This week, a number of domestic new drug clinical trial applications were approved by the FDA!

Clinical trial is a very important part of new drug research and development, and it is also an indispensable link
for each new drug before it is approved for production and put on the market.
At present, with the acceleration of domestic innovative drugs going abroad, more and more
domestic new drugs are carrying out clinical research overseas.
For example, this week, three new drug clinical trial applications have been accepted
by the FDA.
Simcere Pharmaceutical SIM0237 Injection On October 27, Simcere Pharmaceutical announced that the Group's self-developed anti-PD-L1/IL-15 bispecific antibody SIM0237 injection new drug clinical trial application (IND) has been approved by the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic solid tumors
。 SIM0237 is an anti-PD-L1 monoclonal antibody and IL-15/IL-15Rα fusion protein developed based on the group's own protein engineering technology platform, which can block the PD1/PD-L1 immunosuppressive pathway by binding PD-L1, and activate the immune system through IL-15, thereby playing a dual synergistic effect of eliminating immunosuppression and activating the immune system, and exerting anti-tumor effects
.
It is understood that on October 10, 2022, SIM0237 has been accepted
by the China National Medical Products Administration in China's IND.
Ascletis ASC10 On October 26, Ascletis announced on the Hong Kong Stock Exchange that it has submitted an application
for a new drug clinical trial (IND) for ASC10, an oral inhibitor candidate for monkeypox virus polymerase, to the US Food and Drug Administration (FDA).
Preclinical studies have shown that ASC10 has potent antiviral activity
against monkeypox virus and novel coronavirus.
In August 2022, the US Food and Drug Administration (FDA) has approved the ASC10 New Coronavirus Infection Indication New Drug Clinical Trial Application (IND), and the submission of the ASC10 monkeypox indication new drug clinical trial application in the United States will further broaden the layout
of Ascletis viral disease pipeline.
Shutaishen STSA-1002 subcutaneous injection On October 24, Shutaishen announced that the company received a notice from the US Food and Drug Administration (FDA) to accept the application for a new drug clinical trial of
STSA-1002 subcutaneous injection for ANCA-associated vasculitis 。 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 bursts
.
Conclusion In general, with the high enthusiasm for domestic new drug research and development, the continuous increase in R&D investment of pharmaceutical companies, and the acceleration of new drug review and approval, a large number of domestic new drugs will enter the clinical trial stage in the future and accelerate their listing
.
However, it should be noted that new drug research and development is often characterized by high R&D investment and long R&D cycle, and in recent years, pharmaceutical companies have had many cases
of clinical failure.
In this regard, the industry suggests that relevant enterprises should attach importance to the development and clinical application of basic research to new drugs, and actively use high-quality big data and artificial intelligence to mine reliable biomarkers related to disease prevention, diagnosis and treatment to reduce the risk of
new drug research and development failure.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.