Dark Horse Consulting Group (“DHCG” or “the Group”), a leader in strategic and operational biotherapeutics consulting, and Altruist Biologics, a wholly-owned subsidiary of Innovent Biologics and global contract development and manufacturing organization (CDMO) specializing in the development and cGMP manufacture of biologics, today announced the signing of a Memorandum of Understanding (MOU) to establish a strategic collaboration aimed at accelerating the development and global commercialization of biologic therapies.

This partnership unites DHCG’s comprehensive regulatory, CMC, nonclinical, clinical, quality & compliance, supply chain, commercial launch, and business analytics consulting capabilities with Altruist Biologics’ end-to-end cGMP manufacturing infrastructure in China, spanning cell line development, process and analytical method development, formulation development, drug substance manufacturing, drug product manufacturing, and bioconjugation services including antibody-drug conjugates (ADCs). Together, the two organizations will offer client companies a cost-effective and streamlined pathway into clinical and commercial-scale biologics manufacturing, with particular emphasis on programs seeking to leverage China’s world-class biomanufacturing infrastructure.

Biologics manufacturing in China has emerged as a strategic priority for sponsors worldwide, driven by the country’s rapidly maturing regulatory environment, significant cost advantages, and world-class production infrastructure. Yet for companies based outside China, translating that opportunity into executable programs requires navigating a complex web of NMPA requirements, local quality systems, and CMC expectations that differ meaningfully from those of the FDA or EMA. This collaboration is designed to close that gap. Altruist Biologics operates advanced cGMP facilities in Suzhou and Hangzhou with a total production capacity of 232,000 liters, including four 20,000-liter bioreactors at its Hangzhou site. DHCG brings deep expertise guiding sponsors through the regulatory and CMC strategy required to access and succeed in Chinese and global markets.

The formalization of this collaboration marks a significant step toward simplifying what has historically been one of the more demanding aspects of biologics development: aligning manufacturing execution with global regulatory expectations in a market as dynamic and consequential as China. By bringing together DHCG’s strategic consulting depth and Altruist’s proven manufacturing infrastructure under a single collaborative framework, the two organizations aim to give sponsors a clearer, faster, and more reliable path from development decision to cGMP-manufactured product.

“This MOU with Altruist Biologics represents an exciting expansion of DHCG’s partner network in China, and an important new pathway for our clients developing monoclonal antibodies, bispecifics, ADCs, and other biologic modalities,” said Anthony Davies, Ph.D., Founder and CEO of Dark Horse Consulting Group. “Altruist’s Innovent heritage, proven manufacturing track record, and world-class cGMP infrastructure make them an exceptional partner for programs seeking to access China’s biomanufacturing capabilities. Together, we will help developers compress timelines, reduce risk, and ultimately bring life-saving therapies to patients faster.”

“We are delighted to partner with Dark Horse Consulting Group, whose breadth of consulting expertise across CMC, regulatory, nonclinical, and clinical development is highly complementary to Altruist’s end-to-end manufacturing capabilities,” said Kaisong Zhou, Ph.D., Chairman and CEO of Altruist Biologics. “As global biopharmaceutical companies increasingly look to China as a hub for high-quality, cost-effective biologics manufacturing, the combination of Altruist’s proven facilities and quality systems with DHCG’s strategic and operational consulting depth creates a genuinely differentiated offering. We look forward to working together to support developers at every stage of their program.”