Hong Kong CDMO gap delays GenEditBio samples

Hetao could fund shared CDMO capacity for first-in-human gene editing samples.

Hetao Hong Kong Park’s 2026 budget could help speed GenEditBio’s lab-to-clinic path if it prioritises shared CDMO capacity and first-in-human trial pathways for cell and gene therapy startups.

At the Asian Summit on Global Health 2026, Tian Zhu, CEO and co-founder of GenEditBio Limited, said the main manufacturing bottleneck is chemistry, manufacturing and controls, or CMC. For biological products, manufacturing quality is central to the product itself, making CMC advancement and optimisation a major resource burden for startups.

Hong Kong currently has no CDMO facility available, limiting the city’s ability to produce clinical-grade samples locally. Zhu said Hetao could close part of that gap by building shared CDMO and core facilities backed by mainland China and Hong Kong’s import-export advantages. These facilities could be used by GenEditBio to generate the first human clinical samples manufactured in Hetao.

Clinical development is the second bottleneck. Zhu said Hong Kong’s Greater Bay Area Clinical Trial Center and discussions with Hong Kong University Hospitals in Hong Kong and Shenzhen could help move gene editing and other advanced therapies into first-in-human studies. “These two areas definitely can accelerate our development path forward,” Zhu said.

Commercial viability is also needed before gene editing can move into wider public healthcare use. Zhu said Hong Kong biotech companies should look at in vivo, off-the-shelf therapies, which could avoid individualised ex vivo manufacturing and reduce costs.

“I think one way Hong Kong biotech or worldwide biotech companies can leverage is to move from the ex vivo approach to the in vivo approach,” Zhu said.

For 2026, Tian Zhu said biotech developers must also manage regulatory uncertainty by engaging authorities earlier and preparing for multi-regional clinical trials. Capital uncertainty will require more flexible funding routes, including private financing, licensing and co-development.

Hetao’s budget can accelerate GenEditBio only if it funds the infrastructure and trial pathways that startups cannot build alone.