Suzhou, China

26 Jul 2023

Altruist Biologics (“Altruist”), a CDMO subsidiary of Innovent Biologics ("Innovent") (HKEX: 01801) announced strategic partnership with LongBio for the NDA application and commercial production for 2 molecules in its pipeline. With comprehensive experiences in NDA application, quality system in compliance with international standards and sustainable commercial manufacturing capability, Altruist will help LongBio to accelerate the NDA process of its two biologic candidates both in China and global market and provide commercial manufacturing service after market launch. The total amount of this strategic cooperation is over 500 million CNY.

Dr. Naichao Sun, co-founder of LongBio, commented. "Two drugs of LongBio have already entered late stage of clinical trials, and we plan to file registrations in both China and overseas market simultaneously and we are committed to bringing high-quality innovative drugs from China to the global market. As the former CMC team of Innovent, Altruist has launched several biologics to market successfully and established quality system with international standard as well as complete technology development platform. Altruist is familiar with regulations both in China and abroad and extensive experiences in registry filing and commercial manufacturing. Altruist has also passed multiple audits and on-site inspections by NMPA, FDA and EMA. This strategic collaboration will enable the innovative biologics of LongBio to succeed in Chinese market and bring benefit to the world.”

Dr. Kaisong Zhou, CEO, Altruist, commented. "We are very pleased to be able to provide customized biopharmaceutical solutions for LongBio and work together to develop more innovative autoimmune drugs for patients around the world. LongBio’s products are some of the few uncommon differentiated innovative drugs in China. The co-founder, Dr. NaiChao Sun, has experience in successfully developing antibody drugs that were marketed in the U.S. We are pleased to assist LongBio to complete registration and commercialization of its two products both in China and abroad. This strategic collaboration is another major milestone in the development of Altruist, in which we will fully utilize the experiences we have accumulated over the past ten years in the field of biologics development and commercialization including industry-leading process development platforms, extensive experience in domestic and oversea registrations, sustainable and stable commercial production capability, quality system in compliance with international standard, etc. We will leverage our cost advantage of large-scale stainless-steel production line to provide customized one-stop services for Longbio’s biologics including process development, filing and commercial production, which would contribute to the successful launch of their biologics to the market and bring benefit to global patients."