2026 is destined to be an extraordinary year in the history of anti-tumor drug research and development in China. According to statistics from the DXY Insight database, 34 new anti-tumor drugs are expected to be approved for marketing in China for the first time this year, of which 15 have been included in the priority review list by the CDE (Center for Drug Evaluation). From ADCs to CAR-T, from bispecific antibodies to next-generation kinase inhibitors, domestically produced and imported innovative drugs are competing on the same stage, reshaping the future landscape of cancer treatment in China.

Table: 15 New Anti-tumor Drugs Expected to be Approved in China by 2026

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01
Diverse Technological Breakthroughs: From "Targeted" to "Intelligent"

The most significant feature of the 15 blockbuster anti-tumor drugs approved in 2026 is the diversified breakthroughs in technological approaches. This has completely broken the traditional limitations of anti-tumor drug development based on "single target, single mechanism," achieving a shift in treatment paradigm from "precision targeting" to "intelligent synergy." These drugs encompass a variety of cutting-edge technologies, including ADCs (antibody-drug conjugates), bispecific antibodies, CAR-T (chimeric antigen receptor T-cell therapy), CELMoD (cereblon E3 ubiquitin ligase modulator), and next-generation TKIs (tyrosine kinase inhibitors). Breakthroughs in each technological approach are propelling tumor treatment towards greater efficiency, safety, and precision, showcasing the cutting-edge trends in global anti-tumor drug development.

Among them, ADC technology, with its unique advantages of "precise delivery and efficient killing," has become one of the core tracks for the new drug boom in 2026. GSK's Belantamab Mafodotin, as the world's first BCMA (B-cell maturation antigen) ADC to be reapproved, signifies a revaluation of the value of ADC technology in the field of multiple myeloma, bringing a new breakthrough to the treatment of hematological malignancies. Belantamab is not a first-time FDA product; it was first approved by the FDA and the EU in 2020, but GSK withdrew its marketing application after the Phase III trial failed to meet its primary endpoint. In October 2025, based on excellent data from the DREAMM-7 trial, Belantamab regained FDA approval. Its marketing application in China was accepted by the CDE in December 2024, with the indication being for use in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. It has been included in the priority review process and is expected to be approved in Q1 2026.

Its mechanism of action targets BCMA (BCMA is highly expressed in malignant plasma cells of multiple myeloma and is an ideal therapeutic target). A monoclonal antibody precisely delivers the cytotoxic payload MMAF to tumor cells, achieving a highly effective and low-toxicity "precision strike." The DREAMM-7 study showed that mabelantuzumab combined with the BVd regimen for the treatment of relapsed/refractory multiple myeloma prolonged median progression-free survival by nearly three times compared to the control group, reduced the risk of disease progression or death by 59%, and significantly improved overall survival. Data from the Chinese subgroup were even more advantageous, with median progression-free survival not reaching the endpoint (superior to 8.4 months in the control group), and the proportion of complete remission or better and the MRD negativity rate significantly exceeding those of the control group, fully validating its efficacy and safety in Chinese patients.

If mabelantuzumab represents a "return to value" for ADC technology, then Baili Tianheng's BL-B01D1 heralds a "new breakthrough" in bispecific antibody ADC technology. As the world's first EGFR×HER3 bispecific antibody ADC expected to be approved in 2026, BL-B01D1 ushers in a new era of treatment with "dual targets + precise delivery," breaking the limitations of traditional ADCs' "single target" and achieving an innovative upgrade in the technological route. The drug submitted two marketing applications in November 2025 and January 2026, respectively, for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-1/PD-L1 monoclonal antibody therapy and at least two lines of chemotherapy (at least one line platinum-based), and for patients with recurrent or metastatic esophageal squamous cell carcinoma who have failed prior PD-1/PD-L1 monoclonal antibody therapy combined with platinum-based chemotherapy. Both applications have been included in the priority review by the CDE (Center for Drug Evaluation) and are expected to be approved in Q4 2026.

BL-B01D1 is a world-first bispecific antibody ADC independently developed by Baili Tianheng. Its core innovation lies in the perfect combination of bispecific antibodies and ADC technology. One end targets EGFR, and the other targets HER3, enabling it to simultaneously recognize and bind to two antigens on the surface of tumor cells. This not only improves the precision of tumor targeting and reduces off-target effects, but also overcomes the problem of single-target drug resistance through the synergistic effect of dual targets. At the same time, leveraging the precise delivery capability of the ADC, it efficiently delivers cytotoxic drugs into the tumor cells, achieving a "1+1>2" therapeutic effect. Currently, BL-B01D1 is undergoing nearly 40 clinical trials in China and the United States targeting more than ten types of tumors. Preliminary clinical data show that it exhibits excellent anti-tumor activity in various solid tumors, especially showing significant therapeutic advantages in patients with EGFR-resistant non-small cell lung cancer.

Besides ADCs and bispecific ADCs, CAR-T, CELMoD, and next-generation TKIs are also expected to achieve significant breakthroughs in 2026, forming a diversified technological landscape. In the CAR-T field, CARsgen Therapeutics' Surelza (CT041) , the world's first CAR-T product for solid tumors to be submitted for approval, targets Claudin18.2-positive gastric cancer, breaking through the bottleneck in the application of CAR-T therapy in solid tumors . In the CELMoD field, Bristol-Myers Squibb's (BMS) Iberdomide, the first product in its CELMoD pipeline, submitted a marketing application in China in December 2025. Its indication is for use in combination with daratumumab and dexamethasone to treat adult patients with multiple myeloma who have received at least one line of prior therapy. Approval is expected in Q4 2026. It achieves precise degradation of tumor cells by optimizing its molecular structure to enhance its binding ability to cereblon E3 ubiquitin ligase. In the next-generation TKI field, Bayer's BAY... 2927088 (Sevabertinib) , an oral reversible tyrosine kinase inhibitor, is approved in the United States in November 2025 for HER2-activating mutation non-small cell lung cancer. Its marketing application in China was accepted in July 2025 and is expected to be approved in Q2 2026, providing a new oral treatment option for patients with HER2-mutant lung cancer.

02
Solid tumors have become the "main battlefield," with CAR-T and dual anti-tumor therapy working together.

For a long time, the clinical application of cell therapy (especially CAR-T) has mainly focused on hematological malignancies. Solid tumors, due to technical bottlenecks such as complex tumor microenvironments, strong antigenic heterogeneity, and difficulty in CAR-T cell infiltration, have always been a major challenge in cell therapy research and development. In 2026, this pattern will be completely disrupted. With the core products of companies such as Yongtai Biopharmaceutical and CARsgen Therapeutics successively being submitted for production approval or receiving approval, China's solid tumor cell therapy will usher in a "breakthrough year." At the same time, the deployment of bispecific antibody drugs in the field of solid tumors continues to deepen, forming a synergistic effect with CAR-T therapy, and propelling solid tumor treatment into a new stage of "precision immunotherapy."

Yongtai Bio's Acronyx Injection is the first domestically submitted application for approval of a solid tumor cell therapy, focusing on the clinical challenge of preventing recurrence after liver cancer surgery. More than 400,000 new cases of liver cancer are diagnosed in China each year, and approximately 70% of patients experience recurrence and metastasis after surgery. Traditional treatments have limited effectiveness. This drug, submitted for marketing approval in March 2025, is intended for recurrence prevention in high-risk groups after radical resection of liver cancer. It has been included in the CDE's priority review process and is expected to be approved in Q2 of 2026.

Aikelunsa utilizes autologous CIK technology, making it a non-genetically modified personalized cell therapy product. Its core active ingredients are immune subsets such as CD3+CD8+ cytotoxic T cells, offering a safety profile superior to CAR-T therapy. It activates the patient's own immune cells in vitro, and upon reinfusion, eliminates residual micrometastases after surgery, achieving recurrence prevention and metastasis control. Through optimized culture, the cell expansion rate and cytotoxic activity are significantly enhanced. Clinical data shows that it can increase the two-year recurrence-free survival rate of liver cancer patients by approximately 30%, making it a milestone product in cell therapy for solid tumors in China.

Unlike Acronyx, CARsgen's Sorgi-Orencyx (CT041) is the world's first CAR-T product for solid tumors to be submitted for marketing approval, targeting Claudin18.2-positive gastric cancer (Claudin18.2 is highly expressed in solid tumors such as gastric cancer and is an ideal target). This drug is intended for the treatment of Claudin18.2-positive solid tumors. A marketing application was submitted in June 2025 (for advanced gastric/esophageal-gastric junction adenocarcinoma that has failed at least two lines of therapy). It has been included in priority review and is expected to be approved in Q2 2026, breaking the zero-approval status of CAR-T therapy in the field of solid tumors.

Sureljac (orenzac) demonstrated an objective response rate (ORR) of 58.3% in patients with Claudin18.2-positive advanced gastric cancer who had failed at least two lines of prior therapy. The median progression-free survival (PFS) was 7.2 months, and the median overall survival (mOS) was 14.5 months, significantly superior to traditional chemotherapy (ORR less than 20%, mOS less than 6 months). Furthermore, it exhibited good safety with a serious side effect rate of less than 10%. Its marketing applications have been submitted simultaneously to the drug regulatory authorities in both China and the United States, and it is expected to receive simultaneous approval in both countries in the second half of 2026, becoming a global benchmark for CAR-T therapy in solid tumors.

Meanwhile, Amgen/BeiGene's talatumab (the world's first DLL3-targeted bispecific antibody) offers new hope for patients with small cell lung cancer (SCLC) with extremely poor prognosis. SCLC accounts for a high percentage of advanced-stage patients, and chemotherapy has limited efficacy, creating an urgent clinical need. This drug received accelerated approval from the FDA for second-line treatment in 2024, and a marketing application was submitted in China in July 2025 (for third-line treatment of extensive-stage SCLC). It has been included in the priority review process and is expected to be approved in Q3 2026.

This drug is a CD3×DLL3 bispecific antibody. It activates T cells to kill tumor cells by binding to DLL3 on tumor cells and CD3 on T cells. DLL3 is highly expressed in 85%-96% of small cell lung cancer patients and is almost not expressed in normal cells, demonstrating precise targeting. The Phase III study of DeLLphi-304 showed that its median overall survival was 13.6 months, which is 5.3 months longer than chemotherapy, with a 40% reduction in the risk of death. The incidence of grade 3 or higher adverse reactions was significantly lower than that in the chemotherapy group. The relevant research was published in the New England Journal of Medicine, providing high-level evidence-based support.

Furthermore, Vicare Pharmaceuticals' Anritinib , a next-generation TRK inhibitor, represents a new breakthrough in the treatment of solid tumors. Its marketing application was accepted by the CDE in July 2025 for patients (including adolescents aged 12 years and older) with locally advanced or metastatic solid tumors carrying NTRK fusion genes who have no satisfactory alternative therapy or have failed previous treatment. Approval is expected in Q2 2026. This drug has the potential to address the secondary resistance problem of first-generation drugs targeting the same target. Clinical data shows that it is not only highly effective in treatment-naïve patients but also has significant therapeutic advantages in resistant patients and those with refractory brain metastases, further enriching the options for precision treatment of solid tumors.

03
Domestic innovative drugs are driven by both "going global" and "licensing".

After more than a decade of dedicated development, China's innovative anti-tumor drug industry has leaped from "following" to "running alongside" and "leading." Of the 15 blockbuster new drugs approved in 2026, domestically produced drugs accounted for half. No longer limited to a "domestic focus," they are actively embracing the global market with a dual-engine approach of "going global + licensing," becoming sought-after partners for global pharmaceutical companies. Core products from domestic companies such as Lupeng Pharmaceutical, CSPC Pharmaceutical Group, and Zhixiang Jintai are gradually reaching the global stage through licensing agreements and overseas rights transfers, demonstrating the technological strength and international competitiveness of Chinese innovative drugs and marking a new stage of "global collaboration" in China's anti-tumor innovation.

Lupeng Pharmaceutical's lobubrutinib (a fourth-generation covalent and non-covalent BTK inhibitor ) is a typical example of a domestic innovative drug licensing collaboration . In May 2025, it submitted a marketing application in China (for adult mantle cell lymphoma that has previously received BTK inhibitor therapy). It has been included in the CDE priority review and is expected to be approved in Q1 2026. Its core advantage is that it can overcome drug resistance caused by multiple types of BTK mutations, providing a new option for patients with drug-resistant B-cell lymphoma.

In August 2024, Lupeng Pharmaceutical and Hansoh Pharmaceutical reached a strategic cooperation agreement, with the latter acquiring full-process rights to all non-oncology indications of lobrutinib in China. By leveraging the strengths of both parties, they can accelerate the research and development and implementation of non-oncology indications. Lupeng Pharmaceutical is currently conducting multiple clinical studies in the non-oncology field and is expected to achieve a dual layout of "oncology + non-oncology", providing a reference for the licensing cooperation of domestic innovative drugs.

Anituzumab, jointly developed by CSPC and KNJ Biopharma, is the first domestically produced HER2 bispecific antibody to be submitted for marketing approval. Its marketing application (for HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma) was submitted in September 2025 and has been included in the priority review process, with approval expected in Q3 2026. Developed by KNJ Biopharma, the drug was exclusively licensed for its domestic indication in China by a subsidiary of CSPC in 2021 for RMB 1 billion. This collaboration between R&D and commercialization accelerates the clinical translation and promotion of domestically produced bispecific antibodies.

If the licensing collaborations for lobubrutinib and anitumumab embody the "domestic synergy" of domestically developed innovative drugs, then Zhixiang Jintai's veritumab demonstrates the determination and strength of domestically developed innovative drugs to "break through overseas." As the first domestically produced BCMA×CD3 bispecific antibody to be submitted for approval in China, this drug was submitted for marketing authorization in January 2026. It is intended for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three lines of prior therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody). It has been included in the priority review list by the CDE and is expected to be approved in Q4 2026. Its core innovation lies in its asymmetric affinity design—the affinity for BCMA is two orders of magnitude higher than that for CD3. This design can effectively reduce non-specific T-cell activation caused by CD3 antibodies while ensuring the recruitment and activation of T cells to kill tumor cells, thereby reducing in vivo toxicity and improving treatment safety.

More notably, Zhixiang Jintai has licensed the overseas rights to rituximab to Nasdaq-listed Cullinan. Leveraging Cullinan's global R&D and commercialization network, Zhixiang Jintai aims to advance the drug's clinical trials and market launch in overseas markets, achieving its goal of "domestic innovation, global reach." This licensing agreement not only brings Zhixiang Jintai substantial upfront and milestone payments but also enhances the global visibility and influence of domestically produced bispecific antibodies, signifying that Chinese innovative drugs have the capability to compete globally, moving from "local innovation" to "global collaboration."

Furthermore, domestically developed new drugs such as Baili Tianheng's BL-B01D1 and CARsgen's Sureljac and Orenza are actively advancing overseas clinical trials and gradually expanding into the global market, forming a dual-engine pattern of "domestic approval + overseas layout." The overseas expansion and licensing of these domestically developed new drugs not only promotes the globalization of China's innovative anti-tumor drugs but also brings more cost-effective treatment options to cancer patients worldwide, demonstrating the responsibility and commitment of China's biopharmaceutical industry.

0 4
Rare and refractory tumors are entering an era of "precision targeting".

The concept of precision medicine continues to deepen. Among the 15 blockbuster new drugs approved in 2026, many focus on rare and refractory tumors, filling clinical gaps. With their precise targeting and clear efficacy, they bring hope to patients who have "no other treatment options" and promote China's cancer treatment into a new stage of precision and personalization.

Daiichi Sankyo's pyxitinib is the world's first drug for the treatment of giant cell tenosynovitis (TGCT) , a rare tumor with a high recurrence rate after traditional surgery and no effective alternative treatment. It was approved by the FDA in 2019, and a marketing application was submitted in China in January 2025 (for adult patients with inoperable symptomatic TGCT). It has been included in the CDE's priority review

Hutchison MediPharma's Fanregratinib targets FGFR2 fusion intrahepatic cholangiocarcinoma (a refractory tumor that accounts for approximately 10%-15% of patients and has poor response to traditional treatments). As a highly selective FGFR1-3 inhibitor, it submitted a marketing application in China in December 2025 for the treatment of related advanced patients who have previously received systemic therapy. It has been included in the priority review process and is expected to be approved in Q4 2026.

This marketing application is based on data from a single-arm, multicenter, open-label Phase II registration study conducted in China. This study met its primary endpoint of objective response rate (ORR) and achieved positive results on secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS). Clinical data show that vaseratinib significantly improves the objective response rate in patients with FGFR2 fusion-positive intrahepatic cholangiocarcinoma compared to traditional chemotherapy regimens, and effectively prolongs progression-free survival, bringing new hope to patients with this type of refractory tumor. Furthermore, its high selectivity reduces damage to normal tissues, lowers the incidence of adverse reactions, and improves the safety and tolerability of treatment.

Tengagotinib, developed by Pharmaron, focuses on patients with cholangiocarcinoma resistant to FGFR inhibitors, further addressing the challenge of drug resistance in refractory tumors and achieving a "profound breakthrough" in precision medicine. Cholangiocarcinoma is a refractory solid tumor, and FGFR inhibitors are currently an important treatment for FGFR-mutant cholangiocarcinoma. However, many patients develop drug resistance during treatment, leading to disease progression. At this point, there is a lack of effective follow-up treatments, making the clinical need extremely urgent. Tengagotinib submitted a marketing application in China in December 2025 for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have received at least one prior systemic therapy and an FGFR inhibitor. It has been included in the priority review list by the CDE (Center for Drug Evaluation) and is expected to be approved in Q4 2026.

Tengoratinib is an innovative multi-target small molecule kinase inhibitor that exerts its anti-tumor effects by targeting tumor cells and improving the tumor microenvironment. It not only inhibits FGFR family kinases but also acts on other targets related to tumor growth and metastasis, effectively overcoming the resistance problem of FGFR inhibitors and providing a new treatment option for drug-resistant patients. Currently, Pharmaron is conducting multiple clinical trials of entoratinib globally, with indications covering various solid tumors such as cholangiocarcinoma, prostate cancer, breast cancer, and liver cancer. Its clinical application is expected to expand further in the future, bringing hope to more patients with refractory tumors.

Furthermore, AbbVie's Iberometra, a CD20×CD3 bispecific antibody targeting relapsed or refractory follicular lymphoma , submitted its marketing application in China in September 2025 and is expected to be approved in Q4 2026. It has already been approved for multiple indications overseas, providing new immunotherapy options for lymphoma patients. Bristol-Myers Squibb's Iberdomide, targeting relapsed/refractory multiple myeloma, also offers a new treatment option for patients with this type of refractory hematologic malignancy. The launch of these drugs not only fills treatment gaps in the field of rare and refractory tumors but also promotes the in-depth development of precision medicine, making "no cure" a thing of the past and igniting hope for survival for more cancer patients.

05
Conclusion

2026 will be a breakout year for new anti-tumor drugs in China, not only in terms of quantity but also in terms of quality. Fifteen blockbuster new drugs will emerge, encompassing diverse technological approaches and covering multiple tumor types. These include both classic upgrades from foreign giants and strong breakthroughs from domestic innovations; groundbreaking advancements in solid tumor treatment and precision medicine breakthroughs in rare diseases; and deep cultivation of the domestic market alongside collaborative global expansion. Behind all this lies over a decade of R&D accumulation, policy support, and talent development in China's biopharmaceutical industry, marking the official entry of China's anti-tumor innovation into a "golden age."
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