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Gan & Lee Pharmaceuticals Gains Marketing Approval for Insulin Glargine in Mexico
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval for its insulin glargine pre-filled pen in Mexico. This marks the company’s first marketing authorization as a holder (MAH) in the Mexican market. Insulin glargine, a long-acting insulin analogue that requires daily…
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Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
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Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its drug candidate stapokibart (CM310) has been granted priority review status by China’s Center for Drug Evaluation (CDE) for its potential as a treatment for chronic sinusitis with nasal polyps (CRSwNP). The IL-4Rα monoclonal antibody (mAb)…
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Sino Biopharmaceutical’s Benmelstobart Shows Positive Results in RCC Combination Therapy Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced positive interim analysis results from a Phase III clinical study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with anlotinib for the treatment of advanced unresectable or metastatic renal cell carcinoma…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Simcere Pharmaceutical’s Quviviq Secures Hong Kong Marketing Approval for Insomnia Treatment
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received marketing approval from the Hong Kong health authorities for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) will now be available in 50mg and 20mg dosages in the region,…
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NK CellTech’s NK-Cell Therapy Gets Green Light from China’s NMPA for Solid Tumor Treatment
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Laekna Therapeutics’ mCRPC Drug Combo Advances to Phase III with FDA Approval
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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Changchun High & New Technology Industries Gets Green Light for Jinnamab Clinical Trial
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Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product, jinnamab. This marks a significant milestone for the…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
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Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its New Drug Application (NDA) for glecirasib has been accepted by China’s National Medical Products Administration (NMPA) with priority review status. The KRAS G12C inhibitor is being reviewed for its potential as a treatment for second-line…
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Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone with its novel small-molecule chemical drug FCN-159, as indicated on the Center for Drug Evaluation’s (CDE) website. The drug has been granted priority review status for the treatment of plexiform neurofibroma (PN) in children aged…
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Eli Lilly’s Tirzepatide Earns China Approval for Type 2 Diabetes Treatment
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced that it has received its first market approval from the National Medical Products Administration (NMPA) in China for Mounjaro (tirzepatide). The drug is indicated for the treatment of type 2 diabetes mellitus (T2DM) in patients who have…
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Gilead’s Seladelpar Shows Interim Benefits in PBC-Related Itch Clinical Trial
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Gilead Sciences (NASDAQ: GILD) has announced interim results from a long-term study assessing the safety and efficacy of seladelpar, a PPAR-delta agonist, in treating pruritus associated with primary biliary cholangitis (PBC). The trial involved patients who had an inadequate response or were intolerant to ursodeoxycholic acid (UDCA), with 70% of…
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BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
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Zai Lab and Innoviva Win China Approval for SUL-DUR to Treat Hospital-Acquired Pneumonia
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
