Fangda Partners recently assisted Chengdu Kanghua Biological Products Co., Ltd. (“Kangh”) in reaching an exclusive license agreement with HilleVax, Inc. (“HilleVax”) on the research, development, manufacturing and commercialization of Kangh’s recombinant hexavalent virus-like particles (VLP) norovirus vaccine candidate and its derivatives outside of Greater China.

This collaboration between Kangh and HilleVax leads the way for Chinese vaccines to enter the European and the US markets and signals the increasing global significance of Chinese vaccines with the ability of sustainable innovation. The collaboration is expected to facilitate the progress of research, production, manufacturing and global commercialization of the recombinant hexavalent norovirus vaccine both domestically and abroad, accelerate the vaccine’s global distribution, establish its presence in both domestic and international markets, thus providing a high-quality vaccine product to patients worldwide.

Under the license, Kangh will receive an upfront payment of US$15 million from HilleVax with the potential for additional payments of up to US$255.5 million upon achieving certain development and sales milestones. Kangh is also eligible to receive a single-digit tiered royalty on net sales outside of Greater China.

Kangh has developed a recombinant hexavalent norovirus vaccine based on VLPs using genetic engineering technology, covering six of the most common norovirus genotypes. The vaccine theoretically provides protection against over 90% of norovirus infections and associated acute gastroenteritis. It has obtained clinical trials approvals in Australia and the U.S. This vaccine is the world’s first and only recombinant hexavalent norovirus vaccine approved for clinical usage. As part of the exclusive license agreement, Kangh will supply the vaccine (referred to by HilleVax as HIL-216) for use in HilleVax’s near-term clinical trials, including a Phase 1 trial that HilleVax expects to initiate in 2024.

Fangda Partners provided comprehensive legal services to Kangh in the transaction. The team was led by Corporate partners Josh Shin and Henry He for transaction structure design and negotiation and revision of transaction documents. The team members included Bella Wang, Audrey Luo, Jiali Yang and Essie Zhao.Intellectual Property partner Junting Yin provided patent related advice. Capital Markets partner Colin Law led the due diligence and related services for Kangh, with team members including Jonathan Wallenberger and Crystal Huang.