In recent years, under the background of policy support for innovation, enterprises increasing R&D, and introducing new drugs, more and more new drugs are being approved for marketing in China, and new breakthroughs have been achieved in many major disease areas to benefit more patients
.
It is reported that since November, a number of new drugs at home and abroad have been approved for marketing, involving anti-influenza, breast cancer and other fields
.
On November 22, the website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Roche submitted a marketing application for mabaloxavir dry suspension and was accepted
.
It is understood that mabaloxavir tablets were included in the list of urgently needed overseas new drugs in China and officially approved in China in April 2021 for the treatment of acute uncomplicated influenza patients aged 12 years and above, including patients
with a high risk of influenza complications.
The application of this dry suspension in China means that it is expected to bring more treatment options
to patients.
According to public information, mabaloxavir is a "first-in-class" single-dose oral drug, and it is also the first new anti-influenza drug
with an innovative mechanism of action approved by the US FDA in the past 20 years.
On November 21, according to the State Medical Products Administration, Tianjin Hongri Pharmaceutical's tosylamamide injection has been approved by the State Food and Drug Administration for the treatment
of central non-small cell lung cancer with severe airway obstruction.
According to reports, toluenesulfonamide injection is an innovative chemical drug for the treatment of solid tumors, highly selective for tumor cells, is the first approved transfiberobronchoscopic local injection of chemical ablation drugs in China, and is also the first indication to alleviate the severe airway obstruction in adult patients with central non-small cell lung cancer, filling the gap
of respiratory interventional drug treatment.
The drug was submitted for clinical application on November 21, 2003, and the marketing application was accepted by CDE in 2018, and finally approved for marketing after nearly 5 years of review
On November 9, according to the website of the National Medical Products Administration, linperlisib, trade name: Intarui) was conditionally approved by the State Food and Drug Administration for adult patients
with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
This is the first highly selective PI3Kδ inhibitor
approved for marketing in China.
The drug is developed by Shanghai Yingli Pharmaceutical, which made an equity investment of US$20 million (accounting for 6.
67% of the total share capital) in February 2021, and obtained the joint development rights and exclusive commercialization rights
of Linpliser in Greater China.
On November 9, according to Merck's website, its PD-1 inhibitor pembrolizumab (trade name: KEYTRUDA ®) has been approved by the National Medical Products Administration (NMPA) of China in combination with chemotherapy neoadjuvant therapy and continues pembrolizumab monotherapy after surgery for the treatment
of patients with early-stage high-risk triple-negative breast cancer (TNBC) with a well-validated test to evaluate tumors expressing PD-L1 (composite positive score (CPS) ≥20).
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.
According to public information, the antidepressant effect of toludi venlafaxine hydrochloride (ansufaxine hydrochloride sustained-release tablets, LY03005) may be related to
the enhancement of the 5-HT and NE effects of the central nervous system by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE).
The drug is an innovative drug independently developed and has independent intellectual property rights in China, which is suitable for the treatment
of depression.
In addition to a number of pharmaceutical companies announcing the approval of relevant products for marketing, many companies have said that some new drugs have been approved for clinical trials and drug registration certificates, which will further enrich the company's product line and enhance market competitiveness
in the future.
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