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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
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Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Shandong Buchang Pharmaceuticals Partners with Lancet for BC001 Licensing in Eurasia
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Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858), based in China, has announced plans to enter a licensing agreement with Russia’s Lancet Pharmaceuticals, granting the latter regulatory filing, commercialization, and other rights for Buchang’s pipeline candidate BC001 across the Eurasian Economic Union, which includes Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, and Uzbekistan.…
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Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
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Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
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Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
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Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a multi-center, randomized, double-blind Phase III study evaluating the efficacy of its novel drug, lisaftoclax (APG-2575), in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed patients with higher-risk…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Xiamen University, has received priority review status from China’s Center for Drug Evaluation (CDE). This vaccine targets seven high-risk HPV types (HPV16, 18, 31, 33, 45, 52, and 58)…
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Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
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Nanjing Sanhome’s Oritinib Ships Widely for EGFR-mutated NSCLC Treatment in China
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Nanjing Sanhome Pharmaceutical Co., Ltd, a notable player in the pharmaceutical sector, has announced the widespread distribution of its Category 1 chemical drug, oritinib, across key regions in China, including Jiangsu, Shanghai, Beijing, Henan, and Inner Mongolia. The drug has been made available to lung cancer specialists who are now…
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Boehringer Ingelheim’s Zongertinib Earns Breakthrough Designation in China for HER2-Mutated NSCLC
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Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
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Chinese NMPA Approves Hengrui Pharmaceuticals’ Generic Abraxane for Metastatic Pancreatic Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
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Jiangsu Hengrui Pharmaceuticals Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
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Harbour BioMed Reclaims Rights to HBM7008 as Cullinan Therapeutics Cancels Licensing Deal
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Harbour BioMed (HBM), a biopharmaceutical company with operations in the Netherlands, the United States, and Suzhou, China, has announced that its U.S. partner, Cullinan Therapeutics Inc., will be returning the rights to the pipeline molecule HBM7008. This move cancels the licensing agreement that was initially focused on the development and…
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WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
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WestGene Biopharma Co., Ltd., a biotechnology company based in Chengdu, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with clinical trials for its candidate drug, WGc-043. This marks a significant milestone as WGc-043 is the world’s first mRNA therapeutic…
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Hansoh Pharmaceutical Secures Rights to Lupeng’s BTK Inhibitor LP-168 in Licensing Deal
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Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a leading pharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm Lupeng Pharmaceutical Ltd for the next-generation Bruton’s tyrosine kinase (BTK) inhibitor, LP-168. According to the terms of the agreement, Hansoh will assume responsibility for research and…
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Zelgen Biopharmaceuticals’ ZG006 Earns Orphan Drug Designation from FDA for Small-Cell Lung Cancer
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate, ZG006, which is under development for the treatment of small-cell lung cancer (SCLC). ZG006 is…
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Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
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Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
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Eisai and SEED Therapeutics Join Forces on Molecular Glue Degraders for Neurodegeneration and Cancer
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, and SEED Therapeutics Inc., a U.S. biotech firm, have announced their intention to enter into a research collaboration aimed at developing novel molecular glue degraders for neurodegenerative diseases and oncology. Eisai will leverage SEED’s expertise in targeted protein degradation (TPD) to…
