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Fosun Pharma Has Opened a New Era for Biosimilar in China Henlius Receives NMPA Approval for Its First Product HLX01

02-25 2019
Recently, HLX01 (rituximab injection), independently developed by Shanghai Henlius Biotech, Inc.(Henlius), Fosun Pharma’s biologics platform, has granted approval by the China National Medical Products Administration (NMPA). This product is the first approved biosimilar in China, which is mainly used for the treatment of non-Hodgkin's lymphoma (NHL).

Lymphoma is one of the most common form of hematological malignancy. The incidence rate of lymphoma in China is about 5.94 out of every 100,000 people, and about 90% of the cases are non-Hodgkin's lymphoma (NHL), of which the incidence is growing every year. Over many years, non-Hodgkin’s lymphoma (NHL) patients and their families have borne extremely high financial burdens, and they are always looking for drugs that have a price advantage while offering guaranteed quality, safety and effectiveness. The approval of HLX01 has filled the gap in China’s market for biosimilar, may improve accessibility to high-quality biological medicine and has the potential to help many patients with lymphoma.

“We are proud to receive approval for the first China biosimilar product,” said Scott Liu, Ph.D., Co-founder, President and Chief Executive Officer at Henlius. “We have been working diligently on the HLX01 launch plan to ensure HLX01 will be covered by the public health insurance as soon as possible; therefore, many patients will be able to afford and have access to this high-quality biosimilar drug.”

Henlius is a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in February 2010, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and auto-immune disease.

To encourage the development of biosimilars, the China government has drafted and published a series of policies including the Technical Guideline for the Development and Evaluation of Biosimilars (draft) to regulate the development, registration, efficacy and safety of such drugs in recent years. Biosimilars are biological products with similar therapeutic effects to an already-approved reference drug in terms of quality, safety and efficacy. Unlike generic drugs that can reproduce identical to the originator drug, biological drugs have larger molecule weight with complex structures and physical/chemical properties which are more sensitive to the environment. Therefore, researchers need to explore the production process of biosimilars through reverse engineering to find the right cultivation environment for cells, and prove through head-to-head comparative studies that the biosimilars are highly similar to the originator products in terms of clinical pharmacology, efficacy and safety.

The NMPA approval is based on a comprehensive submission data package of extensive analytical characterization, non-clinical data and three clinical trials (Phase 1a, 1b and 3) evaluating clinical pharmacology, immunogenicity, clinical safety and efficacy data which demonstrated a high degree of similarity for HLX01 and the originator product.

“Persistence is the key to success,” said Brian Chen, Chairman of Fosun Pharma “The approval of HLX01 has opened a new era of biosimilar in China, which is also a milestone for Fosun Pharma. Good products are inseparable from the continuous R&D investment and innovation. In the future, we will continue to take responsibility for providing affordable access to high quality products.”

Fosun Pharma always regards innovation as the driving force for its business growth. At present, Fosun Pharma has formed an international R&D layout and strong R&D capabilities through an efficient international R&D team in China, the United States, and India. The Group continues to increase its R&D investment in monoclonal antibody biologic innovative drugs, biosimilars and small-molecular innovative drugs, and pushes forward consistency evaluation projects. From January to September 2018, R&D expenses totally increased 59.13 % as compared to the corresponding period of 2017 to RMB 1.114 billion. In the future, Fosun Pharma will continue to address unmet medical needs, build the global innovation capability, and provide better, more convenient, more accurate and more affordable products and services to customers around the globe.

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