The third new crown oral drug in China was approved for marketing with conditions.
On December 30, the State Food and Drug Administration announced that on December 29, in accordance with the relevant provisions of the “Drug Administration Law” and in accordance with the special approval procedures for drugs, the State Food and Drug Administration conducted emergency review and approval, and conditionally approved Merck’s new crown virus Import registration of the therapeutic drug Monogravir Capsules (trade name: LAGEVRIO).
According to the State Food and Drug Administration, this product is an oral small molecule new coronavirus treatment drug, which is used to treat adults with mild to moderate new coronavirus infection (COVID-19) patients with high risk factors for severe disease, such as advanced age, Patients with severe high-risk factors such as obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, and active cancer. Patients should use the medicine strictly according to the instructions under the guidance of doctors.
This is the third new crown oral drug approved in China after Pfizer Paxlovid (Nimatevir Tablets/Ritonavir Tablets) and Henan Real Bio Azvudine.
The State Food and Drug Administration requires the marketing authorization holder to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit follow-up research results in a timely manner.
How does monogravir work?
Monogravir (MK-4482, EIDD-2801), an oral form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2 (the causative agent of the new coronavirus), was developed by Merck & Co. and Ridgeback Biotech Jointly developed by technology companies.
As the second imported new crown oral drug approved in China, what is the difference between Monogravir and Pfizer Paxlovid?
According to the State Food and Drug Administration, both monogravir and Paxlovid are oral small molecule new coronavirus treatment drugs, and the indications of the two are basically the same. Patients with coronavirus infection (COVID-19). However, according to Pfizer’s official website, Paxlovid should be taken as soon as possible within 5 days after the diagnosis of infection with the new coronavirus and the onset of symptoms.
From the perspective of the mechanism of action, monogravir is an RNA polymerase inhibitor, which can bind to the RNA polymerase of the new coronavirus and introduce wrong nucleotides into the newly synthesized RNA molecules, thereby inhibiting or clearing the virus. .
Pfizer’s Paxlovid belongs to the oral antiviral drug of 3CL protease inhibitor, which is a treatment method combined with Nematvir and Ritonavir. Namatevir is designed to block the activity of SARS-CoV-2-3CL protease. Ritonavir is a common HIV drug. The combination of the two can help slow down the metabolism or breakdown of Namatevir, making it more effective in the body. Higher concentrations remain active for longer to help fight viruses.
In terms of effectiveness, the MOVe-OUT study data of the phase 3 clinical trial of monogravir published in the “New England Journal of Medicine” in December 2021 showed that early treatment with monogravir can significantly reduce the risk of unvaccinated high-risk adults with new coronary pneumonia. patient’s risk of hospitalization or death. An interim analysis of the trial reported that the risk of hospitalization or death was reduced by approximately 50% in the monogravir group compared to the placebo group by day 29.
According to the official website of Merck in June, new data from the Phase 3 MOVe-OUT study were published in the Annals of Internal Medicine. The pre-set exploratory endpoint analysis showed that compared with participants receiving placebo treatment, monogravir A lower proportion of treated participants received acute care or COVID-19-related emergency care: 6.6% of participants treated with monogravir received new crown (COVID-19)-related emergency care, Compared with placebo-treated participants, 10.0% of participants received COVID-19-related emergencies, for a relative risk reduction of 33.8%.
According to data released by Pfizer at the end of 2021, compared with placebo, Paxlovid, taken within three days after the onset of symptoms, can reduce the probability of hospitalization or death in mild and moderate adult patients by 89%.
According to news from Merck’s official website on October 6, Oxford University conducted a non-blind, prospective real-world evidence study (PANORAMIC) in the UK. The study population had a high vaccination rate, and most of them were younger than 65 years old. The preliminary analysis of the study showed that , conventional care plus monogravir compared with usual care, there was no evidence of a difference by Day 28 in reducing hospitalization and mortality (the primary endpoint was not met); the incidence of hospitalization and death by Day 28 was overall Very low (0.8% for both groups). A primary secondary endpoint (time to first self-reported recovery) was reached 6 days earlier in the monogravir group than in the usual care group.
As the world‘s first approved oral anti-coronavirus drug, monogravir was approved for marketing in the UK in November 2021. In December of the same year, it received emergency authorization from the US Food and Drug Administration (FDA) and emergency special approval from Japan. According to Merck’s financial report for the fourth quarter of 2021, the global sales of the drug reached US$952 million, and the company expects its sales to reach US$5 billion to US$6 billion in 2022.
Merck China’s WeChat official account claims that as of December 2022, Merck has supplied more than 9 million courses of monogravir globally, treating about 2.7 million patients infected with the new coronavirus.
In the third quarter of 2022, sales of monogravir were $436 million. Merck narrowed its full-year sales forecast for monogravir to between $5.2 billion and $5.4 billion. In the third quarter, sales of Pfizer’s new crown oral drug Paxlovid reached US$7.514 billion.
Overseas price is higher than Pfizer
In terms of domestic distribution, Merck has chosen to establish cooperation with China National Pharmaceutical Group Co., Ltd. (hereinafter referred to as “Sinopharm”).
In September, Merck and Sinopharm signed a cooperation framework agreement, granting the distribution rights and exclusive import rights of monogravir in China to Sinopharm. In November, Merck signed a distribution agreement with Sinopharm Holding Distribution Center Co., Ltd. on the import and distribution of monogravir in China.
It is understood that Sinopharm Holding Distribution Center Co., Ltd. is a subsidiary of Sinopharm Holding Co., Ltd. (Sinopharm Holding, 01099.HK). According to the official website, Sinopharm Holdings is the core enterprise of Sinopharm Group. It was established in January 2003 and listed on the Hong Kong Stock Exchange in September 2009. It is China’s largest wholesaler and retailer of pharmaceuticals, medical devices and health care products, and a leading supply chain service provider.
At present, Merck has not disclosed the pricing of Monogravir in China. Judging from the approved U.S. regions, according to Reuters, a course of treatment for Monogravir costs about $700, and a course of treatment for Paxlovid costs about $530. In addition, the recommended dosage of monogravir in the United States is 800 mg (four 200 mg capsules), taken orally every 12 hours for 5 consecutive days.
It is worth noting that the Medicines Patent Pool (MPP) announced through its official website in January this year that it had signed agreements with 27 pharmaceutical companies, allowing them to produce and supply Merck’s Monogravir to 105 low- and middle-income countries or regions around the world. To promote the affordability and accessibility of the drug globally.
Among them, 5 Chinese pharmaceutical companies including Fosun Pharma (600196), Borui Pharmaceutical (688166), Shijiazhuang Longze Pharmaceutical, Shanghai Desano, and Langhua Pharmaceutical are among them, and the first four of them are licensed to simultaneously produce raw materials and finished products Pharmaceuticals, Langhua Pharmaceuticals is licensed to produce APIs. Borui Medicine announced at the time that this license is a non-exclusive license; the licensed areas are 105 low- and middle-income countries/regions such as India, Pakistan, and Côte d’Ivoire, excluding China.
Regarding whether the above-mentioned pharmaceutical companies can start production immediately, Merck China responded to The Paper, “In terms of operation, these five companies can apply to the drug patent pool organization to produce. (Whether to produce the drug) mainly depends on the willingness of Chinese drug manufacturers , Manufacturers judge based on their own capabilities and sales expectations for the drug.”
Can the tension of the new crown oral medicine be relieved?
With the current surge in the number of infections, especially the increase in elderly patients, the demand for oral drugs for the new crown has become increasingly strong, and Pfizer Paxlovid has become “hard to find.” After the approval of Merck’s monogravir, the supply of oral drugs for the new crown will be expanded.
Recently, a number of hospitals said that the inventory of Pfizer’s new crown oral drug Paxlovid was tight. Many users posted on social platforms asking about purchasing strategies, and a box of Paxlovid was sold for tens of thousands of yuan in unofficial channels.
However, some regions have begun to uniformly distribute Paxlovid to community health centers. According to a report by the People’s Daily “Health Times” on December 30, the first batch of Pfizer’s new crown oral drugs applied by some Beijing community health service centers has arrived, but the quantity is limited, and the drug prescriptions need to undergo strict evaluation before they can be issued.
According to The Paper reported on December 30, Paxlovid has been put into use in some community health service centers in Shanghai, and can use medical insurance. For example, the Community Health Service Center of Yuyuan Street, Huangpu District has already used it in clinical practice. Chen Jianxin, deputy director of the Malu Town Community Health Service Center in Jiading District, Shanghai, revealed that the Malu Town Community Health Service Center in Jiading District, where he is located, has also stockpiled Pfizer’s new crown oral medicine, which is currently only available to patients over 65 years old who may develop critical illness. Not open to ordinary patients.
At the same time, more new crown treatment drugs are accelerating into the market.
According to the WeChat official account of “Jiangsu Drug Supervision” on December 26, the Jiangsu Provincial Food and Drug Administration held a special scheduling meeting on the research progress of Simcere’s new crown treatment drug SIM0417. SIM0417 is an oral drug for 3CL-targeted COVID-19 treatment jointly developed by Simcere Pharmaceuticals, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Wuhan Institute of Virology. Included in the key scientific research catalog of the State Council’s joint defense and joint control mechanism. On December 16, all 1,208 patients had been enrolled in the phase III clinical trials of the project, and the progress ranks first among domestic 3CL target drugs. It is expected to be launched in February 2023 at the earliest.
On December 29, China Biopharmaceutical Co., Ltd. (China Biopharmaceutical, 01177.HK) announced that Chia Tai Tianqing Pharmaceutical Group Co., Ltd., a subsidiary of China Biopharmaceuticals, and Ping An Shionogi Co., Ltd. (hereinafter referred to as “Ping An Salt”) Wild justice”) signed an exclusive marketing agreement. According to this, Chia Tai Tianqing was granted the exclusive marketing rights for the novel coronavirus infection (COVID-19) drug Ensitrelvir (Ensitrelvir) in mainland China for an initial period of five years.
Sino Biopharma said in the announcement that Ensitrelvir is a new oral treatment for COVID-19. The results of clinical trials show that the drug has a significant improvement effect on the five typical symptoms of COVID-19 of the Omicron strain, and has a significant antiviral effect and good safety. Ping An Shionogi has submitted relevant preparation materials for Ensitrelvir’s new drug marketing application to the Center for Drug Evaluation of the State Drug Administration of China. Its parent company Shionogi Pharmaceutical Co., Ltd. has obtained the production and sales license of Ensitrelvir in Japan in November 2022, and the approved scope of application covers people over the age of 12.
On December 29, the biopharmaceutical company Junshi Biotech (688180.SH, 01877.HK) announced that the global authoritative journal “The New England Journal of Medicine (NEJM, impact factor: 176.079) published online The oral nucleoside anti-2019-nCoV (SARS-CoV-2) drug VV116 (JT001) of Junshi Biotech was compared with the Naimatevir/ritonavir tablet combination drug (PAXLOVID) for severe Phase III clinical study (NCT05341609) results of early treatment of patients with mild to moderate novel coronavirus infection (COVID-19) including high risk factors for death.
The author of this article: Yang Yang, the source of this article: The Paper, the original title: “The third new crown oral drug approved for marketing! What is the effect of Merck’s monogravir, and what is the difference between Paxlovid”
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