Vcell Healthcare Limited (Formerly Dingsai Pharma) Files IPO Prospectus to Advance Commercialization of Biosimilars in China

On July 19, 2019, Celltrion, a South Korean company and global leader in biosimilars, announced the establishment of a joint venture with Hong Kong-based Nan Fung Group: Vcell Healthcare Limited. The joint venture will focus on the development, manufacturing, and commercialization of monoclonal antibody biosimilars in China, aiming to address the significant unmet medical needs of Chinese patients by providing world-class, affordable biosimilar products. Nan Fung Group and Celltrion also stated that they would further explore the possibility of building a world-class biologics manufacturing facility in China in the future.

Under the agreement, Dingsai Pharmaceutical Technology Co., Ltd. has obtained rights to three star biosimilar products from Celltrion that are already marketed globally, including Remsima^®、Truxima^®and Herzuma^®Exclusive license for clinical development, manufacturing, and commercialization in China.

Remsima^®Remsima (infliximab biosimilar) is primarily indicated for autoimmune diseases such as rheumatoid arthritis and is the first antibody biosimilar to receive marketing approval from both the U.S. FDA and the European EMA. As one of the best-selling biosimilar products globally for many years, it is currently marketed in more than 80 countries and regions; Truxima^®MabThera (rituximab), the reference product, is primarily indicated for lymphoma and has been approved for marketing in regions such as Europe and South Korea; Herzuma^®Herceptin (trastuzumab), the reference product, is primarily indicated for breast cancer and metastatic gastric cancer and has currently received marketing authorization in regions such as Europe, South Korea, and Japan. Truxima^®and Herzuma^®Received U.S. FDA approval in November and December 2018, respectively.

Biopharmaceuticals have experienced rapid growth in the global market due to their high target specificity and low toxicity and side effects; currently, eight of the top ten best-selling drugs worldwide are biologics. However, the high cost of biologic drugs has increasingly burdened national healthcare systems. In the face of an aging population and rising social expenditures for treating cancer and chronic diseases, biosimilars—which offer comparable efficacy at a more affordable price—have become a key focus of development in Europe and the United States. Countries such as the United States, the United Kingdom, France, and Germany have introduced policies to actively promote the development of biosimilars. As patents on originator biologics gradually expire, high-quality and cost-effective biosimilars are rapidly replacing originator products in European and American markets.

According to IQVIA data, as of the end of 2018, Remsima^®European market share reaches 57%; Truxima^®As the world’s first oncology biosimilar, it captured a 27% market share within one year of its 2017 launch in Europe, reaching 36% by the third quarter of 2018. According to research by the international medical consulting firm IMS, biosimilars are projected to help reduce global healthcare expenditures by up to $110 billion by 2020.

In China, major monoclonal antibody biologics for the treatment of advanced cancers have gradually been included in the National Reimbursement Drug List through centralized procurement negotiations in recent years, reducing patients’ out-of-pocket expenses. Nevertheless, it is undeniable that the financial burden on both the medical insurance system and patients remains substantial. Domestic production of monoclonal antibody biosimilars is still in its early stages, with most candidates remaining in the research and development phase, unable to meet patient needs and market demand in the short term. In line with developments in Europe and the United States, accelerating the introduction of advanced international monoclonal antibody production technologies, as well as high-quality, cost-effective biosimilars, will be a beneficial choice for both the nation and its people.

Currently, Dingsai Pharmaceutical Co., Ltd. has fully launched Remsima in China^®Phase III clinical registration study, the company stated that it will strive to promote including Remsima^®including three high-quality biosimilar products, to obtain approval from Chinese regulatory authorities as soon as possible and serve the vast number of patients in China at an early date.

“We are thrilled about the establishment of Dingsai Pharmaceutical Co., Ltd. Dingsai Pharmaceutical will serve as the cornerstone for Celltrion’s entry into the Chinese market and its service to Chinese patients,” said Mr. Seo Jung-Jin, Chairman of Celltrion Group. “We will make every effort to expand our business in China as soon as possible, providing Chinese patients with high-quality biosimilar products that have already been approved for marketing in global markets such as the United States, Europe, and South Korea.”

“There is a huge unmet medical need in China for high-quality medicines at reasonable prices,” said Mr. Leung Kam-song, Chairman and CEO of Nanyang Holdings Group. “We hope that Dingsai Pharmaceutical Co., Ltd. can bring world-leading biosimilar products to Chinese patients, and meet the growing domestic demand for high-quality CDMO services by establishing a world-leading biologics manufacturing base in China.”

Headquartered in Incheon, South Korea, Celltrion is a leading biopharmaceutical company specializing in the research, development, and manufacturing of biosimilars and innovative drugs. Celltrion is committed to providing high-quality, affordable antibody biosimilars to patients who previously lacked access to costly large-molecule drug therapies. Celltrion has received approval from both the FDA and the EMA for Inflectra^®and Remsima^®approval, making it the world’s first monoclonal antibody biosimilar to gain approval from regulatory authorities in developed countries.

Nan Fung Group, founded in 1954, is a diversified conglomerate integrating real estate development and investment, life sciences investment, and financial investment. As a member of Nan Fung Group, Nan Fung Life Sciences is a global investment platform dedicated to the life sciences sector. Leveraging Nan Fung Group’s substantial financial strength and long-term commitment to biotechnology, the company strives to become the preferred partner for scientists, entrepreneurs, companies, and investors in the life sciences field. Through direct investments via Nov8 Capital (spanning the United States and China) as well as fund and private equity investments covering the entire biotechnology industry—including drug development, medical devices, and diagnostics—across various stages of development, Nan Fung Life Sciences has emerged as a significant investment force in the life sciences sectors of the United States and Greater China.

Dingsai Pharmaceutical Technology Co., Ltd., headquartered in Shanghai, is a biopharmaceutical company focused on the development, manufacturing, and commercialization of monoclonal antibody biosimilars in China. The company is committed to addressing the unmet medical needs of Chinese patients by providing high-quality biosimilars that are world-class and affordably priced. Dingsai Pharmaceutical Technology Co., Ltd. was established in 2019 as a joint venture between Hong Kong’s Nan Fung Group and South Korea’s Celltrion, Inc.