7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas.

Highlights of new drug approvals in 2024 include:

1. Oncology:

• The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine.
• PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin.

2. Autoimmune diseases:

• IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis.

3. Rare diseases:

• Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH).

Blockbuster drugs expected to be approved in 2025 include:

Oncology:

Amivantamab (Q1)

The world’s first c-Met/EGFR bispecific antibody.

Highlight: Phase III study showed significant extension of median progression-free survival (mPFS).

Talquetamab (Q2)

A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D.

Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%.

Zanidatamab (Q2)

A HER2-targeting bispecific antibody based on Azymetric™ technology.

Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%.

Inavolisib (Q3)

Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer.

Asciminib (Q3)

Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML).

SHR-1701 (Q4)

A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer.

Phase III study demonstrated significant extension in median overall survival.

MRG003 (Q4)

China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma.

Endocrinology and Metabolism:

Tenapanor (Q1)

The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients.

Trend Analysis:

Continued Innovation in Oncology:

The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse.

Breakthroughs in Autoimmune and Rare Diseases:

New biologics are gradually addressing drug resistance and limited treatment options in previous therapies.

Emergence of Domestic Innovative Drugs:

Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies.

The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.