China's First Vaccine Licensing Deal to Europe and the U.S. Surpasses RMB 1.8 Billion: Kanghua Bio's Hexavalent Norovirus Vaccine Goes Global

Recently, Chengdu Kanghua Biological Products Co., Ltd. (hereinafter referred to as “Kanghua Biologics” or the “Company”) entered into an Exclusive License Agreement with HilleVax, Inc. (hereinafter referred to as “HilleVax”). Under the agreement, Kanghua Biologics grants HilleVax the exclusive rights to develop, manufacture, and commercialize the recombinant hexavalent norovirus vaccine and its derivatives in all territories outside China (including Hong Kong, Macao, and Taiwan).

In this transaction, Kangh will receive an upfront payment of $15 million and is eligible to receive up to $255.5 million in milestone payments upon achieving specific development and commercial milestones. Kangh also holds the right to receive single-digit percentage royalties on net sales outside China (including Hong Kong, Macao, and Taiwan).

Kanghua Biological has utilized genetic engineering technology to construct a recombinant hexavalent norovirus vaccine based on Virus-Like Particles (VLPs). This vaccine covers six major prevalent genotypes of norovirus and, in theory, can prevent more than 90% of norovirus infections and the acute gastroenteritis they cause. It has currently obtained clinical trial approvals in Australia and the United States. To date, this recombinant hexavalent norovirus vaccine is the first and only hexavalent norovirus vaccine globally to have received clinical trial authorization. As part of an exclusive licensing agreement, Kanghua Biological will provide the recombinant hexavalent norovirus vaccine (HilleVax product code HIL-216) to HilleVax for use in upcoming clinical trials, with HilleVax planning to initiate Phase I clinical trials in 2024.

Dr. Rob Hershberg

Chairman and CEO of HilleVax

“We are delighted to partner with Kanghua Biologicals, as we aim to establish long-term leadership in the field of norovirus vaccines.”Dr. Rob Hershberg, Chairman and CEO of HilleVaxstated, “Our bivalent norovirus vaccine, HIL-214, is a leading candidate in clinical development. We further believe that HIL-216, as a next-generation, higher-value VLP vaccine, enriches HilleVax’s product portfolio and aligns perfectly with HilleVax’s expertise, capabilities, and long-term vision, which is exciting.”

Mr. Wang Zhentao

Chairman of Kangh

“We are delighted to partner with HilleVax, a company with world-class expertise in norovirus vaccine development and a commitment to reducing the burden ofa company focused on the incidence, mortality, and economic burden associated with norovirus.”Mr. Wang Zhentao, Chairman of Kanghstated, “HilleVax’s pursuit of vaccine R&D aligns with Kanghua’s vision of advancing human health. I believe our collaboration represents not only a commercial success but also a win-win in technological development, marking a significant milestone for Kanghua. It supports our goal of bringing novel vaccine products to the global market and demonstrates the substantial enhancement of Chinese biopharmaceutical companies’ capabilities in vaccine discovery, development, and manufacturing.”

This collaboration between Kanghua Biologics and HilleVax pioneers the entry of Chinese vaccines into European and American markets, marking the increasingly important role that Chinese vaccines are playing on the international stage through sustained innovative capabilities. It will also help advance the research and development, manufacturing, and commercialization of the recombinant hexavalent norovirus vaccine both domestically and internationally, accelerating its global launch, establishing domestic and overseas markets for the recombinant hexavalent norovirus vaccine, and providing high-quality vaccine products to patients worldwide.

HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccines, which listed on the Nasdaq on April 29, 2022. HilleVax’s initial program, HIL-214, is a virus-like particle (VLP)-based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection, and is currently in Phase II clinical trials in the United States.

Chengdu Kanghua Biological Products Co., Ltd. (hereinafter referred to as “Kanghua Biology,” stock code: 300841) is a biopharmaceutical enterprise engaged in the research and development, production, and sales of biological products, committed to improving human life through innovative biopharmaceutical products and services. Established in 2004, Kanghua Biology is equipped with an animal testing center and GMP-compliant production workshops for bacterial and viral vaccines featuring advanced technological standards. Its current product portfolio includes the “ACYW135 Group Meningococcal Polysaccharide Vaccine” (brand name: Maikexin^®) and “Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)” (trade name: HDCV^®）。

Since its establishment, Kanghua Biological has been awarded honorary titles such as “Postdoctoral Innovation Practice Base,” “Sichuan Province Cultivation Enterprise for Constructive Innovation,” and “Sichuan Province Excellent Integrity Demonstration Unit” by the Department of Human Resources and Social Security, the Department of Science and Technology, and other authorities. It has also passed the Good Manufacturing Practice (GMP) certification issued by the China Food and Drug Administration. In recent years, Kanghua Biological has undertaken several scientific and technological projects, with over one hundred technologies applying for patent protection.