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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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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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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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Biotherus Inc. and BioNTech SE Enter Global License Agreement for Cancer Therapies
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China-based biotech company Biotheus Inc. has announced a strategic research collaboration, option, and worldwide license agreement with Germany’s BioNTech SE (NASDAQ: BNTX). The deal grants BioNTech exclusive worldwide options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer therapy. Additionally, Biotheus will provide BioNTech with exclusive licenses…
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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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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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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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Novomics Partners with TopGene to Expand Genomic Testing Services in China
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South Korea-based molecular diagnostics firm Novomics Co. has announced a strategic partnership with China-based Hubei TopGene Biotechnology Co., Ltd to extend its presence in the Chinese market. Under this collaboration, TopGene will facilitate access to Novomics’ genomic testing services, including diagnostic kits and genetic information consulting, specifically for Chinese gastric…
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Novartis Q2 2023 Results Exceed Expectations with 9% YOY Sales Growth
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Swiss pharmaceutical major Novartis AG (NYSE: NVS) has reported its financial results for the second quarter of 2023, with both sales and profits surpassing analyst forecasts. Net sales for the quarter reached USD 13.622 billion, marking a 9% year-on-year (YOY) increase in constant currency terms. Core net income also saw…
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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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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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Bio-Thera Solutions Receives NMPA Approval for CTLA-4 and PD-1 Inhibitor Combo Study
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its BAT4706, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb), in combination with its programmed death-1 (PD-1) inhibitor BAT1308. The study will focus…
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Shanghai Pharmaceuticals Gets NMPA Green Light for Recombinant Human Adenovirus Type 5 Trial
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Shanghai Pharmaceuticals (HKG: 2607; SHA: 601607), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its recombinant human adenovirus type 5 in the treatment of malignant ascites. The filing for this trial was accepted for review…
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Janssen’s Rybrevant Meets Primary Endpoint in Phase III NSCLC Study
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III confirmatory study for the bispecific antibody Rybrevant (amivantamab). The study focused on patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) that harbor epidermal growth factor receptor (EGFR) exon…
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Antengene Corp., Ltd Receives Hong Kong NDA Approval for Xpovio in Relapsed Multiple Myeloma
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China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment…
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Beyond Therapeutics Secures Tens of Millions in Pre-Series A Financing for Ophthalmology and Oncology Pipeline
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Beyond Therapeutics Co., Ltd., a biotechnology company based in Suzhou with a focus on ophthalmology and oncology, has reportedly raised tens of millions of renminbi in a Pre-Series A financing round. The round was led by Ming Bioventures, with contributions from Highpower Industrial and 3D BioOptima. The funds will be…
