On September 22, Shenzhen PanGene Medicine Co., Ltd. (hereinafter referred to as "PanGene Medicine"), a domestic professional immunomics testing service company, officially reached a strategic cooperation agreement with Shenzhen Haplox Biotechnology Co., Ltd. (hereinafter referred to as "Haplox"), a leading national high-tech enterprise in precision medicine and genetic big data, recognized as a "Specialized, Refined, Distinctive, and Innovative" (SRDI) "Little Giant" company.
The collaboration focuses on immunome NGS sequencing technology, specifically targeting the clinical translation and application of Ig/TCR MRD detection for hematological malignancies such as Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), and Multiple Myeloma (MM).
This cooperation actively responds to the FDA's scientific recommendations in industry guidance recognizing MRD as an accelerated approval surrogate endpoint for hematological malignancies. Drawing on successful practices in new drug approvals, the partnership integrates the technological strengths of both parties to:
Develop an Ig/TCR MRD detection product line that meets international standards.
Utilize MRD dynamic monitoring as a cornerstone to optimize the clinical diagnosis, treatment decisions, and prognosis management of ALL, CLL, and MM.
Provide MRD detection solutions for pharmaceutical companies targeting hematological tumors.
Jointly promote the establishment of MRD detection as a key clinical trial endpoint.
Wen Yuan, Co-founder of Haplox, stated: "Haplox already has a mature pharmaceutical service system. Relying on our established in-depth cooperation network with over 100 renowned pharmaceutical companies and our rich experience successfully supporting more than 200 drug clinical R&D projects, we will jointly promote the innovative application of immunome technology in drug R&D. Haplox's accumulated integrated solution capabilities in pharmaceutical services—from clinical trial enrollment support and central laboratory services to big data analysis—will serve as a significant booster for this collaboration. We firmly believe that through complementary advantages, we will accelerate the availability of innovative technologies to benefit more patients."
Looking ahead, Haplox and PanGene Medicine will use this cooperation as a starting point to continuously deepen synergies in technological exploration, product development, and market promotion. This partnership will not only continue to advance the innovative application of multi-omics testing in drug R&D but is also aimed at providing patients with full-cycle precision medical services, contributing to the upgrading and breakthrough of the precision medicine industrial ecosystem.