Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.
The companies made an original deal back in October 2018, in which CC-Pharming agreed to pay iBio US$4.7 million to be its China partner for joint development of products and manufacturing facilities for the Chinese biopharmaceutical market, utilizing iBio’s technology.
This new deal sees iBio expanding the scope of its business venture with CC-Pharming by granting it an exclusive, royalty-bearing commercial licence to iBio’s rituximab (iBio Rituximab) product candidates for the territory of China. In addition, the company will grant CC-Pharming a research license to iBio’s FastPharming System and know-how for the evaluation of multiple product opportunities.
The commercial licence allows CC-Pharming to use iBio’s FastPharming System to develop iBio Rituximab, and fulfils the companies’ intention to share revenue from CC-Pharming’s sale of the product in China. According to the deal, CC-Pharming will be responsible for the development, launch and commercialization of iBio’s rituximab copy biological in China, including costs associated with the marketing and sales of the licensed product. Under the terms of the licence, iBio retains all rights to commercialize iBio technology-based products in markets outside of China.
The companies also said that they plan to develop additional products for the Chinese market in other product categories, particularly research and clinical reagents, non-pharmaceutical skincare products and botanical derivatives. iBio and CC-Pharming are also currently evaluating the business feasibility of developing additional biologicals for oncology, metabolic disorders and fibrotic disease.
iBio has already successfully used its iBioLaunch technology to produce two monoclonal antibody biosimilars, rituximab and palivizumab, in non-transgenic green plants [1, 2]. The company has also made an alliance with GE Healthcare, the health business of General Electric, which may also be focussing on biosimilars [3].
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), approved the first rituximab copy biological, Hanlikon (HLX01), which was developed by Shanghai Fuhong Hanlin Bio-Pharmaceutical (Hanlin), in February 2019 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Also noted on biosimilars: 13 April 2012: Palivizumab biosimilar successfully produced in plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 4]. Available from: www.gabionline.net/Biosimilars/General/Also-noted-on-biosimilars-13-April-2012
2. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar successfully produced in plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-successfully-produced-in-plants
3. GaBI Online - Generics and Biosimilars Initiative. iBio and GE Healthcare form new global alliance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/iBio-and-GE-Healthcare-form-new-global-alliance
4. GaBI Online - Generics and Biosimilars Initiative. China approves rituximab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 4]. Available from: www.gabionline.net/Biosimilars/News/China-approves-rituximab-copy-biological
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Source: China Daily, iBio
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