Zenas BioPharma, Inc.(US:ZBIO)2025-10-08 12:00InnoCare Collaboration - Zenas BioPharma has a collaboration agreement with InnoCare Pharma, a biopharmaceutical company with a market cap exceeding $4.5 billion USD, two marketed products, and over 10 candidates in clinical development[9] - InnoCare will receive global rights to Orelabrutinib and ZB022, and global rights to ZB021 excluding China and Southeast Asia, while retaining global rights to Orelabrutinib in oncology indications[11] - Zenas will receive $35 million USD in cash and 5 million shares of Zenas common stock upfront from InnoCare[11] - Zenas is eligible for up to an additional 2 million shares of Zenas stock and up to $240 million USD in development and regulatory milestone payments for Orelabrutinib, as well as commercial sales milestone payments and tiered royalties on net sales[11] Orelabrutinib (BTKi) Program - A Phase 3 PPMS registration-directed trial has been initiated in the U S for Orelabrutinib, with a Phase 3 SPMS registration-directed trial expected to initiate in Q1 2026[11] - Orelabrutinib treatment in a Phase 2 RRMS trial resulted in a significant reduction in new GdE+ T1 lesions, with a >90% reduction observed at the 80mg QD dose at week 12 (P=0 0018)[48] - The global MS market is expected to exceed $30 billion USD, with SPMS and PPMS representing >$12 billion USD[61] Pipeline Programs - IND clearance and enrollment of the first patient for ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain penetrant TYK2 inhibitor, are expected in 2026[11] - The anti-IL-17 biologics market is currently a $10 billion USD global market with ~50% average annual growth since first approval[74] Obexelimab Program - Phase 3 INDIGO trial for IgG4-RD is fully enrolled with topline results expected around year-end 2025[83] - Phase 2 MoonStone trial for RMS is fully enrolled with (12-week) data expected early Q4 2025[83] - Phase 2 SunStone trial for SLE is enrolling with (24-week) data expected mid-2026[83] - Obexelimab represents a compelling $1 billion+ USD commercial revenue opportunity in the U S alone for IgG4-RD[120]