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AbelZeta and AstraZeneca Team Up for Co-Development of GPC3-Targeted CAR-T Therapy
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AbelZeta Pharma Inc., a Sino-U.S. biotech firm based in Rockville, Maryland, and Shanghai, has announced a co-development agreement with AstraZeneca (AZ, NASDAQ: AZN) for its C-CAR031 chimeric antigen receptor (CAR) T cell therapy. C-CAR031 is an autologous, armored CAR-T therapy specifically targeting GPC3, currently under development for hepatocellular carcinoma (HCC).…
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Shanghai Henlius Partners with China Resource Medicine to Enhance Product Accessibility
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced a strategic partnership with China Resource Medicine Commercial Holdings Ltd. aimed at enhancing product accessibility across the market. Under the terms of the agreement, the two companies will collaborate on product marketing promotion, channel expansion, and supply chain management, although financial details…
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Medtronic Exits $738 Million Deal to Acquire EOFlow Amid Regulatory and Legal Challenges
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U.S.-based Medtronic plc has announced its withdrawal from a previously agreed deal to fully acquire South Korea’s EOFlow (KOSDAQ: 294090), a developer of wearable insulin pumps. According to a recent SEC filing, the original agreement, signed in May 2023 and valued at up to USD 738 million, included separate share…
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AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
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China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Acetabular Component of Hip Prosthesis, classified as a Class III medical device. This innovative product is a 3D-printed titanium alloy orthopedic implant. AK Medical first gained…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
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HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
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China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is on track to receive priority review status for its investigational drug, sovleplenib. This designation is granted due to the drug’s potential to treat adults with primary chronic immune thrombocytopenia (ITP) who are unresponsive…
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Trinomab’s TNM002 Antitetanus Monoclonal Antibody Filing Accepted for Review in China
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China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing for its antitetanus toxin monoclonal antibody (mAb) injection, TNM002, for review. TNM002, developed using Trinomab’s proprietary HitmAb technology platform, has demonstrated strong drug specificity, favorable safety profiles, and exceptional efficacy in neutralizing tetanus toxin in…
