Latest progress

Recently, Salubris announced thatthe clinical trial application of its self-developed innovative small moleculedrug SAL0133 tablets has been accepted by NMPA.

SAL0133 is a potent and broad-spectrum 3C-like protease (3CLpro)inhibitor against novel coronavirus, independently developed by Salubris with proprietary rights.At present, it is intended to be developed for the treatment of mild/commonCOVID-19 in adults.

Preclinical studies have shown that SAL0133 has a clearmechanism of action and a potent and broad-spectrum anti-SARS-CoV-2 effect. Itis not expected to require combination with CYP3A4 inhibitor ritonavir, and thepotential risk of drug-drug interactions is low. It is expected to improvepatient medication compliance with monotherapy administered once daily.

If it is successfully developed and approved for marketing, itwill provide patients with new drug options to meet the unmet clinical needs.

Basic Information

Drug name: SAL0133 tablets

Registry Classification: 1 category

Application information: Registered clinical trials of domesticmanufactured drugs

Acceptance number: CXHL2200945, CXHL2200946 

Acceptance instructions: According to the provisions of Article32 of the Administrative Licensing Law of the People's Republic of China, it isdecided to accept it after examination.

About the 3CL protease

3CLpro plays an important role in the RNA replication ofSARS-CoV-2, mainly acting on the initial replication stage after the virusenters the host cell. Inhibition of 3CLpro protease activity can effectivelyblock virus replication and achieve the effect of anti-SARS-CoV-2.

3CLpro is highlyconserved among Beta coronaviruses. The homology of3CLpro between SARS-CoV-2 and SARS-CoV is more than 96%, and the structure ofthe two is basically the same. Many 3CLpro inhibitors have been reported tohave broad-spectrum anti-coronavirus ability. Since there is no protease withsimilar cleavage sites as 3CLpro in human body, highly specific inhibitors canbe screened with good safety.