iBio and CC-Pharming to launch plant-based rituximab in China

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/sinology)
(Image: Getty/sinology)

Related tags: Biosimilars, China, iBio, bioreactor

iBio grants CC-Pharming exclusive license to commercialize rituximab in China, as well as a research license to bring its FastPharming technology to the country.

Plant-based biopharmaceuticals developer, iBio extends its partnership with Chinese CC-Pharming, a company focusing on plant molecular medicine R&D, which was initially established in 2018​.

Under the extended partnership, CC-Pharming will proceed in the commercialization of iBio’s rituximab in China, after being granted an exclusive license to the product candidate.

Rituximab, a blockbuster therapeutic indicated for the treatment of several autoimmune diseases, is marketed as MabThera and Rituxan by Roche. The first biosimilar to the product, Truxima, developed by Celltrion, received approval in November 2018​, causing a 47% drop off​ to Roche’s rituximab sales in Europe.

Concurrently, CC-Pharming was granted a research license allowing it to establish iBio’s plant-based manufacturing technology, FastPharming, in China.

With FastPharming, iBio replaces single-cell culture systems with plants, which are used as bioreactors, able to develop ‘bio-better’ therapeutics, according to Tom Isett, iBio’s managing director.

“Bio-better means that our product is better than a biosimilar,”​ Isett told us, explaining that the plant expression system allows production of the drug with increased potency compared to traditional mammalian systems, such as Chinese hamster ovary (CHO) cell lines.

According to Isett, the FastPharming system “gives clients research use quantities of materials in weeks, and cGMP-manufactured quantities in less time than the mammalian expression systems require, along with scale-up and eco-friendly benefits.”

Entering an emerging market

iBio has agreed to share the revenues of its product sales in China with CC-Pharming, seeing significant potential for rituximab in the regional market.

According to iBio, about 88,000 new patients are diagnosed with lymphoma in China each year, with 90% of those having non-Hodgkin’s lymphoma, which rituximab is indicated for.

The first rituximab biosimilar was approved​ in China earlier this year; however, iBio states that “it may still be too expensive for many patients”​, and that there remains the need for a more cost-effective version, which the two partners aim to answer.

Under the extended agreement, CC-Pharming will be responsible for the development, launch and commercialization of rituximab, taking on the marketing and sales cost, while iBio retains the rights to commercialize its product outside of China.

The two companies also plan to develop additional products for the Chinese market, including research and clinical reagents, non-pharmaceutical skincare products and botanical derivatives.

Furthermore, iBio and CC-Pharming are “evaluating the business feasibility” ​of developing additional biopharmaceutical products for oncology, metabolic disorders, and fibrotic disease, according to iBio.

Showcasing plant-based bio development

iBio will be presenting its plant-based biopharmaceutical developing capabilities, as well as its contract development and manufacturing organisation (CDMO) business, along with its newly-established​ fill/finish services offering, at the upcoming Biotech Week Boston event.

By exhibiting in Boston, Isett told us that the company aims to “tell the story of plant-based protein production, which has for too long been considered an ‘alternative’ to CHO expression system, instead of being a better, mainstream option.”

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