Press Releases

FDA Grants GeneQuantum Healthcare Clearance to Proceed with Clinical Development of Lead Candidate, GQ1001, in the U.S.

June 19, 2020 – SAN DIEGO, California

GeneQuantum Healthcare (Suzhou) Co., Ltd. announced that on May 27, 2020, the U.S. Food and Drug Administration (FDA) granted the clearance of the Investigational New Drug (IND) application to proceed with the first-in-human, phase I trial of GQ1001, a next generation antibody-drug conjugate (ADC), for the treatment of HER2-positive advanced solid tumors.

Dr. Qin Gang, founder and CEO of GeneQuantum, said, “GQ1001’s IND clearance by the FDA for clinical trials represents another milestone for GeneQuantum. Based on nonclinical data, we believe that GQ1001’s safety and efficacy profile has the potential to bring therapeutic benefits to patients with HER2-positive tumors.”

Dr. Qinhua Cindy Ru, managing director of CRC Oncology, said, “The IND application of GQ1001 marks the first milestone of collaboration between CRC Oncology and GeneQuantum. We are very excited to continue our collaboration to further the development of GQ1001.”

About GQ1001

GQ1001 is a next generation, anti-HER2 antibody-drug conjugate (ADC) developed by GeneQuantum Healthcare designed for specific delivery of cytotoxin to malignant cells. GQ1001 leverages GeneQuantum’s novel intelligent Ligase Dependent Conjugation (iLDC) technology, which adopts a specially engineered ligase and a unique linker-toxin payload intermediate to achieve efficient and high quality site-specific conjugation for manufacture of the ADC.

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About GeneQuantum Healthcare

GeneQuantum Healthcare (Suzhou) Co., Ltd. is a high-tech biopharmaceutical company dedicated to the development of innovative biotherapeutics. The company is focused on the development of a new generation of bioconjugate therapeutics to meet the unmet medical needs of cancer patients globally.

About CRC Oncology

CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs. For more information, visit