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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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J&J’s Tremfya Meets Primary Endpoints in Phase III Crohn’s Disease Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Roche’s Genentech Gets Green Light for Vixarelimab UC Clinical Trial in China
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Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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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…
