Recently, the news of a large number of drugs and devices being approved is continuing to come

According to the data of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, a number of clinical trials and marketing applications of drugs and medical devices were approved
on October 31.
Specifically, on October 31, lacosamide tablets from Shanghai Shanghai Shanghai Pharmaceutical First Biochemical Pharmaceutical Co.
, Ltd.
, a wholly-owned subsidiary of Shanghai Pharmaceutical Bulletin Company, received the "Drug Registration Certificate" (certificate number: 2022S00963) issued by the State Medical Products Administration, and the drug was approved for production
.
According to public information, lacosamide tablets are mainly used for monotherapy and combination therapy
for partial seizures in patients with epilepsy aged 4 years and older.
The drug was developed by UCBPharmaSA and launched in
Europe in 2008.
In January 2021, Shanghai First Biochemical submitted a registration and marketing application to the State Food and Drug Administration for the drug and was accepted
.
As of the disclosure date of this announcement, the company has invested approximately RMB10 million in R&D expenses for the drug
.
Broncus Medical announced on the Hong Kong Stock Exchange that the company's innovative product "Wuquan ™" disposable endoscopic atomization microcatheter in the field of drug-device combination was officially approved for marketing
by the Zhejiang Provincial Drug Administration.
The product is an atomized microcatheter approved in China so far, with a number of patented technologies, wide indications, can be adapted to a variety of drugs, and opens up a wide range of drug-device combination application scenarios
in the field of lung disease treatment.
The product is used in conjunction with an endoscope, guided by a navigation system, to reach the lesion precisely for lavage, spraying or contrast media
.
Thermo Fisher Scientific also announced on the 1st that it has reached a definitive agreement to acquire diagnostic technology company The Binding Site Group from a shareholder group led by European private equity firm Nordic Capital, with an all-cash transaction value of £2.
25 billion, or $2.
6 billion
at current exchange rates.
The Binding Site serves clinicians and laboratory professionals worldwide, providing specialized diagnostic assays and instrumentation to improve the diagnosis and management
of blood cancers and immune system disorders.
It is understood that in fact, with the continuous rise of enthusiasm for new drug research and development at home and abroad, the continuous increase in R&D investment of pharmaceutical companies, and the acceleration of review and approval, a large number of new drugs and devices at home and abroad are entering the clinical and marketing stages
in China.
For example, from October 24 to 28, a number of Class 1 innovative drug clinical trials applied for "implied permission"
.
Including INCYTE's INCB000928 tablets, Luye Pharmaceutical's BA2101 injection, Junshi Biologics' JS015 injection, etc.
, these drugs target indications include progressive ossifying fibroplasia, postpartum depression, atopic dermatitis, tumors, type 2 diabetes, etc
.
In general, under the background of continuous deepening of medical reform and continuous expansion of centralized procurement, the pharmaceutical market environment has changed, and the core of the current pharmaceutical companies to build product competitiveness is innovation and upgrading
.
In the future, the industry expects that with the acceleration of transformation and upgrading of domestic pharmaceutical companies and the advancement of clinical trials of many products, more products will be accelerated to market, and post-market sales are expected to increase rapidly
.
At the same time, the competitiveness of domestic new drugs and medical devices will also be further improved
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.