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AccurEdit Therapeutics Receives CDE Approval for Gene Editing Drug ART001 Targeting Amyloidosis
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AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading specialist in gene editing therapies based in China, has received approval from the Center for Drug Evaluation (CDE) for its investigational drug ART001. This drug is designed to target transthyroxine protein amyloidosis, a severe genetic disorder. ART001 marks a significant advancement in China’s…
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ICER Analysis Flags Pfizer’s ATTR-CM Therapy Vyndamax/Vyndaqel as Costly, Suggests Price Cut
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The Institute for Clinical and Economic Review (ICER), a US-based non-profit organization specializing in drug cost-effectiveness analysis, has released a pricing analysis for treatments of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM). The report particularly focuses on Pfizer’s Vyndamax/Vyndaqel (tafamidis) capsules, which were approved for ATTR-CM in the US…
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Jiangsu QYuns Therapeutics and Huadong Medicine Partner on QX005N Injection Development and Promotion
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has entered into a co-development and market promotion service agreement with Huadong Medicine Co., Ltd (SHE: 000963) for the development and commercialization of QX005N injection. Under the terms of the agreement, Huadong will participate in the clinical…
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Innovent Biologics’ Mazdutide Achieves Primary and Secondary Endpoints in Phase III T2D Trial
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Innovent Biologics Inc. (Innovent) (HKG: 1801), a leading biopharmaceutical company based in China, has announced positive results from the Phase III DREAMS-1 clinical trial for mazdutide (IBI362), a dual agonist targeting the glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) for the treatment of type 2 diabetes (T2D) in Chinese…
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Jiangsu Hengrui Receives NMPA Approval to Study CDK 4/6 Inhibitor Dalpiciclib in Combination with HRS-1358 for Breast Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
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Hansoh Pharmaceutical’s EGFR Inhibitor Ameile Files for Adjuvant Therapy Approval with NMPA
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading biopharmaceutical company based in China, has announced the submission of a market filing application for its epidermal growth factor receptor (EGFR) inhibitor, Ameile (almonertinib), to the National Medical Products Administration (NMPA). The application seeks approval for Ameile as an adjuvant therapy…
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NMPA Approves Chengdu Chipscreen’s Bilessglu for Type 2 Diabetes in Combination with Metformin
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The National Medical Products Administration (NMPA) has granted approval for Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
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Apeiron Therapeutics Sells Rights to CDK7 Inhibitor GTAEXS617 to Exscientia for USD 30 Million
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Apeiron Therapeutics, a Shanghai-based biopharmaceutical company, has reached an agreement to sell all rights to its oral CDK7 inhibitor GTAEXS617 to Exscientia plc (NASDAQ: EXAI), a US-based AI-driven pharmaceutical company. The total transaction value amounts to USD 30 million, comprising an upfront cash payment of USD 10 million and a…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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J&J Halts Development of Epilepsy Therapy ADX71149 After Phase II Trial Failure
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Johnson & Johnson (J&J; NYSE: JNJ), a US-based multinational medical devices, pharmaceutical, and consumer packaged goods manufacturing company, has reportedly discontinued the development of its pipeline epilepsy therapy ADX71149, according to the company’s latest Q2 2024 financials report and information from FiercePharma.com. ADX71149, a positive allosteric modulator (PAM) of metabotropic…
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Sino Biopharmaceutical Submits Market Approval Filing for CDK2/4/6 Inhibitor Culmerciclib in Breast Cancer
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced the submission of a market approval filing for its Category 1 drug culmerciclib (TQB3616). The filing is for the use of culmerciclib in combination with fulvestrant for the treatment of hormone receptor (HR) positive and human epidermal…
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Eli Lilly’s Mounjaro Approved by China’s NMPA for Long-Term Weight Management
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the US, has announced that it has received a new market approval from the National Medical Products Administration (NMPA) in China for its drug Mounjaro (tirzepatide) as a long-term weight management treatment. Administered as a once-weekly injection, Mounjaro is…
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China’s NMPA Suspends Daewoong Bio’s Cefodizime Over Inspection Refusal
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The National Medical Products Administration (NMPA) has issued a notice to suspend the import, sale, and use of cefodizime, an antibiotic drug produced by South Korea-based Daewoong Bio Inc. This decision was made in response to the company’s written refusal to undergo an overseas production site dynamic inspection by the…
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Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
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Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-licensed drug, ganaxolone oral suspension. This medication is indicated for the treatment of epileptic seizures in patients aged 2 years and…
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Anhui Anke Biotechnology Receives NMPA Clearance for Clinical Trial of mRNA Drug AFN0328 for HPV-Related Cancers
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
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Consun Pharmaceutical Gets NMPA Go-Ahead for CKD Drug Clinical Trial
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Consun Pharmaceutical Group Ltd (HKG: 1681), a leading Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to commence clinical studies for SK-08. This Category 1 chemical drug, co-developed with Contract Research Organization (CRO) WuXi AppTec (HKG: 2359), is intended to target…
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Shanghai Ruijin Hospital’s Hainan Subsidiary Adopts ANI Pharmaceuticals’ Veregen for HPV Treatment
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ANI Pharmaceuticals’ Veregen, a topical ointment derived from green tea extract (catechins), has been implemented by Shanghai Ruijin Hospital’s Hainan subsidiary. Marking a significant step for the botanical drug in China, Veregen is the first such drug approved by the US FDA since 1962 and is already in use across…
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Junshi Biosciences’ Loqtorzi Inches Closer to Expanded Indication with NMPA Filing Acceptance
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has taken a significant step forward with the submission of another indication filing for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company has announced that the National Medical Products Administration (NMPA) in China has accepted the filing for review. This…
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Everest Medicines’ Nefecon Receives NMPA Review, Signaling Potential Treatment Milestone for IgAN Patients
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Everest Medicines (HKG: 1952), a biopharmaceutical company dedicated to addressing critical medical needs in Asian markets, has achieved a significant step with its supplementary market approval filing for Nefecon being accepted by China’s National Medical Products Administration (NMPA). The drug, which targets the root cause of immunoglobulin A nephropathy (IgAN),…
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Grand Pharmaceutical Gets Nod for Phase II Sepsis Study of STC3141 in China
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Grand Pharmaceutical Group Limited (HKG: 0512), a China-based pharmaceutical company, has announced that it has received approval to conduct a Phase II clinical study for its drug candidate STC3141 in the treatment of sepsis in China. Design and Scope of the Phase II StudyThe Phase II study is a multi-center,…
