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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…
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Nerviano Medical Sciences Collaborates with Merck on PARP1 Inhibitor NMS-293
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Italy-based Nerviano Medical Sciences S.r.l. (NMS), which is 90% owned by Chinese investment fund SARI under a deal that closed in 2018, has unveiled a collaboration and licensing deal with Germany-based Merck Healthcare KGaA. The agreement grants Merck global rights to develop and commercialize the poly (ADP-ribose) polymerase 1 (PARP1)…
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AstraZeneca and Merck’s Lynparza Receives New Approval in China
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UK-based AstraZeneca (NASDAQ: AZN) and US-based Merck, Sharp & Dohme (MSD, NYSE: MRK) have announced that they have received another indication approval from the National Medical Products Administration (NMPA) for Lynparza (olaparib). The poly (ADP-ribose) polymerase (PARP) inhibitor is now approved as a maintenance therapy for homologous recombination repair deficiency…
