Twelve Breakthrough Anti-Tumor Innovative Drugs Expected to Gain Approval in China in 2026

The 2024 annual drug evaluation report released by the National Medical Products Administration (NMPA) shows that in 2024, the Center for Drug Evaluation (CDE) of the NMPA accelerated the drug marketing registration process. By enhancing communication with applicants, it shortened the time for drug development and technical evaluation, expediting the approval of new and effective drugs urgently needed in clinical practice. The review period for applications under the priority review and approval process was reduced from the standard 200 days to 130 days, with applications for urgently needed rare disease drugs already marketed overseas further shortened to 70 days. On September 12, 2025, the NMPA implemented a 30-working-day review and approval system for innovative drug clinical trial applications, once again speeding up the new drug development process.

Insight database predicts that by 2026, 12 heavy-weight innovative anti-tumor drugs with applications for marketing approval included in the priority review and approval process are expected to be approved for the first time in China. These drugs target treatments for various cancers such as mantle cell lymphoma, non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, solid tumors, intrahepatic cholangiocarcinoma, nasopharyngeal carcinoma, biliary tract cancer, tenosynovial giant cell tumor, and multiple myeloma.

Three Innovative Drugs for Hematologic Malignancies May Be Launched This Year

In hematological malignancies, three innovative drugs are expected to be approved for marketing this year, respectively.BeOne MedicinesSotorasib, Lobutinib from Lupeng Pharmaceutical, and Mabalant Monoclonal Antibody from GSK.

Sotoclax is BeOne Medicines' next-generation BCL2 inhibitor, indicated for chronic lymphocytic leukemia/small lymphocytic lymphoma. Its marketing application was accepted by the CDE in April of last year and included in the priority review and approval process. This drug is another self-developed product for hematological tumors by BeOne Medicines following zanubrutinib. Sotoclax addresses many unmet needs of patients with chronic lymphocytic leukemia and provides new possibilities for improving patient outcomes.

Lobutinib is a fourth-generation covalent and non-covalent BTK inhibitor that can overcome various resistance issues caused by BTK mutations against first, second, and third-generation BTK inhibitors. On May 28, 2025, the drug's marketing application was accepted and included in the priority review for the treatment of adult patients with mantle cell lymphoma who have previously received BTK inhibitor therapy. The drug is also being developed for various hematological tumor indications (such as marginal zone lymphoma, diffuse large B-cell lymphoma, etc.), as well as non-oncology indications like chronic urticaria, multiple sclerosis, and neuromyelitis optica.

Belantamab mafodotin, an ADC (antibody-drug conjugate) targeting B-cell maturation antigen (BCMA) developed by GSK, is used for the treatment of multiple myeloma and was approved for marketing in the United States in October last year. In December 2024, the new drug application for the combination of this drug with bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma was accepted by the National Medical Products Administration (NMPA) and included in the priority review.

Two Solid Tumor Cell Therapies May Be Launched This Year

In terms of gastrointestinal tumors, two innovative drugs are expected to be approved for marketing this year, namely, Surugicel from CARsgen Therapeutics and Anitumab from CSPC/Alphamab Oncology, with indications including gastric cancer and adenocarcinoma of the esophagogastric junction.

Among them, Anilitamab is the first domestically produced HER2 bispecific antibody to be submitted for marketing in China. Its marketing application was accepted in September last year and has been included in the priority review by the CDE. The indication is for use in combination with chemotherapy for HER2-positive locally advanced, recurrent, or metastatic gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least one systemic treatment.

Surugenlecleucel is an autologous CAR-T cell therapy targeting Claudin18.2, intended for development to treat Claudin18.2-positive solid tumors, primarily gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer. On June 26, 2025, the drug's marketing application was accepted for the treatment of patients with advanced gastric/esophagogastric junction adenocarcinoma who are Claudin18.2 expression-positive and have failed at least two prior lines of therapy. This application has been granted priority review. Surugenlecleucel is also the world’s first CAR-T cell therapy product for solid tumors to be submitted for marketing approval.

In the field of cell therapy for solid tumors, another innovative therapy—CIK cell therapy—is expected to emerge this year. The conditional new drug marketing application for Eternity Bio's Aikelunsa was accepted on March 31 last year for use in high-risk populations of postoperative recurrence after curative resection of primary hepatocellular carcinoma, aiming to prevent postoperative recurrence. According to the Insight database, Eternity Bio's Aikelunsa is the first domestically produced cell therapy for solid tumors to be submitted for marketing in China. Currently, no CIK cell therapy products have been approved for marketing in China, and no cell therapies have been approved for use in solid tumors.

Another drug in the field of solid tumor treatment is Anruitini, developed by Vcare Pharma. This drug is a small-molecule targeted anti-tumor innovative medicine and belongs to a new generation of TRK inhibitors. It has the potential to address secondary resistance issues that arise with first-generation drugs targeting the same site. In May last year, it was included in the priority review list. In July of the same year, the domestic (China) marketing application for the drug was accepted, targeting patients aged 12 years and above with solid tumors who carry the NTRK fusion gene, have locally advanced or metastatic disease, or face severe complications from surgical removal, as well as those without satisfactory alternative treatments or who have failed previous treatments.

In addition, in the field of hepatobiliary system tumors, TangoTX's Tengotinib and Hutchmed's Vanligatinib are also expected to be approved for marketing this year. On December 19, 2025, the New Drug Application (NDA) of TangoTX’s Tengotinib was accepted by the National Medical Products Administration (NMPA), intended for the treatment of adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have previously received at least one systemic therapy and FGFR inhibitor treatment. Previously, this indication of Tengotinib had been approved for inclusion in the priority review list and breakthrough therapy list. The indication submitted by Hutchmed’s Vanligatinib for marketing approval is second-line treatment of intrahepatic cholangiocarcinoma, which was accepted by the NMPA in December 2025 and included in the priority review.

In the field of nasopharyngeal cancer treatment,Baili TianhengBL-B01D1, developed by CSPC, is also expected to be approved for marketing this year. This drug is the world’s first EGFRxHER3 bispecific antibody-drug conjugate (ADC). Its marketing application was accepted in November of last year and has been included in the priority review process for treating patients with recurrent or metastatic nasopharyngeal carcinoma, making it the world’s first and currently only bispecific ADC submitted for marketing approval.

Two New Drugs Approved Overseas May Be Launched in China This Year

In the field of major cancer lung cancer treatment, Bayer's BAY 2927088, which was approved for marketing in the United States in November last year, submitted its marketing application in China in July last year and was accepted. It targets HER2-mutated advanced non-small cell lung cancer. This drug is an oral small molecule tyrosine kinase inhibitor (TKI) developed by Bayer, and has received breakthrough therapy designation in both China and the United States. It is expected to become a new targeted treatment option for non-small cell lung cancer patients with HER2-activating mutations.

Daiichi SankyoPexidartinib, which was approved for marketing in the U.S. in 2019, targets a rare benign but invasive tumor—tenosynovial giant cell tumor. This drug is a small-molecule tyrosine kinase inhibitor and is the world’s first approved treatment for tenosynovial giant cell tumor. Its application for marketing in China was accepted in January of last year and has been included in the priority review process.

Information disclosed on the official website of the National Medical Products Administration in November 2025 shows that, since the "14th Five-Year Plan," China has approved 220 innovative drugs for marketing.Innovative HealthcareThe number of medical devices reached 282, which is 6.2 times and 3.1 times the figures during the "13th Five-Year Plan" period, respectively. A total of 415 pediatric drugs and 155 rare disease drugs have been approved for marketing, along with 28 innovative traditional Chinese medicine drugs. The vitality of innovation in the pharmaceutical industry continues to grow. During the "15th Five-Year Plan" period, drug regulatory authorities will adhere to the combination of an effective market and a proactive government, respect the position of pharmaceutical enterprises as innovation leaders, support companies in strengthening the R&D layout of innovative drugs and devices, and help transform new pharmaceutical technologies into new productive forces.

Reporter Wang Kala from The Beijing News

Proofread by Zhai Yongjun