Product-Marketed Products

HANLIKANG

Rituximab Injection

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 the Technical Guideline for the Development and Evaluation of Biosimilars (Tentative) issued in 2015. As of now, HANLIKANG has been approved by the 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.

Drug Instruction

HANQUYOU（Zercepac^® in Europe，Trade names in Australia: Tuzucip^® and Trastucip^®）

Trastuzumab

HANQUYOU (trastuzumab, Zercepac® in Europe，Trade names in Australia: Tuzucip® and Trastucip®) was successfully launched in China and Europe, becoming the first Chinese mAb biosimilar entering both the EU and China market. It is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. HANQUYOU is certificated by China and the EU GMP. It brings more treatment options to patients with HER2 positive breast and gastric cancer worldwide.

Drug Instruction

HANDAYUAN

Adalimumab Injection

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.

Drug Instruction

HANBEITAI

Bevacizumab Injection

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 sNDAs of HANBEITAI for recurrent glioblastoma hepatocellular carcinoma were filed and accepted by the NMPA. The company also plans to file sNDAs for other indications, including, cervical cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in 2022, to benefit a broader patient population.

Drug Instruction

HANSIZHUANG

Serplulimab Injection

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. 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.

Drug Instruction

金年会