Reporter |
Editor |Xie Xin
On the afternoon of January 13, China National Pharmaceutical Group Corporation (Sinopharm) held a ceremony at its Waigaoqiao Bonded Area warehouse in Shanghai for the oral anti-COVID-19 drug Molnupiravir, co-developed by Merck & Co., Inc. (MSD) and Ridgeback Biotherapeutics.Product Name: Lizhuorui) for the China market launch. This means that after the drug received emergency conditional approval from the National Medical Products Administration (NMPA) on December 29, 2022, Molnupiravir has been officially shipped and entered the domestic market for sales and promotion.
Previously, in September 2022, China National Pharmaceutical Group Corporation (Sinopharm) signed a strategic cooperation framework agreement with Merck Sharp & Dohme AG (MSD), obtaining the distribution rights and exclusive import rights for Molnupiravir within China.
In terms of drug supply, Cai Maisong, a member of the Shanghai Municipal Committee of the Chinese People's Political Consultative Conference and Vice President of Sinopharm Holding, told The Paper on January 10 that the first batch of imported Molnupiravir capsules numbered in the hundreds of thousands. Meanwhile, "shipments are arriving daily, and we will continue to procure more." Additionally, according to a report by The Paper, Liu Yong, President of Sinopharm Holding Co., Ltd., stated on January 13 that the drug would be distributed and sold through medical institutions. The initial batch of the drug is expected to reach medical institutions in Shanghai today and can arrive in other parts of China tonight or tomorrow. Previously, after Molnupiravir was approved for use in China, multiple local governments, including Suzhou, sent official requests to MSD (Merck & Co., Inc.), asking for assistance in the urgent procurement of Molnupiravir capsules.
However, The Paper learned from a source that the number of Molnupiravir capsules in the first batch of imports and shipments is more than 300,000 boxes. In addition, the second batch of imported Molnupiravir will arrive in Shanghai on January 18, with a quantity of about 1 million boxes. However, China National Pharmaceutical Group Corporation did not confirm this news.
In terms of pricing, the Tianjin Medical Procurement Center announced on the evening of January 10 that the Molnupiravir capsules had been listed on its platform, with an initial price of 1500 yuan per bottle, lower than prices in major overseas countries. Currently, according to the "Notice on Optimizing Medical Insurance Policies for Treatment Costs of COVID-19 Patients After Implementing 'Class B Management'," all therapeutic drugs included in the "Diagnosis and Treatment Plan for COVID-19 Infection (Tentative 10th Edition)" (hereinafter referred to as the "Tenth Edition Treatment Plan"), including Paxlovid, Azvudine tablets, and Molnupiravir capsules, will be temporarily covered by medical insurance until March 31, 2023.
Moreover, according to the "Guidance on the Price Formation of COVID-19 Treatment Drugs (Trial)" issued by the National Healthcare Security Administration on January 6, drugs officially listed on the network will undergo price reevaluation and dynamic adjustment. The triggering conditions include a decrease of more than 10% in the international median price of the drug and imported drugs being localized for production.
On January 11, MSD issued a statement saying that the company has started negotiations with China National Pharmaceutical Group Corporation for the technology licensing of Molnupiravir production, so that China National Pharmaceutical Group Corporation can produce and supply the drug in China in the future. This means that Molnupiravir may have the potential for further price reduction in the future.
Molnupiravir is currently approved for use in China to treat adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19) who are at high risk of progressing to severe disease, such as those with advanced age, obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, active cancer, and other high-risk factors for severe illness.
The Phase III clinical trial of the drug showed that it is effective for non-hospitalized patients with mild to moderate COVID-19 who have not been vaccinated against the virus and have at least one risk factor associated with poor disease prognosis.For adult patients, Molnupiravir can reduce the risk of hospitalization/death by 30%. In contrast, the Phase II/III clinical trials of Pfizer's COVID-19 oral drug Paxlovid, which was previously approved in China, showed that for high-risk adult COVID-19 patients who received the medication within three days of symptom onset, the drug could reduce the risk of hospitalization or death by 89%.
According to the tenth edition of the diagnosis and treatment plan, this drug is used alongside Paxlovid.The applicable population is adult patients with mild or moderate symptoms within 5 days of onset who have risk factors for progressing to severe disease. In addition, these two drugs are not recommended for use in lactating patients, and the use of Molnupiravir is not recommended for pregnant patients. Patients with severe liver and kidney dysfunction should not use Paxlovid, while there is no mention of precautions regarding the use of Molnupiravir in patients with liver and kidney impairment. This means that the clinical use of Molnupiravir will, to a certain extent, alleviate the current shortage of oral antiviral drugs like Paxlovid and provide more options for related patients, such as those with liver and kidney impairment.