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Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma…
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Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug HRS-5965. The designation is for the treatment of primary IgA nephropathy, the most common primary…
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Sanofi’s Dupixent Approved in Japan for Chronic Obstructive Pulmonary Disease
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. This marks a significant expansion of Dupixent’s therapeutic…
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Novartis’ Pluvicto Gains Expanded FDA Approval for Prostate Cancer Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received expanded indication approval from the US Food and Drug Administration (FDA) for its radioligand therapy (RLT) Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The PSMA-targeted therapy is now approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have been…
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EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company’s (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer’s disease (AD). Despite this setback, the US pharmaceutical giant stated that…
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BMS’s Opdivo/Yervoy Combo Approved by NMPA for First-Line HCC Treatment
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or advanced hepatocellular carcinoma (HCC). This approval makes the Opdivo/Yervoy combination the first and currently…
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Roche’s Ocrevus Approved by China’s NMPA for Multiple Sclerosis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its selective immunosuppressant Ocrevus (ocrelizumab). The drug is approved for the treatment of adults with recurrent multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and…
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AstraZeneca’s Imfinzi Approved by FDA for Bladder Cancer Treatment
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The US Food and Drug Administration (FDA) has approved AstraZeneca’s (NASDAQ: AZN) PD-L1 inhibitor Imfinzi (durvalumab) for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer (MIBC). Clinical Trial ResultsThe approval is supported…
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Sanofi’s Qfitlia Approved by FDA for Hemophilia A and B Prophylaxis
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval from the US Food and Drug Administration (FDA) for Qfitlia (fitusiran). This antithrombin-lowering (AT) therapy is now approved for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A…
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Brii Biosciences Presents Elebsiran Phase II Data at APASL 2025 Meeting
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China-based Brii Biosciences Ltd (HKG: 2137) has published the latest data from its ongoing Phase II ENSURE study for elebsiran (BRII-835, VIR-2218) at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2025). Elebsiran, an investigational small interfering ribonucleic acid (siRNA), is being…
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IASO Biotherapeutics’ Fucaso Approved in Macao for Relapsed Multiple Myeloma
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China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF). This approval marks the first NDA approval for Fucaso outside of mainland…
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Eli Lilly Launches Kisunla in China for Early Alzheimer’s Treatment
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US pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has officially launched Kisunla (donanemab) in China, a Category 1 drug approved in December last year for treating early symptomatic Alzheimer’s disease (AD). This includes adults with mild cognitive impairment (MCI) and mild dementia stage AD. Therapy DetailsKisunla is administered as…
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Laekna Submits Revised Protocol for LAE102 Obesity Trial with Eli Lilly
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Sino-US biotech Laekna Therapeutics (HKG: 2105) announced the submission of a revised clinical protocol to the US Food and Drug Administration (FDA) for LAE102, an Activin Receptor Type 2 A (ActRIIA)-targeted monoclonal antibody (mAb) co-developed with Eli Lilly & Co. (NYSE: LLY). Collaboration DetailsUnder the agreement signed between Laekna and…
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Eisai Transfers Pariet Rights in China to CBC Group-Controlled Peak Pharma
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Japan-based Eisai (TYO: 4523) announced a strategic decision to transfer the rights of its proton pump inhibitor (PPI) Pariet (rabeprazole) in China to Peak Pharmaceutical, a company controlled by CBC Group. Pariet’s Market PresencePariet, with rabeprazole as its active ingredient, has been a leading prescription drug for gastrointestinal disorders such…
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Sinovac Biotech’s SNA02-48 Gains Clinical Approval for Tetanus Prevention
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Beijing Sinovac Biotech Co., Ltd’s (NASDAQ: SVA) subsidiary Sinovac Life Sciences Co., Ltd. and its partner Synermore Biologics announced that their Category I new drug, SNA02-48 injection, has received clinical approval from the National Medical Products Administration (NMPA). This recombinant fully human monoclonal antibody targets tetanus toxin and offers a…
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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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TransThera and Akeso Biopharma Collaborate on HCC Study with Tinengotinib and Bispecific Antibodies
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Chinese companies TransThera Sciences (Nanjing) Inc. and Akeso Biopharma (HKG: 9926) have formed a strategic research collaboration to advance an open, multi-center Phase II study combining TransThera’s tinengotinib (TT-00420) with Akeso’s cadonilimab or ivonescimab for advanced hepatocellular carcinoma (HCC). The National Medical Products Administration (NMPA) has granted clearance for the…
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NMPA Approves Qingfeng’s Suraxavir Marboxil for Influenza A and B Treatment
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China’s National Medical Products Administration (NMPA) has approved suraxavir marboxil, a Category 1 drug developed by Qingfeng Pharmaceutical Group Co. Ltd’s subsidiary Jiangxi Kerui Pharmaceutical Co., Ltd, for the treatment of influenza A and B. The drug is intended for adolescents aged 12 and above as well as adults with…
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Huadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). This marks a significant step forward for the company in expanding its portfolio in autoimmune diseases. Drug Profile and Preclinical ResultsHDM3019…
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YiChang HEC’s Yiqibuvir Approved by NMPA for Chronic HCV Infection
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China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd. (HKG: 1558) announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug yiqibuvir. The non-structural protein 5B (NS5B) inhibitor is approved for use in combination with netanasvir in adult chronic hepatitis C virus (HCV) infections of genotypes…
