▎Edited by the content team of WuXi AppTecPriority 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, registration applications for 59 varieties 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, anti-tumor drugs account for the largest proportion, at 42%.。Looking forward 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 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, not a complete list, sorted by the date of the CDE priority review announcement.)
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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, Ltd. 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 at least one immunomodulatory agent and proteasome inhibitor treatment.。Legend Biotech/Johnson & Johnson: Cilta-cel InjectionMechanism of Action: BCMA-Targeted CAR-T TherapyIndications: Multiple MyelomaCilta-cel (cilta-cel) is Johnson & Johnson (Johnson & Johnson) a CAR-T therapy targeting BCMA co-developed by Johnson & Johnson Innovative Medicine and Legend Biotech. In January 2023, the new drug application for this product was granted priority review by the CDE, proposedFor the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received prior therapy with a proteasome inhibitor and an 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 holds 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.Intended 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) is a third-generation Bcr-Abl kinase inhibitor jointly developed by Otsuka and Takeda. In April 2023, the marketing application of Ponatinib Tablets was included in the 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.。CHIATAI 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 CHIATAI 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 a Bristol-Myers Squibb (Bristol Myers Squibb) A ROS1 and NTRK targeted inhibitor developed by the company, with Zai Lab holding exclusive development and commercialization rights in Greater China (including mainland China, Hong Kong, Macao, and Taiwan). In May 2023, the listing 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/Overland Pharmaceuticals: Telisotuzumab InjectionMechanism of Action: CD19-targeted ADC
Indications: Large B-cell LymphomaTalun妥昔单抗 (Talun妥昔单抗) is an antibody-drug conjugate (ADC) targeting CD19. Overland Pharmaceuticals, a joint venture between Overland Pharma and ADC Therapeutics, holds the rights to the drug in Greater China and Singapore. In June 2023, the marketing application for Talun妥昔单抗 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 Med: Disulfiram InjectionMechanism of Action: PI3K/HDAC Dual-Target Anticancer New DrugIndications: Diffuse Large B-Cell LymphomaBebetter Med's Dualisertib is a novel PI3K/HDAC dual-target anticancer drug developed by BeBetter Med. In July 2023, the marketing application for injectable Dualisertib 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 received at least two prior systemic therapies.。Huadong Medicine/ImmunoGen: Mirvetuximab SoravtansineMechanism 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, Sinomab, in collaboration with ImmunoGen. Sinomab 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: Telitacicept InjectionMechanism of Action: BCMA/CD3 Bispecific AntibodyIndications: Multiple MyelomaTeclistamab, developed by Johnson & Johnson's Innovative Pharmaceuticals, is a bispecific antibody therapy targeting BCMA and CD3. In August and September 2023, the marketing applications for two formulations (30 mg/vial and 153 mg/vial) of 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 therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.。Mechanism of Action: JAK1 InhibitorIndications: Peripheral T-cell LymphomaGolidixitinib is a new-generation oral, highly selective JAK1 inhibitor developed by Dizal Pharmaceutical, intended for the treatment of various hematological tumors, solid tumors, and autoimmune diseases. In August 2023, the CDE included the marketing application of Golidixitinib capsules in the priority review.Indication: Adult patients with r/r PTCL who have previously received at least one standard treatment.。Mechanism of Action: PD-1/VEGF Bispecific AntibodyIndications: Non-Small Cell Lung CancerIvonescimab (AK112/SMT112) is a PD-1/VEGF bispecific antibody developed by Akeso. 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 patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR mutations whose disease has progressed after treatment with EGFR tyrosine kinase inhibitors (EGFR-TKI).。Innovent Bio/GenFleet Therapeutics: Fuzelase TabletMechanism of Action: KRAS G12C InhibitorIndications: Non-Small Cell Lung CancerFuzelase Tablets (IBI351) is a KRAS G12C inhibitor. Innovent Bio has reached an exclusive global licensing agreement with GenFleet Therapeutics, obtaining exclusive rights to develop and commercialize the product in China as the exclusive partner. In October 2023, the marketing application of Fuzelase Tablets was granted 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。Eli Lilly: Pirtobrutinib TabletsMechanism of Action: BTK InhibitorIndications: Mantle Cell LymphomaPirtobrutinib Tablets (pirtobrutinib) is a non-covalent, highly selective BTK inhibitor developed by Eli Lilly and Company. In October 2023, the marketing application of this product was included in the 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 of 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 Bio: Taletrectinib CapsulesMechanism of Action: ROS1 Tyrosine Kinase InhibitorIndications: Non-Small Cell Lung CancerTaletrectinib Capsules (taletrectinib) is a novel next-generation ROS1 tyrosine kinase inhibitor co-developed and commercialized by AnBio and Innovent Bio in China. In November 2023, the CDE granted priority review status to the marketing application of Taletrectinib Capsules.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.For treatmentAdult patients with relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic treatments。InventisBio/CHIATAI TIANQING: Geshurui Xi Tablets (D-1553 Tablets)Mechanism of Action:KRAS G12CSelective InhibitorIndications: Non-Small Cell Lung CancerGarsorasib is a novel, highly efficient drug developed by InventisBio.KRAS G12CSelective Inhibitor. InventisBio has reached a collaboration with CHIATAI 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 included in the 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 existKRAS 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。CHIATAI TIANQING: Bevacizumab Injection, Anlotinib Hydrochloride CapsulesMechanism of Action: Anti-PD-L1 Monoclonal Antibody, Multi-target Receptor Tyrosine Kinase InhibitorIndications: Endometrial CancerBeimosubai Monoclonal Antibody (TQB2450), developed by CHIATAI TIANQING, is an innovative humanized monoclonal antibody against PD-L1 with a completely new sequence. Anlotinib is a novel small-molecule multi-target tyrosine kinase inhibitor developed by the same company. In January 2024, the marketing application for the combination therapy of Beimosubai Monoclonal Antibody Injection and Anlotinib Hydrochloride Capsules was granted priority review by the CDE. The indication is for 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 cannot tolerate first- and second-line chemotherapy regimens.Johnson & Johnson: TalquetamabMechanism of Action: GPRC5D and CD3 Targeting Bispecific AntibodyIndications: Multiple MyelomaTalquetamab, a subcutaneously injectable 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 lines of therapy, 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, an ADC targeting HER2 jointly developed by Daiichi Sankyo and AstraZeneca, has previously been approved in China for the treatment of adult patients with HER2-positive and HER2-low breast cancer. In February 2024, the marketing application of this product was granted priority review by the CDE.As a single agent for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer who have HER2 (ERBB2) activating mutations and have received at least one prior systemic therapy.。In addition to the aforementioned drugs, many other new anti-tumor drugs are also expected to be approved in China in 2024. Due to space limitations, this article will not introduce them one by one. It is hoped that these new drugs will soon reach patients, providing them with new treatment options!ScanBelow IIWeima, youCompiled by the WuXi AppTec content team"Complete PDF File of New Drugs Approved for Marketing in China in 2023"。
[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d[2] Official press releases from various companiesThis article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For reprint authorization, please contact us via the "MedView" WeChat official account. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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