August has ended. According to the Insight database, a total of 25 new drugs submitted marketing applications to the CDE in August, includingFirst Marketing Applications for 9 New DrugsAndNew Indication Applications for 16 New Drugs. From the perspective of therapeutic areas,Among them, 11 are new anti-tumor drugs, accounting for nearly 44% of the total.Notably, among the 11 new anti-tumor drugs,10 New Indications Filed, involving multiple types of tumors such as lung cancer, leukemia, and renal cell carcinoma. This article will provide a brief introduction to these new anti-tumor drugs for readers' reference only.
Non-Small Cell Lung Cancer Field: Three Products Submit New Indications1. Hansoh Pharma "Ametinib"On August 20, CDE accepted the fourth new indication application for Aumolertinib.And include it in the priority review, used to treat unresectable locally advanced disease without progression after platinum-based radical radiotherapy and chemotherapy.EGFR Exon 19 Deletion or Exon 21 (L858R) NSCLC patients with substitution mutations. This application is based on the data from Phase III study HS-10296-304, and the specific study data has not been disclosed yet.Insight database predicts that this application is expected to be approved in the second quarter of 2025.
Source of Screenshot:CDE Official WebsiteAmeitinib is a third-generation EGFR-TKI, which has previously been approved for two indications in China: 1) for second-line treatment of patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are positive for the T790M mutation; 2) first-line treatment for patients with EGFR exon 19 deletion or exon 21 (L858R) Positive for substitution mutations in adult patients with locally advanced or metastatic NSCLC.On July 19 this year, the CDE also accepted the third indication application for Aumolertinib, intended for patients with positive EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.Adjuvant Treatment for Adult Patients with NSCLC After Tumor ResectionInsight database predicts that this application is also expected to be approved in the second quarter of 2025.2. Kelun-Biotech "Lukansatuzumab"On August 20, CDE accepted Kelun-BiotechTROP2 ADC SacituzumabThe second marketing application for the treatment of locally advanced or metastatic diseases that have failed EGFR-TKI and platinum-based chemotherapy.EGFR Mutation NSCLC. The application has been included in the priority review by the CDE, and the Insight database predicts that the application is expected to be approved in the third quarter of next year.
Screenshot source:CDE Official WebsiteThis marketing application is based on a multicenter, randomized, pivotal clinical trial, OptiTROP-Lung03, which evaluated the administration of Lukansatuzumab every two weeks (Q2W) 5 mg/kg intravenous injection compared with docetaxel in treating patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed EGFR-TKI therapy and platinum-based chemotherapy. In a pre-specified analysis, compared with docetaxel,Lukang Satuzumab Demonstrates Statistically Significant and Clinically Meaningful Improvements in ORR and PFS。The first marketing application for Luprocizumab was accepted by the CDE in December 2023, for locally advanced or metastatic triple-negative breast cancer that has received at least two prior systemic therapies.Insight database predicts that this application is expected to be approved in the fourth quarter of this year.。3. Aosaikang Pharmaceutical "Liotinib"On August 23, CDE accepted Aosaikang PharmaceuticalThird-generation EGFR-TKI LiotinibThe second NDA for EGFR exon 19 deletion (19DEL) or exon 21 substitution mutation (L858R) locally advanced or metastaticFirst-line Treatment for Adult Patients with NSCLCInsight database predicts that this application is expected to be approved in the third quarter of 2026.
Source of Screenshot:CDE Official WebsiteThe marketing application was based on a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial (CTR20191523), which aims to evaluate the efficacy and safety of ASK120067 tablets compared to gefitinib as a first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR-sensitive mutations. Currently,The Phase III Clinical Trial Has Reached the Primary Endpoint, specific data has not been disclosed.The first NDA for Riottinib was accepted by the CDE in November 2021 for use in patients with locally advanced or metastatic disease who have progressed on prior EGFR-TKI therapy and have confirmed positive EGFR T790M mutations, either acquired during or after treatment, or as primary EGFR T790M mutations.Second-line Treatment for Adult Patients with NSCLCInsight database predicts that this application is expected to be approved in the first quarter of next year.Two BTK Inhibitors Report New Indications for Leukemia Treatment1. Norvax "Orelabrutinib"On August 21, CDE accepted the BTK inhibitor from InnoCare Pharma.Orelabrutinib TabletsNew indication marketing application.Based on the progress of the ongoing clinical trials of Orelabrutinib, it is speculated that the new indication for this application may be:Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma。Insight database predicts that this application is expected to be approved in the second quarter of next year.
Source of screenshot:CDE Official Website
Previously, orelabrutinib had been approved for 3 indications in China, including:For adult chronic lymphocytic leukemia (CLL) patients who have received at least one prior treatment.CLL)/Small Lymphocytic Lymphoma (SLL) patients and adult mantle cell lymphoma (MCL) Patient;and for the treatment of relapsed/refractory marginal zone lymphoma (MZL) Patient.According to the 2024 interim performance report of InnoCare Pharma,Orelabrutinib sales in Q2 this year were RMB 253 million, compared to RMB 170 million in the same period last year, representing a year-on-year increase of 49%.。With the expansion of new indications, the drug's sales are expected to achieve further growth.2. AstraZeneca "Acalabrutinib Tablets"On August 28, CDE accepted AstraZeneca's BTK inhibitorAcalabrutinib TabletsA new indication for marketing application. Previously, Acalabrutinib capsules have been approved in China for the treatment of mantle cell lymphoma and as a single agent for adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.CLL)/Small Lymphocytic Lymphoma (SLL) patients. Based on the clinical research progress of this drug, it is speculated that the indication for Acalabrutinib Tablets in this application may beFor first-line treatment of patients with chronic lymphocytic leukemiaInsight database predicts that this application is expected to be approved in the second quarter of next year.
Source of screenshot:CDE Official WebsiteAstraZeneca announced in April this year that acalabrutinib had reached the primary endpoint in ChangE, a randomized, multicenter, open-label Phase III clinical trial led by China. The trial data showed that, compared with the combination regimen of chlorambucil and rituximab,Statistically significant and clinically meaningful improvements in PFS were observed across all pre-specified subgroups.Compared with the combination of chlorambucil and rituximab,Acalabrutinib Group Shows Trend of Improved OS Benefit。Renal Cell Carcinoma Field: Three Drugs Apply for New Indications1. Zhengda Tianqing's "Morbusab" + "Anlotinib"On August 1, the CDE accepted Zhengda TianqingBeimusuab InjectionUnitedAnlotinib Hydrochloride CapsulesNew indication marketing application forFirst-line treatment for advanced unresectable or metastatic renal cell carcinoma（RCC), Insight database predicts that this application is expected to be approved in the second quarter of next year.
Source of screenshot:CDE Official Website
Bevacizumab is a PD-L1 monoclonal antibody, which has previously been approved in China for first-line treatment of small cell lung cancer and submitted a new NDA for endometrial cancer in February this year. Anlotinib is a multi-target tyrosine kinase inhibitor, which has previously been approved in China for the treatment of non-small cell lung cancer, soft tissue sarcoma, small cell lung cancer, medullary thyroid carcinoma, and differentiated thyroid cancer. This submission marks its eighth indication for marketing approval in China.The NDA for the new indication this time is based on the ETER100 study (NCT04523272). This is a randomized, open-label, positive drug parallel-controlled, multi-center Phase III clinical study aimed at evaluating the efficacy and safety of Beimoshuab monoclonal antibody combined with Anlotinib versus the control group as first-line treatment for advanced unresectable or metastatic RCC. The study showed that, compared with the control group,Beimosubai Monoclonal AntibodyCombination of Anlotinib as first-line treatment for advanced RCC can significantly reduce the risk of disease progression or death in patients, while improving secondary endpoints such as ORR and OS.. The study has been selected as an LBA abstract for the 2024 ESMO Congress, and CTTQ will announce the specific data of the study at that time.On August 16, CDE accepted PfizerAxitinibAxitinib is a highly selective tyrosine kinase inhibitor that acts on vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3. It was previously approved for use in China in 2015.Second-line Treatment for Adult Patients with Advanced Renal Cell Carcinoma。According to the progress of ongoing clinical trials for Axitinib,Insight database speculates that the new indication of this application may be:For the first-line treatment of patients with metastatic renal cell carcinoma。
Source of Screenshot:CDE Official WebsiteIn an international multicenter Phase II/III clinical trial conducted in the United States, China, India, and other countries and regions (CTR20132930), researchers have compared the effects of axitinib and sorafenib treatment in patients with initial renal cell carcinoma.Trial data show:The mPFS in the axitinib group was 10.1 months., while the sorafenib group was 6.5 months;In terms of ORR, the axitinib group was 35.4%., which was also higher than the 16.7% in the sorafenib group;In terms of OS, the axitinib group was 31.5 months., The sorafenib group was 23.3 months.Other New Anticancer Drugs1. Junshi Biosciences "Toripalimab"On August 12, CDE accepted Junshi Biosciences' PD-1 inhibitor.Toripalimab InjectionNew indication marketing application,For first-line treatment of unresectable or metastatic melanoma。If approved,It is expected to become the first-line immunotherapy for advanced melanoma in China.。
Screenshot source:CDE Official WebsiteThe NDA for this new indication is primarily based on a multicenter, randomized, open-label, active-controlled Phase III clinical study, MELATORCH (NCT03430297), this trial aims to compare the efficacy and safety of Toripalimab versus Dacarbazine in patients with unresectable or metastatic melanoma who have not previously received systemic anti-tumor treatment. The study results indicate,Compared with dacarbazine, toripalimab significantly prolonged PFS in patients.。Toripalimab has previously been approved for 10 indications in China.Junshi's financial report shows that in the first half of the year,Toripalimab Achieves Domestic Market Sales Revenue of RMB 6.71 Billion, a Year-on-Year Increase of Approximately 50%. In addition,ToripalimabTwo additional sNDAs have been accepted by the NMPA, respectively targetingHepatocellular Carcinoma and Melanoma.2. AstraZeneca "Durvalumab"On August 16, CDE accepted AstraZeneca's PD-L1 inhibitor.Durvalumab InjectionThe new indication marketing application. Previously, Durvalumab has been approved for three indications in China, respectively for the treatment of Stage III non-small cell lung cancer, extensive-stage small cell lung cancer, and locally advanced or metastatic biliary tract cancer patients.
Source of screenshot:CDE Official WebsiteBased on the progress of ongoing clinical trials for Durvalumab, the Insight database speculates that the new indication submitted this time may be: 1) in combination with Olaparib, Bevacizumab, and platinum-based chemotherapy for the treatment ofNewly Diagnosed Advanced High-Grade Epithelial Ovarian Cancer（No tumor BRCA mutation) patients; or 2) for those whose condition has not progressed after receiving platinum-based concurrent chemoradiotherapyLimited-stage small cell lung cancerThe patient's consolidation therapy.3. Raydiant Tech "99mTc-3PRGD2"On August 29, CDE accepted the joint application from Radiant Technology and Huayi Technology.Technetium [99mTc] Hydrazinonicotinamide Polyethylene Glycol Bicyclic RGD Peptide InjectionThe marketing application of (99mTc-3PRGD2). 99mTc-3PRGD2 isAn RDC Drug Targeting Integrin, Insight database speculates that the drug's current submission for marketing approval is intended forDiagnosis of Benign and Malignant Pulmonary Tumors and Lymph Node Metastasis。
Screenshot source:CDE Official Website
Non-oncology new drugs applied for marketing in August
In addition to the aforementioned new anti-tumor drugs, many other new drugs in different therapeutic areas were also submitted for marketing approval or filed for new indications NDA in China in August.See the table below), Indications include Alzheimer's disease, Type 1 diabetes, Myasthenia gravis, Myelofibrosis, Hemophilia, Diabetic nephropathy, etc. Due to space limitations, they will not be introduced one by one here.Cover Source:ZCOOL Hello PlusDisclaimer:This article is for information sharing only,不代表 Insight 立场和观点, nor does it recommend or introduce any treatment options. If you have any needs, please consult and contact正规医疗机构.PR Article Collaboration: WeChat insightxbSubmissionWeChat: insightxb; Email: insight@dxy.cn
Diversified functions, traceable data……Insight Database Web Version Awaits Your Experience
Click to read the original text,ImmediatelyUnlock！
