Recently, the Investigational New Drug (IND) application for SHR-5421 for Injection, a China-US dual filing project submitted by Suzhou Sundia Biotech Co., Ltd., a subsidiary of Hengrui Medicine, has received implied approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, authorizing the initiation of clinical trials.

As a key partner of the project, Baino Chuangrui (Wenzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Chuangrui Bio”) provided comprehensive in-depth support throughout the whole process. Leveraging its quality management system compliant with international drug registration standards, robust biologic CMC development expertise and a mature large-scale mammalian cell culture platform, the company delivered core technical and manufacturing assurance for the successful Chinese IND submission and the concurrent US IND filing.

Chuangrui Bio has independently built a high-expression stable cell line development platform based on site-specific integration technology, alongside a complete technical portfolio covering high-density serum-free suspension culture, microcarrier suspension culture of adherent cells and large-scale bioreactor manufacturing. It enables process scaling and technology transfer from lab-scale R&D to clinical sample production, and can continuously supply GMP-compliant clinical material preparation and commercial manufacturing services. The successful delivery of this project fully validates Chuangrui Bio’s comprehensive technical capabilities in mammalian cell high-efficiency expression system development, technology transfer and scaling, quality studies, analytical method development and validation, GMP manufacturing and China-US regulatory filings. The company offers integrated CDMO services to support multi-jurisdictional global registrations and one-stop solutions covering the full lifecycle of novel biologics from pre-clinical pharmaceutical development to commercial production, continuously empowering Chinese innovative drugs to go global.

About SHR-5421
SHR-5421 for Injection is a Class 1 innovative therapeutic anti-tumor biologic independently developed by Hengrui Medicine. It is intended for the treatment of multiple myeloma (MM). No comparable drugs have been approved for marketing at home or abroad to date. It carries distinctive research value and promising clinical prospects, and is expected to bring a new therapeutic option for MM patients.