Rashtriya Newsflash

Frost & Sullivan has conducted comprehensive research on the cell therapy industry and published the “Cell Therapy’s Full-Chain Integration and Commercial Acceleration”. The in-depth report aims to provide a comprehensive analysis of the commercial and R&D status of cell therapies, industry chain structuring, policy landscape, and representative company Sino Biotech. (To read the 2026 In-depth Report on Cell Therapy’s Full-Chain Integration and Commercial Acceleration, visit: https://www.frost.com/growth-opportunity-news/healthcare/precision-health/cell-therapys-full-chain-integration-and-commercial-acceleration/ )

China’s cell therapy sector has reached a historic inflection point with the landmark approval of Amimestrocel, the first landmark stem cell drug, marking the stem cell therapy segment’s definitive transition from experimental research to full-scale commercialization. Priced at merely 1/70th of comparable U.S. therapies, this breakthrough demonstrates China’s capability to deliver world-class regenerative medicines through a comprehensive industrial ecosystem spanning upstream supply chain security, midstream scalable bioprocessing, and downstream closed-loop quality governance.

The commercial debut arrives as the broader cell therapy landscape matures across both stem cell and immune cell modalities. While stem cell therapies gain global regulatory traction for indications including steroid-refractory acute graft-versus-host disease, ALS, knee osteoarthritis, Crohn’s fistula, and acute myocardial infarction, China’s CAR-T sector has simultaneously demonstrated remarkable industrial velocity, with multiple domestic products having reached the market since 2021. This dual-track progress reflects the sector’s evolution from technology adoption to indigenous innovation.

This acceleration is supported by a favorable policy environment, with continued government encouragement for innovation in advanced biotherapies at both national and local levels, fostering an enabling landscape for the sector’s development. These developments position platform companies with end-to-end integration capabilities— as the principal architects of an industry now pivoting toward full-chain standardization, reliable supply security, and sustainable commercial delivery.

Sino Biotech stands as a paradigm of full-chain integration in cell therapy, having established sixteen cell-resource centers nationwide that form an end-to-end ecosystem spanning cryopreserved cell banks, drug discovery, process development, and GMP manufacturing.

At the foundation of this platform lies a proprietary functional-cell-source screening system that integrates multiparametric sorting, high-throughput analytics, and in-vitro/in-vivo validation—securing starting populations of superior therapeutic potential from the origin. This upstream excellence is reinforced by a self-developed suite of chemically defined, serum-free reagents that solve critical industry pain points: the company’s proprietary NK-cell expansion kit achieves over 40% superior activation compared to commercial alternatives while maintaining cytotoxic activity above 95%, and its cryopreservation media routinely deliver post-thaw viability exceeding 90%—eliminating the domestic industry dilemma of products that “survive but underperform.”

Building on this foundation, Sino Biotech has achieved breakthrough manufacturing capabilities through its ultra-high purity immune cell preparation platform, which yields NK cells with over 95% population purity and 5,000-fold expansion—well above industry benchmarks—while retaining near-quantitative cytotoxicity against tumor targets. This technical prowess is governed by drug-grade quality standards married to AI-driven process control, including a self-developed intelligent platform integrating LIMS, unmanned AGV operations, and full-process GPS traceability. The company’s quality system has passed multiple consecutive lot-release audits by the national quality authorities, validating its “quality by design” ethos that ensures batch-to-batch consistency and clinical-translational safety. Together, these integrated capabilities establish Sino Biotech as a core driver of China’s cell therapy sector, propelling the industry from pluralistic discovery to scalable commercial application.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 60 years, Frost & Sullivan has been supporting the Global 1000, emerging businesses, the public sector, and investors in developing growth strategies.

Media Contact
Company Name: Frost & Sullivan
Contact Person: Qian Li
Email: Send Email
Country: China
Website: http://www.frostchina.com