Also known as Hyalase, Vitrase, and Amphadase.
Modeling of MajesTEC‑3 trial data estimates a high cure fraction and nearly fourfold median OS benefit for teclistamab plus daratumumab FASPRO versus standard care in relapsed/refractory myeloma.
Final overall survival data for RYBREVANT plus chemotherapy in EGFR exon 20 insertions and tolerability updates for subcutaneous RYBREVANT FASPRO with prophylactic strategies.
Primary endpoint met in Phase 3 ALKIVIA: efgartigimod improved mean Total Improvement Score at Week 52 versus placebo; benefit emerged by Week 4 and was sustained across IMNM and DM.
OrigAMI-4 showed 42% response rate with >1/3 complete responses; FDA review shortened to ~6 months; drug targets EGFR and MET and is co-formulated with hyaluronidase.
CHMP recommendation follows MajesTEC-3 Phase 3 data showing HR 0.17 for PFS and HR 0.46 for OS at ~3 years in adults with RRMM after ≥1 prior therapy, with manageable safety.
GPRC5D bispecific plus anti‑CD38 combo cut progression risk and delivered 24‑month PFS up to 81% and OS up to 89% in earlier‑line relapsed/refractory multiple myeloma.
FDA accepted priority NDA for oral SERD giredestrant as adjuvant in ER‑positive, HER2‑negative stage I–III breast cancer after phase III lidERA showed 30% iDFS risk reduction; PDUFA 30 Nov 2026.
Phase 1b/2 OrigAMI-4: subcutaneous amivantamab + hyaluronidase achieved 42% ORR (15% CR) in pretreated recurrent/metastatic HNSCC; median DOR not reached (11.8 mo FU); manageable safety.
Phase 3 MajesTEC‑9: teclistamab cut progression/death risk 71% (HR 0.29) and death 40% (HR 0.60) vs PVd/Kd in early RRMM; higher ≥CR (65.9% vs 16.8%); infections and CRS increased
DP15 at Fengxian is operational, completed GMP batches to supply clinical programs. Features isolator aseptic filling for liquid and lyophilized vials (2R-20R), enabling faster tech transfer.
