China Regulators Approve Henlius Bevacizumab Biosimilar Hanbeitai

Shanghai Henlius Biotech has received approval for a bevacizumab biosimilar (Hanbeitai) from Chinese regulators. The company said the National Medical Products Administration (NMPA) has approved the product for treatment of metastatic colorectal cancer (mCRC) and unresectable locally advanced recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC).

This makes the fourth Henlius biosimilar to be approved by the NMPA. The others are rituximab (Hanlikang), trastuzumab (Hanquyou), and adalimumab (Handayuan) biosimilars. The trastuzumab biosimilar is approved in the European Union and markets under the product name Zercepac.

Henlius said since the original approvals of these biosimilars, their indications have been broadened to include hematological malignancies, solid tumors, and autoimmune diseases.

Henlius laboratory employees at work.

Henlius is also developing a programmed death (PD) inhibitor (serplulimab) for the treatment of NSCLC and has a clinical trials program in progress to test the drug in combination with bevacizumab. The company said it believes serplulimab may have potential in the treatment of various solid tumors.

Frontline studies of Hanbeitai and the PD-1 monoclonal antibody serplulimab are being conducted in nonsquamous NSCLC (phase 3) and CRC (phase 2).

“Lung cancer and colorectal cancer are ranked second and third with high incidence of cancers in the world, respectively. They are also ranked first and second in China, and there is a huge demand for treatment,” Jason Zhu, president of Henlius, said in a statement.

He said the clinical equivalence trials of Hanbeitai showed the agent was highly similar to the originator drug, Avastin, in terms of efficacy and safety. “It is believed that the approval of Hanbeitai will further improve the accessibility of bevacizumab and provide a high-quality option for patients with lung cancer and colorectal cancer," Zhu said.

Lung cancer and mCRC are common in China. Henlius said that 810,000 cases of lung cancer are diagnosed each year in the country, and NSCLC is the most common form, accounting for 80% to 85% of lung cancer diagnoses.

“The incidence rate of CRC ranks second among all malignant tumors in China, with over 550,000 new cases in 2020,” Henlius said.

Bevacizumab when added to chemotherapy treatment has been shown to delay disease progression and prolong survival in patients with mCRC and is a standard of care, the company said. The drug binds with vascular endothelial growth factor and inhibits the growth of blood vessels that support the growth of tumors.

Bevacizumab for Ophthalmology

Avastin is also used for treatment of eye disease, such as macular degeneration, although the ophthalmology community in the United States has expressed leeriness of using bevacizumab biosimilars for eye disease, owing to the relative lack of supportive clinical evidence.

Henlius said it is developing an ophthalmic product (HLX04-O) that has the same active ingredients as Hanbeitai for the treatment of wet age-related macular degeneration (wAMD). In the first half of this year, phase 3 clinical trials were approved for initiation in Australia, the United States, Singapore, and the EU countries Latvia, Hungary, and Spain. The company has also initiated treatments in a phase 3 trial of HLX04-O in China, also for wAMD.

The Center for Biosimilars® recently interviewed Ping Cao, vice president of Business Development for Henlius, about the company’s biosimilar development plans and, especially, its adalimumab and PD-1 inhibitor programs.