Domestic innovative drugs are speeding up their overseas expansion! Another application for clinical trials of new drugs was accepted by the FDA

【Pharmaceutical Network Product Information】In recent years, with the improvement of the innovation and research and development capabilities of domestic pharmaceutical enterprises, domestic innovative drugs are accelerating their overseas expansion
.
In 2021, a total of 8 innovative drug marketing applications were accepted
by the US FDA.
In 2022, there are also a number of domestic new drugs rushing to the FDA, including the much-watched cedarquiolence, which is used to treat relapsed/refractory multiple myeloma (MM) in adults, the first FDA-approved cell therapy product in China, and the world's second CAR-T cell immunotherapy
approved for BCMA.
In addition, since the beginning of this year, it has continued to be reported that
the clinical trial application of domestic drugs has been accepted by the US FDA.
Just recently, Shu Taishen issued an announcement that the company received a notice from the US Food and Drug Administration (FDA) to accept the new drug clinical trial application
of STSA-1002 subcutaneous injection for ANCA-associated vasculitis indications 。 It is reported that STSA-1002 is a recombinant anti-human C5aIgG1 fully human monoclonal antibody targeting C5a, which makes C5a lose the ability to bind to receptors by specifically binding to the allergic toxin C5a, blocking C5a-induced biological functions, such as neutrophil chemotaxis, degranulation and oxygen respiration burst, etc.
, while not affecting C5 lysis and the formation of membrane attack complexes (MAC), and retaining the bacteriolytic and bactericidal functions
of the complement system 。 According to the company's online investor briefing held in April, the product is mainly deployed for COVID-19 treatment, with a double report between China and the United States, and was approved by the US FDA in July 2021, and the clinical trial application for new drugs has been accepted by the FDA; In China, Shutaishen obtained clinical approval for STSA-1002 in September 2021, and the company announced on July 27 this year that the State Food and Drug Administration agreed to accept the clinical trial application for the combination of STSA-1002 injection and STSA-1005 injection for the treatment of severe and critical novel coronavirus pneumonia, and obtained the "Drug Clinical Trial Approval Notice"
issued by the State Medical Products Administration on September 27 。 In addition to STSA-1002, since the beginning of this year, there have been a number of domestic new drug clinical trial applications accepted by the US FDA, which witnesses the continuous rise
of domestic new drug strength.
For example, on February 16, China Antibody Pharmaceutical announced that the company had submitted a new drug clinical trial application (IND) for the anti-IL-17RB monoclonal antibody SM17 to the US FDA, and had been accepted by the FDA for the development of asthma.

SM17 is a potential "first-in-class" humanized anti-IL-17RB monoclonal antibody
developed by the company.
IL-17RB is a type I monotransmembrane glycoprotein belonging to the IL-17 receptor family, and SM17 is a humanized Ig G4-κ monoclonal antibody
targeting IL-17RB.
In January this year, Chengdu Pilot also announced that its self-developed class 1.
1 anti-tumor innovative drug HG030 project clinical trial application (IND) has recently been approved
by the US FDA.
HG030 is a second-generation oral small molecule inhibitor of tropomyosin receptor kinase (Trk), which is clinically intended for the first-line treatment of NTRK or ROS1 gene fusion tumors, and can also be used in patients
with solid tumors resistant to first-generation drugs with acquired mutations.
In China, HG030 has been approved
for phase I clinical trial by the China National Medical Products Administration (NMPA) on March 25, 2020.
Capital Securities expects that in the next 5~10 years, with the advancement of domestic enterprise technology and the advancement of existing product research and development and clinical progress, more domestic drugs will be listed overseas, and the strong ability to pay for innovative drugs overseas, especially in developed countries such as Europe and the United States, can bring rich benefits to the company and create a new revenue growth curve
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.