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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
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Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…
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Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
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Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
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Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
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Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received another market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres, now indicated for the treatment of endometriosis. Triptorelin microspheres are an in-house developed long-acting formulation administered via monthly intramuscular injection as…
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CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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LenoMed Medical’s Touch-Insulin Pump Receives NMPA Approval, Aids China’s Diabetes Management
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Shanghai-based LenoMed Medical, a medical device platform company backed by Legend Capital and Legend Star, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed touch-insulin pump. This product, which boasts an infusion accuracy of 0.01U per hour, is lauded as…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
