Since December, a total of 8 drugs at home and abroad have been approved for marketing
.
As drugs become available, patients will have more drug options
.
Let's take a look at these 8 drugs
together.
On December 22, US time, Roche's Genentech announced that the US FDA has approved Lunsumio (mosunetuzumab) for the treatment of adult patients
with follicular lymphoma (FL) who have relapsed or refractory after two or more previous systemic treatments.
According to the data, Lunsumio is a T cell artigated bispecific antibody
that targets the CD20 antigen on the surface of B cells and the CD3 receptor on the surface of T cells.
It can guide T cells in the patient's body to migrate to the vicinity of target B cells and release cytotoxic proteins to destroy B cells
.
Lunsumio is administered in the form of intravenous infusion, the duration is fixed, allowing rest therapy, and it is also possible to infusion
in an outpatient setting.
On December 21, the European Union approved AstraZeneca (AZN.
US) and Merck (MRK.
US) Lynparza in combination with abiraterone and prednisolone in adult men
with metastatic castration-resistant prostate cancer who are not clinically suitable for chemotherapy.
The European Commission's approval of Lynparza (olaparib) is supported
by data from a Phase 3 clinical trial called PROpel.
Lynparza has been approved in the EU for the treatment of certain types of breast, ovarian, pancreatic and prostate cancer
.
Following Lynparza's approval in the EU, AstraZeneca will receive $105 million in regulatory milestone payments from Merck, which is expected to be recorded as cooperative revenue
by Merck in the fourth quarter of 2022.
On December 21, Merck announced that its antifungal drug Nokofi (posaconazole) injection dosage form was officially launched in China for the prevention of invasive Aspergillus and Candida infections and the treatment of invasive aspergillosis
.
So far, the three dosage forms of Nokofi oral suspension, enteric-coated tablets and injection have been approved for marketing
in China.
Posaconazole oral suspension can be used to prevent invasive Aspergillus and Candida infections and treat oropharyngeal candidiasis, posaconazole enteric-coated tablets and posaconazole injection can be used to prevent invasive Aspergillus and Candida infections and treat invasive aspergillosis
.
On December 19, Atara Biotherapeutics and Pierre Fabre jointly announced that the European Commission (EC) has granted marketing authorization to Ebvallo (tabelecleucel) as a monotherapy for the treatment of adults and children older than 2 years of age with relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disease (EBV+PTLD) who have received at least one prior treatment
。
According to the data, Ebvallo (tabelecleucel) is an allogeneic T cell immunotherapy that targets and eliminates EBV-infected cells
in a human leukocyte antigen (HLA)-defined manner.
It has been recognized as a breakthrough therapy by the FDA and PRIME status
by the EMA.
Ferring Pharmaceuticals announced December 16 that the FDA has approved the gene therapy nadofaragene firadenovec-vncg (trade name Adstiladrin) for the treatment of adult patients
with high-risk BCG (BCG) non-responsive non-muscle-invasive bladder cancer (NMIBC) with or without concomitant tumors.
Adstiladrin (nadofaragene firadenovec-VNCG) is a gene therapy used to treat adult patients
with BCG non-responsive NMIBC.
It is a gene therapy based on a non-replicating adenovirus vector containing the gene interferon α-2b, which enters the bladder through a catheter every
three months.
The vector enters the cells of the bladder wall, releasing active genes to do its job
.
On December 16, AbbVie announced that the FDA had approved Vraylar (cariprazine, cariprazine) as an adjunct therapy
for adult major depressive disorder (MDD).
According to the data, cariprazine is an oral, once-daily atypical antipsychotic jointly developed by AbbVie and Gedeon Richter Plc, which was first approved for marketing in September 2015 for the treatment of adult type I bipolar disorder (bipolar depression), manic episodes associated with type I bipolar disorder, and adult schizophrenia
.
The State Food and Drug Administration showed on December 8 that the marketing application of nacetumab injection declared by SciClone Pharmaceutical has been approved
.
The approved indication is for the treatment of patients
with relapsed or refractory high-risk neuroblastoma.
Data show that nacetumab is a humanized monoclonal antibody targeting ganglioside GD2, which can cause antibody-mediated cytotoxic reactions and activate the complement system by binding to GD2 on the surface of tumor cells, thereby achieving the effect
of killing tumors.
Nacetumab was approved for marketing in the US in November 2020 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in children (1 year of age and older) and adults with relapsed/refractory high-risk neuroblastoma who previously presented with partial response, mild remission, or stable disease
.
On December 8, the generic drug of etiban acetate injection of Haosen Pharmaceutical was approved by the State Food and Drug Administration for acute onset
of hereditary angioedema.
This is the first approved generic drug
of etiban in China.
According to the data, etibande is a powerful selective bradykinin B2 receptor and antagonist, and etibant treats the embolic local swelling of acute HAE by inhibiting the effect of bradykinin related to local swelling
, inflammation and pain symptoms of HAE.
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