In 2025, China's innovative drug sector delivered an impressive performance, with the National Medical Products Administration approving 76 innovative drugs for marketing throughout the year. Among them, 34 new drugs dominated the oncology field, highlighting the sustained vigorous research and development vitality and clinical demand in the field of cancer treatment. From breast cancer to hematological cancer to lung cancer, the approval of a series of new drugs is reshaping the landscape of cancer treatment, bringing more hope for survival to patients.
According to data statistics, there are 9 new drugs for breast cancer, including 3 CDK4/6 inhibitors and 2 CDK2/4/6 inhibitors, as well as the first AKT inhibitor in China, Capicetide Tablets, and 2 antibody-drug conjugates (ADCs) targeting Trop2 and HER2, respectively, namely Dardapotide Injection and Boduxutuzumab Injection, providing new options for breast cancer patients in different treatment scenarios.
In April 2025, AstraZeneca's Kapisilte, in combination with Fulvestrant, was approved in China for adult patients with locally advanced or metastatic breast cancer who have progressed after at least one endocrine therapy for metastatic disease, or who have relapsed during or within 12 months after adjuvant therapy, and who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and have one or more PIK3CA/AKT1/PTEN alterations. This drug is the first AKT inhibitor approved in China for breast cancer patients with any specific biomarker (PIK3CA, AKT1, or PTEN) alterations.
In August, the National Medical Products Administration officially approved a new indication for the injectable drug Dardapotam (Chinese brand name: Dazhuoyou), which is used to treat adult patients with unresectable or metastatic breast cancer who have previously received endocrine therapy and have undergone at least one line of chemotherapy for advanced disease, and are hormone receptor (HR)-positive and (HER2)-negative. As a novel antibody-drug conjugate (ADC) targeting TROP2, the approval of this product marks a significant step towards enhancing treatment diversity and providing more treatment options for breast cancer patients.
Eight new drugs have been approved in the field of hematological oncology, including two domestic Bcl-2 inhibitors, Lisaftoclax Tablets and Sotoclax Tablets, which are designed to provide updated high-cure-rate treatment options for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and mantle cell lymphoma. Among them, Lisaftoclax Tablets (APG-2575 Tablets, Lisaftoclax, trade name: Lisentuo®) is a novel selective Bcl-2 inhibitor independently developed by Suzhou Ascentage Pharma. By inhibiting Bcl-2 protein, it restores the normal apoptosis process of cancer cells, thereby exerting anticancer effects. It has been proven to have clear antileukemic activity in patients with chronic lymphocytic leukemia (CLL) and good tolerability. It is reported that this drug has been granted five orphan drug designations by the US Food and Drug Administration (FDA), covering a wide range of diseases including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), acute myeloid leukemia (AML), follicular lymphoma (FL), and Waldenström macroglobulinemia.
In addition, two CD19-targeted CAR-T cell therapies have been approved for the treatment of B-cell lymphoma in the field of hematological oncology, bringing the total number of domestically produced CAR-T therapies in the Chinese market to seven. For example, on November 28th, Heyuan Biotech announced that its self-developed CAR-T cell therapy product, Nacirogensai Injection (brand name: Yuanruida®), has been approved by the National Medical Products Administration of China for the marketing of a new drug, intended for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or higher systemic treatment. This is another new drug approval for Nacirogensai Injection in China, following its approval in November 2023 for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). It marks that China's CD19 CAR-T products with fully independent intellectual property rights have become the first CAR-T cell therapy products in China to cover both leukemia and lymphoma, two major hematological oncology indications.
In addition, six innovative drugs in the lung cancer drug field have been approved for marketing. For example, Ailisi's Ailisi® (KRAS G12C inhibitor, Goleleisai Citrate Tablets) was approved for marketing by the NMPA in May 2025, for use in adult patients with advanced non-small cell lung cancer (NSCLC) who have undergone at least one systemic treatment and have KRAS G12C mutations. This is another innovative lung cancer drug approved for marketing by Ailisi, which will bring new treatment options to patients with KRAS G12C-mutated NSCLC and reshape the treatment landscape for KRAS G12C mutations. It is reported that besides Goleleisai Citrate Tablets, the lung cancer drug field mainly focuses on traditional large targets such as HER2 and EGFR.
Among other drugs targeting solid tumors, there are three new drugs for gynecological tumors, specifically ovarian cancer and cervical cancer, as well as one new drug each for hepatocellular carcinoma, biliary tract cancer, prostate cancer, and nasopharyngeal carcinoma. The explosive growth of innovative cancer drugs in 2025 is not only a result of the deepening reform of drug approval in China, but also a reflection of the improvement in research and development capabilities of pharmaceutical companies.