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Junshi Biosciences’ Tuoyi Approved for First-Line NSCLC Treatment in China
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China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi (toripalimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in tumors with no EGFR/ALK mutations, in combination with chemotherapy. This marks the sixth indication approval for the programmed death-1 (PD-1) inhibitor in…
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Sun-Novo’s STC007 Gains NMPA Approval for Postoperative Pain Study
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007 for postoperative pain. This marks a significant milestone in the development of this innovative therapy. Drug Mechanism…
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WuXi Biologics Partners with Elpiscience for Macromolecule Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced multiple partnerships with compatriot firm Elpiscience Biopharmaceuticals Inc. WuXi Bio will be involved in Elpiscience’s process development and pilot test facilities in Suzhou, facilitating their transformation into a top-tier macromolecule development and GMP compliant service base.…
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Tasly Pharmaceuticals Gains NMPA Approval for B1344 Diabetes Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this…
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Clover Biopharmaceuticals Reports Positive Phase III Data for COVID-19 Vaccine SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced additional positive Phase III clinical trial data for its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The data show that subjects who received SCB-2019 as the third booster, following two doses of inactivated vaccine, exhibited higher levels…
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RemeGen Announces Positive Phase III Results for Telitacicept in SLE
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China-based pharma firm RemeGen (HKG: 9995) has announced the conclusion of a Phase III confirmatory study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE) in China, releasing preliminary data. The study enrolled 335 patients, randomized to receive telitacicept (160mg) or placebo via subcutaneous injection once per week…
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BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
