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Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
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The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This…
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CDE Releases 75th Batch of Generic Reference Preparations with Updated Specifications
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The Center for Drug Evaluation (CDE) has announced the release of the 75th batch of chemical generic reference preparations. This update includes the addition of 14 new specifications and the expansion of 68 existing specifications. Additionally, 16 previously published specifications have seen their Marketing Authorization Holder (MAH) information updated. Review…
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Zhejiang Jianfeng Receives FDA Approval for JFAN-1001 Clinical Trial in NSCLC
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Zhejiang Jianfeng Group Co., Ltd (SHA: 600668), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, JFAN-1001. The drug is indicated for the treatment of locally advanced or metastatic…
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MicroPort CardioFlow Medtech Completes Clinical Implantations of Second-Generation TAVI Device
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MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), a spin-off of China-based MicroPort Scientific Corp (HKG: 0853), has announced the successful completion of seven clinical implantations of its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty. The surgeries were performed in Denmark and Ireland, with all patients recovering well post-operation.…
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CSPC Pharmaceutical Gains NMPA Approval for Clinical Study of Bispecific Antibody NBL-028
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its investigational bispecific antibody (BsAb) NBL-028. The drug targets CLDN6 and CD137, focusing initially on advanced tumors with CLDN6 expression, such as testicular…
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Shanghai Henlius Initiates Global Phase III Study for HanSiZhuang in LS-SCLC
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China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small…
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Aiolos Bio Inc. Raises USD 245 Million in Series A Funding Led by Top Investors
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Aiolos Bio Inc., a US-based biotech company, has officially launched with the successful completion of a Series A financing round, raising USD 245 million. The round was co-led by Atlas Venture, Bain Capital Life Sciences, Forbion, and Sofinnova Investments, with additional participation from RA Capital Management. Lead Candidate AIO-001Aiolos Bio…
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Qilu Pharmaceutical Unveils Promising Data for QL1706 in Cervical Cancer Treatment at ESMO 2023
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China’s Qilu Pharmaceutical showcased compelling data for its combination drug QL1706 (iparomlimab and tuvonralimab) as a potential treatment for cervical cancer at the European Society for Medical Oncology (ESMO) Annual Congress 2023. The focus was on a multi-center, single-arm Phase II study conducted in China, evaluating QL1706 in combination with…
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