On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta® (pertuzumab), Herceptin® (trastuzumab) and hyaluronidase), has been approved by China’s National Medical Products Administration (NMPA). Shortly after, on 10 April 2026, the company reported that the first patient in its phase I clinical trial, HLX319-001, had been dosed.
HLX319 is intended for neoadjuvant/adjuvant treatment of HER2-positive early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer. The pertuzumab and trastuzumab used in HLX319 are Henlius’ self‑developed HLX11/Poherdy® and HLX02/Hanquyou®, together with a proprietary recombinant human hyaluronidase (rHuPH20).
In February 2026, HLX11/Poherdy® (pertuzumab) received a positive CHMP opinion in Europe for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer. It was also the first biosimilar to Genentech/Roche’s Perjeta® approved in the USA where a legal challenge was settled in January 2026.
HLX02/Hanquyou® (trastuzumab) has been approved in China since 2020, and under different names in Canada (August 2024), the US (April 2024), Australia (July 2022), and Europe (July 2020).