This week's 45 innovative drugs have new progress!

According to Insight database statistics, this week (4.

Chemical drugs still account for the majority (25/45), but this week, gene therapy (3) has become the second after chemical drugs, and 3 projects have progressed to a new stage; 2 projects of oncolytic virus have also been launched this week.

The progress distribution of innovative drugs that have changed this week

From: Insight database project progress visualization (http://db.

Zhaoke Pharmaceutical's introduction of new anti-tumor drugs was approved for marketing

On Thursday, the NMPA issued an approval document for the new drug Procarbazine Hydrochloride Capsules introduced by Zhaoke Pharmaceuticals

Procarbazine Hydrochloride was originally developed by Roche and was approved for marketing overseas in 1969, produced by Leadiant Biosciences (formerly Sigma-Tau)

14 new drugs start clinical trials for the first time

1.

Ibrexafungerp, the first fourth-generation antifungal drug with a novel mechanism of action in more than 20 years, was approved by the FDA in June 2021 for the treatment of fungal vaginitis

In February 2021, Hansoh Pharma acquired the development, regulatory approval and commercialization rights of Ibrexafungerp in China for an upfront payment of US$10 million + potential milestones and royalties

HS-10366 Project Overview

From: Insight database project progress (http://db.

HS-10381 was first approved for clinical use in October 2021, and its target has not yet been disclosed

From: Insight database project progress (http://db.

In addition, the research and development of innovative drugs by Hansoh Pharma is accelerating.

From: CDE official website

2.

Novartis has high hopes for zevezumab

According to the Insight database, Zevecimab is currently in Phase III clinical development globally, and China registered Phase I clinical trials at CDE for the first time this week, targeting patients with chronic kidney disease complicated by systemic inflammation
.

Global indication development progress of zevezumab

From: Insight Database Global New Drugs (http://db.
dxy.
cn/v5/home/)

3.
CSPC's new crown mRNA vaccine starts clinical trials

On April 3, CSPC announced that the mRNA vaccine SYS6006 against the new crown was approved for clinical use
.
It is reported that within this week, CSPC has rapidly advanced the project and launched corresponding clinical trials
.

According to official information, SYS6006 is designed with targeted antigen mutations according to the prevalence of the strain.
Preclinical studies have shown that this product has good immune protection efficacy against the current mainstream mutant strains including Omicron and Delta ; through humoral immunity and Cellular immunity provides immune protection to the body and can generate memory B cells to provide long-term protection
.
In addition, the preclinical safety evaluation data also fully proved the safety of the product
.

The product uses advanced production technology, the process is highly controllable, the batch-to-batch consistency is good, and it is easy to achieve scale-up and industrialization; and it has good stability and can be stored at 2-8 °C for a long time
.
CSPC has realized the internalized production and localized substitution of key production raw materials and excipients for mRNA technology, which can meet the demand for large-scale production capacity supply
.

Based on the advantages in safety, efficacy and industrialization, and according to the needs of epidemic prevention and control, the product was included in the special approval procedure by the State Drug Administration and was quickly approved for clinical use
.
CSPC said that with mRNA vaccines as the forerunner, it will continue to deploy other vaccine products and chronic disease products in the field of small nucleic acids
.

3 Gene Therapies Made New Progress This Week

According to the Insight database, a total of 3 gene therapies have made new progress this week, including 2 clinically approved and 1 clinically launched, all of which are gene therapy drugs based on AAV vectors
.

Gene therapy with changes in domestic progress this week

From: Insight database project progress (http://db.
dxy.
cn/v5/home/)

E10B (recombinant human gamma-interferon adenovirus injection) is the second adenovirus vector antitumor drug independently developed by Guangzhou Dubo Bio.
prostate cancer patients
.
E10B has the functions of directly killing tumor cells, inhibiting tumor cell proliferation, inhibiting tumor angiogenesis, and inducing the secretion of cytokines such as tumor necrosis factor.
active target protein, thereby playing a therapeutic role
.

According to the Insight database, its Phase I clinical trial was launched for the first time on April 20, and it plans to recruit 30 people in China
.

From: Insight database clinical trials (http://db.
dxy.
cn/v5/home/)

LX101 ophthalmic injection was developed by Shanghai Longxin Qisheng (Longxin Bio) Biopharmaceutical Co.
, Ltd.
for the treatment of patients with RPE65 biallelic mutation-related hereditary retinal degeneration (IRD)
.
Inherited retinal degeneration caused by biallelic mutations in RPE65 belongs to congenital amaurosis (LCA) type 2, and most patients in this group develop severe visual impairment in infancy or childhood, and due to progressive retinal degeneration, in 30 years.
- Completely blind at age 40
.

LX101 is the first new gene therapy drug for congenital amaurosis to submit a clinical application in China, and the IND application was approved by CDE on April 19
.
Previously, in June 2021, Luxin Bio has launched the first clinical study of gene therapy for LCA in China initiated by researchers.
Public information shows that LX101 has good safety and has seen improvement in vision in many patients.
curative effect
.

From: Insight database project progress (http://db.
dxy.
cn/v5/home/)

VGB-R04 is the first AAV gene therapy product independently developed by Tianze Yuntai for the treatment of hemophilia
B.
Following intravenous injection of VGB-R04, the VGB-R04 expression cassette was delivered to the nucleus via AAV capsid protein-mediated transduction of hepatocytes
.
The VGB-R04 expression cassette exists in the form of cell-free DNA and expresses the highly active natural variant of factor IX (hFIX Padua) protein in liver cells
.
The liver-expressed and secreted hFIX Padua protein acts to replace the missing congenital coagulation factor IX, thereby correcting coagulation disorders in hemophilia B patients
.