Walvax Biotechnology Initiates Phase I Clinical Trial for Lyophilized Varicella-Zoster Virus mRNA Vaccine

Walvax Biotechnology Co., Ltd. has initiated a Phase I clinical trial for its lyophilized varicella-zoster virus mRNA vaccine, marking a significant milestone in the company's pursuit of a next-generation shingles prevention therapy.

The Chinese biopharmaceutical company, listed on the Shenzhen Stock Exchange under ticker 300142.SZ, announced Monday that its subsidiaries—Beijing Walvax Innovative Biotechnology Co., Ltd., Yunnan Vaccine Laboratory Co., Ltd., and Yuxi Walvax Biotechnology Co., Ltd.—together with Fudan University and Shanghai Rnacure Biopharma Co., Ltd., have completed preparatory work and officially launched the clinical study.

The vaccine candidate was developed using Walvax's proprietary mRNA platform technology. Once administered, it is designed to stimulate the body's immune response against the varicella-zoster virus, providing protection against herpes zoster, commonly known as shingles.

Notably, no mRNA-based herpes zoster vaccines have been approved for market use anywhere in the world. The current global landscape of shingles vaccines includes four approved products: three live attenuated vaccines and one recombinant protein vaccine. The entry of an mRNA-based candidate would represent a first-in-class advancement for this therapeutic area.

The Phase I clinical trial initiation follows the completion of all preparatory work and a formal kickoff meeting held on the announcement date. This early-stage study will evaluate the safety, tolerability, and immunogenicity of the lyophilized mRNA vaccine candidate in human subjects.

Walvax's collaboration with Fudan University and Rnacure Biopharma underscores the company's strategy of leveraging academic partnerships to advance its vaccine pipeline. The lyophilized formulation of the vaccine offers potential advantages in storage and distribution compared to traditional cold-chain requirements for mRNA products.

Herpes zoster, caused by the reactivation of the varicella-zoster virus that also causes chickenpox, affects millions globally each year. The condition is particularly prevalent among older adults and immunocompromised individuals, creating significant demand for effective preventive vaccines.

The initiation of this clinical trial positions Walvax at the forefront of mRNA vaccine development in China, as the company seeks to carve out a niche in the competitive global shingles vaccine market with its innovative platform technology approach.