22 New Lung Cancer Drugs Approved in 2026: Breakthrough Therapies for Patients with Specific Genetic Mutations
Xian Janssen
Pharmaceutical R&D and Manufacturer
As the cancer type with the highest incidence and mortality rates globally, lung cancer has seen the most new drug developments and market approvals among all cancers. In 2025, both domestically and internationally...Nine new anticancer therapies have been approved, including targeted therapies, immune checkpoint inhibitors, and more, covering common targets. By 2026, a large number of lung cancer patients will have access to new drugs!
Note: Even better news is that some of these are already in clinical trials in China, meaning patients in China have the opportunity to receive treatment with the latest American anti-cancer drugs at the same time—and it's free. Interested patients can call the Medical Department to submit relevant materials (400-666-7998).
Progression-Free Survival Doubled!Amivantamab Approved for Marketing in China!
Drug Name:Rui Ke® (Amivantamab Injection)
R&D Company:Xian Janssen
Drug Introduction:February 2025,Rui Ke® (Amivantamab Injection)Officially approved for marketing in China,For the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by testing to carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations!It is a novel EGFR-MET bispecific antibody targeting activating and resistant EGFR and MET mutations and amplifications. In May 2021, it received FDA accelerated approval based on positive results from the Phase I study (CHRYSALIS), becoming the world's first and only approved EGFR/cMET bispecific antibody to be marketed.Risk of Disease Progression Drops by 56%! Amivantamab Approved for New Indication in China, EGFR-Mutated Lung Cancer Treatment Enters the "Dual-Target Era"
Time to Market:February 2025
Drug Name:Lukansatuzumab (SKB264 Trade name: Jiatelai)
R&D Company:Sichuan Kelun Botai
Drug Introduction:Lukang Satuzumab (SKB264, Trade Name: Jiatelai) is a representative innovative ADC targeting TROP2 developed by OptiDC, an internationally renowned ADC R&D platform of Sichuan Kelun Botai Biotech. TROP2 is a transmembrane glycoprotein widely distributed on the surface of various epithelial tumors and has the ability to specifically bind to anti-TROP2 antibodies. In non-small cell lung cancer (NSCLC), the positive expression rate of TROP2 is as high as 89%, making TROP2 a highly promising target for the treatment of NSCLC.
Time to Market:March 2025
Drug Name: OpdivoMonoclonal Antibody
R&D Company:Bristol-Myers Squibb
Drug Introduction:On April 22, Bristol-Myers Squibb announced that the PD-1 inhibitor Opdivo (nivolumab injection) had received additional indications approved by China's NMPA:In combination with platinum-based chemotherapy as neoadjuvant therapy, followed by Opdivo as a single-agent adjuvant treatment after surgery, for the treatment of resectable stage II, IIIA andStage IIIB with no known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase(ALK) Rearranged adult non-small cell lung cancer (NSCLC) patients。
Time to Market:April 2025
Previously treated with EGFR-TKI and progressed, andT790MPatients with mutation-positive locally advanced or metastatic NSCLC; In December 2021, the product was approved.First-line treatment hasEGFRExon 19 deletion or exon 21 (L858R) Adult patients with locally advanced or metastatic NSCLC who are positive for substitution mutations;In March 2024, the product was approved for use in China.Unresectable locally advanced disease without progression after platinum-based radical chemoradiotherapyEGFRExon 19 deletion or exon 21 (L858R) Substitution mutation in NSCLC patient treatment.
Name of the drug:Glecirasib Tablets (glecirasib, JAB-21822)
R&D Company:JACOBIO
Product Introduction:JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Preclinical research data shows that it can be used alone to treat solid tumors with KRAS G12C mutations, and after resistance occurs with KRAS G12C inhibitor treatment, combining it with an SHP2 inhibitor is expected to effectively overcome and reverse the resistance to KRAS inhibitors. On May 22, 2025, the revolutionary domestically-developed anticancer drug, Glecirasib (JAB-21822) Citrate Tablets, which is effective against KRAS mutations, was officially approved for marketing by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China. It is indicated for monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy. Meanwhile, this drug has also been given its own powerful name—Airkai!
Time to Market:May 2025
Name of the drug:Bo Rui Ti Ni
R&D Company:Anshi Bio
Product Introduction:Vebreltinib (Brand name: BoRuiTiNi, PLB-1001) is a potent and highly selective c-MET inhibitor. Its notable advantage lies in its ability to efficiently cross the blood-brain barrier, offering potential for the treatment of central nervous system tumors. June 30, 2025，Borotinib Enteric-Coated Capsules Approved by NMPA for New Indication, officiallyFor the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification。
Time to Market:June 2025
Drug Name:Savolitinib (Savolitinib, trade name: Volrefsa)
R&D Company:Hutchmed
Product Introduction:Savolitinib, a domestically developed highly selective c-MET inhibitor in China, can inhibit MET exon 14 skipping mutations and MET amplification. On June 30, 2025, it was approved for a new indication, in combination with Osimertinib, for the treatment of MET-amplified EGFR-TKI resistant NSCLC. Clinical data show that this combination therapy can achieve a median PFS of 8 months in patients with MET amplification who are resistant to EGFR, providing a precise solution for resistant patients.
Time to Market:June 2025
Drug Name:Nivolumab + Ipilimumab
R&D Company:Bristol-Myers Squibb
Product Introduction:This is the world's first approved dual immunotherapy combination, which activates systemic anti-tumor immunity through the synergistic effects of a PD-1 inhibitor and a CTLA-4 inhibitor. On July 28, 2025, it was approved by the NMPA for first-line treatment of advanced NSCLC with PD-L1 TPS≥1% and EGFR/ALK negativity. Clinical data show that its 3-year overall survival rate (OS rate) reached 42%, significantly better than chemotherapy, providing a chemotherapy-free first-line immunotherapy option for patients with negative driver genes.
Time to Market:July 2025
Name of the drug:Di Luo A Ke (Ensartinib, Trade Name: An Luo Qing)
R&D Company:Zhengda Tianqing
Product Introduction:Dilorac is a new generation ALK inhibitor, which has potent inhibitory effects on ALK fusion and drug-resistant mutations (such as G1202R), and exhibits excellent brain penetration. On August 22, 2025, it was approved by the NMPA for first-line treatment of ALK-positive advanced NSCLC. Clinical data show its ORR exceeds 90%, with an ORR of 86% in patients with brain metastases, offering a better first-line treatment option for ALK-positive patients.
Time to Market:August 2025
Name of the drug:Zorzetinib (Brand name: Sheng Hetu)
R&D Company:Boehringer Ingelheim
Product Introduction:Zongai Tinib is an orally administered, highly selective HER2 inhibitor that covers various mutation types, including HER2 exon 20 insertion mutations and kinase domain mutations. On August 29, 2025, it was approved by the NMPA for use in previously treated HER2-activating mutation advanced NSCLC. Clinical data showed an ORR of 55%, a disease control rate (DCR) of 88%, and good safety, providing a convenient oral targeted option for patients with HER2-mutant lung cancer.
Time to Market:August 2025
Drug Name:Capmatinib (Capmatinib, Trade Name: Tabrecta)
R&D Company:Novartis
Product Introduction:Capmatinib is a highly selective c-MET inhibitor that can inhibit MET exon 14 skipping mutations and MET amplification-driven tumor growth. On September 15, 2025, it was approved by the NMPA for the treatment of advanced NSCLC with MET exon 14 skipping mutations. Clinical data show that its ORR in patients with MET exon 14 mutations reaches 68%, with a median progression-free survival (PFS) of 12.4 months, providing the first precision-targeted treatment option for this rare mutation patient population.
Time to Market:September 2025
Drug Name:Glecirasib Tablets (glecirasib, JAB-21822)
R&D Company:JACOBIO
Product Introduction:JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Preclinical research data shows that it can be used alone to treat solid tumors with KRAS G12C mutations, and after resistance occurs in KRAS G12C inhibitor treatment, combining it with an SHP2 inhibitor is expected to effectively overcome and reverse the resistance problem of KRAS inhibitors. On May 22, 2025, the revolutionary domestically-developed anticancer drug, Glecirasib Citrate Tablets (Glecirasib, JAB-21822), which is effective against KRAS mutations, was officially approved for marketing by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA). It is indicated for monotherapy in adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy. Meanwhile, this drug now has its own renowned brand name—Airui Kai!
Time to Market:May 2025
Drug Name:Mefanitinib (Mefanitinib, brand name: Mairuidong)
R&D Company:Shanghai Berya Pharmaceutical Co., Ltd.
Product Introduction:Mobocertinib is a highly selective EGFR inhibitor, particularly effective in inhibiting the EGFR L858R mutation. It also demonstrates excellent penetration into brain metastases. On October 24, 2025, it was approved by the NMPA for first-line treatment of advanced NSCLC with EGFR L858R mutations. Clinical data show that its objective response rate (ORR) in patients with the L858R mutation is significantly better than traditional chemotherapy, with an 85% control rate for brain metastases, providing a more precise first-line option for patients with the "disadvantaged mutation" of EGFR L858R.
Time to Market:October 2025
Drug Name:Telisotuzumab vedotin（Teliso-V）
R&D Company:AbbVie
Product Introduction:On May 14, 2025, a historic breakthrough in the development of new anti-cancer drugs was achieved! Telisotuzumab vedotin (Teliso-V) received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic, high c-Met protein overexpression (OE) non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy.As the only innovative therapy currently approved globally for this indication, Teliso-V, with its dual advantages of "precise targeting + c-Met overexpression," officially ushers in a new era of "exclusive treatment" in this field! This breakthrough not only fills a clinical gap but also means that countless patients who once faced treatment difficulties have finally transitioned from "no available treatment" to "precise resolution," bringing entirely new hope for survival!
Time to Market:May 14, 2025
Drug Name:Taletrectinib (Brand name: Davolux)
R&D Company:Innovent Biologics
Product Introduction:Taletrectinib is a new-generation ROS1/TRK dual-target inhibitor, demonstrating potent inhibition of ROS1 fusion and drug-resistant mutations (such as G2032R). On June 11, 2025, the U.S. FDA granted accelerated approval for its use in ROS1-positive advanced NSCLC. Clinical data shows that the drug’s median progression-free survival (PFS) reached 45.6 months (nearly 4 years), with an objective response rate (ORR) of 91% in patients with brain metastases, offering a long-term precision treatment option for ROS1-positive patients.
Time to Market:June 2025
Drug Name:Datopotamab Deruxtecan (Trade name: Dato-DXd)
R&D Company:Daiichi Sankyo / AstraZeneca
Product Introduction:Dedabotumab is a TROP2 ADC drug composed of an anti-TROP2 antibody linked to a topoisomerase I inhibitor, enabling precise targeting and killing of TROP2-positive tumor cells. On June 23, 2025, the U.S. FDA granted accelerated approval for its use in EGFR-mutant NSCLC patients who have undergone EGFR-targeted therapy and platinum-based chemotherapy. Clinical data show that the drug achieved an objective response rate (ORR) of 37%, with a median progression-free survival (PFS) of 8.3 months, offering a novel ADC treatment option for patients with EGFR resistance.
Time to Market:June 2025
Drug Name:Sunvozertinib (Brand name: Zegfrovy)
R&D Company:Dizal Pharmaceutical
Product Introduction:Sunvozertinib is an orally administered, highly selective EGFR inhibitor, particularly potent in targeting EGFR exon 20 insertion (ex20ins) mutations. On July 2, 2025, the U.S. FDA granted accelerated approval for its use in patients with advanced NSCLC harboring EGFR ex20ins mutations who have progressed after platinum-based chemotherapy. Clinical data show that the drug achieved an objective response rate (ORR) of 59.8%, with an ORR of 48.4% in patients with brain metastases, offering an effective oral targeted therapy option for this difficult-to-treat mutation.
Time to Market:July 2025
Drug Name:Zorzetinib (Brand name: Shenghetu)
R&D Company:Boehringer Ingelheim
Product Introduction:Zong'ai Tinib is an orally administered, highly selective HER2 inhibitor that covers various mutation types, including HER2 TKD mutations and exon 20 insertion mutations. On August 8, 2025, the U.S. FDA granted accelerated approval for its use in previously treated HER2-TKD activating mutation-positive advanced non-squamous NSCLC. Clinical data show that the drug achieved an objective response rate (ORR) of 55% and a disease control rate (DCR) of 88%, with good safety, providing a convenient oral targeted option for patients with HER2-mutant lung cancer.
Time to Market:August 2025
Drug Name:Sevabertinib
R&D Company:Bayer
Product Introduction:Savetinib is a highly selective HER2 kinase domain (TKD) mutation inhibitor that effectively inhibits tumor proliferation driven by HER2 TKD mutations. On November 19, 2025, the U.S. FDA granted accelerated approval for its use in previously treated HER2-TKD activating mutation-positive advanced non-squamous NSCLC. Clinical data showed that the drug achieved an objective response rate (ORR) of 42% and a median progression-free survival (PFS) of 5.3 months, offering a precise targeted therapy option for patients with HER2-mutant lung cancer.
Time to Market:November 2025
The above new drugs are only a small part of many R&D hotspots, and there are stillA large number of new drug developments and innovative technologies are underway, and it is believed that more drugs will be approved for marketing in 2026! In addition, several anticancer drugs under development have also shown broad-spectrum anticancer capabilities."Ark Aid Program"Can provide patients with the opportunity for free treatment using newly marketed and unmarketed drugs.
This article is original content from Global Oncologist Network. Reproduction is strictly prohibited without authorization.
Scan to Add Patient Group
Cancer News｜New Technologies｜New Drug Development｜Authoritative Experts
Join the group to receive free anti-cancer resources
