D3 Bio Announces FDA Fast TrackDesignation for D3S-003 for KRAS G12D-Mutated Advanced Non-Small Cell LungCancer
SHANGHAI, August 21, 2026 — D3Bio Inc. (“D3 Bio” or the “Company”), a global clinical-stage biotechnologycompany dedicated to developing innovative oncology therapeutics, todayannounced that the U.S. Food and Drug Administration (FDA) has granted FastTrack Designation to D3S-003, the company’s investigational KRAS G12Dinhibitor, for the treatment of patients with locally advanced or metastaticnon-small cell lung cancer (NSCLC) harboring a KRAS G12D mutation whose diseasehas progressed on or after prior therapy with an anti-PD-(L)1 antibody andplatinum-based chemotherapy.
"Fast Track Designation from the FDAis an important recognition of both the serious unmet need faced by patientswith KRAS G12D-mutated NSCLC and the potential differentiated profile ofD3S-003," said Dr. George Chen, Founder, Chairman and ChiefExecutive Officer of D3 Bio. “KRAS G12D has long been considered one of themost challenging oncogenic drivers to address, and patients whose diseaseprogresses following immunotherapy and platinum-based chemotherapy have feweffective treatment options. This designation enables closer and more frequentcollaboration with the FDA as we accelerate the global development of D3S-003,and it further highlights the continued progress of D3 Bio’s KRAS franchise andthe strength of its R&D capabilities."
About D3S-003
D3S-003 is D3 Bio's in-house developed,highly selective, potent and orally bioavailable small molecule KRAS G12Dinhibitor that binds both the GDP-bound (OFF) and GTP-bound (ON) forms of theKRAS protein, thereby achieving comprehensive pathway inhibition. D3S-003exhibits the following competitive advantages: (i) superior potency andselectivity for enhanced efficacy and safety; (ii) dual-state inhibition forcomprehensive pathway blockade; (iii) independence from cyclophilin A forgreater consistency and broader applicability; (iv) favorable pharmacologicprofile and broad therapeutic window; and (v) oral bioavailability. D3S-003 iscurrently being evaluated in a global Phase I clinical trial, with IND andclinical trial clearances received from the U.S. FDA in January 2026, the MFDSin South Korea in April 2026, and the NMPA in China and the TGA in Australia inMay 2026.
About Fast Track Designation
Fast Track Designation is a processdesigned by the FDA to facilitate the development and expedite the review ofdrugs intended to treat serious or life-threatening conditions wherepreliminary evidence indicates the potential to address an unmet medical need.
About KRAS G12D-Mutated NSCLC
KRAS is one of the most frequently mutatedoncogenes in human cancer, and KRAS G12D is among the most prevalent KRASvariants across solid tumors, including NSCLC, pancreatic and colorectalcancers. Patients with KRAS G12D-mutated advanced NSCLC who have progressedfollowing anti-PD-(L)1 therapy and platinum-based chemotherapy currently haveno approved targeted treatment options and face a poor prognosis, representinga significant unmet medical need.
About D3 Bio
D3 Bio is a global biotechnology companyfocused on the discovery, development and registration of novel oncology andimmunology therapies with first- or best-in-class potential. Guided by deepclinical insight and biomarker-driven strategies, the Company is advancing apipeline of programs targeting key oncogenic drivers and immune pathways. D3Bio owns global rights to all its programs.
For further information, please visit www.d3bio.com.
Media / InvestorContact: ir@d3bio.com