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According to PDUFA's expected target date, it is expected that in November, the US FDA will make a regulatory decision
on the approval of 3 innovative drugs.
If the approval process is faster, another innovative drug is expected to be approved
in November.
▲New drug expected to be approved in the United States in November (WuXi AppTec content team map)
▲New drug expected to be approved in the United States in November (WuXi AppTec content team map)Name of the drug: Teplizumab
Name of the drug: TeplizumabCompany name: Provention Bio
Company name: Provention BioIndications: Type 1 diabetes mellitus
Indications: Type 1 diabetes mellitusProvention
Bio's teplizumab is a monoclonal antibody drug that targets CD3 antigens on the surface of T cells, which can weaken the autoimmune attack on islets β cells, thereby protecting β cells from destruction, thereby preventing or delaying the onset
of type 1 diabetes.
For people who are genetically susceptible to type 1 diabetes, the disease has begun to develop before the appearance of obvious symptoms of hyperglycemia, mainly manifested as the appearance of autoantibodies (anti-insulin and anti-pancreatic antibodies, etc.
) and abnormal
glucose tolerance.
During this time, β cells in the pancreas remain largely intact, providing a vital window
to intervene and preserve β cells.
Currently, there is a lack of ways to
prevent the onset of type 1 diabetes in high-risk groups.
FDA received teplizumab's Application for Biological Product Licensing (BLA) with a PDUFA date set for November 17
, 2022.
If approved, it would be the first therapy
to change the course of type 1 diabetes.
Previously, the FDA had granted Teplizumab breakthrough therapy designation
.
Phase 2 clinical results show that teplizumab can delay the onset of type 1 diabetes by 2 years or more
.
The median time to diagnosis of type 1 diabetes in the Teplizumab group was 48.
4 months, compared with 24.
4 months
in the placebo group.
Teplizumab was statistically shown to reduce the risk of developing type 1 diabetes by 59% (HR = 0.
41;
95% CI, 0.
22 - 0.
78;
P=0.
006), the results of this trial were published in the New England Journal of Medicine
.
In early October, Sanofi obtained co-commercialization rights for
the drug.
Drug name: Etranacogene dezaparvovec
Drug name: Etranacogene dezaparvovecCompany name: CSL Behring/uniQure
Company Name: CSL Behring/uniQureCSL Behring/Indications: Hemophilia B
Indications: Hemophilia Betranacogene by CSL Behring/uniQure
Dezaparvovec is a gene therapy designed to deliver transgenes
expressing a variant of coagulation factor IX (FIX) Padua using an AAV5 vector.
This FIX variant has higher FIX activity, meaning normal clotting can
be done at lower expression levels.
Hemophilia B is a life-threatening degenerative disease in which patients have a mutation in the gene encoding FIX, resulting in a FIX deletion or defect.
Patients with the condition are prone to bleeding from joints, muscles, and internal organs, resulting in pain, swelling, and joint damage
.
Current treatment includes lifelong prophylactic FIX transfusions to temporarily replace or replace low levels of clotting factors
.
The FDA received the drug's BLA at the end of May this year and granted it priority review status, with the PDUFA date set for November 24
, 2022.
If approved, it would be the first gene therapy
to treat hemophilia B.
This BLA is based on the results
of the Phase 3 clinical trial HOPE-B.
The results of the trial showed that the annual bleeding rate (ABR) of patients treated with one-time gene therapy was reduced by 64% (p=0.
0002)
after 18 months of treatment compared with the lead-in period before treatment.
It is worth mentioning that this trial is the first to study the efficacy
of this gene therapy in patients who carry adeno-associated virus neutralizing antibodies in their bodies.
The results of the trial showed that no evidence
of neutralizing antibodies affecting FIX activity was found in patients with a neutralizing antibody titer of up to 678.
2.
。 After 18 months of treatment, the annual bleeding rate (ABR) was reduced by 64% compared with the lead-in period before treatment (p=0.
0002)
Drug name: Mirvetuximab soravtansine
Drug name: Mirvetuximab soravtansineCompany name: ImmunoGen
Company name: ImmunoGenIndications: Advanced ovarian cancer
Indications: Advanced ovarian cancerImmunoGen's mirvetuximab
Soravtansine is an antibody-conjugated drug (ADC)
that targets folate receptor α (FRα).
FRα is a member of the folate receptor family, and studies have shown that FRα is highly expressed
in 76-89% of epithelial ovarian cancers and 35-68% of triple-negative breast cancers.
FRα-mediated signaling pathways can affect tumor cell division and migration, and inhibition of FRα may produce a certain degree of direct anticancer activity
.
Of all the gynaecological cancers, ovarian cancer is one
of the deadlier.
Due to the lack of specific symptoms, most patients are already at an advanced stage (stage III or IV) when they are diagnosed
.
The FDA received the drug's BLA at the end of May this year and granted it priority review status, with the PDUFA date set for November 28, 2022
。 This BLA is based on results from a Phase 3 clinical trial SORAYA, which showed that patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRα received mirvetuximab
With soravtansine administration with a median follow-up of 8.
1 months, patients achieved an objective response rate (ORR) of 32.
4% (95%
CI: 23.
6%, 42.
2%), including 5 complete remissions (CR).
It is worth mentioning that in October 2020, Huadong Pharmaceutical obtained the exclusive development and commercialization rights
of the drug in Greater China for more than 300 million US dollars.
Name of the drug: Adagrasib
Name of the drug: AdagrasibCompany name: Mirati Therapeutics
Company name: Mirati TherapeuticsIndications: Non-small cell lung cancer
Indications: Non-small cell lung cancerMirati Therapeutics' adagrasib is a highly specific powerful oral KRAS
G12C inhibitor optimized for long-lasting target inhibition
.
Adagrasib has a half-life of up to 24 hours and a wide tissue distribution, and is able to cross the blood-brain barrier, helping to maximize the drug's potency
.
Studies have shown that KRAS mutations and wild-type KRAS amplification are frequently seen
in patients with colorectal cancer (~45% in the US, ~49% in China), pancreatic cancer (~90% in the US, ~87% in China), and non-small cell lung cancer (NSCLC, ~35% in the US, ~13% in China).
Among them, KRAS
G12C is the most common KRAS mutation in patients with NSCLC, occurring in 14% of lung adenocarcinomas, and patients generally have a poor
prognosis.
The FDA received a New Drug Application (NDA) for the drug in early February of this year, with the PDUFA date set for December 14
, 2022.
The NDA application uses the FDA's real-time oncology review (RTOR) pilot program, which means the drug could be approved
as early as November.
This NDA is based on cohort results
from the Phase 2 clinical trial KRYSTAL-1.
While carrying KRAS
In patients with advanced NSCLC with G12C mutations, adagrasib achieved an objective response rate (ORR) of 43% and a disease control rate (DCR)
of 80%.
Previously, the drug was granted breakthrough therapy designation
by the US FDA.
In China, Zai Lab has rights to develop this innovative therapy in Greater China
.
The query of the drug clinical trial registration and information disclosure platform shows that the drug is used in KRAS in China
Clinical trials in NSCLC patients with G12C mutations have entered the phase 3 clinical trial stage
up to phase 3.
to develop this innovative therapy in Greater China.
