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Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing…
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Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
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China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as…
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ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors
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China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy,…
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CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical Products Administration (NMPA) for JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. The targeted indication for this novel therapy is advanced malignant tumors, marking a significant step forward in the development of innovative cancer treatments in China.…
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Antengene’s Xpovio Receives Marketing Approval in Indonesia
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country. Indications ApprovedThe drug is approved for: Drug BackgroundXpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based…
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RongCan Biotech’s mRNA HPV Vaccine Receives FDA Clinical Approval
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China-based mRNA specialist RongCan (Shanghai) Biotech Co., Ltd announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its mRNA-based human papillomavirus (HPV) therapeutic vaccine. Clinical Approval and SignificanceThis approval marks a significant step forward in the development of therapeutic options for HPV-related conditions.…
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Zhejiang Huahai’s HB0034 Meets Primary Endpoint in GPP Study
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its multi-center, double-blinded, randomized, placebo-parallel controlled pivotal study for HB0034, a Category 1 biologic product for acute generalized pustular psoriasis (GPP), has achieved the primary efficacy endpoint and all secondary efficacy endpoints. Study ResultsGPP is a rare, life-threatening, systemic neutropenic…
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Fosun Pharma’s 24-Valent Pneumococcal Vaccine Receives NMPA Approval for Phase I Trial
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) subsidiary Fosun Adgenvax (Chengdu) Biopharmaceutical Co.,Ltd. is set to commence a Phase I clinical study for its 24-valent pneumococcal polysaccharide conjugate vaccine in China, following clearance from the National Medical Products Administration (NMPA). Vaccine ProfileThe preventative biologic product is…
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Suzhou Abogen’s RSV mRNA Vaccine IND Approved by China’s CDE
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China-based nucleic acid drug developer Suzhou Abogen Biosciences announced that the Investigational New Drug (IND) filing for its freeze-dried respiratory syncytial virus (RSV) mRNA vaccine has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). RSV and Vaccine TechnologyRSV is a common viral…
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BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
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BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change its name to BeOne Medicines Ltd, announced that it has received another indication approval from the US Food and Drug Administration (FDA) for its Tevimbra (tislelizumab). The PD – 1 inhibitor is now approved for…
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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
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Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic agent TNKase (tenecteplase) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS) in adults. Drug ProfileTNKase, a tissue plasminogen activator, is administered as a single…
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Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
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Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia. Background and PartnershipsEisai entered into a licensing agreement with…
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Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
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China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy. Drug ProfileFP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA).…
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GSK’s Depemokimab Accepted for FDA Review as Ultra-Long-Acting Biologic
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GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has accepted indication approval filings for its depemokimab, a monoclonal antibody (mAb) targeting IL-5, with a PDUFA target date set for December 16, 2025. The UK-based pharmaceutical giant is seeking FDA approval for the drug’s…
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Juvestar and Raziel Therapeutics Launch Phase III Study for RZL-012 in China
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Juvestar Biotech Co., Ltd., a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Israel-based Raziel Therapeutics jointly announced the initiation of a Phase III study for RZL-012 in submental fat (SMF) reduction in China. Drug ProfileRZL-012, an injectable lipolytic drug developed by Raziel for…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for Clinical Trials
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HDM1005, a long-acting agonist targeting the GLP-1 receptor and GIP receptor. The drug is set for development to treat adult patients with heart failure with preserved…
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Tonghua Dongbao’s Tongboli Under GMP Inspection in Egypt
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) announced that the on-site Good Manufacturing Practice (GMP) inspection by the Ministry of Health of Egypt for its Tongboli, a biosimilar version of Novo Nordisk’s GLP-1 receptor agonist Victoza (liraglutide), is well underway in the country. Product BackgroundTongboli, the Victoza knockoff, received marketing approval…
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United Laboratories’ UBT251 Receives FDA Green Light for Phase II CKD Study
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that it has received approval from the US Food and Drug Administration (FDA) to assess its Category 1 drug UBT251 in a Phase II study for the treatment of chronic kidney disease (CKD). Drug ProfileUBT251 is a triple agonist targeting…
