Chime Biologics, a contract development and manufacturing organization (CDMO), and Hope Medicine Inc., a clinical-stage biotech, are collaborating to develop and manufacture the first-in-class monoclonal antibody drug HMI-115.

Under the terms of the agreement, Chime Biologics will provide a one-stop-shop CMC solution for Hope Medicine’s HMI-115 monoclonal antibody from technology transfer, process optimization, scale-up, clinical phase III GMP production, process characterization, process validation, BLA filing support, to commercial manufacturing.

Hope Medicine will leverage Chime Biologics’ extensive experience in 2000L cGMP manufacturing, late-stage CMC development and BLA filings to jointly accelerate HMI-115 mAb development and manufacturing for speedy clinical advancement of targeting endometriosis and androgenetic alopecia, benefiting more female patients and alopecia patients.

Damian Tu, president of Hope Medicine, said, “HMI-115 is Hope Medicine’s most critical and advanced clinical antibody drug asset. We are very pleased to enter this strategic collaboration with Chime Biologics, a leading CDMO service company with strong experience in late-stage biologics development, manufacturing, and regulatory support, as well as with strong customer-centric culture and mindset. With the help from Chime Biologics, I am confident that we will be able to launch HMI-115 mAb in a fast pace and benefit patients that are suffering from EM and AGA. Hope Medicine’s vision is to bring more first-in-class drugs and highly differentiated products to the world, especially to China. We look forward to more collaborations with Chime Biologics.”

Jimmy Wei, president of Chime Biologics, said, “We are pleased to be a strategic partner of Hope Medicine. We are fully committed to driving the commercialization of HMI-115 mAb for the treatment of endometriosis and androgenetic alopecia to ensure the successful launch of this novel antibody drug. Currently, Chime Biologics has completed several late-stage CMC projects and is also in the process of commercial manufacturing for several post-market drugs. We are proud to empower our global partners to deliver clinical value for the benefit of patients.”