AIM Vaccine Gains U.S. FDA Approval for mRNA Shingles Vaccine Trial
By Thomas Yuan

BEIJING — AIM Vaccine has received approval from the U.S. Food and Drug Administration to begin clinical trials for its mRNA herpes zoster vaccine, the company announced on March 23, marking another major step in its global expansion and bolstering its position as China’s mRNA vaccine pioneer.

The new shingles vaccine demonstrated superior performance in preclinical trials, with T cell immunity, IgG antibody titers, and FAMA titers significantly outperforming an internationally available recombinant subunit vaccine, according to third-party testing agencies.

The approval is the second green light from the U.S. FDA for AIM’s mRNA pipeline, following the earlier clearance of its mRNA RSV vaccine. With a growing portfolio that includes mRNA candidates for influenza, rabies, and respiratory illnesses, AIM has signaled its intent to compete on the international stage by leveraging its modular mRNA platform — a system praised for its ability to rapidly develop new vaccines by adjusting mRNA sequences to encode different antigens.

A Breakthrough Platform

A research report by Fosun International Securities emphasized AIM's advantage as the first Chinese firm to establish a comprehensive mRNA vaccine research and development system, enabling “one-time development and multiple reuse” across various disease targets. The platform not only shortens the R&D cycle, but also significantly reduces production costs, offering a key strategic edge.

“There is currently no shingles vaccine based on this technical route approved globally,” the report noted. “With current vaccination rates among target populations as low as 0.1 percent, market potential is enormous.”

Industry analysts at Zhushi Consulting forecast that by 2030, China’s shingles vaccine market could reach 20 billion yuan, while the global market could grow to $23.9 billion. The AIM shingles vaccine’s patent design is said to avoid key IP barriers, paving the way for potential entry into Western markets, despite the company not yet having an established distribution network in the U.S. or Europe.

Vast Untapped Demand

In China, where approximately 90 percent of the population carries the herpes zoster virus, around one-third are expected to develop shingles in their lifetime. According to Cui Yong, deputy director of dermatology at the China-Japan Friendship Hospital, more than 1.5 million new cases emerge annually among those over 50.

With an aging population, Frost & Sullivan projects that the over-50 demographic in China will reach 570 million by 2030, and that shingles vaccine coverage could rise to 12.6 percent — a dramatic increase from today’s figures.

At present, no specific treatment for shingles exists, and the disease is increasingly affecting younger adults, creating a pressing need for innovative health products and preventive biotechnologies.

Market Responds

AIM’s breakthrough has not gone unnoticed by the capital markets. On March 17, days after its U.S. trial approval, AIM Vaccine’s shares surged 11.08 percent on the Hong Kong Stock Exchange — despite the company having issued a profit warning just days earlier.

Analysts believe the stock rally was driven by investor optimism over the company’s R&D pipeline and its ability to reduce losses in 2024. “The market is betting on AIM’s pipeline potential and its strategic transformation,” said a financial consultant from a domestic securities firm.

Comparisons with global mRNA leaders added further momentum. Earlier this month, Moderna announced that its first mRNA tumor vaccine could launch by 2027, prompting a 15.94 percent surge in its stock. Likewise, Everest Medicines rose 20.12 percent after announcing its first patient dosing for an mRNA cancer therapy.

Fosun International predicts AIM’s revenue could grow at a 47 percent compound annual rate through 2027, with net profits exceeding 1.52 billion yuan by that year. Guozheng International projects the company could launch one to two new products annually, turning its mRNA innovation platform into a core growth engine and opening new commercial frontiers in both domestic and international medical technology markets.

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