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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…
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CStone Pharmaceuticals Doses First Patient in CS2009 Phase I Study for Solid Tumors
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China-based CStone Pharmaceuticals (HKG: 2616) announced the first patient dosing in a global, multi-center Phase I study for its CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. No infusion reactions or other adverse events were observed, marking a promising start to the clinical evaluation of the drug. Drug ProfileCS2009, an…
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Laekna’s LAE120 Receives FDA Approval for Solid Tumor Clinical Trials
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Sino-US biotech company Laekna, Inc. (HKG: 2105) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug LAE120 in advanced solid tumors. The drug, a selective USP1 allosteric inhibitor, has a unique chemical structure that differentiates it from other USP1…
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SynerK’s SNK-2726 Gets FDA Green Light for Phase I Hypertension Study
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SynerK, an RNA-targeted therapy developer with operations in Boston, US, and Beijing and Suzhou, China, announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its SNK-2726. The angiotensinogen (AGT)-targeted small nucleic acid (siRNA) drug is expected to…
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Innovent Biologics Doses First Patient in IBI363 Melanoma Study vs Keytruda
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the first patient dosing in the pivotal regulatory study for its IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein. The trial compares IBI363 monotherapy with Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not…
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Eyebright Medtech Plans Private Placement to Expand Contact Lens Production
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China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050), an ophthalmic medical device manufacturer, announced plans for a private placement of 3,593,615 shares at RMB 79.2 (USD 10.9) per share. The proceeds, expected to reach RMB 285 million (USD 39 million), will be used to expand its contact lens production…
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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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AstraZeneca and Amgen’s Tezspire Shows Positive Results in Phase III Study
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AstraZeneca (NASDAQ: AZN) and Amgen (NASDAQ: AMGN) have jointly announced positive results from the Phase III WAYPOINT study for their co-developed drug Tezspire (tezepelumab). Tezspire is a thymic stromal lymphopoietin (TSLP) – targeted monoclonal antibody (mAb) that has been approved for severe asthma in over 60 countries worldwide. Study ResultsThe…
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CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy, Satricabtagene autoleucel (CT041), has been awarded Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is Claudin18.2-positive advanced gastric / gastroesophageal junction cancer (G…
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CSPC Pharmaceutical’s Sirolimus Receives BTD for Malignant PEComa Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its sirolimus (albumin-bound) as a monotherapy for malignant perivascular epithelioid cell tumor (PEComa). Drug ProfileSirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor.…
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Bayer’s BlueRock Therapeutics Gets Fast Track for OpCT-001 Therapy
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German pharmaceutical giant Bayer (ETR: BAYN) and its wholly owned subsidiary BlueRock Therapeutics LP announced that they have received Fast Track Designation from the US Food and Drug Administration (FDA) for OpCT-001. The investigational therapy, derived from induced pluripotent stem cells (iPSC), is intended for the treatment of primary photoreceptor…
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Chipscreen Biosciences’ CS12088 Gets NMPA Clearance for Hepatitis B Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that the National Medical Products Administration (NMPA) has granted clearance to conduct a study of its investigational drug CS12088 in adult patients with chronic hepatitis B. Drug Mechanism and Preclinical DataCS12088 is an HBV nucleocapsid assembly regulator that interferes with the…
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Hengrui Pharmaceuticals Gets NMPA Green Light for SHR-A2009 Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that the National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II clinical study for its drug candidate SHR-A2009. The study will assess the safety, tolerability, and efficacy of SHR-A2009 as a treatment for advanced solid tumors in…
