Porton Advanced and Dark Horse Consulting Group Announce Memorandum of Understanding Providing A Streamlined Path to Conducting IITs in China

CRANBURY, N.J. and SUZHOU, China, May 12, 2026 /PRNewswire/ -- Porton Advanced, a premier contract development and manufacturing organization (CDMO) specializing in Advanced Therapy Medicinal Products (ATMPs), and Dark Horse Consulting Group ("DHCG" or "the Group"), a leader in strategic and operational biotherapeutics consulting, recently announced the signing of a Memorandum of Understanding (MOU) to establish a strategic collaboration aimed at accelerating the development and clinical translation of cell and gene therapies globally.

This partnership unites DHCG's comprehensive regulatory, CMC, nonclinical, clinical, quality & compliance, supply chain, commercial launch, and business analytics consulting capabilities with Porton Advanced's end-to-end GMP manufacturing infrastructure, spanning lentiviral vectors, AAV, mRNA/LNP, plasmids, and engineered cell therapies including CAR-T, CAR-NK, and iPSC-derived products. Together, the two organizations will offer client companies a cost-effective and rapid pathway into clinical-stage manufacturing, with particular emphasis on enabling Investigator-Initiated Trials (IITs) in China.

For clients seeking to conduct Investigator-Initiated Trials in China, one of the most rapidly growing and strategically significant markets for advanced therapies, this collaboration addresses a persistent challenge: navigating the intersection of international regulatory strategy and local manufacturing. Porton Advanced holds 24 IND clearances across the NMPA and FDA and has successfully supported over 30 IITs to date. DHCG brings deep experience guiding sponsors through the complex regulatory and clinical design requirements that such programs demand.

By combining these capabilities under a formal collaborative framework, DHCG and Porton Advanced will enable sponsors and investigators to move their programs forward with greater speed, confidence, and efficiency, reducing friction at the manufacturing-regulatory interface that can result in delays in IIT initiation.

"This MOU with Porton Advanced represents a streamlined pathway for our client partners that are interested in undertaking an IIT in China," said Anthony Davies, Ph.D., Founder and CEO of Dark Horse Consulting Group. "For programs targeting the Chinese market, particularly those pursuing IITs, having a trusted, proven manufacturing partner with NMPA-aligned quality systems will provide DHCG clients with decreased times to first-in-human, and rapid tech transfer and manufacture. We are committed to helping developers move therapies to patients faster, and this MOU is a direct expression of that commitment."

"We are thrilled to enter into this agreement with Dark Horse Consulting Group, whose advisory capabilities spanning CMC, regulatory, nonclinical, and clinical are highly complementary to our manufacturing capabilities," said Andrew Chen, CEO of Porton Advanced. "As demand for IIT-enabling services in China from overseas sponsors continues to grow, the combination of Porton Advanced's end-to-end cell and gene therapy CDMO capabilities and proven track record, as well as DHCG's strategic consulting depth creates a genuinely differentiated offering for developers at every stage."

About Dark Horse Consulting Group

Dark Horse Consulting Group, a worldwide consulting organization with offices in North America, Europe, and APAC, was founded in 2014 with the purpose of accelerating development and delivery of cell and gene therapies through unmatched expertise. Since then, The Group's focus has expanded dramatically, with consulting team subject matter expertise now encompassing strategy, operations, Quality, regulatory affairs, manufacturing, modeling, supply chain, commercial launch, and business optimization across the biopharma landscape. DHCG's white-glove client service is grounded in rigorous scientific and technical expertise to support clients from early discovery through commercial launch. The Group comprises three business units: DHC, BioTechLogic, and Converge Consulting, with Bruder Consulting & Venture Group forming a specialized Regenerative Medicine department of DHC as of early 2026 and CJP joining the group as a Dark Horse Consulting company, also in early 2026.

About Porton Advanced

Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization.

Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV, etc), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc) and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector GMP-compliant production lines, 12 cell therapy GMP-compliant production suites and a multitude of clean rooms. As of now, we have successfully supported our clients to secure 24 global IND approvals from NMPA, FDA, and Medsafe, with 11 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.

Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling effective drugs to benefit the public sooner.

SOURCE Porton Advanced