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Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs. Nintedanib’s Approval History…
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Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
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The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval…
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Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO) Esperoct (turoctocog alfa pegol) is on track for priority review for the treatment of hemophilia A in adults and children. The drug is indicated for on-demand treatment and control of bleeding events, perioperative management, and…
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Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
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AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is now approved for use in adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic…
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Roche’s Alecensa Achieves Milestone in Adjuvant Therapy Trial for Early-Stage NSCLC
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Switzerland-based pharmaceutical giant Roche (SWX: ROG) has released an update from an interim analysis of a late-stage trial for its ALK inhibitor Alecensa (alectinib) as adjuvant therapy in the early setting for resected non-small cell lung cancer (NSCLC) with ALK mutations. These mutations are present in approximately 5% of NSCLC…
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Japan’s MHLW Reviews GSK’s Nucala for Chronic Rhinosinusitis with Nasal Polyps Indication
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has begun the review process for an indication extension filing submitted by the UK pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK). The filing seeks to expand the use of GSK’s anti-IL-5 biologic Nucala (mepolizumab) as a treatment for adults with chronic…
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Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
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US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical Products Administration (NMPA) has approved an indication extension for its Verzenios (abemaciclib). The drug is now indicated as adjuvant therapy for hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and lymph…
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Shanghai Junshi Biosciences’ JS207 Bispecific Antibody Receives NMPA Clinical Trial Approval
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) in China has approved a clinical trial filing for its bispecific antibody (BsAb) JS207. The drug is under development to target PD-1 and VEGF for the treatment of advanced malignant tumors. Pre-Clinical…
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United Laboratories’ UBT251 Receives Tacit Approval for Obesity Clinical Study in China
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate, UBT251, has been tacitly approved in China for a clinical study to assess its effectiveness against overweight and obesity conditions. UBT251: A Triple Agonist for Metabolic ConditionsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP…
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Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
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The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB, HKG: 9688) Margenza (margetuximab), an Fc-engineered monoclonal antibody (mAb) targeting HER2 and developed by MacroGenics Inc., has been approved for the China market. The drug is indicated for the treatment of metastatic HER2-positive breast cancer…
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MicuRx Pharmaceuticals Initiates Phase III Trial for MRX-4 in Complex Skin Infections
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its drug candidate MRX-4, focusing on the treatment of complex skin and soft tissue infections in China. The multi-center, randomized, double-blind, double-simulation Phase III trial aims to assess the safety and efficacy of MRX-4…
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Genexine’s Eftansomatropin Alfa Achieves Phase III Endpoints in Growth Hormone Deficiency Trial
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South Korea-based Genexine (KOSDAQ: 095700) has announced that its long-acting growth hormone product candidate, eftansomatropin alfa (GX-H9; TJ101), has achieved Phase III endpoints in a clinical trial conducted in China. The study, CTJ101PGHD301, demonstrated the safety and efficacy of the drug in children with growth hormone deficiency. Eftansomatropin Alfa’s Efficacy…
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AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an indication extension approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its orphan drug Soliris (eculizumab). The drug is now approved as a treatment for generalized myasthenia gravis (gMG) in pediatric patients who…
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AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
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The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors…
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Bayer Funds Landmark Trials for Kerendia in Heart Failure Treatment Expansion
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Germany-based pharmaceutical company Bayer (ETR: BAYN) has announced funding for three investigator-sponsored collaborative studies aimed at expanding its late-stage clinical development program of the mineralocorticoid receptor antagonist (MRA) Kerendia (finerenone) for heart failure (HF). These new trials will broaden the patient pool to include those with reduced (HfrEF), mildly reduced…
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EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
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The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications…
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Shandong Buchang Pharmaceuticals’ BC001 for mCRC Accepted for Review by NMPA
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its investigational injectable product BC001. The product is intended for use in first and second-line metastatic colorectal cancer (mCRC) patients who have experienced…
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Sirnaomics’ STP707 siRNA Drug Shows Promising Results in Phase I Solid Tumor Study
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) has revealed that all patients have been dosed in a Phase I clinical study for its siRNA drug candidate STP707, which targets multiple solid tumors. The study is designed to assess the safety, tolerability, and anti-tumor activity of STP707 in six dose…
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Servier Group’s Pancreatic Cancer Therapy Onivyde Launches in Major Chinese Cities
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France-based Servier has announced the first prescriptions for its pancreatic cancer therapy, Onivyde (irinotecan), in 10 hospitals across major cities in China, including Tianjin, Beijing, Shanghai, Nanjing, Fuzhou, and Guangzhou. The drug is used to treat metastatic pancreatic cancer after gemcitabine treatment, in combination with 5-fluorouracil (5-FU) plus leucovorin (LV).…
