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AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
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Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two innovative drugs: AbbVie’s (NYSE: ABBV) analgesic Aquipta (atogepant) and Novartis’ (NYSE: NVS) cancer therapy Piqray (alpelisib). This marks a significant milestone for both companies, expanding access to these treatments in the Mexican market. Aquipta: A…
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Ascletis Pharma’s ASC22 Combo Therapy Shows Promise in HIV Functional Cure Clinical Trial
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China-based Ascletis Pharma Inc., (HKG: 1672) has announced that the Shanghai Public Health Clinical Center presented clinical results of ASC22 (envafolimab) in combination with chidamide as a novel combination therapy aimed at achieving a functional cure for human immunodeficiency virus (HIV) infection. The findings were showcased at the 12th International…
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Jiangsu Hengrui Pharmaceuticals and Hansoh Pharmaceutical Group Get NMPA Approval for Solid Tumor Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy involving its adebrelimab (SHR-1316) with Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) Ameile (almonertinib) or SHR-A2009, with or without chemotherapy, for the treatment…
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Eli Lilly’s Mirikizumab and Chia Tai Tianqing’s Lanifibranor Enter Breakthrough Therapy Review
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US pharmaceutical major Eli Lilly’s (NYSE: LLY) mirikizumab and China-based Chia Tai Tianqing’s lanifibranor have both entered into the breakthrough therapy review process, marking a significant step in advancing treatments for moderate to severe active Crohn’s disease (CD) and non-cirrhotic non-alcoholic steatohepatitis (NASH) with liver fibrosis, respectively. Mirikizumab: Anti-IL-23 Monoclonal…
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Vcanbio’s VUM02 Stem Cell Therapy Accepted for Review by China’s CDE for aGvHD Treatment
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that the Center for Drug Evaluation (CDE) has accepted another clinical trial filing for its VUM02 (human umbilical cord-derived mesenchymal stem cells) for review. The Category 1 therapeutic biologic product is under development as a treatment for acute…
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BeiGene’s Tislelizumab Receives Positive CHMP Opinion for Esophageal Cancer Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a first market approval. The regulatory decision on whether to approve tislelizumab monotherapy for unresectable, locally…
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CanSino Biologics Granted Approval by Health Canada for Zoster Vaccine Candidate CS-2032
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China-based vaccines specialist CanSino Biologics Inc., (HKG: 6185) has announced receiving approval from Health Canada to conduct a Phase I clinical study assessing the safety and preliminary immunogenicity of CS-2032, a recombinant vaccine candidate for the zoster virus. This adenovirus vector-based vaccine is co-developed with UK firm Vaccitech Ltd under…
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Bavarian Nordic’s RSV Vaccine Candidate Fails Phase III Trial, Discontinues Program
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Denmark-based Bavarian Nordic A/S (CPH: BAVA) has revealed that its pipeline respiratory syncytial virus (RSV) vaccine candidate, MVA-BN RSV, did not achieve all primary endpoints in a Phase III trial. Consequently, the company has decided to discontinue its RSV program, including a co-development partnership with China-based Nuance Pharma for Greater…
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Antengene Corp. Receives FDA Fast-Track Designation for Xpovio in Myelofibrosis Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera. Background on Xpovio and…
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Hansoh Pharmaceutical’s Ibrexafungerp NDA Accepted for Review by China’s NMPA for VVC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) filing for its ibrexafungerp, intended for the treatment of vulvovaginal candidiasis (VVC) in adult and post-menarche females. Phase III Study Results and NDA FilingThe filing is…
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GenScript Biotech’s CAR-T Therapy Carvykti Reports USD 117 Million in Sales
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has reported sales of USD 117 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), as of June 30, 2023. The sales data, provided by…
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Ocumension Therapeutics’ OT-101-S Myopia Treatment Accepted for CDE Review
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Chinese ophthalmology specialist Ocumension Therapeutics (HKG: 1477) has announced that the Center for Drug Evaluation (CDE) has accepted the Phase III clinical filing for its in-house developed OT-101-S, a treatment aimed at delaying or arresting child myopia. This development marks a significant step forward in the advancement of this novel…
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Johnson & Johnson Reports 7.5% YOY Sales Growth in Q2 2023, Driven by Pharma and Devices
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Johnson & Johnson (J&J; NYSE: JNJ) has published its financial results for the second quarter of 2023, reporting robust sales growth of 7.5% year-on-year (YOY) in constant currency terms, reaching USD 25.5 billion. The performance was driven by all business segments, with the pharmaceutical unit Janssen expanding by 3.8% YOY…
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Jiangsu Simcere Pharmaceutical Gets NMPA Approval for Quviviq, Anti-Insomnia Drug
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its anti-insomnia drug, Quviviq (daridorexant), co-developed with Swiss firm Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) is now cleared for testing in the treatment of…
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Pfizer’s GBS Vaccine Candidate GBS6 Shows Promise in Phase II Maternal Immunization Study
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Pfizer (NYSE: PFE) has this week published the Phase II data for its Group B Streptococcus (GBS) vaccine candidate, GBS6, which is designed as a maternal immunization to protect infants against invasive GBS disease. The results reveal that the hexavalent vaccine generated a robust antigenic response in pregnant women, with…
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Merck and Telix Pharmaceuticals Initiate Phase I Study for CAIX-Expressing Tumors Therapy
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A Phase I study assessing the combination of German-major Merck’s (NYSE: MRK) DNA-PK inhibitor, peposertib, and Australia-based Telix Pharmaceuticals’s (ASX: TLX) targeted radiation therapy, TLX250 (177Lu-DOTA-girentuximab), has enrolled its first participant. This open-label dose escalation and dose expansion trial is designed to evaluate the safety profile, dosing, and activity of…
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Janssen’s Sirturo (Bedaquiline) Expands Indication to Include Adolescents with MDR-TB
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its medication Sirturo (bedaquiline). The product is now approved for the treatment of adolescents aged 12-18 years and weighing ≥30kg with multidrug-resistant pulmonary tuberculosis (MDR-TB),…
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Chongqing Zhifei Biological Launches Phase I Clinical Trial for Group B Meningococcal Vaccine
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122) has announced the commencement of a Phase I clinical study for its recombinant Group B meningococcal vaccine (Escherichia coli), marking a significant step in assessing the vaccine’s safety, tolerability, and preliminary immunogenicity. This product is the first of its kind to enter clinical…
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Chipscreen Pharmaceutical’s Epidaza Granted Priority Status for DLBCL Treatment in China
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The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s (SHA: 688321) Epidaza (chidamide) has been granted priority status for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin,…
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HutchMed’s Elunate-Tyvyt Combo Receives Breakthrough Therapy Designation in China for Endometrial Cancer
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib) and Tyvyt (sintilimab) has been granted Breakthrough Therapy Designation (BTD) in China for the treatment of patients with mismatch repair normal (pMMR) advanced endometrial cancer. These patients have previously failed at least one line of…
