Benzinga | Jan 7, 2021 07:16AM EST

GlycoMimetics And Apollomics Announce APL-106 Granted Breakthrough Therapy Designation In China For Treatment Of Acute Myeloid Leukemia

FOSTER CITY, Calif. and HANGZHOU, China and GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (NASDAQ:GLYC), today announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).



"This Breakthrough Therapy Designation for APL-106 reinforces its potential and is an important regulatory milestone for Apollomics as we prepare to initiate our clinical development work in China for patients suffering from AML," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is an aggressive disease and relapsed/refractory patients have an extremely poor prognosis. We look forward to initiating our Phase 3 bridging study this year and working with the CDE on a potentially accelerated clinical development program to address this important patient need."

In September 2020, the NMPA CDE granted Investigational New Drug (IND) approval for APL-106 enabling the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML.

The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China. The BTD is designed to expedite the development and review of therapies that are being developed for treatment of serious diseases for which there is no existing treatment or where preliminary evidence indicates significant advantages of the therapy over available treatment options.1