Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.
Celltrion said this week it created a joint venture company in order to pursue the commercialization of 3 biosimilars in China.
Celltrion formed Vcell Healthcare Limited with Nan Fung Group; Vcell also signed a licensing agreement with Celltrion.
Vcell will obtain the exclusive rights in mainland China to develop, manufacture and commercialize 3 biosimilar products from Celltrion: CT-P13 (Remsima, Inflectra, an infliximab product referencing Remicade), CT-P10 (Truxima, a rituximab product referencing Rituxan) and CT-P6 (Herzuma, a trastuzumab product referencing Herceptin).
In addition, Celltrion and Nan Fung Group will explore the opportunity to develop a biologics manufacturing facility in China.
CT-P13, approved in the European Union and the United States is sold in more than 80 countries worldwide. Truxima is also approved in the United States and in Europe; Herzuma carries those approvals as well as approvals in Japan.
Vcell aims to launch the products quickly after following China’s regulatory approval process. If approved, the 3 would join the 1 other approved biosimilar in China, a biosimilar rituximab approved in February 2019 (Henlius’ HLX01). Approval of this rituximab product was a milestone for the Chinese market, as it was not only the first rituximab biosimilar to be approved in the market, but also the first biosimilar to be cleared under the country’s biosimilar approval pathway.
Executives from the 2 companies were enthusiastic about the announcement.
"We are extremely excited about the establishment of Vcell Healthcare Limited, which will serve as the cornerstone for our entry into the Chinese market,” said Seo Jung-Jin, Celltrion’s chairman, in a statement. “We will make our best efforts to start business in China as soon as possible and provide Chinese patients with our outstanding biosimilar products which have already been approved in the global markets such as the US, Europe, and South Korea."
"China has huge unmet medical needs for high quality drugs with affordable prices,” added Antony Leung, chairman and chief executive officer Nan Fung. “We hope Vcell Healthcare Limited could bring world-class biosimilar products to benefit Chinese patients and establish a state-of-the-art manufacturing base in China to serve growing demand for high quality CDMO in the country."