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康日百奥生物科技（苏州）有限公司

Bioworkshops Suzhou, a biopharmaceutical company headquartered in Hong Kong, collaborates with international partners to develop pioneering and superior antibody products for China and the global market. We specialize in creating clinical drug substances and products using cell culture methods, adhering to international standards. Our mission is to expedite the development and approval of biological products faster than any other Chinese competitor through the strategic application of manufacturing science.

Recently, the company has acquired a 28,000 square-meter facility in Suzhou and invested over RMB300 million in constructing state-of-the-art development and clinical manufacturing facilities in 2019. This investment positions us well to aim for the first IND approval in 2020.

Our team is comprised of talented and productive professionals, led by experienced founders from Australia and China who have a track record of launching and guiding biologics development and manufacturing organizations worldwide for over two decades. In the last five years alone, they've successfully launched more than ten new antibody products for the US, Australian, and Chinese markets, and completed the design, construction, and startup of four biologics development and manufacturing centers:

- Clinical and commercial production facilities
- Inspected for compliance with US-FDA, NMPA, TFDA, and TGA regulations for filing CTAs/INDs and commercial products

We've swiftly assembled a startup team and are actively recruiting additional experts to grow our workforce to over 150 employees within the next year.

Quality management is a critical component of our operations, requiring a deliberate approach with a commitment to continuous improvement. Bioworkshops' Quality Management System covers all aspects of our business, with a special emphasis on ensuring pharmaceutical product quality during development and manufacturing processes to meet Chinese, European, and American Good Manufacturing Practice (GMP) standards.

Our facility is situated in the heart of Suzhou Industrial Park, where we are constructing high-capacity drug discovery, development, and manufacturing facilities that include:

- Development capacity for up to 8-12 IND applications annually
- Clinical drug substance manufacturing to 2,000L scale
- Aseptic filling of liquid products into vials
- Best-in-class bioprocesses and analytical capabilities

At Bioworkshops, our founding values emphasize a strong culture and shared purpose, focusing on:

- Innovation and excellence in biologics development
- Trust-based relationships grounded in honesty
- Sustainability measured by workplace safety, environmental impact, and long-term business success
- Enthusiasm for ambitious goals and creative problem-solving
- Respect for the persistent effort required to achieve ambitious goals in our industry