With the acceleration of new drug review and approval and the continuous improvement of the domestic new drug research and development environment, local pharmaceutical companies are working hard to develop new drugs and new indications
.
Recently, a number of local pharmaceutical companies announced on the same day that drug clinical trials have been approved at home and abroad, involving Aosaicom and Enhua Pharmaceutical
.
Osaicon
Aosaikon announced on December 19 that AskGene Pharma, Inc.
, a subsidiary of the company, recently received a clinical trial approval notice for ASKG915 for injection issued by the U.
S.
Food and Drug Administration ("U.
S
.
FDA").
According to the data, ASKG915 for injection is a PD-1 antibody/IL-15 prodrug bifunctional fusion molecule with independent intellectual property rights, which is a biological innovative drug independently developed by the company and has international independent intellectual property rights, and is the first antibody-cytokine fusion protein
incubated by the company's prodrug technology platform SmartKine®.
According to the announcement, according to the legal and regulatory requirements related to registration in the United States, the drug has been reviewed and approved by the US Food and Drug Administration (FDA) and can carry out clinical trials in the United States, and if the clinical results are positive, it will further enrich the bioinnovative drug pipeline of Aosaicom and enhance the company's market competitiveness
.
Enhua Pharmaceutical
On December 19, Enhua Pharmaceutical announced that it had recently received the "Drug Clinical Trial Approval Notice" for Class 1 chemical NH130 citrate tablets approved and issued by the National Medical Products Administration, and will carry out clinical trials in the near future, and the indication applied for is intended for the treatment of Parkinson's disease psychiatric (PDP).
Enhua Pharma's NH130 citrate is a potent 5-HT2A receptor reverse agonist, and preclinical test results show that NH130 citrate is effective in animal models of PDP without affecting motor function
.
At the same time, adverse reactions such as cardiotoxicity and phospholipid deposition are small, the safety window is large, and it has good pharmacokinetic properties
.
Up to now, Enhua Pharmaceutical's NH130 project has invested a total of about 13 million
yuan in R&D expenses.
The industry believes that the emergence of NH130 citrate has made up for the gap in the field of PDP treatment, and if it can be successfully listed, it will bring a new treatment plan
to patients.
Rico Biotech
On December 19, Rico Biotech announced that the new adjuvant recombinant herpes zoster vaccine REC610 has been approved
for clinical trials by the Philippine National Food and Drug Administration.
REC610 is equipped with a novel adjuvant BFA01 independently developed by Rico Biologics, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies
.
The study was a randomized, observer-blind, GlaxoSmithKline Shingrix-active-controlled Phase I clinical trial to evaluate the safety and immunogenicity
of REC610 in healthy adult subjects 40 years of age and older.
epilogue
Since 2022, a large number of new drugs and good drugs under development have emerged in the domestic drug market, and the progress of drugs has been continuous
.
Incomplete statistics show that more than 50 new drugs have been approved for marketing during the year, involving anti-tumor drugs and rare disease drugs
.
The industry expects that with the continuous development of domestic pharmaceutical innovation and the continuous advancement of clinical trials, the domestic innovative drug industry will accelerate into the harvest period
.
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