BridgeBio Pharma, Inc. and Kyowa Kirin Co. announced a partnership wherein BridgeBio?s affiliate, QED Therapeutics, grants Kyowa Kirin an exclusive license to develop and commercialize infigratinib for achondroplasia, hypochondroplasia, and other skeletal dysplasias in Japan. In exchange, BridgeBio will receive an upfront payment of USD 100 million as well as royalties up to the high-twenties percent on sales of infigratinib in Japan, with the potential for additional milestone-based payments.

Infigratinib is an oral small molecule designed to inhibit FGFR3 and thus target FGFR3-driven skeletal dysplasias at their source, including achondroplasia and hypochondroplasia. In December 2023, BridgeBio dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial, evaluating the efficacy and safety of infigratinib in children with achondroplasia aged 3 to <18 years with open growth plates. The Phase 3 builds on the success of PROPEL 2, a Phase 2 trial of infigratinib in achondroplasia which demonstrated a +3.38cm/yr increase in annualized height velocity, the strongest clinical result published to date.

In Japan, Kyowa Kirin will start to discuss with Pharmaceuticals and Medical Devices Agency (PMDA) of Japan in 2024, with the aim of initiating a Japanese registrational trial in 2025.