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HANLIKANG (rituximab injection) is the company's first proprietary product. It is the first-ever China-manufactured biosimilar approved by the NMPA in accordance with Technical Guideline for the Development and Evaluation of Biosimilars (Tentative) issued in 2015. As of now, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis for which the originator rituximab has not been approved in China, benefiting a wider patient population with differentiated strategies.
HANQUYOU(Zercepac® in the EU,Trade names in Australia: Tuzucip® and Trastucip®)
The Company's first product indicated for the treatment of autoimmune diseases. HANDAYUAN (adalimumab injection) was approved by the NMPA in December 2020. It is indicated for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. It is the first China-developed adalimumab biosimilar that is manufactured in a China and Europe GMP certificated manufacturing site, as well as the only adalimumab biosimilar evaluated in a Phase 3 clinical study among Chinese patients with plaque psoriasis.
HANBEITAI, Henlius’ fourth product, was approved by the NMPA to treat metastatic colorectal cancer (mCRC) and advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) in November 2021, providing an alternative option to patients. Furthermore, the sNDA of HANBEITAI for recurrent glioblastoma was filed and accepted by the NMPA. The company also plans to file sNDAs for other indications, including hepatocellular carcinoma, cervical cancer, recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in 2022, to benefit a broader patient population.
HANSIZHUANG (serplulimab injection, anti-PD-1 mAb), company’s first self-developed innovative monoclonal antibody, was approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors in March 2022, providing an alternative treatment option for patients with MSI-H solid tumors. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company and innovative therapies, and has initiated many clinical trials on immuno-oncology combination therapies of HANSIZHUANG worldwide, covering a wide range of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc.
Adverse Drug Event Reporting
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