China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
Mountainfield Venture Partners and Chengdu, China-based Keymed Biosciences Co. Ltd have partnered to form San Diego-based Timberlyne Therapeutics, which will progress Keymed’s CD-38 monoclonal antibody globally excluding China.
Abbvie Inc. and Simcere Zaiming Pharmaceutical Co. Ltd. are part of the volley of large deals accompanying the opening of the 43rd annual J.P. Morgan Healthcare Conference in San Francisco. The two have agreed to develop SIM-0500, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is in phase I studies in the U.S. and China to treat refractory multiple myeloma.
Wuxi Biologics Co. Ltd. is licensing a preclinical trispecific T-cell engager to Candid Therapeutics Inc. in a deal worth up to $925 million plus royalties.
CSPC Pharmaceutical Group Ltd. on Jan. 13 gained the National Medical Products Administration’s approval of Shanzeping (prusogliptin tablets; DBPR-108) as a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor to treat adult patients with type 2 diabetes.
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.
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.
Ausperbio Therapeutics Inc. raised $110 million from two financing rounds in 2024 to advance its lead antisense oligonucleotide candidate as a functional cure for chronic hepatitis B.