Sinovac Pharmaceutical's new crown oral drug research and development is racing against time SHEN26 into phase II clinical trials

After the beginning of winter, the new crown epidemic began to spread in various places again, and many families will buy and stock up on some drugs
that can be used for new crown treatment.
The twenty measures for epidemic prevention and control introduced not long ago also mentioned the need to accelerate the reserve
of drugs related to the treatment of new crown pneumonia.
Some studies believe that the new crown small molecule oral drug will be one of the
important guarantees for future epidemic prevention and control.

At present, among the new crown drugs listed in China, there are only 2 small molecule drugs
.
According to incomplete statistics, as of November 23, 2022, 20 listed companies in the A-share market are developing anti-new crown specific drugs, a total of 26 drugs, but most of them are still in the preclinical or phase I stage
.
In the face of the global epidemic and the adjustment of domestic epidemic prevention policies, these companies with new crown drug pipelines have also attracted attention
from all parties.

On the 24th, Sinovac Pharmaceutical (688136.
SH), an A-share listed company, announced that its phase II clinical research protocol of SHEN26 capsules, a small molecule oral drug of the new crown, was approved by the medical ethics committee of Shenzhen Third People's Hospital
, the team leader.
This marks the full launch
of the phase II clinical study of SHEN26 capsules.
As soon as the news came out, Sinovac Pharmaceutical's stock price soared
all the way that day.

In addition to the refresh of the research progress to make investors happy, the product advantages of SHEN26 capsules themselves are also the reasons
for external attention and optimism.
As the two mainstream targets of the current new crown drug market - RdRp and 3CL, the safety, efficacy and drug resistance of the two classes of drugs have attracted the most attention
.

SHEN26 capsule is a broad-spectrum RNA-dependent RNA polymerase (RdRp) inhibitor with a mechanism of action consistent with
Remdesivir, one of the mainstream anti-coronavirus drugs currently on the market.
According to laboratory data, SHEN26 capsules have efficient in vitro inhibitory activity against different new coronavirus variants (wild strain, Alpha, Beta, Delta, Omicron), and the oral administration method is more convenient
in treatment.

In terms of safety testing, SHEN26 capsules have a low risk of off-target side effects, teratogenic, mutagenic and other research results are negative, with a high therapeutic index and good safety
.
In a Phase I clinical study, SHEN26 capsules have been shown to have a better safety profile
.

In terms of drug resistance, the analysis of relevant research papers in Nature found that RNA polymerase inhibitors represented by remdesivir maintained good activity against some strains resistant to 3CL protease inhibitors and had good development value
.
At the same time, there are also studies that suggest that the combination therapy of RNA polymerase inhibitors and 3CL protease inhibitors may be the future trend
.

At present, the new crown virus diagnosed patients are mainly mild symptoms, oral small molecule drugs will become the mainstream drug of the new crown, the domestic market size may reach tens of billions, the international market size according to several anti-new crown drug companies predict that it may reach hundreds of billions level
.
At the same time, as a small molecule drug, SHEN26 capsule has a broad spectrum for coronavirus, and its comprehensive advantages such as good pharmacokinetic properties, simple chemical structure and low synthesis difficulty will be conducive to cost control and drug popularization
.

In addition, it is worth noting that Sinovac has filed a communication application
for SHEN26 capsules with the US Food and Drug Administration (FDA).

SHEN26 was jointly discovered by the team of Professor Zhang Xumu of Southern University of Science and Technology and Professor Guo Deyin of Sun Yat-sen University, and was jointly developed
by Shenzhen Kexing Pharmaceutical Co.
, Ltd.
, a subsidiary of Sinovac Pharmaceutical, and Shenzhen Antaiwei Biopharmaceutical Co.
, Ltd.
and Pingshan Institute of Biomedical Research of Southern University of Science and Technology.

At present, there are only a few approved new crown oral drugs worldwide, and there is an urgent need for oral drugs that take into account both efficacy and price, and if the research and development of SHEN26 capsules progresses rapidly, it is expected to be approved for marketing in 2023 and seize the domestic market
.
At that time, Sinovac's overseas commercialization capabilities will also play an advantage and sell domestic new crown drugs abroad
.