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Novartis’ Scemblix Demonstrates Superior MMR Rates in Phase III ASC4FIRST Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) unveiled longer-term results from the pivotal Phase III ASC4FIRST study for its Scemblix (asciminib) at the 66th American Society of Hematology (ASH) annual meeting. The study demonstrated superior major molecular response (MMR) rates for Scemblix at week 96 compared to standard-of-care (SoC) tyrosine kinase…
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Tecvayli (Teclistamab) Demonstrates Positive Results in MajesTEC-5 and MajesTEC-4 Trials
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Janssen-Cilag International NV, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), announced the presentation of results from the MajesTEC-5 and MajesTEC-4 studies for its bispecific antibody (BsAb) Tecvayli (teclistamab) at the 66th American Society of Hematology (ASH) annual meeting. The studies focused on patients with newly…
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Merck’s Zilovertamab Vedotin Shows 100% CR Rate in Phase II Study for DLBCL: ASH Presentation
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US pharmaceutical giant Merck (NYSE: MRK) has revealed promising data from the Phase II waveLINE-007 study for its antibody drug conjugate (ADC) zilovertamab vedotin at the 66th American Society of Hematology (ASH) annual meeting. Zilovertamab Vedotin’s Potential in Treating DLBCLZilovertamab vedotin, an ADC that targets receptor tyrosine kinase-like orphan receptor…
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AstraZeneca’s Calquence Combo Shows 35% Reduced Risk in CLL: AMPLIFY Phase III Results
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At the 66th American Society of Hematology (ASH) annual meeting, UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) revealed the latest results from the Phase III AMPLIFY study for its drug Calquence (acalabrutinib) in combination with venetoclax for adult patients with chronic lymphocytic leukaemia (CLL). AMPLIFY Study Design and FindingsThe AMPLIFY…
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Abbisko Therapeutics Presents Positive Phase II Results for Pimicotinib in cGvHD at ASH
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the presentation of preliminary Phase II study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) at the 66th American Society of Hematology (ASH) annual meeting. The study focused on patientszhe who have either progressed or not responded to…
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Jacobio Pharma’s BET Inhibitor JAB-8263 Shows Promising Results in Myelofibrosis Phase I Study
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Jacobio Pharma (HKG: 1167) has announced the presentation of preliminary results from the Phase I study of its bromodomain and extra-terminal domain (BET) inhibitor, JAB-8263, in the treatment of myelofibrosis (MF), at the 66th American Society of Hematology (ASH) annual meeting. JAB-8263 Demonstrates Good Tolerability and Efficacy in Phase IThe…
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Youcare Pharmaceutical Gets FDA Clearance for Herpes Zoster mRNA Vaccine YKYY026
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate, YKYY026, aimed at preventing herpes zoster. YKYY026: An Innovative mRNA Vaccine with Proprietary Delivery SystemYKYY026 is a novel mRNA vaccine that utilizes Youcare…
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Duality Biologics’ DB-1311 ADC Shows Promising Results in Global Phase 1/2a Trial
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Duality Biologics, in partnership with BioNTech (NASDAQ: BNTX), has announced the initial data from the global 1/2a phase clinical trial of its B7H3-targeting antibody-drug conjugate (ADC), DB-1311 (BNT324). The trial marks a significant advancement in the treatment of patients with locally advanced or metastatic solid tumors who have previously received…
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Chipscreen Biosciences’ Chiauranib Phase III Trial Results for SCLC Announced
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China-based innovative drug company Chipscreen Biosciences (SHA: 688321) has announced the completion of the analysis of results from the Phase III clinical trial for its drug candidate chiauranib, used as a monotherapy for third-line and above small cell lung cancer (SCLC). The independent review committee (IRC) has assessed the trial’s…
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Immunofoco’s IMC002 CAR-T Therapy Receives FDA Fast Track Designation for Gastric Cancer
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Immunofoco, a biotechnology company specializing in immunotherapy, has announced that its self-developed autologous CAR-T product, IMC002, targeting CLDN 18.2, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of patients with unresectable locally advanced, recurrent, or metastatic CLDN…
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Shanghai Juncell Therapeutics’ GC101 TIL Therapy Receives CDE Approval for Pivotal Phase II Trial
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Shanghai Juncell Therapeutics has announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has approved the first pivotal Phase II registration clinical trial for its GC101 TIL injection. The trial, designated as NCT06703398, is for the treatment of advanced melanoma patients who have progressed or are intolerant…
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Novatim Immune Therapeutics’ Y-0301 Receives FDA Clearance for Clinical Trials
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China-based cancer immunotherapy specialist Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has announced receiving clinical clearance from the US Food and Drug Administration (FDA) for its innovative drug candidate, Y-0301, a bispecific nanobody targeting MET and EGFR pathways. Y-0301: A Pioneering Bispecific NanobodyY-0301, the world’s first bispecific nanobody developed through Novatim’s…
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HighField Biopharmaceutical’s HF50 Receives Tacit Clinical Approval from NMPA for HER-2 Positive Tumors
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Hangzhou-based HighField Biopharmaceutical, a specialist in immuno-oncology biotech focused on targeted lipid-based therapies, has revealed that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its drug candidate HF50. This T-cell redirecting antibody fragment-anchored liposomes (TRAFsomes) product will be tested in clinical trials for HER-2…
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Shenyang Hongqi Pharma Secures NMPA Approval for Pretomanid in TB Treatment
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The National Medical Products Administration (NMPA) of China has officially approved pretomanid, developed by Shenyang Hongqi Pharmaceutical Co., Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196). This approval marks a significant advancement in the treatment of drug-resistant tuberculosis (TB) patients. Innovative Mechanism of Action Pretomanid is…
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Jiangsu Hengrui’s SHR-A2102 Earns Breakthrough Therapy Designation for Urothelial Carcinoma
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received breakthrough therapy designation (BTD) from the National Medical Products Administration of China for its pipeline candidate, SHR-A2102. The designation is in recognition of the molecule’s potential in treating locally advanced or metastatic urothelial carcinoma in patients who…
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Roche’s Columvi Supplemental sBLA Accepted by FDA for Relapsed DLBCL Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its drug Columvi (glofitamab). Roche is seeking FDA approval for the use of Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the…
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Teva Pharmaceutical to Divest Holdings in Teva Takeda Pharma to JKI
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Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has announced its intention to sell all holdings in Teva Takeda Pharma Limited and its wholly owned subsidiary Teva Takeda Yakuhin Ltd. to JKI, a company established by a fund managed and operated by J-Will. This strategic move aligns with Teva’s Pivot to…
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Dewpoint Therapeutics Partners with Mitsubishi Tanabe Pharma to Develop ALS Treatment
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US-based Dewpoint Therapeutics Inc. has entered into a strategic partnership with Japan-headquartered Mitsubishi Tanabe Pharma Corporation (MTPC) to enhance the development of Dewpoint’s novel TDP-43 small molecule condensate modulator (c-mod) for amyotrophic lateral sclerosis (ALS). This collaboration aims to address the mislocalization of the TAR DNA-binding protein 43 (TDP-43), a…
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AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has reported receiving a new indication approval from the US Food and Drug Administration (FDA) for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The approval is for the use of Imfinzi in treating adult patients with limited-stage small cell lung cancer (LS-SCLC)…
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Merck Initiates Phase III MOVE-NOW Study for Lagevrio COVID-19 Antiviral
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US pharmaceutical giant Merck & Co., Inc. (NYSE: MRK) has announced the commencement of the Phase III MOVE-NOW study for its oral antiviral COVID-19 medicine, Lagevrio (molnupiravir), in adults with COVID-19 who are at high risk for disease progression. This trial marks a significant step in the ongoing development and…
