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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…
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Kintor Pharmaceutical Initiates Long-Term Safety Trial for Androgenetic Alopecia Treatment KX-826
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the start of the long-term safety trial for KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). This in-house developed treatment has completed its first patient enrollment in China. Phase III Clinical Trial Design and ObjectivesThe…
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Shanghai Junshi Biosciences’ Tuoyi Receives NMPA Review for ES-SCLC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication of Tuoyi (toripalimab). The drug is proposed to be used in combination with etoposide and platinum for the treatment of extensive stage small cell…
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Qihan Biotech’s QN-019a Receives Clinical Clearance for Gene-Edited iPSC-Derived Cell Therapy in China
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Hangzhou Qihan Biotech Co., Ltd., a leading specialist in xenotransplantation based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its product QN-019a. This marks the first Investigational New Drug (IND) approval in China for a gene-edited induced pluripotent stem cell…
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Antengene Initiates Phase I ERASER Study for ATG-017 in Combination with Nivolumab
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced the first patient dosing in its Phase I ERASER study. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ATG-017 in combination with nivolumab for the treatment of advanced solid tumors. The trial is conducted…
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Sichuan Huiyu Pharmaceutical’s KRAS G12C Drug HYP-2090PTSA Accepted for NMPA Review
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 investigational drug, HYP-2090PTSA. This small molecule drug candidate targets KRAS G12C and PI3K and is under review for potential use…
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Sanofi and AstraZeneca Receive FDA Approval for RSV Prevention Treatment Beyfortus
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France-based Sanofi (NASDAQ: SNY) has announced that it, along with AstraZeneca (AZ; NASDAQ: AZN), has received marketing approval from the US Food and Drug Administration (FDA) for their codeveloped drug, Beyfortus (nirsevimab). The drug is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in…
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NMPA Releases 70th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 70th batch of reference drugs for the purpose of generic quality consistency evaluation (GQCE) work. This release is a part of ongoing efforts to ensure the quality and consistency of generic drugs in the market. Changes in the Official Version Compared…
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Mabwell Bioscience’s 7MW3711 ADC for B7-H3 Gets Clinical Trial Approval in China
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its antibody drug conjugate (ADC), 7MW3711, which targets B7-H3. This ADC is set to be assessed as a potential treatment for advanced solid tumors. B7-H3’s Role in Cancer and 7MW3711’s…
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Bayer’s Kerendia Officially Launched in China for Type 2 Diabetes-Related CKD
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German pharmaceutical giant Bayer’s (ETR: BAYN) Kerendia (finerenone), the first nonsteroidal, selective mineralocorticoid receptor (MR) antagonist, has been officially launched in China for the treatment of type 2 diabetes-related chronic kidney disease (CKD). The drug received market approval in June 2022 and was included in the National Reimbursement Drug List…
