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On the evening of February 15, GenScript announced that its subsidiary Legend Bio had received an email notification from the US FDA on the 11th, suspending the Phase I clinical trial of one of its CAR-T products
Suspended the Phase I clinical trial of one of its CAR-T products
The trial, code-named "LB1901," is a CAR-T therapy targeting malignant CD4+ T cells to treat adult patients with relapsed or refractory T-cell lymphoma
Another CAR-T targeting BCMA has been declared for listing in the United States, and the FDA will determine whether to approve it before February 28
The Health Knowledge Bureau learned from Legend Bio that the clinical trial was not stopped by the FDA, but that the patients tested had a condition
The clinical trial was not stopped by the FDA, but the patients tested had a condition
China's innovative drugs have recently encountered difficulties in going overseas
Legend Bio said it was unclear when clinical trials would resume
Legend Bio said it was unclear when clinical trials would resume
FDA is a "hurdle"
"LB1901"'s trip to the sea, the legendary creature has been in preparation for a long time
In addition to CAR-T Sidaki Orenza, Legend Bio's product with the fastest R&D progress is LB1901, which has been advanced to clinical phase I in both China and the United States
At present, the main competitor globally is the American gene therapy company iCell.
Leading the implementation of this trial is the largest clinical trial site for oncology drugs in the United States, the University of Texas MD Anderson Cancer Center
Only six months after the trial started, the first feedback was received: the only participant who received the injection had a low cell count, and the trial was forced to be suspended according to the trial protocol
The only participant who received the injection had a low cell count, and the trial was put on hold according to the protocol
In November 2021, Legend Bio announced that the marketing approval of its CAR-T product, Chidakiorenza, was delayed by the FDA because "the FDA needs more time to review the information submitted by the company
Marketing approval of its CAR-T product, Cedarquiorenza, delayed by FDA because "FDA needs more time to review information submitted by companies"
In August 2020, Cidaki Orenza has already received the first batch of breakthrough therapy designations granted by the China Food and Drug Administration, but Legend Bio still decided to list in the United States first, and then submit a listing application to the Chinese regulatory authorities .
However, Legend Bio still decided to list in the United States first and then submit a listing application to Chinese regulators.
On February 28th, the FDA will give the final approval for Sidaji Orenza.
back to the roots
back to the roots If there are no domestic new drugs, you don't want to go overseas, but it is difficult to go overseas
.
In the early morning of February 11, the FDA Oncology Drug Advisory Committee concluded the discussion on the marketing review of Innovent Bio's PD-1 sintilimab
.
Since the clinical data of sintilimab is only for China, the U.
S.
experts overwhelmingly opposed the result by 14:1 and asked the drug to supplement the clinical practice
.
S.
experts overwhelmingly opposed the result by 14:1, requesting this drug to supplement clinical trials
After the collapse of Cinda, the issue of domestic innovative drugs going overseas has been magnified again
.
The current general view in the industry is that the FDA is not setting up "obstacles" for domestic pharmaceutical companies, but prohibiting opportunism
.
In fact, the basic standard for FDA approval of new drugs has not changed, and it has always been to "address unmet clinical needs in a safe and effective manner"
.
.
"The most essential function of each country's drug administration is to be responsible to the people of the country," a person from a domestic innovative pharmaceutical company once told the Health Knowledge Bureau: "If the drug is approved in China, all the data are white or black.
It’s also not possible
.
Imported drugs into China also need to do clinical trials
.
”
.
"
So, if a pharmaceutical company conducts clinical trials in multiple centers around the world, can it be successfully listed in the United States?
Take BeiGene as an example of innovative pharmaceutical companies going overseas
.
According to statistics from the Health Knowledge Bureau, as of 2021, BeiGene has invested in three commercialized products of PD-1 replacement inhibitor lelizumab, BTK inhibitor zanubrutinib, and PARP inhibitor pamiparib.
The research and development expenditure is more than 8.
5 billion yuan
.
Among them , half of the 35 clinical trials of tislelizumab are conducted overseas; the number of overseas clinical trials of pamidalizumab is also as high as 9, which is three times that of domestic trials
.
Does FDA recognize it? Take zanubrutinib as an example, this drug has currently been granted 6 orphan drug designations by the FDA
.
Wu Xiaobin, president of BeiGene, once said that in the future, the company's revenue from overseas will exceed the Chinese market
.
.
However, not all views are so optimistic
.
Some insiders believe that the driving force for China's new drugs to go overseas is not to "prove the value of Chinese new drugs" or to create a larger market, but to "better fight against competitors" in the domestic market
.
