# LePure Biotech

Chinese firms like LePure Biotech are aggressively reverse-engineering and scaling domestic production of single-use bags and tubing to break the historical duopoly of US and German suppliers.

Source: https://en.bioecon.ru/companies/lepure-biotech/
Updated: 2026-06-24

- Country: China

## Verifiable facts

| Fact | Value | Source |
| --- | --- | --- |
| Funding | Completed Series C financing round of hundreds of millions of RMB led by Novo Holdings, General Atlantic, and Goldman Sachs Asset Management in January 2023 | https://www.vcbeathealth.com/article/37618, https://www.vcbeathealth.com/article/42454 |
| Capacity | Annual production capacity includes 1.2 million sets of single-use process bags, 2,500 sets of bioprocess equipment, 300 tons of culture media, and 3 million bottles of clean products across various facilities | https://lepurebiotech.com.cn/about-lepure-biotech/global-layout/, https://www.lepure-bio.com/En/disposable-bags |
| Certification | ISO 9001 and ISO 13485 certified quality management systems | https://lepurebiotech.com/about-lepure-biotech/, https://www.lepurebiotech.com/ |
| Certification | Validation services accredited under ISO 17025 and CNAS | https://www.lepurebiotech.com/, https://www.lepurebiotech.com/news/ |
| Regulatory approval | Completed FDA Drug Master File (DMF) filings for single-use bag product lines including LeKrius, LeRybow, and LeRugia | https://www.lepurebiotech.com/news/ |
| Production site | Manufacturing bases located in Shanghai (Songjiang, Lingang), Suzhou, Zhongshan, and Zhejiang | https://lepurebiotech.com.cn/about-lepure-biotech/global-layout/, https://www.lepurebiotech.com/about-lepure-biotech/factory-subsidiary/ |

Independent sources: lepure-bio.com, vcbeathealth.com

## Technologies

- [Single-use assemblies](https://en.bioecon.ru/technology/single-use-assemblies/)