ith the tremendous development of China’s innovative drug industry as backdrop, 2025 saw the number of new drugs approved by the National Medical Products Administration (NMPA)—the country’s regulatory authority—reach triple digits for the first time, an increase that was driven primarily by therapies developed domestically. The new entrants cover an array of different modalities, therapeutic areas, and developers, showcasing the maturity and increasing diversification of China’s pharmaceutical landscape.

Established Modalities Maintain a Larger Presence

As in previous years, in 2025, small molecules represented the mainstream of new drugs authorized by the NMPA, accounting for 60% of the total with 72 products. Similarly, mAbs claimed 15% of approvals (18 products) thanks to their long-validated technology.

Representing a smaller share were the more innovative modalities. BsAbs and peptide therapies saw four new entrants each, while ADCs, cell therapies, and fusion proteins received three approvals each.

ADC=antibody-drug conjugate; BsAb=bispecific antibody; mAb=monoclonal antibody.

The Cancer Sector Continues to Attract the Most Players

The oncology field last year continued as the hot spot for innovative drug approvals in China. Breast cancer was the most active area with a total of nine new entrants, including the PI3Kα inhibitor inavolisib, the AKT inhibitor capivasertib, the TROP2- and HER2-targeted ADCs datopotamab deruxtecan and trastuzumab botidotin respectively, as well as multiple CDK inhibitors, namely bireociclib, lerociclib, tibremciclib, fovinaciclib, and culmerciclib.

In addition to breast cancer, multiple breakthrough therapies have been launched in other solid tumor indications such as non-small cell lung cancer (NSCLC), prostate cancer, and ovarian cancer. These innovative targeted treatments include the EGFR/c-Met-targeted amivantamab, the KRAS^G12C inhibitor glecirasib, the VEGF-A-directed biologic sevacizumab, as well as the radiopharmaceuticals lutetium Lu 177 vipivotide tetraxetan and ⁶⁸Ga-gozetotide.

ADC=antibody-drug conjugate; BsAb=bispecific antibody; mAb=monoclonal antibody.

Outside the oncology field, cardiovascular (CVD) and metabolic diseases were another important area for new drug approvals in 2025. Among them, six new drugs were launched for type 2 diabetes (T2D), including the DPP-4 inhibitor prusogliptin, the anti-CD3 biologic teplizumab, the GLP-1R agonist efsubaglutide α, as well as the combination therapies retagliptin + henagliflozin + metformin and retagliptin + metformin. Notably, mazdutide was not only cleared for T2D but also for weight loss, subsequently reaching blockbuster status in the field of metabolism.

The number of innovative drug products approved in the rare disease and immune disease fields continues to increase. Throughout last year, multiple rare disease treatments such as the gene therapy dalnacogene ponparvovec, the siRNA drug fitusiran, and the enzyme replacement therapy velaglucerase β entered the Chinese market, bringing life-saving drugs to these patients. Meanwhile, the immunology field welcomed new entrants such as risankizumab, rozanolixizumab, and remibrutinib.

Domestic Players Account for Most of China’s Approvals

In 2025, China’s innovative drug industry continued its strong development momentum and was responsible for 81% of the increase in new entrants, marking the first time that local product approvals outnumbered foreign arrivals.

Among the 120 new medicines cleared by the NMPA, 63 came from domestic developers, representing 52% of the total. These local players cover various modalities such as small molecules, antibodies, and cell therapies, while their therapeutic areas span key fields such as oncology, metabolism, immunology, and rare diseases.

The rise of China-originated innovative drugs is reflected not only in quantity but also in the multiple innovation breakthroughs these products achieved. In 2025, mazdutide, the world’s first approved GLP-1R/GCGR dual agonist, was successfully launched. In addition, the recombinant human papillomavirus (HPV) 9-valent vaccine was approved, standing out as the first nonavalent HPV vaccine launched in China. Finally, lisaftoclax was approved as China’s first Bcl-2 inhibitor indicated for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

At the company level, some Chinese developers stood out due to their innovation output capacity. The top-ranking domestic company had nine new drugs approved, covering seven small molecules, one ADC, and one mAb; several other companies also had multiple products authorized, forming an echelon of diversified, innovative pharmaceutical companies.

Notably, 61 drugs obtained their first global approval in China, their modalities ranging from small molecules and mAbs to vaccines, ADCs, cell and gene therapies, peptides, and fusion proteins. Although these China-first products come mainly from local developers, they also include five molecules from US originators: the CDK4/CDK6 inhibitor lerociclib, the PI3K/HDAC inhibitor ifupinostat, the antiviral olgotrelvir, the myosin inhibitor aficamten, and the anti-VEGF-A mAb sevacizumab.

Big Pharma Continues Betting on the Chinese Market

Despite falling behind Chinese therapies for the first time, the number of imported drugs obtaining NMPA approval last year increased slightly to 57, a 48% share. These cover a wide range of therapeutic areas and modalities and include many first-in-class molecules such as fitusiran, the world’s first antithrombin-targeting siRNA therapy; and caplacizumab, the world’s first nanobody drug developed for immune thrombotic thrombocytopenic purpura (iTTP).

The leading multinational corporation saw six new drugs approved in China, including three small molecules, two radiopharmaceuticals, and one mAb; several other pharma multinationals also launched multiple new drugs, continuing to deepen their innovation strategy in China.

Going forward, with the continuous optimization of China’s review and approval system and the continuous improvement of local innovation capabilities, the country is expected to welcome more high-quality new drugs to meet the needs of its patient pool.

Appendix: New drugs approved by the NMPA in 2025