Bispecific Antibody Becomes a Hotspot for Pharmaceutical Research in China

by Grace Wang Nov 25, 2022

Introduction to BsAb Drugs

Bispecific antibody (BsAb) is an artificial protein that can simultaneously bind to two different antigens or two epitopes on the same antigen.

Compared to traditional monoclonal antibody that can bind only to the same epitope on the antigen, BsAbs are more capable of identifying cancer cells and binding to antigens that are expressed weakly.

On the other hand, BsAbs contain toxicity which may induce cytokine release syndrome and neurotoxicity. Besides, BsAbs are limited by drug resistance because of target loss, insufficient immune response, and higher immune checkpoints.

Overall, BsAbs can be applied to therapeutic treatment, clinical diagnostics, and medical imaging. Though relatively new among cancer therapies, BsAb drugs have a hotspot for research. Globally, more than 700 BsAb drugs are under research.

Status Quo in China

The passion of developing BsAb drugs has also been ignited in China, where over 300 BsAb drugs are being developed, among which nearly 100 have entered the clinical trial stage. By 2030, the Chinese BsAb market is expected to reach 10.8 billion USD.1

Currently, eight BsAb drugs have been approved worldwide, by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or China National Medical Products Administration (NMPA), respectively.

Among the eight products, three have been approved in China. Cadonilimab is the only one developed by a Chinese company, that is, Akeso. Priced at 13,220 yuan (about 1,847 USD) for 125mg/vial, Cadonilimab is estimated to cost no more than 198,000 yuan annually.2

BsAb Drugs with Marketing Authorization

Name (Brand)

Company

Target

Year of Approval

Indication

FDA

EMA

NMPA

Catumaxomab

(Removab)

Trion

EpCam×

CD3

-

2009 (withdrawn from the market in 2017)

-

Malignant ascites

Blinatumomab

(Blincyto)

Amgen

CD3×

CD19

2014

2015

2020

Acute lymphoblastic   leukemia

Emicizumab

(Hemlibra)

Roche

FIX×

FX

2017

2018

2018

Hemophilia A

Amivantamab

(Rybrevant)

J&J

EGFR×

cMet

2021

2021

-

Non-small cell lung cancer

Faricimab

(Vabysmo)

Roche

ANGPT2×

VEGFA

2022

2022

-

Neovascular age-related macular degeneration; diabetic macular edema

Mosunetuzumab

(Lunsumio)

Roche

CD20×

CD3

-

2022

-

Follicular lymphoma

Cadonilimab

(Kai Tan Ni)

Akeso

PD-1

×CTLA-4

-

-

2022

Cervical cancer

Teclistamab

(Tecvayli)

J&J

BCMA×

CD3

2022

2022

-

Multiple Myeloma

In the future, more BsAb drugs are expected to be approved in China, as over 30 domestic pharmaceutical companies, including Hengrui, Alphamab Oncology, and BeiGene, have already developed pipelines for BsAbs.

Chinese Market: Opportunities and Challenges

China's overall regulatory environment is favorable for BsAb drug's R&D. To develop and market BsAb drugs in China, companies are recommended to apply for expedited approval programs that China grants to clinically significant drugs. Companies should also refer to official guidelines such as Technical Guidelines on Clinical Development of Bispecific Antibody Drugs for Cancer during R&D.

In addition, companies need to consider pricing. As commercial medical insurance in China are not very mature, companies may choose to negotiate with the National Healthcare Security Administration (NHSA) to make the drug included into the National Reimbursement Drug List, a list of drugs reimbursed by social healthcare insurance. Under such a circumstance, price cut would be a necessity.

Grace Wang
ChemLinked Regulatory Analyst
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