-
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855) lisaftoclax (APG-2575) and AceLink Therapeutics(Suzhou)’s AL01211 are on track to receive priority review and breakthrough therapy designation (BTD) statuses respectively from the US Food and Drug Administration (FDA). Lisaftoclax, an oral BCL-2 inhibitor, is indicated…
-
Daiichi Sankyo’s Pexidartinib Poised for Priority Review in China for TGCT Treatment
•
The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
-
Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
•
Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
-
CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
•
The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
-
Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
•
BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical Co., Ltd and Chengdu Institute of Biological Products Co., Ltd., part of Sinopharm, are on the path to priority review for their respective medical innovations. Ruidio’s Technetium [99mTc] hydrazine nicotinamide polyethylene glycol bicyclic RGD peptide…
-
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
•
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
-
Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
•
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Xiamen University, has received priority review status from China’s Center for Drug Evaluation (CDE). This vaccine targets seven high-risk HPV types (HPV16, 18, 31, 33, 45, 52, and 58)…
-
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
•
The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
-
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
•
HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for Tazverik (tazemetostat) for review. The company is seeking initial approval for Tazverik as a treatment for recurrent or refractory follicular lymphoma (FL), and the filing has been…
-
Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
•
Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
-
InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
•
The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, is on track to receive priority review status for its drug candidate Minjuvi (tafasitamab) in combination with lenalidomide. This treatment is intended for adult patients with recurrent or refractory…
-
Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
•
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb)…
-
Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
•
Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
-
Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
•
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
-
Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
•
Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2…
-
Guangzhou and Zhuhai Unveil Measures to Stimulate Biopharmaceutical Industry Growth
•
In a bid to bolster the biopharmaceutical and health industries, the cities of Guangzhou and Zhuhai in Guangdong province have released Measures aimed at “Promoting High-Quality Development of the Biopharmaceutical Industry.” These policies are designed to refine the development environment and enhance the competitive edge of the sector. Guangzhou’s policy,…
-
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
•
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
-
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
•
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ) FcRn blocker nipocalimab into its fast-track program for development as a therapy to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. This move comes after the drug was classified as…
-
Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
•
The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio (elranatamab), a bispecific antibody targeting BCMA and CD3, is on track for priority review as a potential treatment for triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). This development signifies a significant step…
-
Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
•
China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
-
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
•
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
-
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
-
Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
•
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an IL-23 monoclonal antibody, is set to undergo priority review for the treatment of moderate to severe active Crohn’s disease (CD). The drug, which previously received breakthrough therapy designation (BTD) status, is already approved for use…
-
J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
•
The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
-
CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
•
The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
-
Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
•
Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD),…
-
MSD’s Belzutifan and Sperogenix’s Vamorolone Targeted for Priority Review by China’s CDE
•
The Center for Drug Evaluation (CDE) website has indicated that Merck, Sharp & Dohme’s (MSD; NYSE: MRK) belzutifan and Sperogenix Therapeutics Ltd’s vamorolone are on track to receive priority review statuses in China. Belzutifan, which targets von Hippel Lindau (VHL) disease-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma,…
-
BMS Seeks FDA Priority Review for Krazati in Advanced Colorectal Cancer
•
Bristol Myers Squibb (BMS; NYSE: BMY) has submitted a priority review application to the U.S. Food and Drug Administration (FDA) for an additional indication of its KRASG12C inhibitor, Krazati (adagrasib), in combination with cetuximab (Merck’s Erbitux) for pre-treated patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA…
-
Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
•
This week, the U.S. FDA granted priority review status to an indication extension filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab), seeking approval as a treatment for primary advanced or recurrent endometrial carcinoma, the most prevalent gynecological cancer. The FDA anticipates reaching a…
-
FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
•
The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK; NYSE: GSK) application to extend the age range for its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 who are at increased risk for RSV disease. Arexvy was previously approved…
-
AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic…
-
Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
•
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
-
Pfizer and Genmab’s Tivdak Earns Priority Review from FDA for Full Registration
•
The US Food and Drug Administration (FDA) has accepted for priority review a filing from Pfizer (NYSE: PFE) and Genmab (NASDAQ: GMAB) for the full registration of their antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin). Tivdak currently holds an accelerated approval from 2021 for the treatment of recurrent or metastatic cervical…
-
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
•
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is poised to receive priority review status for the local topical treatment of atopic dermatitis (AD) in patients aged two years and above. This priority status is granted due to the drug’s classification under “new varieties,…
-
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
•
The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
-
InventisBio’s KRAS G12C Inhibitor D-1553 Advances Toward Priority Review in China
•
According to the China Center for Drug Evaluation (CDE), Shanghai-based InventisBio Co., Ltd. (SHA: 688382) is on track to secure priority review status for its KRAS G12C inhibitor, D-1553, aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed KRAS G12C mutation, particularly in patients…
-
Amgen’s Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer Treatment
•
The US Food and Drug Administration (FDA) has granted priority review status to Amgen (NASDAQ: AMGN) for its potential first-in-class bispecific T-cell engager (BiTE) tarlatamab as a second-line treatment for advanced small cell lung cancer (SCLC). The action date for the review is set for June 12, 2024. This decision…
-
HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
•
China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is on track to receive priority review status for its investigational drug, sovleplenib. This designation is granted due to the drug’s potential to treat adults with primary chronic immune thrombocytopenia (ITP) who are unresponsive…
-
Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
•
The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
-
Roche’s Mosunetuzumab and AnHeart’s Taletrectinib Poised for Priority Review in China
•
The China Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Lunsumio (mosunetuzumab) and AnHeart Therapeutics’ taletrectinib are on track to receive priority review status. Mosunetuzumab, a bispecific antibody targeting CD20 and CD3, has already been approved for the treatment of adult recurrent refractory follicular lymphoma (FL)…
-
Jiangsu Aidea Pharmaceutical’s AINUOVIRINE Receives Priority Review Status from CDE
•
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a Chinese pharmaceutical company, has announced that its ainuovirine has been granted priority review status by the Center for Drug Evaluation (CDE) for an additional indication. The new indication targets the combination therapy of ainuovirine with nucleoside-based antiretroviral drugs for the treatment of…
-
AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
•
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
-
BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
•
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
-
Eli Lilly’s Donanemab on Track for Priority Review in China for Early-Stage Alzheimer’s
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Eli Lilly’s (NYSE: LLY) donanemab is set to receive priority review status for the treatment of early-stage Alzheimer’s disease (AD). This development is significant as it pertains to the drug’s potential use in patients with mild cognitive impairment or…
-
Enhertu Receives Priority Review Status for HER2-Positive Gastric Cancer Treatment in China
•
The Center for Drug Evaluation (CDE) website has indicated that Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), is set for priority review status in China. This priority review is specifically for the ADC’s potential use as a…
-
BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
•
The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab) is set to receive priority review status for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma in patients with high HER2 expression who have previously received systemic treatment. This priority review status is a…
-
Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
•
The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd’s (HKG: 6990) drug candidate, SKB264, is on track to obtain priority review status for the treatment of unresectable, locally advanced, or metastatic triple negative breast cancer (TNBC) in China. This development is particularly significant…
-
Jenscare Scientific’s Ken Valve Enters NMPA Priority Review for Aortic Valve System
•
Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer based in Ningbo, has announced that its regulatory filing for the transcatheter artificial aortic valve system, Ken Valve, has been accepted into the priority review process by the National Medical Products Administration (NMPA). This marks a significant…
-
Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
•
The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
-
CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
•
China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant…
-
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
•
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
-
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
•
The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
