In recent years, with the introduction and landing of a series of policy documents such as encouraging drug innovation to implement priority review and approval, while China's innovative drug industry is booming, the efficiency of drug review and approval is also constantly improving
.
Since the beginning of this year, 27 varieties have been included in the priority review list
.
It is worth noting that the CDE website recently shows that there are new actions in priority review, and 4 varieties are included in the public announcement
of varieties to be prioritized for review.
Among them, the reason for the preferential review of acetaminophen suppositories of Zhejiang Erbao Pharmaceutical and the caraglutamic acid tablets of Yuanda Pharmaceutical (China) is the new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics
of children.
Acetaminophen suppositories are symptomatic treatment of mild to moderate pain and/or fever and are indicated for infants
weighing more than 3 kg.
According to data from the intranet, more than 20 companies have production approvals for acetaminophen suppositories, but no companies have been evaluated
.
At present, only Zhejiang Erbao drugs are under review with imitation 3 types of birth, and it is expected to win the first evaluation
.
Caraglutamate tablets are used for hyperammonemia caused by N-acetylglutamate synthase deficiency, hyperamoniaemia caused by isovalerycinemia, hyperamoniaemia caused by methylmalonic acidemia, hyperamoniaemia caused by propionic acidemia
.
Caragutine original products were developed by Orphan Europe and have been approved overseas for the maintenance treatment of acute hyperammonemia and chronic hyperammonemia caused by NAGS deficiency
.
At present, only Broad Pharmaceutical (China) in China is under review for imitation of 3 types of production, and is expected to become the first approved enterprise
in China.
Zhejiang Pharmaceutical Science and Technology Development Co.
, Ltd.
's glycerol phenylbutyrate oral solution, which was announced on August 15 for priority review, is suitable for the long-term treatment
of patients with urea circulatory disorders (UCDs) that cannot be controlled by restricting protein intake and/or simply supplementing amino acids.
UCDs are a rare and life-threatening condition that manifests as hyperammonemia in the neonatal period or later, which can lead to severe neurocognitive decline, coma, and even death
if the patient is not treated in time.
Sanofi China's α of ive glucosidase for injection was approved by CDE on August 15 as a priority review variety for long-term enzyme replacement therapy
in patients with Pompe disease (acidic α glucosidase [GAA] deficiency).
Pompeii disease is a rare progressive neuromuscular disease, while ev glucosidase α is a highly effective enzyme replacement therapy that targets 6-phosphate mannose (M6P) receptors, thereby improving gaA delivery
to muscle cells.
In August 2021, the product was approved by the FDA for the treatment of late-onset Pompeii disease in patients aged 1 year and older; It was approved for listing
in Europe in June this year.
Industry analysts believe that the review of new drugs in China has accelerated, and the number of new highs has been continuously created, mainly benefiting from favorable policies
.
It is understood that in order to encourage the drug research and development of innovative drugs, meet the unmet clinical drug needs, and accelerate the review and approval speed of innovative drug species, in 2022, China has promulgated a number of relevant policies to encourage innovation, such as the interpretation of the "14th Five-Year Plan" Pharmaceutical Industry Development Plan, the "Drug Review Center to Accelerate the Review of Innovative Drug Listing Applications (Trial) (Draft for Comments)", etc
.
In this context, the industry expects that the development of innovative drugs will continue to heat up, and more innovative drugs will also accelerate the market
.
