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Salubris Pharmaceuticals’ First-in-Class Anti-Tumor Drug SAL008 Accepted by NMPA
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing for its first-in-class anti-tumor biologic drug SAL008 has been accepted for review by the National Medical Products Administration (NMPA). The drug, indicated for advanced solid tumors, has previously entered Phase I clinical trials in Europe.…
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Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
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Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient…
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CDE Releases 63rd Batch of Chemical Generic Reference Preparations
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The Center for Drug Evaluation (CDE) has released the 63rd batch of chemical generic reference preparations, adding 22 new specifications and updating information for 39 previously published specifications. This update is part of the CDE’s ongoing efforts to streamline the approval process for generic drugs and ensure the availability of…
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Jiangsu Launches Sunshine Procurement Platform for Drugs and Medical Consumables
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Jiangsu province has launched its drugs and medical consumables sunshine procurement services website, providing a comprehensive platform for interested parties to access policy updates, gather information about products for online procurement, download national and provincial volume-based procurement (VBP) product lists, query drugs and medical consumables online procurement prices, and track…
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Merck’s Keytruda Gains 9th Indication Approval in China for Hepatocellular Carcinoma
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US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 9th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used as a monotherapy to treat hepatocellular carcinoma (HCC) previously treated with sorafenib or oxaliplatin. Approval Based…
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Convalife and Jointown Partner for Global Drug Development and Commercialization
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Shanghai-based Convalife Pharmaceuticals has entered into a strategic partnership with fellow Chinese firm Jointown Pharmaceutical Group Co., Ltd (SHA: 600998) to collaborate on new drug development and the global research, development, and commercialization of related products. The partnership aims to leverage the strengths of both companies to advance innovative cancer…
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Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
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Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid…
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VectorBuilder Raises $56.6M in Series C to Expand Life Science R&D
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Guangzhou-based VectorBuilder, a genetic engineering specialist incubated by the state-owned Guangzhou Industrial Investment and Capital Operation Holding Group, has reportedly raised RMB 410 million ($56.6 million) in a Series C financing round. The funding round saw participation from investors including Guangzhou Industrial Investment and Capital Operation, Legend Capital, Yuexiu Industry…
