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Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
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Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S., has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-viral drug Descovy (emtricitabine, tenofovir alafenamide fumarate). The NMPA has granted approval for the use of…
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BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
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Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its fixed dose combination (FDC) drug, henagliflozin, metformin sustained-release tablets. This new formulation is designed to enhance blood glucose control in…
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MicroPort CardioFlow Medtech’s AnchorMan System Receives NMPA Approval as First Semi-Closed LAA Occluder in China
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received marketing approval from the National Medical Products Administration (NMPA) for La Ronda’s AnchorMan left atrial appendage occluder system. This marks the first semi-closed…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
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Sino Biopharmaceutical Ltd Secures Exclusive Rights for Generic Everolimus in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis AG’s Afinitor (everolimus). This achievement marks a significant milestone as the company’s product is set to enjoy…
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AstraZeneca and Sanofi’s RSV Prevention Drug Beyfortus Approved by China’s NMPA
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AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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Sino Medical Secures Approvals for Key Coronary Devices in Taiwan, India, and Uzbekistan
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that it has received market approvals in Taiwan, India, and Uzbekistan for its SC HONKYTONK coronary artery balloon dilation catheter, NC Rockstar non-compliant coronary artery balloon dilation catheter, and HT Supreme drug-eluting stent system. The NC…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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Cryofocus Medtech Secures NMPA Approval for Cryotherapy Equipmen
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Shanghai-based Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its cryotherapy equipment, which supports its innovative frozen adhesion treatment system. The cryotherapy equipment comprises a main unit, a foot switch, and an exhaust pipe, and…
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NMPA Approves Pulnovo Medical’s Novel Catheter for Treating Pulmonary Arterial Hypertension
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The National Medical Products Administration (NMPA) has granted marketing approval for Pulnovo Medical’s disposable circular pulmonary artery radiofrequency ablation catheter, marking it as a novel product in the medical device landscape. This innovative catheter employs a puncture intervention technique to access the bloodstream, targeting pulmonary arterial hypertension by disrupting the…
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Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its fixed-dose combination tablets of rosuvastatin and ezetimibe. This therapy is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). This product marks the first…
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AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
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AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for its ligand-conjugated antisense oligonucleotide (LICA) Wainua (eplontersen) as a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN/ATTRv-PN) in adults. Developed in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS),…
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Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
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Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National Medical Products Administration (NMPA) for Livtencity (maribavir), a significant milestone for the treatment of adult patients with cytomegalovirus (CMV) infection/disease following hematopoietic stem cell transplantation or solid organ transplantation. The drug is particularly indicated for…
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Beijing Balance Medical Secures NMPA Approval for Innovative Mitral Valve Annuloplasty Ring
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a Chinese medical device company, has received market approval from the National Medical Products Administration (NMPA) for its proprietary mitral valve annuloplasty ring product. This development marks a significant milestone for the company, which aims to provide advanced cardiac solutions to patients.…
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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
