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Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
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Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or…
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Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
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Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been…
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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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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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China’s NMPA Proposes Reforms to Enhance Radiopharmaceutical Review and Approval
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China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming and Improving the Administration of Review and Approval of Radiopharmaceuticals,” seeking public feedback. The document outlines a series of reforms aimed at enhancing the regulatory framework for radiopharmaceuticals in the country. Expanding Expertise in Radiopharmaceutical…
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Pfizer’s Talzenna Shows Positive Results in Phase III TALAPRO-2 Study for mCRPC
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2 study for its oral poly ADP ribose polymerase (PARP) inhibitor, Talzenna (talazoparib). The study evaluated the drug in combination with Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with or without homologous…
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Junshi Biosciences Launches PD-1 Inhibitor Tuoyi for Advanced NSCLC in China
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Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market launch meeting for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in China. The drug received its sixth indication approval last month for treating…
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WuXi Biologics Partners with neoX Biotech to Advance AI-Driven Drug Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into a long-term partnership with compatriot firm neoX Biotech, an artificial intelligence (AI) empowered company. The collaboration will focus on the process development and large-scale manufacturing of neoX’s in-house developed macromolecule drugs. Financial details of the…
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Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks…
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Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation for its core product MRG003 in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) had previously obtained Orphan Drug…
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Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
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China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its HX008, a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug, which was first approved in China in July this year for…
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3D Medicines Partners with Denfo Medical for Cancer Therapy Development
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China-based 3D Medicines has entered into a strategic partnership with compatriot firm Denfo Medical Group, focusing on the research and development (R&D) and commercialization of novel cancer therapies. The collaboration will also cover cancer chroniclization management and novel drug services. Denfo Medical will leverage its interconnected, digitalized, and intelligent online…
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Zai Lab Licenses Seagen’s Tivdak for Greater China Development and Commercialization
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Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based biotech Seagen Inc. (Nasdaq: SGEN) to license development and commercialization rights in Greater China (including mainland China, Hong Kong, Taiwan, and Macau) to Tivdak (tisotumab vedotin). This strategic partnership aims to bring this innovative antibody-drug…
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Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography…
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Angel Pharmaceuticals Gains CDE Approval for Mupadolimab Phase I/Ib Study
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China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China. Drug Overview and MechanismMupadolimab…
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Shuangcheng Pharma Licenses US Rights for Paclitaxel Injection to Meitheal
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China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHA: 002693) has announced a licensing and supply agreement with US-based Meitheal Pharmaceuticals, Inc., and compatriot firm Hong Kong King-Friend Industrial Co., Ltd. The agreement grants the two companies exclusive rights to Shuangcheng’s paclitaxel for injection (albumin-bound, 100mg/vial) in the US market. Meitheal will…
