Priority review is one of the policies of the National Medical Products Administration (NMPA) of China to accelerate drug approval. According to the "2023 Annual Drug Evaluation Report" released by the Center for Drug Evaluation (CDE) of the NMPA, in 2023, 59 varieties of registration applications were approved for marketing under the priority review and approval process. Since the implementation of the "Drug Registration Administration Measures" in 2020, a total of372 drug registration applications included in the priority review and approval process，Among them, anticancer drugs accounted for the largest proportion, which was 42%.。
Looking ahead to 2024, which anti-tumor drugs are expected to be approved for marketing through the priority review process? Based on the priority review information from the CDE's official website, this article will share information on more than 20 anti-tumor drugs that are expected to be approved for marketing in China through the priority review process in 2024, for readers' reference only.(*Note: This article only shares some of the new drugs that have been officially included in the priority review by the CDE, and it is not a complete list. The drugs are sorted according to the publication date of the CDE’s priority review.)
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CARsgen Therapeutics: Zevor-cel InjectionMechanism of Action: CAR-T Product Targeting BCMAIndications: Multiple Myeloma
Zevor-cel Injection (CT053) is a fully human B-cell maturation antigen (BCMA)-targeted autologous CAR-T cell candidate product developed by Carsgen Therapeutics. In October 2022, the marketing application of Zevor-cel Injection was granted priority review by the CDE.For adult patients with relapsed or refractory multiple myeloma who have previously failed treatment with at least one immunomodulatory agent and proteasome inhibitor.。Legend Biotech/Johnson & Johnson: Cilta-cel InjectionMechanism of Action: CAR-T Therapy Targeting BCMAIndications: Multiple MyelomaCilta-cel (cilta-cel) is Johnson & Johnson (Johnson & Johnson) Johnson & Johnson Innovative Medicine, a subsidiary of Johnson & Johnson, and Legend Biotech have jointly developed a CAR-T therapy targeting BCMA. In January 2023, the new drug application for this product was granted priority review by the CDE.For the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received one proteasome inhibitor and one immunomodulatory agent.。Luye Pharma: Lurbinectedin for Injection
Mechanism of Action: Selective Oncogene Transcription Inhibitor
Indications: Small Cell Lung CancerLurbinectedin is a selective oncogene transcription inhibitor. The drug was initially developed by PharmaMar, and Luye Pharma has the exclusive rights for the development and commercialization of the drug in China. In March 2023, the marketing application for injectable Lurbinectedin was granted priority review by the CDE.Proposed for the treatment of adult patients with metastatic small cell lung cancer (SCLC) whose tumors have progressed during or after platinum-based chemotherapy.In December 2023, the drug was approved for marketing in the Macao region of China.Takeda/Otsuka Pharmaceutical: Ponatinib TabletsMechanism of Action: Bcr-Abl InhibitorIndications: Chronic Myeloid Leukemia, Leukemia, etc.Ponatinib tablets (ponatinib) are a third-generation Bcr-Abl kinase inhibitor jointly developed by Otsuka and Takeda. In April 2023, the marketing application for ponatinib tablets was granted priority review by the CDE.The proposed indications include: 1) Chronic Myeloid Leukemia (CML) with resistance or intolerance to prior medications; 2) Relapsed or refractory Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL); 3) T315I-positive CML or T315I-positive Ph+ALL.。Zhengda Tianqing: TQ-B3525 Tablet
Mechanism of Action: PI3Kδ/α Dual Inhibitor
Indications: Follicular LymphomaTQ-B3525 is a highly selective novel phosphatidylinositol 3-kinase δ/α (PI3Kδ/α) dual inhibitor developed by Chia Tai Tianqing. In May 2023, the CDE included the marketing application of TQ-B3525 tablets in the priority review.Intended for the treatment of patients with relapsed or refractory follicular lymphoma who have previously received at least two systemic therapies.。Zai Lab/Bristol-Myers Squibb: Ripretinib Capsules
Mechanism of Action: ROS1/NTRK Targeted Inhibitor
Indications: Non-Small Cell Lung CancerRipretinib (TPX-0005) is Bristol-Myers Squibb (Bristol Myers Squibb) A ROS1 and NTRK targeted inhibitor developed by the company, Zai Lab has exclusive development and commercialization rights for this drug in Greater China (including mainland China, Hong Kong, Macao, and Taiwan). In May 2023, the marketing application for Repotrectinib was granted priority review by the CDE.Indication: For the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.。ADC Therapeutics/OncoC4: Tisotumab InjectionMechanism of Action: ADC Targeting CD19
Indications: Large B-cell LymphomaTalunotuzumab is an antibody-drug conjugate (ADC) targeting CD19, and Overland ADCT Biopharma, a joint venture between Overland Pharmaceuticals and ADC Therapeutics, holds the rights to the drug in Greater China and Singapore. In June 2023, the marketing application for Talunotuzumab was granted priority review by the CDE.Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy。Bebetter Pharmaceuticals: Disulfiram InjectionMechanism of Action: PI3K/HDAC Dual-Target Anticancer DrugIndications: Diffuse Large B-Cell LymphomaBebetter Pharma has developed Bualisit as a novel PI3K/HDAC dual-target anticancer drug. In July 2023, the marketing application for injectable Bualisit was granted priority review by the CDE.Intended for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) who have previously received at least two systemic therapies.。Huadong Medicine/ImmunoGen: SomaetuximabMechanism of Action: FRα-Targeted ADCIndications: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancerSomiromab is an innovative ADC targeting the FRα developed by Huadong Medicine's wholly-owned subsidiary, Sinopharm East China, in collaboration with ImmunoGen. Sinopharm East China holds the exclusive rights for clinical development and commercialization of this product in Greater China. In July 2023, the marketing application for the Somiromab Injection was granted priority review by the CDE.Intended for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy.。Johnson & Johnson: Telitacimab InjectionMechanism of Action: BCMA/CD3 Bispecific AntibodyIndications: Multiple MyelomaTeclistamab, developed by Johnson & Johnson's innovative pharmaceutical division, is a bispecific antibody therapy targeting BCMA and CD3. In August and September 2023, the marketing applications for two dosage forms (30 mg/vial and 153 mg/vial) of the teclistamab injection were granted priority review by the CDE.The proposed indication is: monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least three prior treatments (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody).。Dizhe Pharmaceuticals: GolixitinibMechanism of Action: JAK1 InhibitorIndications: Peripheral T-cell LymphomaGolidocitinib, a new-generation oral, highly selective JAK1 inhibitor developed by Dizal Pharmaceutical, is being developed for the treatment of various hematologic malignancies, solid tumors, and autoimmune diseases. In August 2023, the CDE included the marketing application of Golidocitinib capsules in the priority review.For the indication: adult patients with r/r PTCL who have previously received at least one standard treatment.。Akeso Biologics: EftilacimabMechanism of Action: PD-1/VEGF Bispecific AntibodyIndications: Non-Small Cell Lung CancerIvonescimab (AK112/SMT112) is a PD-1/VEGF bispecific antibody developed by Akeso Biopharma. In August 2023, the new drug application for Ivonescimab was granted priority review by the CDE.Indication: In combination with pemetrexed and carboplatin for the treatment of locally advanced or metastatic non-squamous NSCLC with EGFR mutations that has progressed after treatment with EGFR tyrosine kinase inhibitors (EGFR-TKI).。Innovent Biologics/Greatstone Pharma: Fuzelai TabletsMechanism of Action: KRAS G12C InhibitorIndications: Non-Small Cell Lung CancerFuzelase Tablets (IBI351) is a KRAS G12C inhibitor. Innovent Biologics has reached an exclusive global licensing agreement with GenFleet Therapeutics, obtaining the development and commercialization rights for this product in China as the exclusive partner. In October 2023, the marketing application of Fuzelase Tablets was included in the priority review by the CDE.Intended for the treatment of patients who have received at least one systemic therapyKRAS G12CMutant-type advanced non-small cell lung cancer。Lilly: Pirtobrutinib TabletsMechanism of Action: BTK InhibitorIndications: Mantle Cell LymphomaPirtobrutinib tablets (pirtobrutinib) are a non-covalent, highly selective BTK inhibitor developed by Eli Lilly and Company. In October 2023, the marketing application for this product was granted priority review by the CDE.The proposed indication is: adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received BTK inhibitor treatment.。Kelun-Biotech: Injectable SKB264Mechanism of Action: TROP2-ADCIndications: Triple-negative breast cancerSKB264 is an innovative antibody-drug conjugate (ADC) targeting TROP2 developed by Kelun-Biotech. In November 2023, the marketing application for this product was granted priority review by the CDE.Intended for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have previously received at least two systemic treatments (at least one of which was for advanced or metastatic stage).。AnHeart Therapeutics/Innovent Biologics: Taletrectinib CapsulesMechanism of Action: ROS1 Tyrosine Kinase InhibitorIndications: Non-Small Cell Lung CancerTaletrectinib Capsules, a novel next-generation ROS1 tyrosine kinase inhibitor, are co-developed and commercialized in China by AnHeart Therapeutics and Innovent Biologics. In November 2023, the CDE included the marketing application of Taletrectinib Capsules in the priority review.Intended for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer who have failed ROS1-TKI therapy.。Roche: Motuzumab InjectionMechanism of Action: CD20/CD3 T Cell Engager Bispecific AntibodyIndications: Follicular LymphomaMosunetuzumab Injection is Roche（Roche）A CD20/CD3 T cell-engaging bispecific antibody has been developed, representing a chemotherapy-free, off-the-shelf new immunotherapy option. In November 2023, the product's marketing application was granted priority review by the CDE.Used for treatmentAdult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic therapies。Yifang Biotech/Zhengda Tianqing: Geshurui Xi Tablets (D-1553 Tablets)Mechanism of Action: KRAS G12CSelective InhibitorIndications: Non-Small Cell Lung CancerGarsorasib, developed by Innovent Biologics, is a novel and highly effective KRASG12CSelective inhibitor. Eternity Bio has reached a collaboration with CT Tianqing, granting the latter exclusive rights to develop, register, manufacture, and commercialize the product in mainland China during the agreement period. In December 2023, the product's marketing application was accepted for priority review by the CDE.Applicable to patients whose disease has progressed or become intolerable after first-line systemic treatment, and who have been confirmed by testing to haveKRAS G12CTreatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Mutations。Pfizer: Elranatamab InjectionMechanism of Action: BCMA×CD3 Bispecific AntibodyIndications: Multiple MyelomaElranatamab (PF-06863135) is a subcutaneously injectable BCMA/CD3 bispecific antibody developed by Pfizer. In January 2024, the product's marketing application was granted priority review by the CDE.Applicable to patients who have previously received at least three treatments(Including one proteasome inhibitor, one immunomodulator, and one anti-CD38 monoclonal antibody)Treatment of adult patients with relapsed or refractory multiple myeloma。China Resources Tianqing: Beimoshu Monoclonal Antibody Injection, Anlotinib Hydrochloride CapsulesMechanism of Action: Anti-PD-L1 Monoclonal Antibody, Multi-Target Receptor Tyrosine Kinase InhibitorIndications: Endometrial CancerBeimosuab (TQB2450) is an innovative, fully humanized anti-PD-L1 monoclonal antibody with a novel sequence developed by Zhengda Tianqing, and Anlotinib is a new small-molecule multi-target tyrosine kinase inhibitor developed by the same company. In January 2024, the marketing application for the combination therapy of Beimosuab Injection and Anlotinib Hydrochloride Capsules was granted priority review by the CDE, targeting the treatment of recurrent or metastatic endometrial cancer that is not highly microsatellite unstable (non-MSI-H) or deficient in DNA mismatch repair (non-dMMR), and has failed or been intolerant to first- and second-line chemotherapy regimens.Johnson & Johnson: TarquetumabMechanism of Action: GPRC5D and CD3 Targeting Bispecific AntibodyIndications: Multiple MyelomaTalquetamab, a subcutaneously injected bispecific antibody targeting GPRC5D and CD3 developed by Johnson & Johnson, had its product marketing application granted priority review by the CDE in February 2024.Indicated for adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.。
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Daiichi Sankyo/AstraZeneca: Trastuzumab Deruxtecan for InjectionMechanism of Action: HER2-Targeted ADCIndications: Non-Small Cell Lung CancerTrastuzumab deruxtecan is an ADC targeting HER2 jointly developed by Daiichi Sankyo and AstraZeneca. It has previously been approved in China for the treatment of HER2-positive and HER2-low adult breast cancer patients. In February 2024, the marketing application of this product was granted priority review by the CDE.Monotherapy is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer who have HER2 (ERBB2) activating mutations and have previously received at least one systemic therapy.。In addition to the aforementioned drugs, many other new anti-tumor medications are also expected to be approved in China in 2024. Due to space limitations, this article will not introduce them one by one. Hopefully, these new drugs will soon reach patients, providing them with new treatment options!
