On 4 December 2024, Shanghai Henlius Biotech announced that an NDA for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab), has been accepted by China’s Center for Drug Evaluation of the National Medical Products Administration.
The indications include: use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence; and use in combination with trastuzumab and docetaxel for treatment of patients with HER 2-positive, metastatic or unresectable local recurrent breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
The new drug application was based on the data generated by HLX11 in comparison with Roche’s Perjeta® (pertuzumab), which includes analytical studies of similarities and clinical comparison studies. The data demonstrated that HLX11 is highly similar to Perjeta® in terms of quality, safety and efficacy.
This news follows Shanghai Henlius’ announcement of record net profits for the first half of 2024. In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 and HLX11 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.