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On November 24, CSPC Pharmaceutical Group issued an announcement that its development of "SYHX1901 tablets" has been approved by the Food and Drug Administration for clinical trials
for the treatment of adult patients with severe new coronary pneumonia.
The announcement also mentioned that the drug is a small molecule compound, a JAK/TYK2 inhibitor, which can inhibit cytokine storms
by inhibiting key targets in signaling pathways related to inflammatory responses in B cells and T cells.
Cytokine storm, or immune storm, is the cause
of death in most critically ill patients.
Under normal conditions, the immune system is in a controlled state and does not harm the body itself
.
When a cytokine storm occurs, the immune system fights the virus while causing great damage to the human body, even leading to death
.
CSPC has made a variety of layouts
around the prevention and treatment of the new crown.
Its mRNA new crown vaccine is undergoing multiple clinical trials
.
In addition, public information shows that CSPC has registered bioequivalence (BE) tests of self-developed products for Pfizer Paxlovid's two main components, nirmatrelvir and ritonavir
, in September this year.
The so-called BE experiment is an experiment used to verify the comparison of the effect of generic drugs and original drugs, and the "generic drug consistency evaluation" carried out vigorously in previous years requires generic drug companies to do BE experiments
.
-01-
-01-Shiyao has registered clinical trials for nematevir and ritonavir
Shiyao has registered clinical trials for nematevir and ritonavirPfizer's antiviral oral drug Paxlovid consists of
two pills, nimatevir and ritonavir.
Among them, it is mainly nematevir
that inhibits the replication of the new coronavirus.
Ritonavir provides an auxiliary effect to ensure the blood concentration
of nematevir.
A search of the website of "China Clinical Trials Registry" shows that CSPC registered the bioequivalence trial of nematevir tablets on September 26, 2022, and the trial was also hosted by Hangzhou Shulan Hospital
.
According to the trial registration information, the purpose of the trial is to evaluate the nematevir tablets and Pfizer Manufacturing Deutschland produced by Sinopharma Pharmaceutical Group
Bioequivalence of the reference preparation nematevir tablets produced by GmbH
.
Image source: China Clinical Trials Registry website
Public information shows that Pfizer Manufacturing Deutschland GmbH
i.
e.
Pfizer's manufacturing company
in Germany.
Sinopharmaceutical, a joint venture invested and established by CSPC Group in the mainland, is a professional antibiotic raw material and preparation production base in China and a major generic drug supplier in China.
The website of the "China Clinical Trial Registry" also shows that on September 19, 2022, CSPC also registered the bioequivalence trial
of ritonavir tablets with Shulan Hospital.
The test agent ritonavir tablets of this trial are also produced by Sino Pharmaceutical
.
Image source: China Clinical Trials Registry website
Coincidentally, recently, several people infected with the new crown virus in the cabin of Shijiazhuang said that they were issued pink and white tablets and were required to sign an informed consent form
.
The informed consent form received by several infected people revealed that this was a clinical trial
"evaluating the efficacy and safety of nematevir tablets in adult patients with COVID-19.
"
At present, it is not certain that the experiences of these netizens are related
to CSPC Group.
However, considering that Shiyao is based in Hebei, combined with its two registered bioequivalence trials, industry insiders speculate that a possibility cannot be ruled out: Shiyao is leading its self-produced Paxlovid clinical trial
for mild new crown disease.
However, the registrant contacts for the two bioequivalence trials denied this speculation
.
She said that the equivalence trial has not yet begun, that no other trials of the drug have been conducted, and that the drug has not been clinically
tested in Shijiazhuang.
The head of research at Shulan Hospital said that "projects related to the new crown are confidential"
.
-02-
-02-Who has the right to make Paxlovid in China?
Who has the right to make Paxlovid in China?At the beginning of 2022, the Medicines Patent (Medicines Patent) of the Medicines Patent Pool
Pool (MPP) granted five Chinese companies the right
to produce Pfizer Paxlovid from royalties.
Among them, Jiuzhou Pharmaceutical was approved to produce APIs, and Disono, Huahai Pharmaceutical, Propharma and Fosun Pharma were approved to produce APIs and preparations
.
It is worth noting that the purpose of this grant by the MPP patent pool is to increase access to the drug in low- and middle-income countries, where China is not included
.
Taking Fosun Pharma as an example, the company issued an announcement in March 2022 stating that its authorized content is to produce generic drugs of nematevir and nirmatevir/ritonavir combinations, and "in the region (i.
e.
, India, Pakistan, Côte d'Ivoire, etc.
).
95 low- and middle-income countries, excluding China) commercialized licensed products and related rights"
.
In other words, the five pharmaceutical companies were only authorized to produce Paxlovid at the time, but the products could not be sold
in the Chinese market.
in the Chinese market.
At the same time, because ritonavir's core patent rights in China have expired, the licenses obtained by these five companies do not include ritonavir
.
According to the FDA's website, only Ascletis Ritonavir tablets have been approved for marketing
after consistency evaluation.
Ascletis has reached an agreement
with Pfizer on a collaboration on this drug.
In October 2022, Ascletis issued an announcement that "Pfizer China will be non-exclusively authorized to use part of the registration data of Ascletis ritonavir tablets in Chinese mainland for the new crown drug PAXLOVID, and to manufacture and supply ritonavir tablets for Pfizer China in Chinese mainland", which is valid for 5 years
.
However, ritonavir, which has almost no patent restrictions, is destined to be a place for many pharmaceutical companies to compete for
.
.
Sinonuo, which has registered ritonavir bioequivalence clinical equivalence, is one of
many companies.
In addition, on the drug clinical trial registration and information disclosure platform, it can be seen that many companies such as Shiyao Zhongnuo, Simcere, Lepu and so on are doing equivalence trials of ritonavir, but most of the indications are HIV
.
What's more noteworthy is nimatevir – it's still under patent protection
.
.
From the above-mentioned trial registration information, it can be seen that Shiyao has begun clinical research
on nematevir tablets produced by Shinuo.
Recently, the epidemic situation in many places across the country has intensified, and new crown treatment drugs may be the focus of
competition among many pharmaceutical companies in the next period.
What's next? In addition to the self-developed products of many pharmaceutical companies, who will become the first imitator of Pfizer Paxlovid is also a topic
worth paying attention to.
