•
China-based Cytocraft Biotech Development has announced that its cell therapy, SDT-T002, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of advanced liver cancer that has failed standard treatment. Cascade Primed Immune Cells (CAPRI) Cell Therapy OverviewCytocraft boasts its Cascade Primed Immune Cells (CAPRI)…
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib REFINE study for its drug candidate STC3141 in sepsis has successfully reached the clinical endpoint in Australia and Belgium. Design and Results of the Phase Ib REFINE StudyThe open-label, multi-center, dosage escalation Phase Ib clinical study was…
•
The Janssen subsidiary of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an additional indication application to the US Food and Drug Administration (FDA) for its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel). The application seeks approval for the treatment of relapsed or refractory multiple myeloma (r/rMM) in adults who have…
•
Guangdong-based antibody drug developer Dartsbio Pharmaceuticals has partnered with the Shanghai Institute of Materia Medica (SIMM) to receive tacit clinical trial approval from the National Medical Products Administration (NMPA) for their antibody drug conjugate (ADC), DS001. The molecule is set to be assessed as a potential treatment for various advanced…
•
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the US Food and Drug Administration (FDA) has accepted for review the market filing for its semaglutide active pharmaceutical ingredients (APIs). This development marks a significant step for the company as it seeks to enter the global market with its…
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF). Therapeutic…
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment…
•
Chengdu-based adeno-associated virus (AAV) gene therapy developer, Genevector Biotechnology Co., Ltd., has announced the first patient dosing in a clinical study for its product candidate, JWK001. The molecule is under assessment as a potential treatment for neovascular age-related macular degeneration (nAMD). JWK001’s Mechanism of Action and Preclinical PerformanceJWK001 employs AAV…
•
Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
•
Austria-based Croma-Pharma has revealed that the first patient is set to be enrolled in a clinical trial in China to support the approval of its hyaluronic acid dermal filler, Princess Volume Lidocaine. This randomized, multi-center, blinded, parallel Phase III study will confirm the safety and efficacy of Croma’s product, focusing…
•
China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
•
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The Role of OX40 in Immune Response and BAT6026’s MechanismOX40, an immune checkpoint expressed…
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for…
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its in-house developed Category 1 chemical drug, SYH2051. The molecule is set to be assessed in the treatment of general solid tumors. ATM…
•
China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a…
•
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented updates on the clinical development of its JAK1 inhibitor golidocitinib (DZD4205) and DZD8586 at the 17th International Conference on Malignant Lymphoma (ICML) annual meeting. Golidocitinib: A Promising Treatment for PTCLGolidocitinib, the world’s first and only JAK1 inhibitor in regulatory trial stages, received…
•
UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that its Soliris (eculizumab), a first-in-class C5 complement inhibitor, has obtained its third indication approval from the National Medical Products Administration (NMPA) in China. This approval allows the use of Soliris to treat adult patients with refractory generalized Myasthenia gravis (gMG)…
•
Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib), which is aimed at treating chronic graft versus host disease (cGVHD). Understanding cGVHD and the Role of CSF-1R InhibitionThe pathological and physiological…
•
China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has declined its New Drug Application (NDA) for geptanolimab, a programmed-death 1 (PD-1) inhibitor, for the treatment of recurrent/refractory peripheral T-cell lymphoma (PTCL). The drug, which was under development to treat a range of…