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Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
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NMPA Approves Shanghai Magic Medicine’s Innovative Multimodal Tumor Treatment System
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The National Medical Products Administration (NMPA) has granted marketing approval to Shanghai Magic Medicine’s multimodal tumor treatment system, marking it as the 209th novel device approved in China. This approval signifies a significant advancement in the field of oncology treatment options within the country. Integrating Liquid Nitrogen Freezing and Radio…
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NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus
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The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks…
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NMPA Approves Shenzhen Core Medical’s Implantable Left Ventricular Assist System
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The National Medical Products Administration (NMPA) has issued market approval for the implantable left ventricular assist system developed by China-based Shenzhen Core Medical Technology Co., Ltd. This marks the fourth such device to reach the market in China, expanding options for patients with advanced heart failure. Product Composition and Clinical…
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NMPA Clears Medtronic’s Corindus for Marketing of Advanced Coronary Surgery Systems
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The National Medical Products Administration (NMPA) has granted marketing approval for the “coronary artery interventional surgery control system” and “disposable coronary artery interventional surgery control system attachment,” both developed by Medtronic Inc.’s subsidiary Corindus Inc., based in the US. Enhancing Surgical Precision and SafetyThis approval highlights a significant step forward…
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NMPA Grants Market Approval for Lanzhou Kejin Taiji’s Carbon Ion Therapy System
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The National Medical Products Administration (NMPA) in China has issued market approval to Lanzhou Kejin Taiji Corporation, Ltd. for its carbon ion therapy system, marking it as the second home-grown carbon ion therapy system in the country designed for the treatment of malignant solid tumors. Enhanced Features of the New…
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CStone Pharmaceuticals and Blueprint Medicines’ Ayvakit Wins FDA Approval for ISM Treatment
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Partners CStone Pharmaceuticals (HKG: 2616) and Blueprint Medicines have announced that the US FDA has approved Ayvakit (avapritinib), a tyrosine kinase inhibitor, for the treatment of adults with indolent systemic mastocytosis (ISM). ISM is a rare hematologic disorder that can lead to a range of debilitating symptoms across multiple organ…
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CANbridge Pharmaceuticals’ Maralixibat Approved by NMPA for Alagille Syndrome
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China-based rare disease specialist CANbridge Pharmaceuticals Inc., (HKG: 1228) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug maralixibat (CAN108). The drug is approved to treat pruritus due to cholestasis in patients with Alagille Syndrome (ALGS) aged 1 year and above. Understanding Alagille Syndrome…
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Betta Pharmaceuticals’ Befotertinib Approved by China’s NMPA for EGFR-Mutated NSCLC
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has…
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CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug tildrakizumab, which will be used to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Tildrakizumab: A Humanized Monoclonal Antibody for PsoriasisTildrakizumab…
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BeiGene’s Brukinsa Receives Canadian Approval for Chronic Lymphocytic Leukemia
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China-based BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), has received the latest indication approval in Canada for the treatment of chronic lymphocytic leukemia (CLL). This approval marks the fourth total approved Canadian indication for Brukinsa, following earlier approvals…
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Chia Tai Tianqing’s Biosimilar Rituximab Approved by China’s NMPA for Lymphoma Treatments
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China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Roche’s MabThera (rituximab), which is used for the treatment of follicular lymphoma (FL), CD20 positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Phase III Study…
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MabPharm’s CMAB007 Receives NMPA Approval for IgE-Mediated Asthma Treatment
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Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has attained market approval from the National Medical Products Administration (NMPA) for its CMAB007, a biosimilar version of Roche/Genentech’s anti-IgE dermatology and asthma therapy omalizumab (trade name: Xolair). This approval marks the first home-grown therapeutic biologic…
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BeiGene’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or…
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Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic…
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MicroPort MedBot Receives NMPA Approval for Mona Lisa Prostate Puncture Robot System
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for the ISR’obot Mona Lisa prostate puncture robot positioning system. This product is a result of a joint venture between MicroPort MedBot and Biobot Surgical Pte. Ltd,…
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BioRay Pharmaceutical’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment
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BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone…
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Grand Pharmaceutical’s Novasight Hybrid System Receives Marketing Approval in China
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Novasight Hybrid System, a first-in-class intravascular dual mode imaging equipment for coronary artery imaging, has been approved for marketing in China. This marks a significant advancement in the field of cardiovascular diagnostics. Integrating IVUS and OCT TechnologiesThe Novasight Hybrid…
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Sanofi’s VaxigripTetra Expands Influenza Vaccine Access to All Ages in China
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine, VaxigripTetra, has been granted market approval by the National Medical Products Administration (NMPA) in China. This approval extends the vaccine’s usage to include individuals aged three years and above, building on the earlier approval for…
