Recently, CDE issued a notice to publicly solicit opinions on the "Technical Guidelines for Clinical R&D of Children's Antineoplastic Drugs", which covers four major chapters, including background, overall considerations for clinical R&D of pediatric antineoplastic drugs, clinical R&D paths for pediatric antineoplastic drugs, and issues requiring special attention, and the time limit for soliciting comments is 1 month
from the date of issuance.
The notice is mainly to provide ideas and technical suggestions
for the clinical research and development of new anti-tumor drugs in children.
Data show that in 2018~2020, a total of about 121,100 children and adolescents have been diagnosed with cancer in
China.
In children, nearly 60% of patients have solid tumors
.
However, at present, in the treatment of solid tumors in children, it is obvious that there is a dilemma
of less drugs.
It is understood that as of February 25, 2022, there are only 8 items related to tumor indications searched with the keyword "children" on the drug clinical trial registration and information disclosure platform, and 5 are pharmacokinetic studies
carried out in adult healthy volunteers.
One data available for reference is a search using "lung cancer", with 661 results
.
This situation and the current research and development enthusiasm of pharmaceutical companies in anti-tumor drugs fully show that the research and development of children's anti-tumor drugs is obviously insufficient, and there are more urgent clinical needs in the field of children's cancer treatment
.
Therefore, in recent years, the national level has begun to try to solve the problem of
difficulty in using medicines for children.
The Center for Drug Evaluation of the State Medical Products Administration is also focusing on improving the current situation of off-label use in pediatric clinics, and solving the dilemma of "children take medicine by breaking and guessing when using medicine
".
For example, in August 2019, the newly revised Drug Administration Law clearly stipulates that the state shall take effective measures to encourage the development and innovation of children's drugs, support the development of new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children, and give priority to the review and approval
of children's drugs.
In September 2021, the state issued the Outline for the Development of Chinese Children (2021-2030), and China's children's drug market received policy support
.
In November of the same year, the Department of Drug Administration of the National Health Commission issued a document to solicit public comments on the Measures for the Administration of the National Essential Drugs List (Revised Draft), and "children's drugs" were added to the scope of basic drugs for the first time, which is widely believed by the industry to be of great significance
for promoting the development of children's drugs and promoting the development of clinical pharmacy.
In fact, under the favorable policy, more and more domestic enterprises have begun to try to develop
in the field of children's tumors.
For example, Junshi Biotechnology, Betta Pharmaceutical, Chia Tai Tianqing, Hengrui Pharmaceutical, Qilu Pharmaceutical and other pharmaceutical companies have participated in the research and development of children's cancer drugs to varying degrees
.
Among them, BeiGene's GD2 monoclonal antibody Kaiser Bai was also approved in China in August last year for the treatment of two children with indications for high-risk and relapsed refractory treatment, and was commercially supplied nationwide at the end of December of the same year, and has been clinically used
in more than a dozen children's cancer centers across the country so far.
In addition, BeiGene's pediatric oncology drug Belintopolomab (injectable bellintolumab) was also approved in May this year to increase the indication for children
.
The B7-H3-targeted chimeric antigen receptor T cell injection independently developed by Boshengji Pharmaceutical Technology (Suzhou) Co.
, Ltd.
was implicitly approved by CDE in clinical trials on July 4 this year and became a CAR-T therapy for children's solid tumors.
The product has been approved as an orphan drug by the US Food and Drug Administration (FDA) and a rare disease designation
by the FDA in March this year.
.
.
.
.
.
.
In general, in the past, pharmaceutical companies were reluctant to get involved in the development of children's anti-tumor drugs, subject to a variety of factors, but under the influence of a series of favorable policies, the industry expects that pharmaceutical companies' enthusiasm for research and development in this field will continue to rise, and more pediatric cancer patients will usher in benefits in the future
.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"share:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
