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Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
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Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review status for its dexmethylphenidate hydrochloride sustained release capsules, which are being developed for potential pediatric use. The molecule is intended to treat attention deficit hyperactivity disorder (ADHD) in children. Phase III Clinical Study and EfficacyThe…
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Amneal Pharmaceuticals Receives China Approval for Sevelamer Carbonate
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US-based Amneal Pharmaceuticals Inc. (NYSE: AMRX) has announced that it has received approval from the Chinese market for its sevelamer carbonate, marking the company’s inaugural product approval in China. The drug is indicated for the treatment of hyperphosphatemia in patients with chronic kidney disease who are undergoing dialysis. Sevelamer represents…
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CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
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Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking…
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NMPA Drafts Guidelines for Supervising Online Drug Exchange Platforms
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The National Medical Products Administration (NMPA) has released draft “Online Third-party Drug Exchange Platforms Inspection Guidelines” for public review, with feedback accepted until September 15, 2023. These guidelines are designed to provide a framework for drug regulatory authorities to supervise and inspect enterprises offering third-party platform services in the pharmaceutical…
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Genentech Files for FDA Approval of Crovalimab for PNH, Challenging Soliris
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Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar…
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uBriGene and YolTech Therapeutics Join Forces to Advance mRNA Therapy and Gene Therapy
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China-based uBriGene Biosciences Inc., a prominent contract development and manufacturing organization (CDMO) specializing in cell and gene therapy, has announced a partnership with YolTech Therapeutics, a leading developer in mRNA therapy and gene therapy. This collaboration aims to combine YolTech’s expertise in lipid nanoparticles (LNP) technology for nucleic acid drug…
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CDE’s 2022 Drug Review Report: A Year of Pandemic Response and Regulatory Milestones
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The Center for Drug Evaluation (CDE) has released its comprehensive 2022 annual drug review report, shedding light on the regulatory activities and statistics from the past year. This report provides a detailed account of the drug approval process amidst the ongoing COVID-19 pandemic and beyond. Pandemic-Related Drug Approvals and Clinical-Value…
