooperation framework agreement on anti-new crown oral drugs in Beijing

Merck said that it has been in active communication with Chinese regulatory authorities on the introduction of monolavir, and has completed the rolling required by the Center for Drug Evaluation of the State Drug Administration. Submitted and awaiting further feedback, we hope to bring this drug to Chinese patients who need it as soon as possible.

According to the terms of the cooperation framework agreement, after Monolavir is approved in China, Sinopharm Group China Bio will actively promote the local Monoprevir technology transfer after obtaining the technology transfer from Merck & Co. Production and supply will continue to contribute to the fight against the new crown epidemic.

It is reported that monolavir, an oral anti-coronavirus drug, is the world’s first authorized oral anti-coronavirus drug. It is a novel ribonucleoside analog prodrug that can Inhibits the replication of SARS-CoV-2, the causative agent of novel coronavirus pneumonia (COVID-19). The mechanism of action of monoprevir is that after entering the body, it is metabolized to the nucleoside analog N-hydroxycytidine (NHC), which is incorporated into the viral RNA by viral RNA polymerase, resulting in the accumulation of errors in the viral genome, thereby Inhibit viral replication. Monoravir is administered at a dose of 800 mg (4 200 mg oral capsules) every 12 hours for 5 days in countries where marketing authorization or use authorization has been obtained. In controlled trials, the drug reduced the risk of hospitalization or death in mild to moderate patients by about 50 percent.

Globally, monolavir has obtained marketing authorization or emergency use authorization in more than 40 countries or regions, including the United States, the European Union, Australia, Japan, South Korea, Hong Kong, and Taiwan. As of the end of August 2022, Merck had supplied more than 8.6 million courses of monoprevir to more than 30 markets around the world, treating more than 1.8 million patients.

To supplement supply from licensed generic drug manufacturers, Merck and UNICEF have reached an agreement to deploy 3 million courses of Mordine in low- and middle-income countries in the first half of 2022 noraway.

Professor Wu Hao, Chief Physician of the Department of Infection and Immunology, Beijing You’an Hospital Affiliated to Capital Medical University, said: “The main research data of monolavir show that in patients with progressive disease Among adults with mild-to-moderate COVID-19 with severe disease risk factors, the use of monoprevir has demonstrated significant benefits: reduced risk of hospitalization or death, significant reduction in mortality, potential improvement in patient-reported symptoms and signs outcomes, At the same time, it can quickly clear the infectious activity of the new coronavirus in patients, effectively control the spread of the new coronavirus, and at the same time, cytology and animal model studies have found that it is also effective for certain mutant strains.” Professor Wu Hao also said, “We look forward to this technical cooperation to better promote the landing and application of this drug in China, and bring more options for clinicians to treat patients with COVID-19.”

“Monolavir is an important addition to a range of anti-epidemic measures to help contain the impact of COVID-19 on patients, healthcare systems and global public health. We are delighted to partner with Sinopharm Collaborating to bring this important therapy to Chinese patients is another major effort we have made in the global fight against the epidemic and in promoting the widespread use of monogravir around the world,” said Dai Fucai, CEO and President of Merck & Co.

Sinopharm Group Chairman Liu Jingzhen said, “Sinopharm Group China Bio has strong strength and rich experience in biopharmaceutical research and development, production and commercialization. A series of major achievements have been made in the prevention and control of the disease. Reaching this cooperation with MSD is another positive practice in realizing the ‘curable’ of the new crown pneumonia and further building a community of human health. It is hoped that both parties will give full play to their respective advantages, deepen international cooperation, and serve China as soon as possible. Patients are provided with high-quality, convenient, and affordable medicines.”

In 1989, in order to solve one of the most serious public health problems in China at the time, Merck transferred the world’s most advanced genetically engineered hepatitis B vaccine production technology to China to protect the Chinese people from Vulnerable to hepatitis B virus infection and related diseases. Today, 33 years later, Merck is actively negotiating the technology transfer of Monoravir with Chinese partners, striving to benefit more Chinese patients.