Monoclonal antibody copy biologicals accepted for review in China Posted 01/03/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).

Innovent announced on 29 January 2019 that its proposed bevacizumab copy biological IBI 305 had been accepted for review by the NMPA. Innovent’s product is a copy biological of Roche’s Avastin (bevacizumab), which is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

Innovent’s application for IBI 305 is based on clinical data generated from two clinical studies, namely a phase III comparative study of efficacy and safety in advanced non-small cell lung cancer (NSCLC) patients and a pharmacokinetics study in healthy subjects. Both studies directly compared IBI 305 to bevacizumab and met their predefined primary endpoints, according to Innovent.

Innovent also had an application for its adalimumab copy biological (IBi 303) accepted for review by the NMPA in November 2018 [1].

HLX22 is a proposed monoclonal antibody copy biological made by China-based Shanghai Henlius Biotech (Henlius). IBI 305 is a proposed bevacizumab copy biological from Chinese biologicals maker Innovent Biologics (Innovent).

Henlius announced on 26 November 2018 that HLX22, a monoclonal antibody injection for the treatment of gastric and breast cancer, had been accepted for review by the NMPA. Henlius signed a license agreement with AbClon granting the company exclusive rights to develop and commercialize HLX22 globally back in 2016. Henlius says that the product has performed well in the preclinical stage. HLX22 is therefore expected to not only to be used as mono-therapy in the treatment of gastric and breast cancer, but also in combination with HLX02 (a trastuzumab copy biological developed by Henlius). This would, according to Henlius, make it a ‘potentially first-in-class combination therapy in gastric cancer in the world’.

Henlius also reported that it had completed its phase I trial in rheumatoid arthritis for its adalimumab copy biological (HLX03). Its phase III trial for HLX03, which was initiated in October 2017, is still ongoing. The company also reported positive phase III results for its rituximab copy biological (HLX01) in December 2018 [2]. HLX01 was assigned into the NMPA’s priority evaluation list in early 2018, ‘making it potentially the first approved copy biological in China’, according to Henlius. The company also has a bevacizumab copy biological which started a phase I trial in non-small cell lung cancer in NSCLC in May 2016 [3].

Related article
Adalimumab copy biologicals accepted for review in China

References
1. GaBI Online - Generics and Biosimilars Initiative. Another adalimumab copy biological accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/News/Another-adalimumab-copy-biological-accepted-for-review-in-China 
2. GaBI Online - Generics and Biosimilars Initiative. Positive results for Chinese rituximab and trastuzumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Chinese-rituximab-and-trastuzumab-copy-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab

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Source: Henlius, Innovent

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