HONG KONG – Celltrion Inc., of South Korea, and Hong Kong-based conglomerate Nan Fung Group Holdings Ltd. said they have built a joint venture named Vcell Healthcare Ltd., geared toward the Chinese market. Under a licensing agreement, Vcell will acquire the exclusive rights in mainland China to develop, supply and commercialize Celltrion's three biosimilar products, Remsima (CT-P13), Truxima (CT-P10) and Herzuma (CT-P6).

Vcell plans to commercialize the biosimilars in China upon receiving regulatory approvals from the authority. Details of the timeline have not been confirmed, according to Celltrion.

"The venture company has been set up to expand Celltrion's market into China as we haven't launched our products in the region yet," a spokesman at Celltrion told BioWorld Asia. "The initial capital of Vcell Healthcare is about $200 million, an investment by Celltrion and Nan Fung Group. Based on the fund, we plan to start building a manufacturing facility in China in the first half of next year while currently looking for the site of the facility."

Remsima is a biosimilar of Remicade (infliximab, Janssen Biotech Inc.), for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease. As the first antibody biosimilar approved in the U.S. and EU, Remsima has been marketed in more than 80 countries.

Referencing Rituxan (rituximab, Biogen Inc. and Roche Holding AG), Truxima is a treatment of blood cancers and inflammatory conditions. Herceptin (trastuzumab, Roche Holding AG) biosimilar Herzuma is indicated for breast cancer. All three biosimilars have received approval from the FDA and EMA, and Herzuma also has been approved in Japan.

To make the first cornerstone of marketing in mainland China, Celltrion built its branch Celltrion Healthcare Hong Kong Ltd. in April.

Founded in 2002, Celltrion has focused on developing antibody biosimilars and novel biologics and also operates contract manufacturing organization services. Besides the three biosimilars, there are currently 11 biologic drugs in its pipeline.

Five of the candidates are for the treatment of pandemic and seasonal influenza, breast cancer, influenza, hepatitis B virus and rabies. Besides infliximab, the Korean drugmaker is also developing five more biosimilars referencing Avastin (bevacizumab, Genentech Inc./Roche Holding AG) and Erbitux (cetuximab, Eli Lilly and Co.) to treat colorectal cancer; Synagis (palivizumab, MedImmune) to treat respiratory diseases; and Humira (adalimumab, Abbvie Inc.) and Enbrel (etanercept, Amgen Inc.) to treat rheumatoid arthritis.

Celltrion is also working on Remsima SC, a subcutaneous version of existing Remsima. The company completed a phase III trial in August and submitted the application to the EMA in November 2018. Data were presented earlier this year at the Congress of the European Crohn's and Colitis Organization. An IND was filed in April with the FDA.

Boosting manufacturing, investments

Celltrion operates two manufacturing plants in Korea. According to the company, they are capable of producing biologics with a scale of more than 1.4 million injections a year. To increase its manufacturing capability, the biopharmaceutical corporation is constructing its third facility that will produce 120,000 liters a year and is expanding the capacity of its first facility to 100,000 liters a year.

The Korean company surprised the global pharmaceutical industry recently by announcing a major investment plan for the next 10 years. In May, Celltrion Chairman Jungjin Seo said the firm would invest KRW40 trillion (US$33.5 billion) by 2030 to develop next-generation biosimilars to treat cancer, expand its manufacturing facilities and tap into big data and AI for novel pharmaceutical products. However, there are doubts as to whether Celltrion will be able to fund the huge investment. (See BioWorld, May 22, 2019.)

Celltrion's new partner, Nan Fung Group, is a private company operating various businesses. The 65-year-old conglomerate has operations in real estate development and investment, life sciences investment, financial service, textile service, hotel and shipping businesses. Nan Fung Life Sciences, the group's global investment platform for life science and the health care sector founded in 2017, has a presence in the U.S. and greater China through direct investment via venture capital firm Pivotal Bioventure Partners LLC. As a member of Nan Fung Life Sciences, Pivotal Bioventure Partners China specializes in pharma and med-tech investment.

The stock price of Celltrion (KRX:068270) rose by KRW4,000 (US$3.40) to KRW184,500 (US$1,569) on the news last Friday.

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