In recent years, China's huge pharmaceutical market is attracting the attention
of more and more multinational pharmaceutical companies.
At present, many enterprises are actively adjusting their management structures in China and promoting the listing of new drugs
.
Among them, Pfizer has been making frequent
moves in terms of products and personnel structures since the beginning of this year.
For example, recently, the website of the Drug Evaluation Center (CDE) of the State Food and Drug Administration showed that the application for the listing of Pfizer JAK3 inhibitor litecotinib capsules was accepted for the treatment of adolescents aged 12 and over and adults alopecia areata
.
Litecotinib is a new once-a-day oral covalent dikinase inhibitor developed by Pfizer, which is highly selective for JAK3 kinase and tyrosine kinase in the TEC family, and can inhibit IL-15 and CD8 cytokine signaling, which are important factors
driving the immune system to kill hair follicle cells.
It is worth mentioning that on September 9, local time, Pfizer announced that the US FDA and the European EMA have accepted the new drug listing application of litecotinib, and it is expected that the FDA and EMA will make decisions
in the second and fourth quarters of 2023 respectively.
On September 6, according to the CDE website, Biohaven's oral small molecule antagonist Rimegepant sulfate (Rimegepant), an oral small molecule antagonist targeting CGRP receptors, was declared for listing (acceptance number: JXHS2200074).
According to the previously disclosed information, the indications for this declaration are most likely to be: acute migraine
.
It is understood that Pfizer reached a partnership with Biohaven in November 2021 for a total of $1.
24 billion, and acquired interests in two CGRP antagonists, including an interest in the oral migraine drug Rimegepant (Nurtec® ODT) outside the United States, and a U.
S
.
regional interest in Zavegepant (which is also developing intranasal + gel dual dosage forms).
On June 19, Pfizer's innovative drug for acute leukemia, Bebosa (Oga Itulzumab for injection) held a marketing meeting
.
According to public information, Bebosa is the first ADC drug approved by the FDA to target CD22, which can fill the gap
in the diagnosis and treatment of acute lymphoblastic leukemia.
In China, Bebosa was officially approved
in China in December 2021 for "innovative drugs with obvious therapeutic advantages".
At present, the first prescriptions of Bebosa across the country have been issued one after another, which will officially benefit patients with acute leukemia in
China.
In addition, in February, China's State Food and Drug Administration also conditionally approved the import registration
of Pfizer's Naimatvir tablets/ritonavir tablets combination packaging (i.
e.
, Paxlovid).
Paxlovid is an oral small molecule new crown virus treatment for adults with mild to moderate novel coronavirus pneumonia (COVID-19) patients with advanced risk factors for severe illness, such as patients with advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease and other severe high-risk factors
.
It is understood that since the beginning of this year, in addition to Pfizer, there are many multinational companies such as AstraZeneca, Roche, etc.
are also actively adjusting their corporate structure, and have "actions" in terms of resources, personnel and products
.
For example, on September 5, AstraZeneca Andatang ® (generic name: dapagliflozin, a sodium-glucose synergistic transporter-2 [SGLT2] inhibitor) indications for chronic kidney disease were approved in China; On September 2, the website of the Food and Drug Administration showed that Bayer Rivaroxaban new indications have been approved for listing.
.
.
Analysts believe that thanks to the reform of China's drug review and approval system and the continuous support of China's drug regulatory authorities to innovate drugs, there will be more foreign new drugs and new indications in the future that will be accelerated to be approved for listing
in China.
At the same time, the personnel adjustment and strategic layout of multinational pharmaceutical companies in China will also accelerate the transformation and upgrading
.
