Guangdong develops world's first HDAC/PI3Kα dual-target inhibitor

Recently, the world's first-in-class HDAC/PI3Kα targeted anti-cancer drug, Ibrutinib Hydrochloride for Injection, developed in Guangdong, was officially approved for market launch by the National Medical Products Administration.

The drug is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of prior systemic therapy. Due to its advantages in clinical research data, this product was included in the Center for Drug Evaluation (CDE)'s "Breakthrough Therapy Designation" and rapidly approved for market launch through the priority review pathway.

The drug was declared by Guangzhou Bibete Pharmaceutical Co., Ltd. It marks the fourth innovative drug approved in the Guangzhou Development Zone and Huangpu District in 2025. Since 2018, a total of 12 first-in-class innovative drugs have been approved in the Guangzhou Development Zone and Huangpu District, accounting for 92% of the city's total and 50% of the province's total.

As the core area of Guangzhou's biomedical industry, this district has witnessed rapid growth in the scale of its biomedical sector. Specifically, the number of enterprise entities has surged from 1,000 in 2017 to 4,800, representing a 3.8-fold increase. The number of industrial enterprises above designated size has grown from 40 in 2017 to 146, marking a 2.5-fold increase. Additionally, the revenue scale of the biomedical and health industry has expanded from 65 billion yuan in 2017 to 240 billion yuan, also showing a 2.5-fold increase.

Reporter | Chen Jinxia

Photo | Guangzhou Development Zone and Huangpu District

Editor | Hu Nan, James, Shen He

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