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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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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 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 & 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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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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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 (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 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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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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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 (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 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,…
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), 7MW3711. The drug targets B7-H3, a receptor overexpressed in various cancers, and is specifically indicated for the treatment of small cell lung cancer…
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Roche’s Valcyte (valganciclovir). Valganciclovir is a crucial medication primarily used to treat cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS)…
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
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Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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Eli Lilly & Co. (NYSE: LLY) has encountered a setback in its drug development pipeline with the failure of the Phase II trial for LY3361237, an antibody agonist targeting the BTLA immune checkpoint, in the treatment of systemic lupus erythematosus (SLE). The trial, registered on clinicaltrials.gov as NCT05123586, was terminated…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…