Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.
The antibody-drug conjugate (ADC) arena continues to ring up deals, as Avenzo Therapeutics Inc. signed an exclusive license agreement with Duality Biotherapeutics Inc., whereby Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, described as a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding greater China).
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Hutchmed, Innovent, Telix.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Hutchmed, Hutchinson Pharmaceuticals, Huangdong, Lantheus, Radiopharm, Synerk.
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
In a deal worth up to $1 billion, Ideaya Biosciences Inc. is in-licensing Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s SHR-4849, a phase I DLL3-targeting opo-I-payload antibody-drug conjugate (ADC). Under terms of the deal, San Francisco-based Ideaya will develop and commercialize SHR-4849 worldwide outside of greater China, and Shanghai-based Hengrui is eligible to receive up to $1.04 billion that includes a $75 million up-front fee, $200 million in development and regulatory milestone payments, and commercial success-based milestone payments. Hengrui is also eligible to receive royalties on net sales outside of greater China.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
RSS
