壹定发(EDF)最新

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.

HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe) was successfully launched in the U.S., China and Europe, becoming the Chinese mAb biosimilar entering the U.S., 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 and brings more treatment options to patients with HER2 positive breast and gastric cancer worldwide.

HANBEITAI (bevacizumab injection) was approved by the NMPA in November 2021. It is indicated for metastatic colorectal cancer (mCRC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), recurrent glioblastoma, cervical cancer, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. Proposed to be combined with HANSIZHUANG (PD-1) for immuno-oncology combination therapies to treat various tumors.

HANSIZHUANG (serplulimab injection, anti-PD-1 mAb), company’s first self-developed innovative monoclonal antibody, was launched in 2022. It has been approved by the NMPA for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous non-small cell lung cancer (nsqNSCLC) and gastric cancer (GC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC and for the treatment of perioperative gastric cancer. 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 worldwide, covering a wide range of indications in the fields of lung cancer and gastrointestinal tumours, etc. 

HANNAIJIA (neratinib), an orally administered small-molecule pan-HER tyrosine kinase inhibitor (TKI), was approved by NMPA in June 2024, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. It can be used as sequential therapy after completion of HANQUYOU (trastuzumab) that is self-developed by the company to further reduce the risk of recurrence for patients with early-stage HER2-positive breast cancer.

FUTUONING (Fovinaciclib), a novel CDK4/6 inhibitor, received approval from NMPA in May 2025. Its currently approved indications are as follows: 1) for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy; 2) in combination with fulvestrant for the treatment of adult patients with HR-positive,  HER2-negative recurrent or metastatic breast cancer with disease progression following endocrine therapy. Henlius is responsible for the commercialization of FUTUONING in China.

BILDYOS^® (denosumab), independently developed and manufactured by Henlius, has been approved in the United States and the European Union, marking the first “China-origin” denosumab approved in ex-China markets. The product is approved for all five indications of the reference product, including osteoporosis, offering more treatment options for the growing aging population.

BILPREVDA^® (denosumab), independently developed and manufactured by Henlius, has been approved in the United States and the European Union, marking the first “China-origin” denosumab approved in ex-China markets. The product is approved for all three indications of the reference product, including cancer-related bone disease, offering more treatment options for the growing aging population.

HANBEIYOU (pertuzumab, trade name in US and Europe: POHERDY^®), independently developed and manufactured by Henlius, has been approved for marketing successively by the US Food and Drug Administration (FDA), the European Commission (EC), and the China National Medical Products Administration (NMPA) in November 2025, April 2026, and May 2026, respectively, making it a China-developed pertuzumab approved in China, the European Union, and the United States. It is also the first pertuzumab biosimilar approved in the US and EU. The product is approved in China for use in combination with trastuzumab and chemotherapy for neoadjuvant treatment of HER2-positive locally advanced and early breast cancer, as well as adjuvant treatment for HER2-positive early breast cancer at high recurrence risk. It is also indicated for HER2-positive metastatic breast cancer in patients with no prior anti-HER2 therapy. This covers all approved indications of the reference pertuzumab injection in Chinese mainland.