Dricenta Weekly Updates

US FDA granted Priority Review to Imfinzi (PD-L1 mAb) + Padcev (Nectin-4 ADC) as perioperative tx for cisplatin-ineligible MIBC, supported by VOLGA’s significant EFS and OS improvements; PDUFA is expected in Q4’26

China NMPA accepted the BLA for ris-rez (B7-H3 ADC) in ≥3L osteosarcoma pts aged ≥12 years, following its Priority Review inclusion, advancing China’s B7-H3 ADC landscape.

FDA granted FTD and ODD to SOT106 (LRRC15 ADC), strengthening sarcoma development and accelerating 2026 FIH plans

Suzhou commercial manufacturing facility received its first EMA GMP certification with zero critical findings, supporting EU commercialization of biologics including ADCs

China CDE granted BTD to iza-bren (EGFR×HER3 bsADC) + PD-1 mAb for 1L PD-L1+ mTNBC, marking iza-bren’s first 1L BTD

Submitted IND application (CXSL2601042) for TQB6411 (EGFR×c-Met bsADC) in solid tumors, currently under CDE review, supporting further expansion beyond its ongoing lung & esophageal cancer programs

FDA granted ODD to nuzefatide pevedotin (EphA2 Bicycle Drug Conjugate) for PDAC, adding regulatory momentum as the asset advances in Ph2 rec PDAC

U.S. FDA BLA for ifinatamab deruxtecan (B7-H3 ADC) was voluntarily withdrawn for previously treated ES-SCLC after FDA discussions determined data from IDeate-Lung01 Ph2 did not support accelerated approval

Unveils LCB43-101001 (BCMA ADC; novel TOP1i payload), achieving complete tumor responses in multiple myeloma models.

Terminated the Ph1 BL-M17D1 (HER2 ADC) study in HER2-expressing/mut solid tumors after enrolling only 3 pts vs 120 planned, citing internal portfolio prioritization & resource management

Dosed the first pt in pivotal Ph3 CLINCH-3 of ATG-022 (CLDN18.2 ADC) in 3L+ gastric/GEJ cancer, targeting registration with BTD support

Enrolled the first pt in the Ph1/2 study of APL-2501 (CLDN6/9 ADC) in adv solid tumors, leveraging DAR8 hydrophilic linker for broader coverage and therapeutic window

Expanded ADC discovery collaboration, deploying vLab® Virtual Assays to simulate biology, optimize candidates, and reduce wet-lab experimentation

Strategic collaboration combines AI-driven antibody discovery with NovoCode™ site-specific conjugation to co-develop dual-payload and dual-target ADCs.

>$1B deal validates RNA splicing-derived targets for ADC, T-cell engager and multispecific development.

Developed an explainable toxicity knowledge graph integrating regulatory/literature evidence with AI, GraphRAG & structural-modeling workflows to map context-specific toxicity mechanisms of ADCs

Strategic XtalPi Science partnership integrates AI-driven antibody and linker-payload design to accelerate innovative drug R&D.

$1.5B oncology bispecific pact leverages Earendil’s AI-enabled platform to expand Roche’s next-generation pipeline.

Raised $75M Series C (total capital raised: $223M) to scale its AI-driven protein-design platform & advance its biologics pipeline, including BHB810 (CDH17 ADC) in Ph1/2 for adv GI tumors

Raised nearly RMB100M exclusive financing from Fengnian Capital to expand technology, manufacturing capacity & global reach for complex sugars/modified nucleotides, positioning the company as an upstream supplier for site-specific glycan-based ADC conjugation with improved conjugation-site & DAR control

Plans to expand beyond ADCs into AOCs & BBB-shuttle/CNS programs, targeting 15 clinical-stage pipelines by 2030

pCPA signed LOI for Blenrep (BCMA ADC), advancing potential public coverage in R/R multiple myeloma.

Breaks ground on $1.5B Singapore ADC facility, creating 800+ skilled jobs and enabling end-to-end commercial manufacturing by 2029

Introduced NDC platform; eliminates linkers and DAR control, simplifying ADC manufacturing while enabling high-payload delivery.