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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 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 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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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, 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 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)…