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With the change of domestic epidemic prevention and control policies, the number of new crown positive patients has increased
significantly.
Judging from the research and judgment of the development trend of the epidemic disclosed in various places, the peak of the first wave of the epidemic may arrive around January this year
.
Based on this, the "new crown special drug" that was somewhat silent some time ago has received renewed attention
.
01 Merck Sharp & Dohme new crown oral drug was conditionally approved for import
01 Merck Sharp & Dohme new crown oral drug was conditionally approved for importOn December 29, the State Food and Drug Administration conditionally approved Merck's new coronavirus treatment monogravir capsules (trade name: Lizhuorui/LAGEVRIO, Molnupiravir) in accordance with the special approval procedure for drugs, becoming the third new crown oral drug
approved in China after Pfizer Paxlovid (nematevir tablets/ritonavir tablets) and Henan real biological azvudine.
According to the State Food and Drug Administration, this product is an oral small molecule new coronavirus treatment drug, which is used to treat adult patients with mild to moderate new coronavirus infection (COVID-19) with high-risk factors for progression to severe disease, such as patients 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 disease
.
Patients should take the drug strictly according to the instructions under the
guidance of a physician.
Monoravir was first approved for marketing in the UK in November 2021 and is the world's first approved oral drug
for the new crown.
As of December this year, Merck has supplied more than 9 million courses of monoravir worldwide, treating about 2.
7 million patients
infected with the new coronavirus.
As an oral small molecule anti-new crown drug, monoravir has broad-spectrum antiviral activity and is widely used in a wide range of people, especially for the elderly and people with underlying diseases
.
It also has the characteristics of
short course of treatment and rapid removal of viruses from the body after medication.
7 million patients
with novel coronavirus infection.
It also has the characteristics of
short course of treatment and rapid removal of viruses from the body after medication.
Data from the MOVe-OUT study of the phase 3 clinical trial of monoravir, published in the New England Journal of Medicine in December 2021, suggest that early treatment of monoravir significantly reduces the risk of hospitalization or death in unvaccinated high-risk
adult patients with novel coronary pneumonia.
An interim analysis of the trial reported a approximately 50%
reduction in the risk of hospitalization or death in the monoravir group up to day 29 compared to placebo.
in the monoravir group as of day 29.
In terms of price, from the approved US regions, a course of monoravir costs about $700, and Paxlovid costs about $530
.
In addition, the recommended dose of monoravir in the United States is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days
.
.
At present, Merck has not disclosed the pricing of monoravir in China, and its official said that everything is subject to the public information released by the government
.
02 Pfizer Paxlovid into the community
02 Pfizer Paxlovid into the communityAs the first approved imported new crown drug in China, Pfizer's Paxlovid has always maintained a high degree of
social attention.
According to the approval information of the State Food and Drug Administration for the import registration of Paxlovid, this product is an oral small molecule new coronavirus treatment drug, which is used to treat adult patients with mild to moderate novel coronavirus pneumonia (COVID-19) with factors at risk of progression to severe disease, such as patients with advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease and other high-risk factors for severe disease
.
From the perspective of the mechanism of action, the above-mentioned monoravir belongs to an RNA polymerase inhibitor, which can bind to the RNA polymerase of the new coronavirus and introduce the wrong nucleotides into the newly synthesized RNA molecule, thereby inhibiting or eliminating the virus
.
Pfizer's Paxlovid is an oral antiviral drug of 3CL protease inhibitors, which is a combination
of nematevir and ritonavir.
Nematevir is designed to block SARS-CoV-2-3CL
The activity of proteases, ritonavir is a common HIV drug, and the combination of the two helps slow down the metabolism or breakdown of nematevir, keeping it active in the body at higher concentrations for longer to help fight the virus
.
.
According to surging news reports, Paxlovid has been put into use in some community health service centers in Shanghai and can use medical insurance
.
Chen Jianxin, deputy director of the Maluzhen Community Health Service Center, revealed that his community health service center has a reserve of Pfizer's new crown oral medicine, which is currently only available to patients over 65 years old who may be critically ill, and is temporarily not open
to ordinary patients.
.
At present, it is only available to patients over 65 years old who may become critically ill, and is temporarily not open
to ordinary patients.
Earlier, a news circulated on the Internet that "Beijing will distribute the antiviral drug nematevir/ritonavir tablets (Paxlovid) to various community health service centers in the near future, and after community doctors receive training, they will guide new crown patients in their jurisdiction to take antiviral treatment", and will organize community doctors in the city to participate in emergency training
on drug application on the afternoon of December 26.
Cyberland confirmed that Beijing Community Hospital had indeed received relevant notices and some doctors had participated in the training
.
It is worth mentioning that at present, the Beijing Municipal Medical Insurance Bureau has also included nematevir/ritonavir tablets (Paxlovid) into the scope of medical insurance drug reimbursement
.
.
03 Azvudine or sold out
03 Azvudine or sold outOn August 9 this year, azvudine tablets were officially included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Ninth Edition)
".
According to the Diagnosis and Treatment Protocol, the drug can be used to treat adult patients
with common novel coronavirus pneumonia (COVID-19).
The results of the international multi-center phase III clinical study of azvudine tablets show that it has the effect of inhibiting the replication of the new coronavirus, accelerating the elimination of the new coronavirus, reducing symptoms and shortening the course of the disease, and the dosage is lower and safer
.
At the same time, due to the target SARS-CoV-2
With relatively conservative RdRp and a low mutation rate, Azvudine has the potential to be effective against multiple variants
.
.
At the same time, due to the target SARS-CoV-2 With relatively conservative RdRp and a low mutation rate, Azvudine has the potential to be effective against multiple variants
.
Azvudine, which is cheaper, performs much better in the market compared to imported drugs
.
Recently, Fosun Pharma, a strategic partner of Azvudine manufacturer, said: "It has reached strategic cooperation with a number of domestic business partners such as Sinopharm and China Resources Pharmaceutical, giving full play to their respective resource advantages, jointly improving the national terminal accessibility of Azvudine, and accelerating the coverage
of the channel network.
" ”
At present, Azvudine has completed the network in 31 provinces, autonomous regions and municipalities across the country, and is speeding up the terminal distribution of hospitals across the country, and has now covered more than 2,000 hospitals
across the country.
According to Cyberblue, Jinan, Tai'an and many other places can buy azvudine
online.
The author personally purchased two boxes of azvudine online a week ago, and today the relevant platform has shown that the drug is out of stock
.
In addition, azvudine drugs are also very popular
offline.
On December 16, Azvudine went on sale in Jinan Quanfu Hospital
, 500 reservations were made in less than an hour after accepting the reservations, and 5,000 copies were sold out
in two days.
It is worth noting that according to the medication guidance of azvudine, it is mainly used to treat adult patients
with common novel coronavirus pneumonia.
It is not recommended to use in pregnant and lactating patients, and patients with moderate to severe liver and kidney function impairment should be used
with caution.
Many medical experts have also repeatedly reminded that under the guidance of professionals, please purchase and use on demand, and do not "hoard medicine"
.
in two days.
04 Junshi VV116 is on top journals, no second to Pfizer PAXLOVID
04 Junshi VV116 is on top journals, not second to Pfizer PAXLOVIDPAXLOVIDON DECEMBER 29, THE NEW ENGENG JOURNAL OF MEDICINE (NEJM) PUBLISHED THE RESULTS
OF THE PHASE 3 CLINICAL TRIAL OF JUNSHI VV116 "HEAD-TO-HEAD PFIZER POXLOVID" ONLINE.
The results showed that VV116 was non-inferior to PAXLOVID in terms of duration of clinical recovery and fewer
adverse events in adult patients with mild to moderate COVID-19 with high-risk factors.
adverse events.
According to Junshi Biologics, VV116 is a new oral nucleoside anti-SARS-CoV-2 drug independently developed in China, which can inhibit SARS-CoV-2 replication
.
According to public information, VV116 is jointly developed
by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Xinjiang Institute of Physical and Chemical Technology, Chinese Academy of Sciences, Central Asia Drug Research and Development Center/China-Ukraine Medical Science and Technology City, Lingang Laboratory, Suzhou Wangshan Wangshui Biomedical Co.
, Ltd.
and Junshi Biotechnology.
Industry insiders said that whether to publish in top medical journals can objectively and fairly reflect the quality of
a clinical trial.
Although VV116 has not yet been approved by NMPA in China, its clinical trial has been published in the New England Journal of Medicine, which plays a very important role
in promoting the future internationalization and market recognition of VV116.
.
In 2021, VV116 was approved in Uzbekistan for the treatment
of patients with moderate/severe COVID-19.
According to the previous disclosure, Junshi Biologics' etesivimab (JS016), the first new coronavirus neutralizing antibody in China to enter the clinical stage and participate in the global anti-epidemic, obtained emergency use authorization
in more than 15 countries and regions in 2021.
It is understood that VV116 has two other phase III clinical studies underway
.
One is placebo-controlled
COVID-19 patients with mild to moderate COVID-19 with high-risk factors.
The second is for ordinary risks, which may or may not be accompanied by high-risk factors, mainly carried out
in China.
As for the question of when it will be launched, according to 21 Economic Network, a relevant person from the investment relationship department of Junshi Biotechnology recently said that the VV116 drug has not yet submitted a marketing application, and maintains continuous communication
with the drug regulatory department.
"At present, the results of this phase III trial, the regulatory authorities believe that more data is needed, so we do not support the use of this phase III clinical study to submit a marketing application
.
" The person said
.
.
"
In addition to the above four, the current imported and domestic "new crown special drugs" have back strength
.
Shanghai Pharmaceutical announced on December 24, 2022 that its wholly-owned subsidiary, Shanghai Pharmaceutical Holdings, will act as the exclusive importer and distributor
of imports of Ensitrelvir, an oral anti-novel coronavirus drug of Ping An Shiono, in Chinese mainland.
China Biopharma announced on December 29, 2022 that its subsidiary, Chia Tai Tianqing, signed an exclusive marketing agreement
with Ping An Shionogi.
Accordingly, CT Tianqing was granted exclusive marketing rights to Ensitrelvir in Chinese mainland for an initial period of five years
.
In addition, domestic "new crown specific drugs" under development, including Hanyu Pharmaceutical's HY3000 nasal spray and Shutaishen's BDB-001 injection, also hope to enter the emergency review and approval channel
in accordance with the special approval procedures for drugs.
According to the information disclosed on the official website of the State Food and Drug Administration, in 2021, the department reviewed 81 registration applications (new coronavirus vaccines and therapeutic drugs) included in the special approval process, of which 15 approved new coronavirus treatment INDs (accepting applications for new drug clinical trials) and recommended approval of new coronavirus treatment NDAs
(new drug marketing authorization applications).
The era of domestic new crown drugs may be coming
.
