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Nanjing F&S Pharmatech Secures First Generic Approval for Novartis’s Entresto in China
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Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s (NYSE: NVS) heart failure therapy, Entresto (sacubitril, valsartan). This marks a significant milestone as Nanjing F&S’s version, an in-house developed…
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European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
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The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior…
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Novartis’s Leqvio (Inclisiran) Approved in China for Hypercholesterolemia Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration (NMPA) for its cholesterol-lowering drug Leqvio (inclisiran). The drug is approved for use as an adjunct treatment with diet for adult patients with primary hypercholesterolemia, including heterozygous familial and non-familial cases, or mixed type dyslipidemia.…
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Sichuan Huiyu Pharmaceutical’s Plerixafor Gains Marketing Approval from Italian Medicines Agency
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received marketing approval for its plerixafor from the Italian Medicines Agency (AIFA). The drug is approved for use in combination with granulocyte colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) into the…
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Lifetech Scientific Corporation Receives NMPA Approval for Epione Navigation System
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its product, Epione. Epione is an in-licensed puncture surgery navigation and positioning system designed for navigation and positioning in adult abdominal solid organ puncture surgery. Origin and Commercialization…
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Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
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The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE) respiratory syncytial virus (RSV) vaccine, Abrysvo, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD in infants through active immunization of pregnant women between 32 and 36 weeks of gestation. This marks…
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AstraZeneca’s Forxiga Gains New Indication Approval in China for Chronic Heart Failure
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UK-based pharmaceutical major AstraZeneca plc (AZ, NASDAQ: AZN) has announced that China’s National Medical Products Administration (NMPA) has granted a new indication approval for its SGLT-2 inhibitor, Forxiga (dapagliflozin). The drug is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits…
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NMPA Approves Rapid Medical Ltd’s Intracranial Thrombectomy Stent for Marketing
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The National Medical Products Administration (NMPA) has granted marketing approval to Rapid Medical Ltd for its intracranial thrombectomy stent. This medical device, which comprises a head end, wire mesh, push shaft, control wire, and handle, is equipped with controllable expansion technology that enhances its utility in surgical procedures. Enhanced Surgical…
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Innovent Biologics’ Tafolecimab Receives NMPA Approval for Hypercholesterolemia Treatment
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb). The approved indication is for primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as mixed…
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CStone Pharmaceuticals Reports 2023 Interim Financials and Business Milestones
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China-based CStone Pharmaceuticals (HKG: 2616) has announced its 2023 interim financial results alongside key business highlights. The company reported total revenues of RMB 261.5 million (USD 40 million) for the six months ended June 30, 2023, with pharmaceutical product sales contributing RMB 246.9 million (USD 34 million), marking a 53%…
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J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
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The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).…
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Pfizer’s Elrexfio Earns Accelerated FDA Approval for Relapsed/Refractory Multiple Myeloma
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This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least four prior lines of therapy. The decision was based…
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Beijing Balance Medical Receives Approval for Innovative Expandable Artificial Heart Valve in China
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a leading medical technology company in China, has announced the approval of its limited expandable artificial biological heart valve by the Chinese regulatory authorities. This innovative valve is designed to replace diseased, injured, or malformed aortic, mitral, and tricuspid valves, as well…
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Grand Pharmaceutical Group Gets NMPA Approval for Generic Eplerenone for Hypertension
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of eplerenone, an aldosterone receptor antagonist. The drug, co-developed with Nanjing Cavendish Bioengineering Technology Co., Ltd., is indicated for the treatment of hypertension. Eplerenone:…
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Our United Corporation’s Linear Accelerator Approved as Innovative Medical Device by NMPA
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Xi’an-based Our United Corporation has announced that its medical electronic linear accelerator has been approved by the National Medical Products Administration (NMPA) as an innovative medical device. This marks a significant milestone for the company and the field of radiation therapy in China. Comprehensive Features of the Linear AcceleratorThe product,…
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GSK’s Jemperli Receives FDA Approval for First-Line Treatment of Advanced Endometrial Cancer
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GSK plc (NYSE: GSK), a major UK pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted market approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab), as a first-line treatment for advanced or recurrent endometrial cancer. This indication is for patients who are to first…
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Viatris Inc. Secures FDA Nod for Generic Symbicort Equivalent, Breyna
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US-based Viatris Inc., (NASDAQ: VTRS) has announced that the US Food and Drug Administration (FDA) has approved the company’s Abbreviated New Drug Application (ANDA) for Breyna (budesonide + formoterol fumarate dihydrate), a generic version of AstraZeneca’s originator product Symbicort. This approval positions Viatris as the first company to offer an…
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MicroPort MedBot’s SkyWalker Orthopedic Surgery Robot Gains TGA Approval in Australia
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing approval from the Therapeutic Goods Administration (TGA) in Australia for its in-house developed orthopedic surgery robot, SkyWalker. This marks another significant milestone for the company as it expands the global footprint of its innovative medical…
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Shanghai Benemae’s Benaglutide Approved by NMPA for Adult Weight Management in China
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The National Medical Products Administration (NMPA) has indicated on its website that benaglutide, developed by Shanghai Benemae Pharmaceutical Co., Ltd, has been granted approval for adult weight management in China. This marks the second hypoglycemic drug approved for weight loss in the country, following Huadong Medicine Co., Ltd’s (SHE: 000963)…
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Sino Biopharmaceutical Receives NMPA Approval for Biosimilar Herceptin for HER2+ Cancers
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Swiss giant Roche’s (SWX: ROG) Herceptin (trastuzumab). This biosimilar drug is intended to treat human epidermal growth factor receptor 2 (HER2) positive early breast cancer,…
