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Recently, Fosun Kite Aquilencel injection for the marketing application of a new indication for adult large B-cell lymphoma that is ineffective in first-line immunochemotherapy or relapses within 12 months after first-line immunochemotherapy is intended to be included in the priority review
.
Aquilenca injection is China's first approved CAR-T product, which was approved for marketing in China in June last year, and more than 200 Chinese patients have been treated
so far.
Aquilencyl injection, a product introduced by Renaissance Kate to Gilead company Kite, was approved for marketing in the United States in October 2017, and is the world's first CAR-T cell product for the treatment of relapsed or refractory large B-cell lymphoma after receiving second-line or above systemic therapy, and is now in its fifth year of marketing
.
According to the CPM new drug R&D monitoring database of China Pharmaceutical Industry Information Center, there are 8 indications in the research and development stage of Aquilencel injection, namely mature B-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, non-Hodgkin lymphoma, marginal zone lymphoma, acute lymphoblastic leukemia, chronic lymphoblastic leukemia and mantle cell lymphoma
.
Progress in the research and development of aquilencel injection
Progress in the research and development of aquilencel injection
Data source: CPM new drug R&D monitoring database of China Pharmaceutical Industry Information Center
Last year, CAR-T approved for marketing in China, in addition to Aquilencel injection, also has JW Therapeta Ultra Aurencel injection approved in September
.
This is the first cellular immunotherapy product approved for relapsed or refractory follicular lymphoma in China, and has now completed the infusion of
260 Chinese patients.
Progress in the research and development of relma-cel injection
Progress in the research and development of relma-cel injection
Data source: CPM new drug R&D monitoring database of China Pharmaceutical Industry Information Center
In February this year, cedarquiolence, jointly developed by Legend Biologics and Janssen, was officially approved by the US FDA for the treatment of relapsed/refractory multiple myeloma, becoming the third domestic CAR-T successfully marketed and the first CAR-T product
approved for marketing in the United States.
Johnson & Johnson just released a third-quarter report of about $55 million in sales
.
Currently, cedarquiolensis is undergoing a number of phase III clinical trials
for new indications.
The chairman of Johnson & Johnson Global Pharmaceuticals said that it will continue to expand the range of indications for the drug, "The drug has very large growth potential and is expected to become one of
the company's more than $5 billion brands.
" ”
This year is the first full year
of commercialization of cell therapy in China.
According to JW Therapeutics this year's semi-annual report, the revenue of relma-cel injection in the first half of 2022 is about 66 million yuan, which is still far from
the sales of cedargiolensis with sales of tens of millions of US dollars.
There are many reasons why the development of domestic CAR-T is not as good as that in Europe and the United States, among which the patient's ability to pay is the main limiting factor
.
Last year, Aquilenca injection passed the preliminary review of medical insurance, but due to its high value and high price, and the small patient group, it did not enter the medical insurance
.
However, Aquilensai injection has been included in many local supplementary medical insurance and commercial insurance, such as provincial Huimin insurance
.
This year, relma-cel injection was shortlisted for the preliminary review, and Aquilencel injection did not participate in this year's medical insurance negotiations, and the outcome is unknown
.
CPM new drug R&D monitoring database shows that at present, two BCMA CAR-T therapies, Iquilenca injection developed by Reindeer Biologics and Zevokiolencel injection from Keji Pharmaceutical, have submitted marketing applications
in June and October this year, respectively.
With the successive approval of new drugs and the introduction of policies, it is believed that Chinese patients will usher in more choices
.
Progress of domestic CAR-T marketing application
Progress of domestic CAR-T marketing application
Data source: CPM new drug R&D monitoring database of China Pharmaceutical Industry Information Center
