Hongjun Yang

• Defined business strategy, therapeutic focus areas(CNS, Cancers, etc.), priority and early-stage growth roadmap. • Built core scientific and operational teams, established infrastructure for R&D and partnerships. • Led fundraising activities and external engagement to accelerate translation from discovery to clinical development.

Innovative molecular diagnostics company leveraging proprietary XNA technology. • Directed development and FDA EUA submissions for multiple COVID-19 diagnostic products (DNA, antigen, variant detection, 4-in-1 respiratory panel, Monkeypox). • Led regulatory writing, submission strategy, and cross-functional coordination. • Defined CDx strategy for oncology (NSCLC, CRC) using NGS and multiplex PCR; integrated single gene assays into multigene CDx panels. • Established partnerships with biopharma and academic institutions for rare cancer diagnostics (e.g., glioma, Pacak Zhuang syndrome). • Organized 20+ international webinars; interviewed by CGTN four times. • Drove new applications of XNA technology in PDC, CRISPR, and CAR T.

• Led global biomarker and CDx strategy supporting clinical development and regulatory submissions for Lynparza and Imfinzi. • Participated in 20+ clinical studies; reviewed 70+ protocols/CTPs. • Successfully contributed to China launches of Osimertinib, Olaparib, and Durvalumab. • Built strong working relationships with CDER/CDRH and global regulatory teams. • Established clinical sample management systems ensuring ICH and HGR compliance.

• Led global biomarker and CDx strategy supporting clinical development and regulatory submissions for Lynparza and Imfinzi. • Participated in 20+ clinical studies; reviewed 70+ protocols/CTPs. • Successfully contributed to China launches of Osimertinib, Olaparib, and Durvalumab. • Built strong working relationships with CDER/CDRH and global regulatory teams. • Established clinical sample management systems ensuring ICH and HGR compliance.

• Led development of a Chinese next generation sequencing (NGS) platform. • Designed and delivered an ISFET based semiconductor sequencing chip. • Recommended for chaired professorship and nominated for CAS academician.

• Developed commercialization strategy for NGS-based personalized profiling. • Invented patented saliva collection device, expanded IP portfolio. • Built an online breast cancer sample management database with KOL input.

• Established China operations, raised institutional funding, and built R&D team. • Directed IND enabling studies for first siRNA therapeutic; built CMC and QA systems. • Formed clinical collaborations with hospitals, CROs, and government agencies. • Received innovation award; company later IPO’d on HKEX (2021).

• Transformed academic lab into commercial biochip enterprise. • Implemented industrial standards, QA systems, and workforce training. • Received Outstanding Contributor Award from TEDA.

• Built national biochip R&D platforms (DNA, protein, tissue, bioinformatics). • Recognized by Affymetrix as the first qualified service provider in China. • Established the first GSK central lab in China, meeting GLP/GCP standards. • Initiated Asia HapMap program (published in Nature, 2005). • Organized major international conference featuring Leroy Hood’s first “P4 Medicine” keynote. • Pioneered CRO business model for national R&D centers.

After “9.11”, I took the mission from the Board, promoted this technology and raised $15M fund, and successfully finished “spin-off” from Gene Logic and establish a new company, MetriGenix, Inc. based on the development of flow-thru chip technology I initiated and carried on at Gene Logic.

• Developed flow-through microfluidic chip platform (20 min hybridization). • Raised $15M and spun off MetriGenix with major investors (GE, Siemens, Oxford). • Discovered 22 gene signatures distinguishing NSCLC subtypes (validated by NCI). • Published extensively; awarded multiple US patents.

A solid foundation for natural sciences.

My thesis was presented in The Eighth Biennial Congress of International Solar Energy Society in 1982.

9 publications