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Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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Beijing Balance Medical Technology’s ePTFE Implant Accepted for NMPA Review
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for an expanded polytetrafluoroethylene (ePTFE) implant. This Category III medical device is specifically processed and manufactured for the repair or reconstruction of the pericardium during cardiac surgery.…
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Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530), has announced that the National Medical Products Administration (NMPA) has accepted its market filing for the drug candidate SSGJ-608 for review. The company is seeking regulatory approval for the anti-IL-17A monoclonal antibody to treat moderate…
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Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
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Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of lecanemab, an amyloid-beta (Aβ) monoclonal antibody, for the treatment of adult patients…
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Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
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The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted a marketing approval filing from Swiss pharmaceutical giant Novartis (NYSE: NVS) for its radioligand therapy (RLT), Pluvicto (177Lu vipivotide tetraxetan). This acceptance marks a significant step towards making this innovative treatment available to patients in…
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Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative oncology treatments, have jointly announced the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd). This application seeks…
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J&J Submits Regulatory Filings for Darzalex Faspro and Subcutaneous Daratumumab
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Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its therapies Darzalex Faspro (daratumumab and hyaluronidase-fihj) to the US Food and Drug Administration (FDA) and for the subcutaneous (SC) formulation of Darzalex (daratumumab) to the European Medicine Agency (EMA). The company is seeking new indication…
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Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
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AIM Vaccine Submits Market Filing for 13-Valent Pneumococcal Conjugate Vaccine in China
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing for its in-house developed 13-valent pneumococcal conjugate vaccine to the National Medical Products Administration (NMPA). Streptococcus pneumoniae disease is a high-priority target for vaccine prevention efforts. The 13-valent pneumococcal conjugate vaccine is designed for infants…
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Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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RemeGen’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious…
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RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
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LINDIS Biotech’s Catumaxomab Receives Positive Opinion from EMA’s COMP for Malignant Ascites Treatment
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LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
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LENZ Therapeutics’ Presbyopia Therapy LNZ100 Accepted for FDA Review
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LENZ Therapeutics, Inc. (NASDAQ: LENZ), a US-based biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for LNZ100 (aceclidine), a therapy for presbyopia. The FDA has set an action date of August 8, 2025, for the application. LNZ100…
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Sino Biopharmaceutical’s Anlotinib Receives Ninth Indication Approval from China’s CDE for Soft-Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company in China, has announced that it has received another indication approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its oral multi-target kinase inhibitor, anlotinib. The request is for anlotinib to be used in…
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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
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Ji Xing Pharmaceuticals (Jixing) and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is under development for…
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Jiangsu Hengrui’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its drug candidate, hetrombopag olamine. This new indication is for the use of hetrombopag olamine in combination with…
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RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
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Novartis’s Brolucizumab Accepted for Review by China’s CDE for Potential DME Treatment
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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Johnson & Johnson’s Darzalex Combo Therapy Gets EMA Nod for Multiple Myeloma, Aims to Set New Standard
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Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio with a market filing to the European Medicines Agency (EMA) for its drug Darzalex (daratumumab). The application seeks an indication extension for the subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, lenalidomide, and dexamethasone…
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Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
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Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
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Shanghai Fosun Pharmaceutical’s SBK010 Stroke Treatment Accepted for NMPA Review
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted a market filing for its chemical drug SBK010 for review. SBK010, which is licensed from Chengdu Shibekang Biomedical Technology Co., Ltd, another…
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Innovent Biologics Submits Market Approval Filing for Picankibart in Plaque Psoriasis to China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has reportedly submitted a market approval filing to the Center for Drug Evaluation (CDE) for its investigational drug picankibart (IBI112), intended for the treatment of moderate to severe plaque psoriasis. Picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody…
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China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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Haisco Pharmaceutical’s HSK21542 for Itching in Dialysis Patients Receives NMPA Review
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
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Ocumension Therapeutics’ OT-502 Receives NMPA Acceptance for Post-Cataract Inflammation Treatment
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Ocumension Therapeutics (HKG: 1477) announced on September 23, 2024, that the National Medical Products Administration (NMPA) in China has accepted its New Drug Application (NDA) for OT-502 (DEXYCU, dexamethasone implant). This ophthalmic new drug is designed to treat postoperative inflammation and is indicated for suppressing inflammation and related complications in…
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Fosun Pharmaceutical’s PD-1 Inhibitor HanSiZhuang Recommended for Approval by EMA’s CHMP
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a leading pharmaceutical company in China, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang, in combination with carboplatin and…
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J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
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Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
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Jiangsu Hengrui Medicine’s SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for SHR-1701 in combination with fluorouracil and platinum for the first-line treatment of locally advanced unresectable, recurrent, or metastatic adenocarcinoma of…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult…
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Novo Nordisk Advances in China with Submission of Sogroya for Adult Growth Hormone Deficiency
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Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Sogroya (somapacitan), a long-acting somatotropin. This once-weekly treatment is designed to address adult growth hormone deficiency (AGHD) and has already received approval in the US in…
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Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
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The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma…
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Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
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The Center for Drug Evaluation (CDE) has given the green light for the review of a new indication submission for Jiangsu Hengrui Medicine Co., Ltd’s (SHA: 600276) ivarmacitinib, as per the latest update on the CDE’s website. The potential new indication is speculated to be adult alopecia areata, aligning with…
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Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
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BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a long-acting erythropoietin (EPO) product, rhEPO-Fc, developed by Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), for review. The product is intended for the treatment of anemia associated with chronic kidney disease (CKD). Anemia is a common…
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HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal of its New Drug Application (NDA) for fruquintinib, a VEGFR inhibitor, in combination with paclitaxel for the second-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in China. The decision to withdraw was made…
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J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
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US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
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Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs
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China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing approvals in China for two advanced treatments targeting neurodegenerative and autoimmune conditions, according to the Center for Drug Evaluation (CDE) website. Tonghua Golden-Horse’s octohydroaminoacridine succinate, designed to treat mild to moderate Alzheimer’s disease (AD), and…
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Diversifying HPV Protection: Beijing Wantai’s Vaccine Filing Competes with Gardasil 9 in China
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 603392), has announced that the National Medical Products Administration (NMPA) has accepted for review the market approval filing for its innovative recombinant human papillomavirus (HPV) vaccine. This nine-valent vaccine, which targets HPV…
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CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
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CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation from the US Food and Drug Administration (FDA) for its drug candidate Halneuron, which contains tetrodotoxin, for the treatment of chemotherapy-induced neuropathic pain (CINP). Halneuron is an innovative injectable form of tetrodotoxin, a naturally occurring…
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Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
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Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its investigational compound OB756. The company is seeking regulatory approval for the treatment of patients with medium to high-risk myelofibrosis (MF). OB756 is a novel JAK2 inhibitor…
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Pfizer’s Hemophilia Treatment Marstacimab Accepted for Review in China
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The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing for Pfizer Inc.’s (NYSE: PFE) Category 1 biologic drug marstacimab (PF-06741086), according to the agency’s website. This regulatory milestone in China follows similar submissions to the U.S. Food and Drug Administration (FDA) and the European…
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Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
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Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
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This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma A/S (NASDAQ: ASND), a Denmark-based pharmaceutical company specializing in rare diseases, for its hypoparathyroidism treatment, palopegteriparatide. The therapy, to be marketed as Yorvipath, is a once-daily prodrug of parathyroid hormone (PTH[1-34]) designed to address the…
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Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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Innovent Biologics’ Mazdutide NDA for Type 2 Diabetes Accepted for Review in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review the second New Drug Application (NDA) for its investigational drug mazdutide (IBI362). Mazdutide is a novel glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR)…
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Cutia Therapeutics’ CU-30101 NDA Accepted for Review by China’s NMPA
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Cutia Therapeutics (HKG: 2487), a company specializing in dermatological treatments, has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for CU-30101, a topical lidocaine and tetracaine cream. This pharmaceutical product is designed to provide rapid and long-lasting anesthetic effects, leveraging the…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Belief BioMed and Takeda’s Hemophilia B Gene Therapy BBM-H901 Accepted for NMPA Review
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Belief BioMed Group (BBM), a Shanghai-based gene therapy specialist, and Takeda have announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for BBM-H901, a gene therapy for hemophilia B. This development marks a significant milestone for the treatment, which is being designed…
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Johnson & Johnson Pursues FDA Approval for Spravato as Monotherapy for Treatment-Resistant Depression
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Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval for its anti-depression drug Spravato (esketamine) in the U.S. by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks to establish Spravato CIII nasal spray as…
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Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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Sino Biopharmaceutical Submits Market Approval Filing for CDK2/4/6 Inhibitor Culmerciclib in Breast Cancer
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced the submission of a market approval filing for its Category 1 drug culmerciclib (TQB3616). The filing is for the use of culmerciclib in combination with fulvestrant for the treatment of hormone receptor (HR) positive and human epidermal…
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Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This…
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Jiangsu Simcere Pharmaceutical’s Quviviq Approval Application Accepted for Review by China’s NMPA
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
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Ocumension Therapeutics and Shandong Boan Biotechnology File for Market Approval of Biosimilar Aflibercept in China
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Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
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Sino Biopharmaceutical’s Rovadicitinib Gets CDE Nod for Review in Myelofibrosis
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the Center for Drug Evaluation (CDE) in China has accepted for review its market approval filing for the investigational Category 1 drug rovadicitinib (TQ05105). The drug is being developed for the treatment of moderate- to high-risk myelofibrosis (MF), a serious bone marrow…
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NMPA Accepts 3SBio’s Filing for Anemia Treatment SSS06, Potential Game Changer for Dialysis Patients
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3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the National Medical Products Administration has accepted its filing for market approval of SSS06, a recombinant erythropoiesis stimulating protein injection (rESP, CHO cells). This development marks a significant milestone for the company as it aims to…
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HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
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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…
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Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating…
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Harbour BioMed Resubmits Biological License Application for Batoclimab in China
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the resubmission of a biological license application (BLA) to China’s National Medical Products Administration (NMPA) for its drug candidate batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). Batoclimab…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Suzhou Zelgen’s Recombinant Human Thyroid Stimulating Hormone Accepted for NMPA Review
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for recombinant human thyroid stimulating hormone (rhTSH). The biomacromolecular drug is intended for use in radioactive iodine (131I) whole body…
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Zymeworks and BeiGene Submit BLA in China for Zanidatamab as Second-Line HER2-Positive BTC Treatment”
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Zymeworks Inc. (NASDAQ: ZYME), a Canadian biotech company, in partnership with BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), has submitted a Biologics License Application (BLA) to Chinese regulators for zanidatamab, a bispecific antibody for the treatment of HER2-positive biliary tract cancer (BTC) as a second-line therapy. Zymeworks’ zanidatamab is designed…
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Fosun Pharma’s FCN-159 Receives Priority Review Status from NMPA for Pediatric Neurofibromatosis
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for the novel small-molecule drug candidate FCN-159, granting it priority review status. The filing seeks approval for the treatment of plexiform neurofibroma (PN)…
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Luye Pharma Submits Market Approval Application for Rivastigmine Patch in Japan
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced a market approval filing with the Japanese regulatory authorities for its rivastigmine twice-weekly transdermal patch, LY03013. The company is seeking marketing authorization for the drug to treat symptoms of mild-to-moderate Alzheimer’s disease (AD). Developed on Luye’s…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
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Astellas Resubmits FDA Application for Vyloy as Treatment for CLDN18.2-Positive Cancer
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has resubmitted its first-in-class anti-CLDN18.2 biologic Vyloy (zolbetuximab) to the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This resubmission follows an earlier rejection and comes…
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CStone Pharmaceuticals’ Sugemalimab Receives Positive CHMP Opinion for NSCLC Treatment in Europe
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CStone Pharmaceuticals (HKG: 2616), a biopharmaceutical company based in China, has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of sugemalimab in combination with chemotherapy as a first-line…
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Sino Medical Sciences’ Innovative Drug-Coated Stent System Accepted for NMPA Review
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical technology company, has announced that the National Medical Products Administration (NMPA) has accepted for review its marketing approval filing for a self-expanding intracranial drug-coated stent system. Designed for the treatment of intracranial atherosclerotic stenosis, the product is intended to support…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, developed by Eli Lilly, a leading pharmaceutical…
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Boan Biotech’s Dulaglutide Biosimilar Accepted for Review by China’s CDE
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted its marketing filing for BA5101, a biosimilar version of Trulicity (dulaglutide) for blood glucose control in adults with type 2 diabetes. Trulicity, originally developed by US pharmaceutical giant Eli…
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Henlius Biotech’s Denosumab Biosimilar Secures EMA Review for European Market Entry
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that the European Medicine Agency (EMA) has accepted two marketing approval filings for its drug candidate HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab). Denosumab, a recombinant anti-RANKL human monoclonal antibody injection, is utilized for various…
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Shanghai Fosun Pharma’s FCN-159 File for Dendritic and Histiocytic Tumors Accepted by China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for the novel small-molecule drug FCN-159 for review. The drug is being considered for the treatment of dendritic and histiocytic tumors, indications that have previously…
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Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
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NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for Cevira (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix, excluding in…
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Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
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Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer…
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FDA Reviews BMS’ Opdivo Subcutaneous Formulation for Broad Indications
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The US Food and Drug Administration (FDA) has agreed to review a submission from Bristol-Myers Squibb (BMS; NYSE: BMY) for a subcutaneous formulation of its anti-PD-1 therapy Opdivo (nivolumab). The new formulation utilizes Halozyme Therapeutics’ (NASDAQ: HALO) proprietary hyaluronidase (rHuPH20) and aims to cover all previously approved indications for the…
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LEO Pharma’s Enstilar Outperforms Daivobet in Phase III Psoriasis Trial in China
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Denmark-based dermatology specialist LEO Pharma A/S has announced positive outcomes for its drug candidate Enstilar (LEO 90100) in a Phase III clinical trial conducted in China. The trial focused on evaluating Enstilar as a potential treatment for Chinese patients with stable plaque psoriasis. The primary objective of the study was…
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Merus’s Zenocutuzumab Receives Priority Review Status from FDA for Lung and Pancreatic Cancer Indications
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Dutch biotechnology company Merus (NASDAQ: MRUS) has announced that the US Food and Drug Administration (FDA) has accepted for review its market approval filing for zenocutuzumab, a first-in-class HER2/HER3 bispecific antibody (BsAb), for the treatment of NRG1+ non-small cell lung cancer (NSCLC) and pancreatic cancer. The application has been granted…
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Betta Pharmaceuticals Files for Market Approval of CDK4/6 Inhibitor BPI-16350 in China
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Betta Pharmaceuticals Co., Ltd (SHE: 300558), a Chinese pharmaceutical company, has announced that it has filed for market approval in China for its drug candidate BPI-16350. The cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is being developed in combination with fulvestrant for the treatment of locally advanced or recurrent hormone…
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Jacobio Pharma Applies for Approval of KRAS G12C Inhibitor Gecirasib in China
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Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to China’s Center for Drug Evaluation (CDE) for its investigational drug glecirasib. The KRAS G12C inhibitor is being sought after for approval as a treatment for second-line and above advanced or metastatic…
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Keymed Biosciences’ IL-4Rα Monoclonal Antibody for Allergic Rhinitis Accepted by China NMPA
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China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that the National Medical Products Administration (NMPA) has accepted for review its market filing for stapokibart (CM310), an IL-4Rα monoclonal antibody (mAb) drug candidate, for the treatment of seasonal allergic rhinitis (SAR). The market filing is supported by a Phase…
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Cutia Therapeutics Submits New Drug Application for Androgenic Alopecia Treatment in Hong Kong
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Cutia Therapeutics (HKG: 2487), a dermatology-focused pharmaceutical company, has announced the submission of a New Drug Application (NDA) for its proprietary CU-40102 (external einasteride spray) for the treatment of androgenic alopecia to the Department of Health of Hong Kong, China. CU-40102 is positioned as the world’s first and currently only…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty Receives CE Mark for European Expansion
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China-based MicroPort Scientific Corp (HKG: 0853), a leading medical device company, announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has secured the CE mark for its VitaFlow Liberty transcatheter aortic valve and its recyclable delivery system. This regulatory approval paves the way for the product’s market entry…
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Huadong Medicine’s Lidocaine-Containing Hyaluronic Acid Gel Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted for review the market approval filing for its Category III medical device, MaiLi Extreme, a lidocaine-containing crosslinked sodium hyaluronate gel. This high-end hyaluronic acid product, which received the CE mark in June…
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Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for albenatide (CJC‑1134‑PC) for review. The company is seeking initial approval for the drug as an adjunct to diet and exercise to improve blood glucose control…
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Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
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China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Joincare Pharmaceutical’s TG-1000 Shows Promise in Phase III Flu Treatment Trial
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Joincare Pharmaceutical Group Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has reportedly completed the unblinding of a Phase III trial for TG-1000, an investigational influenza antiviral drug. The trial has shown positive preliminary data, indicating that the company is now preparing to file a New Drug Application (NDA) in…
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Luye Pharma’s Subsidiary Boan Biotech Completes Phase III Trial for Eylea Biosimilar BA9101
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Shandong Boan Biotechnology Co., Ltd., a subsidiary of China-based Luye Pharma Group (HKG: 2186), has achieved a significant milestone with the completion of a Phase III clinical study for its proprietary ophthalmology product BA9101. This biosimilar version of Bayer’s Eylea (aflibercept) targets the treatment of recurrent or metastatic esophageal squamous…
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AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
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Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval filing for a biosimilar version of semaglutide, originally developed by Denmark’s Novo Nordisk, has been accepted for review in China. This biosimilar is aimed at controlling blood glucose levels in patients with type 2 diabetes…
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RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the…
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Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
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China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval filings for its PCSK9 monoclonal antibody, ongericimab (JS002). The filings target heterozygous familial hypercholesterolemia and primary hypercholesterolemia, as well as mixed dyslipidemia in patients who are intolerant to or contraindicated for statins. The National Medical…
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FDA Reviews Eisai’s Monthly Maintenance Therapy for Early Alzheimer’s with Leqembi
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Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication extension filing from Japan’s Eisai (TYO: 4523) for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy intended as a once-monthly maintenance treatment for early Alzheimer’s disease (AD). Currently, the intravenous therapy has conditional approval in the United…
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Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
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Legend Biotech’s Carvykti Earns FDA Committee’s Unanimous Recommendation for Expanded Use
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that its subsidiary Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), has received a recommendation from the US FDA’s Oncologic Drugs Advisory Committee (ODAC). Following a review…
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Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication…
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FDA Advisory Committee Backs Wider Use of Abecma in Relapsed or Refractory Multiple Myeloma
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An advisory committee to the US Food and Drug Administration (FDA) has recommended the use of Abecma (idecabtagene vicleucel), a CAR-T therapy developed by Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy bio (NASDAQ: TSVT), for the treatment of triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/rMM). This recommendation…
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Genor Biopharma Secures NMPA Review for Lerociclib in Advanced Breast Cancer Indication
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Genor Biopharma Co., Ltd. (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has accepted its filing for another indication approval of lerociclib (GB491), a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor. The new indication seeks to utilize lerociclib in combination with letrozole for patients with hormone receptor-positive…
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Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
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Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
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J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
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The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for its IL-23p19-subunit inhibitor Tremfya (guselkumab) as a potential treatment for moderately to severely active ulcerative colitis (UC). The regulatory body will now review data from a late-stage study that…
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Everest Medicines’ Velsipity NDA Accepted in Macau, Poised for First Asian Approval
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Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC) has been accepted for review by the regulatory authority in Macau. This marks Macau as the first region in Asia, within Everest’s licensed…
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Eli Lilly Delays Donanemab Action Date as FDA Calls for Advisory Committee Review
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Eli Lilly (NYSE: LLY) has announced a delay in the action date for its Alzheimer’s disease candidate, donanemab, with the U.S. Food and Drug Administration (FDA) pushing the timeline beyond the fourth quarter of 2024. The delay follows the FDA’s request for an advisory committee meeting to evaluate donanemab’s Phase…
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Visen Pharmaceuticals’ TransCon hGH Accepted for Review by China’s NMPA
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Visen Pharmaceuticals, a joint venture between Denmark-based Ascendis Pharma and Chinese healthcare-focused investment firm Vivo Capital, has announced that the National Medical Products Administration (NMPA) has accepted for review a marketing approval filing for its lonapegsomatropin, TransCon hGH, a once-weekly long-acting growth hormone. This drug, which is the first long-acting…
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EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
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The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple…
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Hybio Pharmaceutical Gets FDA Nod for Liraglutide Raw Materials with DMF Adequacy Letter
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a China-based pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the US Food and Drug Administration (FDA) for its liraglutide raw materials. The letter indicates no comments and no deficiencies, which is a significant step…
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EMA Reviews Datopotamab Deruxtecan Filings from AstraZeneca and Daiichi Sankyo for Oncology Indications
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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Aosaikang’s Marketing Approval Filing for Delafloxacin Accepted by China’s NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the National Medical Product Administration (NMPA) in China has accepted for review its marketing approval filing for the Category III chemical injectable drug delafloxacin. Delafloxacin is a new generation broad-spectrum fluoroquinolone antibiotic indicated for the treatment…
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Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
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Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted for review its market approval filing for the injectable Arcalyst (rionacept). The drug is indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged…
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Innovent Biologics’ Taletrectinib Receives Second NDA Acceptance in China for ROS1 Positive NSCLC
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently…
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AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
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AIM Vaccine Co., Ltd (HKG: 6660) has delivered a series of updates on the development progress of its vaccine candidates. The company has submitted a preliminary market filing for its 13-valent pneumococcal conjugate vaccine, designed to prevent invasive diseases caused by 13 pneumococcal serotypes, including bacteremic pneumonia, meningitis, sepsis, and…
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Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
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Chia Tai Tianqing’s Anlotinib-Benmelstobart Combo Therapy Receives CDE Review for Endometrial Cancer
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Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
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CanSino Biologics’ 13-Valent Pneumococcal Vaccine CRM197 Accepted for NMPA Review
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CanSino Biologics Inc., (HKG: 6185), a leading Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its CRM197, a 13-valent pneumococcal polysaccharide conjugate vaccine (TT vector). This development marks a significant step forward in the advancement of…
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BeiGene’s Tislelizumab Receives CHMP Recommendation for Three NSCLC Indications in Europe
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BeiGene (NASDAQ: BGNE) has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended its programmed death-1 (PD-1) inhibitor tislelizumab for a marketing license for three non-small cell lung cancer (NSCLC) indications. The CHMP’s positive opinion is for: Patients with EGFR or ALK mutation-positive…
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Sanofi’s Dupixent Receives FDA Priority Review for COPD Indication Extension
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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),…
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Merck’s Keytruda Under Priority Review for New Indication in Endometrial Carcinoma
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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…
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FDA Grants Priority Review for GSK’s Arexvy to Expand RSV Vaccine Age Range to 50-59
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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…
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Nanjing Zenshine’s ZX-7101A NDA Accepted by NMPA for Uncomplicated Influenza Treatment
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Nanjing Zenshine Pharmaceuticals Co., Ltd., a China-based small molecule drug developer, has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZX-7101A, an anti-influenza treatment targeting uncomplicated influenza in adults. The NDA is supported by data from a multi-center, randomized, double-blinded, placebo-controlled Phase…
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SciClone and Menarini File for Import License of Antibacterial Drug Vaborem in Macau
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted an import drug pre-license filing for Vaborem (meropenem vaborbactam) in Macau. The company is seeking regulatory approval for the new antibacterial drug to treat complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and complicated complex urinary…
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Shanghai Junshi Biosciences’ Toripalimab Aims for Singapore Approval in Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has submitted market approval applications in Singapore for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug is proposed for use as a first-line treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC)…
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AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
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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…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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Eisai’s Uric Acid Excretion Drug Urece Accepted for Review in China
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The Center for Drug Evaluation (CDE) in China has indicated on its website that it has accepted for review the New Drug Application (NDA) filed by Japan-based Eisai (TYO: 4523) for its drug Urece (dotinurad). This marks a significant step towards potentially bringing the uric acid excretion promoting drug to…
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BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
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BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center…
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SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
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SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
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Huadong Medicine’s Relmapirazin Approval Filing Accepted by NMPA for GFR Measurement
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Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that its market approval filing for relmapirazin, a Category 1 chemical drug and fluorescent tracer for measuring glomerular filtration rate (GFR), has been accepted for review by the National Medical Products Administration (NMPA). This tracer is designed for use…
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Eisai’s Lemborexant Sleep Aid Lemborexant Filed for NMPA Approval in China
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The China Center for Drug Evaluation (CDE) website has indicated that Japan-based Eisai (TYO: 4523) has filed lemborexant, marketed under the trade name Dayvigo, for approval with the National Medical Products Administration (NMPA) in China. Lemborexant is a dual orexin receptor antagonist that competitively binds to two types of orexin…
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Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
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The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted by Astellas (TYO: 4503), a Japanese pharmaceutical company, for its first-in-class anti-CLDN18.2 biologic zolbetuximab. The drug was under consideration for the treatment of locally advanced unresectable or metastatic HER2-negative CLDN18.2-positive gastric or gastroesophageal junction (GEJ)…
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Genrix Bio Seeks China Approval for New Xeligekimab Use in Axial Spondyloarthritis
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Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted a new indication filing for its innovative biologic product xeligekimab, which has now been accepted for review by the National Medical Products Administration (NMPA). This latest filing seeks approval for xeligekimab to treat radiologically…
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Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
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Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission of a new indication supplementary approval filing for its bispecific antibody (BsAb) drug candidate, cadonilimab (AK104). The company is seeking to expand the use of cadonilimab in combination with chemotherapy as a first-line treatment for…
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JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an additional indication application for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection), targeting recurrent or refractory mantle cell lymphoma (r/r MCL). The National Medical Products Administration (NMPA) has accepted the filing…
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Jiangsu Vcare PharmaTech Submits NDA to US FDA for Vicagrel, a P2Y12 Receptor Antagonist
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Jiangsu Vcare PharmaTech Co., Ltd, a Chinese pharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its vicagrel, a P2Y12 receptor antagonist. The drug is proposed for the treatment of acute coronary syndrome (ACS), ischemic stroke, and thrombotic cardiovascular and diagnosed…
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InventisBio’s KRAS G12C Inhibitor Garsorasib NDA Accepted for Review by China’s NMPA
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InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for its candidate garsorasib (D-1553) has been accepted for review by China’s National Medical Products Administration (NMPA). The KRAS G12C inhibitor is intended for the treatment of locally advanced or metastatic non-small…
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BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
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The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
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FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
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The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD)…
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Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
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China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by the Taiwan Food and Drug Administration (TFDA). The application seeks approval for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon is a patented…
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Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
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The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
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Guangdong Zhongsheng Pharmaceutical’s ZSP1273 for Influenza A Accepted for Review by NMPA
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has accepted for review its market approval filing for ZSP1273, a Category 1 drug candidate and a potential treatment for influenza A. ZSP1273 is recognized as the first small-molecule RNA…
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FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
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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…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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Sino Biopharmaceutical Submits Market Approval Application for Recombinant Coagulation Factor VIIa
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the submission of a market approval application for its in-house developed recombinant human coagulation factor VIIa. The application has been accepted for review by China’s National Medical Products Administration (NMPA). The drug candidate is being developed…
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Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
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Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed death-1 (PD-1) drug, HanSiZhuang (serplulimab), seeking approval for use in combination with chemotherapy for first-line non-squamous non-small cell lung cancer (nsqNSCLC). The filing, accepted for review by the National Medical Products Administration (NMPA), marks the…
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Sisram Medical’s Profhilo Accepted for Review by China’s NMPA
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Sisram Medical Ltd (HKG: 1696), an Israel-based company within the Fosun Pharmaceutical Group (SHA: 600196), has announced that its licensed injection filler product, Prohiro, has had its market filing accepted for review by China’s National Medical Products Administration (NMPA). Profhilo, an injectable sodium hyaluronate solution, is recognized as one of…
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Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has had its New Drug Application (NDA) for SKB264 accepted for review by China’s National Medical Products Administration (NMPA). This application is based on results from the OptiTROP-Breast01 study,…
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Keymed Biosciences’ Stapokibart Filing Accepted for Priority Review in China for Atopic Dermatitis
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Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a monoclonal antibody targeting the IL-4 receptor alpha (IL-4Rα), has been accepted for priority review by the National Medical Products Administration (NMPA) for the treatment of moderate to severe atopic dermatitis (AD). The filing is supported…
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Trinomab’s TNM002 Antitetanus Monoclonal Antibody Filing Accepted for Review in China
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China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing for its antitetanus toxin monoclonal antibody (mAb) injection, TNM002, for review. TNM002, developed using Trinomab’s proprietary HitmAb technology platform, has demonstrated strong drug specificity, favorable safety profiles, and exceptional efficacy in neutralizing tetanus toxin in…
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Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
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Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent (reversible) Bruton tyrosine kinase (BTK) inhibitor, according to the China Center for Drug Evaluation (CDE) website. The application targets adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously undergone BTK inhibitor…
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Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), based in China, has announced that its market approval filing for the programmed death-1 (PD-1) monoclonal antibody camrelizumab, in combination with multi-kinase inhibitor famitinib for recurrent or metastatic cervical cancer, has been accepted for review by the National Medical Products Administration (NMPA). This…
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Akeso Biopharma Files New Indication for Penpulimab in First-Line NPC Treatment
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Akeso Biopharma (HKG: 9926) has announced a new indication filing for its programmed death-1 (PD-1) inhibitor, penpulimab (AK105), seeking approval for its use in first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with chemotherapy. The application is currently under review by China’s Center for Drug Evaluation (CDE).…
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Shanghai Junshi’s Loqtorzi Enters Australian Market Approval Process for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Therapeutic Goods Administration (TGA) in Australia has accepted its market approval filing for Loqtorzi (toripalimab), a programmed death-1 (PD-1) inhibitor. The application seeks approval for two indications: as a first-line treatment in combination with cisplatin and gemcitabine…
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Asieris Pharmaceuticals’ Hexvix for Bladder Cancer Accepted for Review by China’s NMPA
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Asieris Pharmaceuticals (SHA: 688176), a specialist in urogenital cancer based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its Hexvix (APL-1706) for the diagnosis and management of bladder cancer. Hexvix stands as the only globally approved agent…
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Sinocelltech’s PD-1 Inhibitor SCT-I10A for HNSCC Accepted for NMPA Review
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Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that its market approval filing for the investigational product SCT-I10A, a programmed-death 1 (PD-1) monoclonal antibody (mAb), has been accepted for review by the National Medical Products Administration (NMPA). The filed indication is for the treatment of head and…
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Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in South Korea
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for Nefecon (sustained-release budesonide) has been accepted for review by South Korea’s Ministry of Food and Drug Safety (MFDS). The therapy is under consideration for approval as a treatment for primary immunoglobulin A nephropathy…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Fosun Pharmaceutical’s FCN-437c filing Accepted for Review by China’s NMPA
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Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196; SHA: 600196) has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for FCN-437c. The small molecule drug candidate is under development for the treatment of hormone receptor (HR) positive and human epidermal growth factor…
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Beijing Balance Medical Technology’s Transcatheter Aortic Valve System Accepted for NMPA Review
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China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for a transcatheter aortic valve system for review. Product Features and Clinical ApplicationsThe product is designed for patients with severe aortic valve stenosis who are at…
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Fujian Cosunter’s COVID-19 Therapy GST-HG171/Ritonavir NDA Accepted by NMPA
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for the Category 1 product GST-HG171/ritonavir, an oral therapy for COVID-19, has been accepted for review by China’s National Medical Products Administration (NMPA). Therapeutic Profile of GST-HG171/RitonavirGST-HG171 is identified as a…
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China’s NMPA Accepts EOC Pharma Group’s Filing for Vascepa (Icosapent Ethyl) for Review
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The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Vascepa (icosapent ethyl) for review. The drug is targeted for the prevention and reduction of cardiovascular event risks in adult patients with hypertriglyceridemia who are diagnosed with cardiovascular…
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Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for Arcalyst (rilonacept) for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs). The drug is specifically filed for approval in treating familial cold autoimmune syndrome…
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Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
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Jiangsu Hengrui Medicine (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted its market filing for the drug candidate HR20031 for review. The drug is intended for type 2 diabetes patients with poorly controlled blood glucose who have previously…
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Clover Biopharmaceuticals Submits Market Filing for Seasonal Influenza Vaccine in Brazil
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the submission of a market filing for its seasonal influenza vaccine in Brazil. This move marks a strategic expansion for the company as it seeks to broaden the reach of its vaccine offerings. Product Details and AdvantagesThe product in question is a…
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Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted the market filing for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine), targeting folate receptor α (FRα). This marks a significant step towards making the treatment available for patients in China. Acquisition…
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BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as…
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CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug Application (NDA) for its maralixibat (CAN108) has been accepted for review by the National Medical Products Administration (NMPA) in China, with the added benefit of priority review status. This marks a significant step forward in…
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AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
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AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug candidate, capivasertib, in combination with Faslodex (fulvestrant), according to the China Center for Drug Evaluation (CDE) website. The filing has been accepted for review, marking a significant step forward in the treatment of hormone receptor…
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Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
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China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its product, paliperidone palmitate extended-release injectable suspension (LY03010), via the 505(b)(2) regulatory pathway. The drug is under consideration for approval as a treatment for schizophrenia…
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HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the approval of fruquintinib as a treatment for adult patients with previously treated metastatic colorectal cancer (CRC).…
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Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
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Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the progress of its programmed death-1 (PD-1) inhibitor, toripalimab, at the US Food and Drug Administration (FDA). Toripalimab is under license from China’s Junshi Biosciences (HKG: 1877; SHA: 688180). The FDA has completed its clinical study…
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Cutia Therapeutics Files for Market Approval of CU-10201 with NMPA for Acne Treatment
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Cutia Therapeutics (HKG: 2487), a developer focused on dermatology therapies, has announced the submission of a market approval filing for its CU-10201 (4% minocycline foam agent for external use) to the National Medical Products Administration (NMPA) in China. The drug, which targets the treatment of non-nodular moderate to severe acne…
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Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) has accepted for review the New Drug Application (NDA) for its medication Xtandi (enzalutamide), which is intended for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). NDA Basis and Study ResultsThe NDA is…
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Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a filing by UK-based GlaxoSmithKline (GSK; NYSE: GSK) for its first-in-class candidate, momelotinib, as a potential treatment for the blood cancer myelofibrosis. The submission is supported by Phase III clinical trial results that show significant improvements…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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Haisco Pharmaceutical’s HSK16149 for Post-Herpes Neuralgia Accepted for NMPA Review
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products Administration (NMPA) has accepted for review a market approval filing for its drug candidate HSK16149 as a treatment for post-herpes neuralgia (PHN). This in-house Category 1 drug, an oral gamma-aminobutyric acid (GABA) analogue, is under…
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FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
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The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been…
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Huadong Medicine’s Subsidiary Viora Ltd’s V20 Accepted for NMPA Review
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted a Category III market filing for its wholly owned subsidiary Viora Ltd’s V20 optical radiofrequency therapy instrument. This development marks a significant step forward for the company’s entry into the Chinese medical…
