Since September, a large number of domestic pharmaceutical companies have been approved for clinical trials of new drugs

【Pharmaceutical Network Industry Dynamics】The core of building product competitiveness is innovation and upgrading, and at present, with the tide of innovation sweeping the pharmaceutical industry, a large number of domestic pharmaceutical companies independently developed new drug clinical trials have begun to be approved
.

Recently, Suzhou Xingyao Kunze Biopharmaceutical Co.
, Ltd.
(hereinafter referred to as Xingyao Kunze), a liver disease treatment innovation platform company incubated by Fosun Pharma's Rehabilitation Capital New Drug Innovation Fund, announced that the clinical trial application (IND) of Xingyao Kunze's pilot product HT-101 injection for the treatment of chronic hepatitis B virus infection (CHB) has been approved by the Drug Evaluation Center (CDE) of
the State Drug Administration.

According to the data, HT-101, a GalNAc-coupled siRNA innovative drug entity, will become the first GalNAc-coupled siRNA hepatitis B product
in China to enter the clinical stage.

In the field of hepatitis B, in addition to HT-101, Xingyao Kunze also laid out the neutralizing antibody HT-102
against the hepatitis B S antigen.

On September 25, GST-HG171, an oral anti-COVID-19 drug project developed by Guangsheng Zhonglin, a holding subsidiary of Guangshengtang, a listed company, was approved by the National Drug Review Center and officially entered the clinical trial stage
.

Guangsheng Zhonglin is an innovative drug platform of Guangshengtang, focusing on liver disease and antiviral fields, GST-HG171 molecule developed for the new crown virus is a highly active, highly selective oral 3CL protease inhibitor, which has shown excellent antiviral efficacy and safety
in preclinical studies.

On September 19, Hengrui Pharmaceutical announced that its subsidiary, Shanghai Hengrui Pharmaceutical Co.
, Ltd.
, received the "Notice of Approval of Drug Clinical Trial" on SHR-A2102 injection approved by the State Food and Drug Administration, and will carry out clinical trials
in the near future.

SHR-A2102 binds to the target antigen on the surface of tumor cells, so that the drug is endocytosized into the cells and releases small molecule toxins to kill tumor cells, and is clinically intended for the treatment
of malignant tumors.

After inquiry, at present, no similar products in China have been approved for listing, and there is no relevant sales data
.

Up to now, SHR-A2102 injection related projects have invested a total of about 26.
2 million yuan in research and development costs.


On September 14, Buchang Pharmaceutical announced that its holding subsidiary, Sichuan Luzhou Buchang Biopharmaceutical Co.
, Ltd.
, recently received the "Drug Clinical Trial Approval Notice"
on BC008-1A injection approved by the State Drug Administration.

According to the data, BC008-1A injection (recombinant anti-PD-1/TIGIT humanized bispecific antibody injection) is a specific dual antibody drug targeting PD-1 and TIGIT, which can directly block the PD-1 and TIGIT signaling pathways to lift the inhibition of T lymphocytes, thereby facilitating the activation of T cells and enhancing immune monitoring, identification and killing of tumor cells.
Simultaneously block the potential synergistic effects that PD-1 and TIGIT may have to enhance the anti-tumor effect
.

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In general, clinical trials are a very important part of the development of new drugs, and they are also an indispensable part
of each new drug before it is approved for production and put on the market.

The industry expects that with the high enthusiasm for new drug research and development at home and abroad, the increasing investment in research and development of pharmaceutical companies, and the acceleration of new drug review and approval, a large number of domestic new drugs will gradually enter the clinical trial stage and accelerate the listing
.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.