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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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Ningbo Menovo Pharmaceutical Partners with Nanjing Huawe Medicine for High-End Product Development
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Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has entered into a strategic partnership with Nanjing Huawe Medicine Technology Group Co., Ltd, a move aimed at leveraging synergies in research and development (R&D) and manufacturing resources. The collaboration seeks to reduce drug development costs and enhance product competitiveness in the high-end…
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CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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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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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
