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Zelgen Biopharmaceuticals Receives NMPA Approval for ZG005 Clinical Trial in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase I/II clinical study for its pipeline drug candidate, ZG005, aimed at treating advanced solid tumors. ZG005 is an…
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Zelgen Biopharma’s ZG006 Shows Promising Anti-Tumor Efficacy in Phase I/II SCLC Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced positive preliminary results from a Phase I/II clinical study assessing the tolerability, safety, efficacy, and pharmacokinetics of ZG006 in patients with advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma. The study, which included a dosage…
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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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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
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Suzhou Zelgen’s Jacktinib Tablets Achieve Positive Results in Phase II IPF Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced the successful completion of a Phase II clinical study for its Category 1 product candidate, jacktinib tablets, in the treatment of idiopathic pulmonary fibrosis (IPF). The study demonstrated that jacktinib tablets effectively delayed the decline…
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Suzhou Zelgen’s Recombinant Human Thyroid Stimulating Hormone Accepted for NMPA Review
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for recombinant human thyroid stimulating hormone (rhTSH). The biomacromolecular drug is intended for use in radioactive iodine (131I) whole body…
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Zelgen Biopharmaceuticals’ Jacktinib Meets Primary Endpoint in Severe Alopecia Areata Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that its Phase III clinical trial for jacktinib tablets, a Category 1 product candidate for severe alopecia areata, has successfully met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial was conducted to evaluate the…
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Zelgen Biopharmaceuticals Gets NMPA Approval for Jacktinib Vitiligo Trial in Adolescents and Adults
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II/III study for its Category 1 product candidate, jacktinib tablets. The study will focus on adolescent and adult patients suffering from non-segmental vitiligo.…
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Chinese Biopharma Companies Set to Showcase Oncology Pipelines at ASCO 2024
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A cohort of Chinese biopharmaceutical companies, including Wuhan YZY Biopharma Co., Ltd (HKG: 2496), Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), JW Therapeutics (HKG: 2126), and CStone Pharmaceuticals (HKG: 2616), are preparing to present updates on their pipeline products at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting,…
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Suzhou Zelgen Receives NMPA Approval for Jacktinib Cream Trial in Vitiligo Patients
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II/III study for its Category 1 product, jacktinib cream, in adolescent and adult patients suffering from non-segmental vitiligo. Jacktinib, a Janus kinase (JAK) inhibitor, exhibits…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Zelgen Biopharmaceuticals Partners with Grand Life Sciences for Exclusive Marketing of Recombinant Human Thrombin
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Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) has announced an exclusive marketing promotion service agreement with Grand Life Sciences Co., Ltd., aimed at advancing the commercialization of Zelgen’s recombinant human thrombin product in Greater China. Under the terms of the agreement, Grand Life will serve as the sole marketing promotion…
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Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Solid Tumor Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline drug candidate, ZG005. The trial will evaluate the efficacy of ZG005 in combination with the Category 1 anti-cancer drug donafenib…
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Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its Phase III clinical study for the drug candidate, recombinant human thyroid stimulating hormone for injection (rhTSH), has successfully reached its pre-set primary endpoint. Following this achievement, the company will proceed with a pre-BLA (Biologics License…
