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Luye Pharma’s Weekly Rivastigmine Patch Approved in Japan for Alzheimer’s
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China-based Luye Pharma Group (HKG: 2186) announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its rivastigmine twice weekly transdermal patch. The product, branded as Rivaluen LA Patch 25.92mg/51.84mg in Japan, is now approved for suppressing the progression of dementia symptoms in mild…
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BeiGene’s Tevimbra Recommended for EU Approval in Small Cell Lung Cancer
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BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), the China-based oncology specialist proposing to rename to BeOne Medicines Ltd., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Tevimbra (tislelizumab) in combination with etoposide and platinum chemotherapy. This…
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Otsuka Files FDA Application for Sibeprenlimab in IgAN Treatment
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Japan-based Otsuka Pharmaceutical Co., Ltd. announced the filing of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for sibeprenlimab, an investigational monoclonal antibody for adults with immunoglobulin A nephropathy (IgAN). This marks a significant step toward making the therapy available in the US. Drug MechanismSibeprenlimab…
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UCB’s Rystiggo Approved in China for Generalized Myasthenia Gravis
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Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from China‘’s National Medical Products Administration (NMPA) for Rystiggo (rozanolixizumab). This chimeric monoclonal antibody is now approved for use in combination with conventional therapy for adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific…
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Hengrui Pharmaceuticals’ Ivarmacitinib Approved for Rheumatoid Arthritis in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug, recently approved for active ankylosing spondylitis (AS) in China, is now also approved for treating adult patients with moderate to severe…
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Huapont Life Sciences Gains NMPA Approval for Generic Daivobet
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China-based Huapont Life Sciences Co., Ltd (SHE: 002004) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of LEO Pharma’s Daivobet (calcipotriol, betamethasone). This approval marks the first generic version of Daivobet to be approved in China. Drug Composition and MechanismDaivobet…
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Ascletis Pharma’s ASC30 Shows Positive Results in US Phase Ib Obesity Study
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China-based Ascletis Pharma Inc. (HKG: 1672) announced positive interim results from a Phase Ib study (NCT06679959) evaluating its investigational GLP-1R biased small molecule agonist, ASC30, in patients with obesity in the US. The study is a randomized, double-blinded, placebo-controlled trial involving a single subcutaneous (SQ) injection. Drug ProfileASC30 is a…
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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…
