Three COVID-19 Vaccines Enter Clinical Trials and Two Therapies Show Positive Results: CanSino, CSPC, CNBG, Protalix/Chiesi, and AstraZeneca/Ionis Announce Key Advances

According to the latest announcements from various companies, three COVID-19 vaccines have been approved for clinical trials, and two therapies have shown positive clinical results! These include CanSino's COVID-19 mRNA vaccine, Shijie's COVID-19 mRNA vaccine SYS6006, CNBG's second-generation recombinant protein vaccine, an innovative Fabry disease therapy from Protalix BioTherapeutics and Chiesi Global Rare Diseases, and an antisense oligonucleotide (ASO) therapy jointly developed by AstraZeneca and Ionis Pharmaceuticals.

Three COVID-19 Vaccines Approved for Clinical Trials

CanSino: COVID-19 mRNA Vaccine Approved for Clinical Trials

On April 4, CanSino Biologics announced that the clinical trial application for its COVID-19 mRNA vaccine had been approved by the NMPA. Preclinical research results showed that this vaccine could induce high-titer neutralizing antibodies against multiple important variants identified by the World Health Organization (including currently circulating strains). Compared with existing COVID-19 vaccines developed based on the prototype strain, this vaccine demonstrated broader spectrum efficacy and could more effectively protect the body from infection by existing variants.

CSPC Group: COVID-19 mRNA Vaccine SYS6006 Approved for Clinical Trials

On April 3, CSPC Pharmaceutical Group announced that the clinical trial application for its COVID-19 mRNA vaccine SYS6006 had been approved by the NMPA, allowing it to carry out clinical research in China. According to the announcement, SYS6006 is an mRNA vaccine targeting SARS-CoV-2 variants and demonstrates strong protective efficacy against current major mutations, including Omicron and Delta. Additionally, SYS6006 exhibits good stability and can be stored long-term at 2-8℃.

China National Biotec: Second-Generation Recombinant Protein Vaccine Approved for Clinical Trials

On April 3, China National Pharmaceutical Group (Sinopharm) announced that its second-generation recombinant protein COVID-19 vaccine had received clinical trial approval from the National Medical Products Administration. According to the announcement, the second-generation recombinant COVID-19 vaccine (NVSI-06-08) was developed by the Sinopharm Research Institute using a self-established computational structural vaccinology platform. Building on the first-generation recombinant COVID-19 vaccine (NVSI-06-07), it integrates computational analysis of mutation sites' evolutionary patterns and immune escape capabilities of circulating strains to design a second-generation broad-spectrum COVID-19 vaccine (mutation-integrated trimeric RBD). This marks a significant advancement for Sinopharm in the recombinant vaccine technology pathway, following the approval and market release of two inactivated COVID-19 vaccines.

Positive Clinical Results for 2 Therapies

Positive Results from Pivotal Phase 3 Clinical Trial of Innovative Fabry Disease Therapy

On April 5, Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced positive topline results from the pivotal Phase 3 clinical trial of investigational therapy pegunigalsidase alfa (PRX-102) in patients with Fabry Disease. Pegunigalsidase alfa is an innovative pegylated α-galactosidase A therapy administered every two weeks. Based on these positive results, the two companies anticipate resubmitting a Biologics License Application (BLA) to the U.S. FDA in the second half of this year.

Fabry disease is an X-linked genetic disorder caused by a deficiency in the activity of α-galactosidase A in lysosomes, leading to the accumulation of the metabolic substrate globotriaosylceramide (GL-3) in blood vessels, kidneys, heart, nerves, and other organs, ultimately resulting in chronic kidney disease, renal failure, cardiovascular disease, and stroke.

Pegunigalsidase-α is a stabilized version of recombinant α-galactosidase A expressed by plant cells and chemically modified. Short-chain PEG is used to covalently bind protein subunits through chemical cross-linking, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, the observed half-life in blood circulation is approximately 80 hours.

In this 24-month, randomized, double-blind, active-controlled Phase 3 trial, adult patients with Fabry disease and declining kidney function received either pegunigalsidase-α or an approved enzyme replacement therapy. The trial results showed that pegunigalsidase-α met the non-inferiority criteria for the primary endpoint of renal function compared to the active control group.

Positive Results from Phase 2b Clinical Trial of Antisense Oligonucleotide Therapy

AstraZeneca and Ionis Pharmaceuticals jointly announced that AZD8233 (also known as ION449), an antisense oligonucleotide (ASO) therapy co-developed by the two companies, reduced low-density lipoprotein cholesterol (LDL-C) levels by 73% in a Phase 2b clinical trial for patients with hypercholesterolemia, achieving the primary endpoint of the trial.

AZD8233 is a subcutaneous injection ASO therapy targeting PCSK9. By inhibiting the expression of PCSK9, it increases the level of LDL receptors, enabling them to remove more LDL from the blood, thereby reducing LDL-C levels.

Editor: Qijin

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