Global pharmas race to introduce bispecific antibodies

to take over Keytruda's throne

BMS secures new drug from German BioNTech, to be developed as lung cancer treatment

Active research on PD-1-VEGF dual-targeting antibodies…Pfizer and MSD also join the competition

Major global pharmaceutical companies are challenging the throne held by the immunotherapy Keytruda with their respective bispecific antibodies.

 

Recently, BMS signed a partnership agreement with Germany's BioNTech to develop a new bispecific antibody, while Pfizer successfully introduced a bispecific antibody from China's 3SBio last month.

 

MSD also secured bispecific antibodies from a Chinese pharmaceutical company in preparation for the post-Keytruda era.

 

According to data released by KoreaBIO on the 4th, BMS recently secured the development rights for BioNTech's bispecific antibody candidate “BNT327.” Under the agreement, BMS will pay BioNTech a contract fee of USD 1.5 billion (approximately KRW 2 trillion) and an additional USD 2 billion in unconditional milestone payments by 2028.

 

The total deal value, including milestones and the upfront payment, amounts to USD 11.1 billion (approximately KRW 15.3 trillion).

 

MSD

BNT327 is a new bispecific antibody that combines two complementary mechanisms of action proven in oncology into a single molecule.

 

This new drug candidate targets both PD-1, the biomarker targeted by the existing Keytruda, and vascular endothelial growth factor (VEGF)-A.

 

By inhibiting VEGF-A, BNT327 is expected to reverse the immune-suppressive effects of tumors in the tumor microenvironment and block the supply of blood and oxygen to tumor cells, thereby preventing tumor growth and proliferation.

 

BNT327 is currently being developed as a first-line treatment for small cell lung cancer and non-small cell lung cancer.

 

According to BioNTech, more than 1,000 clinical trial patients have been treated with the drug to date.

 

BioNTech said in a statement, “Our major global partners are working to set new treatment standards in the anticancer drug market dominated by immunotherapies like Keytruda.” Pfizer also signed a partnership agreement with China's 3Sbio last month to secure SSGJ-707, a bispecific antibody candidate targeting PD-1 and VEGF-A.

 

The upfront payment is USD 1.25 billion, with the total contract value reaching USD 4.8 billion (KRW 6.6 trillion) upon achievement of key milestones.

 

Currently, SSGJ-707 is under clinical trials in China targeting various solid tumors, including non-small cell lung cancer, colorectal cancer, and gynecological cancers.

 

MSD, the developer of Keytruda, has also secured a PD-1 and VEGF-A bispecific antibody candidate.

 

Last November, MSD acquired the new drug candidate LM-299 from China's LaNova Medicine for up to USD 3.3 billion.

 

The contract price was USD 588 million.

 

LM-299 is currently under Phase I clinical trial in China.

 

Will competition intensify for the global sales lead Keytruda?

 

Major global pharmaceutical companies are targeting the market for Keytruda, the global No.1 top-selling drug.

 

Last year, Keytruda's sales reached USD 29.482 billion (approximately KRW 43 trillion), an 18% increase from 2023.

 

Last year, the total sales of major immunotherapy drugs amounted to USD 51.723 billion (approximately KRW 75 trillion), with Keytruda holding 57% of the market share.

 

Keytruda first surpassed USD 10 billion in sales in 2019 and continued to grow, reaching USD 20.937 billion in 2022, successfully breaking the USD 20 billion mark for the first time.

 

Immunotherapies like Keytruda target the PD-1/PD-L1 biomarker expressed in major solid tumors.

 

As a result, their indications are being expanded to various types of solid tumors, leading to a surge in sales.

 

In addition to their efficacy, immunotherapies have the advantage of having fewer side effects.

 

Compared to first-generation cytotoxic anticancer drugs and second-generation targeted anticancer drugs, cancer immunotherapies are known to have fewer side effects.

 

These drugs reinforce the body's own immune system to achieve anticancer effects, resulting in relatively mild side effects such as hair loss, nausea, vomiting, diarrhea, and bone marrow suppression.

 

The industry attributes the growth in Keytruda’s sales to the expansion of indications for Keytruda and its demonstrated efficacy in combination with antibody-drug conjugates (ADCs).

 

Recently, Keytruda has demonstrated efficacy as a combination therapy for first-line treatment of non-small cell lung cancer, leading to a steady increase in prescriptions.

 

Positive clinical results are also emerging for various solid tumors, including breast cancer, stomach cancer, lung cancer, and melanoma.

 

In the domestic market, Keytruda continues to hold the lead in overall pharmaceutical sales.