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Cristina Chang: Hemophilia B Gene Therapy BBM-H901 Approved in Macao

Cristina Chang/LinkedIn

Aug 14, 2026, 16:09

Cristina Chang: Hemophilia B Gene Therapy BBM-H901 Approved in Macao

Cristina Chang, Chief Medical Officer at Harvest Integrated Research Organization (HiRO), shared a post on LinkedIn:

”The one-time gene therapy BBM-H901 (dalnacogene ponparvovec) has been officially approved in the Macao region of China for the treatment of adults with moderate to severe hemophilia B, thus expanding access to the medication beyond mainland China.

Developed by Belief Biomed (BBM), BBM-H901 became China’s first and only approved hemophilia B gene therapy when it was cleared by regulators last year for use in patients in the Asian nation. Macao, although part of China, has its own regulatory framework for drug approvals.

‘As the first gene therapy drug for hemophilia B in both mainland China and Macao … we are delighted to leverage Macao’s position as an international gateway to extend the reach of this innovative achievement to the Macao region and even broader markets,’ Xiao Xiao, BBM’s cofounder, chairman, and chief science officer, said in a company press release announcing the approval.

‘This approval reflects the Macao Special Administrative Region Government’s forward-looking support for cutting-edge medical technologies and provides patients in the region with a breakthrough treatment option that keeps pace with international standards,’ Xiao added.

BBM manufactures BBM-H901, while Takeda China is responsible for marketing it in mainland China, Hong Kong, and Macao.”

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