In the increasingly crowded R&D track and fiercer market competition, many pharmaceutical companies are accelerating the promotion of scientific and technological innovation and internationalization strategies to enhance their competitiveness
.
Affected by this, the research and development of drug clinical trials is also accelerating, and a number of Chinese pharmaceutical companies have recently reported new progress
in clinical trials and marketing.
On November 21, Luye Pharmaceutical announced that the key clinical trial of paliperidone palmitate sustained-release suspension injection (LY 03010) developed by the group for the treatment of schizophrenia and schizoaffective disorder has completed data analysis, and the results show that the preset endpoint has been reached, based on the results of communication with the FDA in the early stage, LY 03010 plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) through the 505(b)(2) route
。
It is worth mentioning that before that, Luye Pharmaceutical also announced that the holding subsidiary Boan Biotech denosumab injection (Boyoube) was officially approved for osteoporosis
in postmenopausal women with high-risk fractures.
This is the first domestic desulsumab injection approved for marketing
.
Boyoubei is a biosimilar of Amgen's Proli, which was launched
in December 2020.
In 2021, Proli generated worldwide sales of $3.
248 billion
.
In addition, Luye Pharmaceutical's self-developed Toludi venlafaxine hydrochloride sustained-release tablets (Ruoxinlin) have also been approved for marketing for the treatment of depression
.
Ruoxinlin is the first class 1 innovative drug independently developed in China with independent intellectual property rights for the treatment of depression, which has become a major breakthrough
in the field of treatment of domestic innovative drugs.
On November 20, Mabwell announced that the company recently received the "Notice of Clinical Research Continuation" issued by the US Food and Drug Administration ("FDA"), and the new drug clinical trial application of 9MW3011 was officially approved by the FDA
.
It is reported that 9MW3011 can regulate iron homeostasis
in the body by specifically binding to upregulate the level of hepcidin expression in hepatocytes, inhibit the absorption and release of iron, and reduce serum iron levels.
Last month, 9MW3011 has received the "Notice of Acceptance" approved and issued by the National Medical Products Administration, and the clinical trial application has been accepted
.
The indications are intended to include a variety of diseases classified as rare diseases in different parts of the world, such as β-thalassemia, polycythemia vera and other diseases related to iron homeostasis
.
It is reported that since November, in fact, a number of domestic pharmaceutical companies have also released the news
of the approval of Class 1 new drugs.
For example, on November 9, the State Food and Drug Administration (NMPA) conditionally approved the marketing of Linperlisib, a Class 1 innovative drug (trade name: Intarui), of Shanghai Yingli Pharmaceutical, through the priority review and approval process, which is suitable for adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
On November 4, the application for omec amtiv mecarbil sustained-release tablets submitted by Mistar Pharmaceutical/Cytokinetics has been accepted for the treatment of heart failure with reduced ejection fraction (HFrEF); On November 3, the State Medical Products Administration approved the marketing of Class 1 innovative drug Toludi venlafaxine hydrochloride sustained-release tablets (trade name: Ruoxinlin) declared by Shandong Luye Pharmaceutical Co.
, Ltd.
.
.
The industry believes that from the current point of view, it can be seen that the enthusiasm of domestic pharmaceutical companies for innovation is very high
.
It is expected that with the continuous advancement of pharmaceutical innovation in the future, more achievements will appear, helping China's pharmaceutical innovation industry to achieve further development
.
={"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)]; 
