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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving approval to introduce Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), at Ruijin Hospital’s Hainan branch. The treatment is indicated for FRα positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in…
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Jiangxi Jemincare Group has overseen the official launch and first prescription of its omalizumab biosimilar, CMAB007, a version of Roche/Genentech’s (SWX: ROG) anti-IgE dermatology and asthma therapy Xolair, in Beijing. The drug’s launch comes less than two months after it received market approval. Therapeutic Applications of OmalizumabOmalizumab is utilized to…
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
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China-based Transcenta Holding Ltd has reported receiving clinical trial approvals from China’s Center for Drug Evaluation (CDE) and South Korea’s Ministry of Food and Drug Safety (MFDS) for their pipeline candidate osemitamab (TST001), a CLDN18.2-targeted monoclonal antibody. Both regulatory bodies have approved the plan for TranStar 301, a global Phase…
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has announced receiving approval from the US FDA to conduct a clinical study for its pipeline candidate, BD111, in the treatment of type I herpes simplex virus (HSV-1) stromal keratitis. HSV-1 is a pathogen responsible for a range of diseases, including oral…
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China-based HutchMed Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of a Phase I clinical study for its investigational novel selective allosteric inhibitor, HMPL-415, which targets Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2). The trial, aimed at assessing the molecule in general solid tumors, marked its first patient dosing…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug has been filed for use in adult cervical dystonia, marking a significant step…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its anti-interleukin-5 (IL-5) antibody, SHR-1703. The drug candidate is set to be assessed as a treatment for eosinophilic granulomatous polyangiitis, a rare…
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China-based 3SBio Inc. (HKG: 1530) has announced receiving marketing approval from the National Medical Products Administration (NMPA) in China for its nalfurafine orally disintegrating tablets. The drug is used to improve pruritus in hemodialysis patients in situations where existing treatment efficacy is not ideal. This marks the first and only…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its esflurbiprofen patch, a generic version of Japan firm Taisho Pharmaceutical’s Loqoa tape. The intended indication for the patch…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving marketing approval in China for its Category 3 product, desvenlafaxine, signifying that it has passed the generic quality and consistency evaluation (GQCE). Desvenlafaxine: A Third-Generation Anti-DepressantDesvenlafaxine is a third-generation anti-depressant that functions by inhibiting the reuptake mechanism of 5-hydroxytryptamine norepinephrine,…
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US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or…
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, a treatment for prostate cancer requiring androgen castration therapy. This innovative formulation is designed to provide a smoother drug release during the…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). This glucagon-like peptide-1 (GLP-1) receptor agonist is now approved for use in weight loss management. Expanding…
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress…