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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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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 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 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 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 (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 (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 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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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 (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 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 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 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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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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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 (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 (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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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 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 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…