Sinovac: The new crown treatment drug SHEN26 has completed the enrollment of phase II subjects

On January 2, Sinovac Pharmaceutical (688136.
SH) announced that its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co.
, Ltd.
, successfully completed the enrollment of all subjects in the phase II clinical study of SHEN26 capsules
.

According to the announcement, at this stage, Sinovac Pharmaceutical is conducting a "randomized, double-blind, placebo-controlled phase II clinical study of SHEN26 capsules for the treatment of mild and common novel coronavirus infected patients", and the main endpoint indicator is the change in SARS-CoV-2 viral RNA level (RT-PCR test) relative to the baseline
.

In completed Phase I clinical trials, SHEN26 capsules have shown good tolerability and safety
.
At the same time, the recently completed IIT study evaluating the safety and efficacy of SHEN26 capsules in patients with mild and common novel coronavirus infection has achieved positive results, and the results show that SHEN26 capsules can shorten the nucleic acid conversion time of patients with mild and common new coronavirus infection, and the safety is good
.

SHEN26 capsule is a broad-spectrum, potent novel coronavirus polymerase (RdRp) inhibitor, which can achieve antiviral effect by inhibiting viral nucleic acid synthesis, and has efficient in vitro inhibitory activity
against different new coronavirus variants (wild strain, Alpha, Beta, Delta, Omicron).

In terms of safety testing, SHEN26 capsules have a low risk of off-target side effects, genetic toxicity and other research results are negative, with a high therapeutic index and good safety
.

Since the beginning of this year, Sinovac Pharmaceutical's series of pipelines around the antiviral layout has made important progress, in addition to SHEN26 capsules successfully completed the enrollment of all subjects, the company's human interferon α1b inhalation solution and human interferon α2b spray have also been approved to enter clinical trials, and the research and development strength is remarkable
.

In addition, in response to investors' questions, Sinovac revealed that in the recent new crown superimposed on the autumn and winter flu season, the company's antiviral drug interferon α1b (Serokin) shipments and orders for injection have increased
significantly.
Sinovac Pharmaceutical's human interferon for injection (Cerokin) can be applied to pediatrics, respiratory medicine, etc.
, and the instructions are clearly used for viral diseases in children, and the clinical application areas include respiratory infectious diseases
in children.