Chinese pharmaceutical companies have accelerated their overseas expansion, and a number of new drug clinical applications have been accepted by the FDA

【Pharmaceutical Network Industry News】With the improvement of the innovation and research and development capabilities of domestic pharmaceutical companies, domestic innovative drugs are accelerating their overseas expansion
.
Since 2022, a number of domestic new drugs have successfully rushed to the FDA, including the much-watched cedarchicel
.
At present, the overseas expansion of Chinese pharmaceutical companies continues to accelerate, and affected by this, it has recently been reported that a number of domestic new drug clinical trial applications have been accepted by the FDA
.
For example, GenScript Biotechnology announced that the US Food and Drug Administration ("FDA") has approved the clinical trial application (IND) of Legend Biologics to advance the clinical development
of LB2102.
LB2102 is an autologous chimeric antigen receptor T cell (CAR-T) therapy under investigation for the treatment of adult patients
with extensive-stage small cell lung cancer (SCLC).
LB2102 is designed to selectively target δ-like ligand 3 (DLL-3).

DLL-3 is a ligand
that is highly expressed in various malignancies such as SCLC, large cell neuroendocrine carcinoma (LCNEC), some neuroendocrine tumors, and some prostate cancers.
DLL-3 is also implicated
in tumor growth, migration, and invasion.
This Phase I, first-in-human, open-label clinical study aims to evaluate the safety and initial efficacy of LB2102 in patients with extensive-stage SCLC or LCNEC and to determine the recommended dose for Phase II Prior to this, Aosaicom also announced that the company's subsidiary, AskGene Pharma, Inc.
("AskGene"), recently received a "Notice of Acceptance" for the clinical trial application of ASKG915 for injection issued by the
FDA 。 It is reported that ASKG915 for injection is a PD-1/IL-15 bifunctional fusion protein 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 also the first antibody-cytokine fusion protein
incubated by the company's self-developed cytokine prodrug technology platform SmartKine®.
The drug is intended for the treatment of advanced solid tumors, which is expected to cover the existing cancers with poor efficacy of PD-1 monotherapy, and further fill the market gap
of anti-tumor immunotherapy.
If successfully approved by the FDA, it will further enrich the company's bioinnovative drug pipeline and enhance the company's market competitiveness
.
It is worth mentioning that Sinovac SHEN26 capsules also plan to submit a clinical application to the US Food and Drug Administration (FDA) in the near future, and has submitted a communication meeting application
on November 20.
The company is fully promoting the clinical research of SHEN26 project and the IND application of the FDA
.
At present, SHEN26 capsules have shown satisfactory safety and tolerability
in phase I trials.
In addition, the preparation of the phase II/III clinical study of SHEN26 project has been completed, including the selection of multiple clinical centers and the development of clinical protocols
.
The industry expects that in the next 5~10 years, with the advancement of domestic enterprises' technology and the advancement of existing product research and development and clinical progress, more drugs will be listed overseas, and overseas, especially in developed countries such as Europe and the United States, the strong ability to pay for innovative drugs may bring rich benefits to more Chinese pharmaceutical companies and create a new revenue growth curve
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.