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TYK Medicines Receives CDE Approval for CDK7 Inhibitor TY-2699a Clinical Study
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Shanghai-based TYK Medicines has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its small molecule drug candidate, TY-2699a. This oral, selective CDK7 inhibitor is under development for the treatment of various cancers, including breast, ovarian, prostate, pancreatic, and small…
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BeiGene’s Tislelizumab Secures First Approvals Outside China Mainland in Macau
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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by…
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Yizun Biomedicine’s CNK-UT Cell Therapy Initiates Patient Enrollment for Solid Tumor Trial
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Hangzhou-based cell therapy specialist Yizun Biomedicine Co., Ltd has announced the completion of first patient enrollment and reinfusion in an investigator-initiated trial (ITT) for its CNK-UT cell therapy, targeting advanced solid tumors at Shulan Hangzhou Hospital. CNK-UT Cell Therapy: A Universal Cell Technology for Tumor TreatmentCNK-UT is a groundbreaking universal…
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Zelgen Biopharmaceuticals’ ZG0895 Receives FDA Approval for Clinical Trials in Advanced Solid Tumors
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate ZG0895, which targets advanced solid tumors. ZG0895 is a highly selective toll-like receptor (TLR8) agonist developed in-house, designed to offer a new…
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BiOneCure Therapeutics and Nanjing Leads Biolabs Collaborate on Innovative ADCs for Solid Tumors
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US-based biotech company BiOneCure Therapeutics Inc. has entered into a strategic collaboration with China-based Nanjing Leads Biolabs. The partnership aims to develop a range of innovative antibody drug conjugates (ADCs) that target solid tumors, marking a significant step in the advancement of cancer treatments. Combining Expertise to Target Solid TumorsBiOneCure…
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CIM’s Cancer Vaccine CIMAvax Confirmed Immunogenic in US Study, Cuba Announces
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The Cuba-based Molecular Immunology Center (CIM), part of the state-run conglomerate BioCubaFarma, has shared updates on the status of clinical trials (CTs) for two of its drug candidates being conducted abroad. CIM Director Tania Crombet revealed that a US study, in collaboration with the Roswell Park Cancer Institute, has confirmed…
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LaNova Medicines and AstraZeneca Ink Global Licensing Deal for GPRC5D-Targeting ADC LM-305
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Shanghai-based LaNova Medicines Ltd, a developer of cancer therapies, has announced a significant global licensing deal with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The agreement concerns LM-305, a pre-clinical antibody drug conjugate (ADC) that targets GPRC5D. AstraZeneca will receive exclusive global rights to research, develop, and commercialize LM-305, in…
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Mabwell’s B7-H3 Targeting ADC 7MW3711 Accepted for Review by China’s NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that its clinical trial application for 7MW3711, an antibody drug conjugate (ADC) targeting B7-H3, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of advanced solid tumors.…
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CStone Pharmaceuticals’ Partner Servier Secures EU Approvals for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has announced receiving two new indication approvals for Tibsovo (ivosidenib), a first-in-class IDH1 inhibitor, from the European Committee. This marks a significant expansion in the drug’s approved uses for treating specific types of leukemia and cholangiocarcinoma. New Indications for Tibsovo in EuropeTibsovo is…
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Joincare Pharmaceutical Receives NMPA Approval for Triptorelin Microspheres for Prostate Cancer
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a China-based pharmaceutical company, has announced that it has obtained market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres. This treatment is designed for prostate cancer patients who require androgen castration therapy. Innovative Treatment Option for Prostate Cancer…
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Zai Lab’s Repotrectinib on Track for Priority Review by China’s CDE for ROS1+ NSCLC
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The Center for Drug Evaluation (CDE) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB) repotrectinib is on track to receive priority review status in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ROS1-positive. This priority review status is a reflection of…
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Sichuan Kelun Pharmaceutical’s A166 Anti-HER2 ADC NDA Accepted for Review by NMPA
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review its Category 1 new drug application (NDA) for A166, an anti-HER2 antibody drug conjugate (ADC). The drug is intended for the treatment of HER2 positive locally…
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Mabwell Bioscience’s 9MW3911 Receives NMPA Approval for Clinical Trial in Advanced Tumors
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb). The National Medical Products Administration (NMPA) has given the go-ahead for the drug to be assessed as a treatment for advanced…
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Akeso Biopharma Initiates Phase III Study for Ivonescimab in Non-Small Cell Lung Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the initiation of a Phase III clinical study for its bispecific antibody (BsAb) ivonescimab (AK112), which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF) in non-small cell lung cancer (NSCLC). Global Phase III HARMONi Study Design and Patient DosingThe global,…
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Zai Lab Limited Reports Q1 2023 Financial Results and Product Highlights
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China-based Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) has announced its financial results for the first quarter of 2023, along with recent product highlights and corporate updates. The company reported total product revenues of USD 62.8 million for the quarter, marking a 36% year-on-year (YOY) growth. Product Sales and ContributionsThe…
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Yifan Pharmaceutical’s F-627 Receives NMPA Approval for Neutropenia Treatment in Cancer Patients
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has announced receiving market approval from the National Medical Products Administration (NMPA) for its efbemalenograstim alfa (F-627). This in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein is indicated for the prevention and treatment of neutropenia in…
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Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
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China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC)…
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Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
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China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed…
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US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi
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China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has…
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RemeGen Ltd Receives Approval for Phase I Clinical Study of RC198 in Solid Tumors
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RemeGen Ltd (HKG: 9995) has announced that it has received approval from the Human Research Ethics Committees of Australia to conduct a Phase I clinical study for its investigational drug RC198. The study will focus on patients with locally advanced unresectable or metastatic solid tumors. RC198: An Fc Fusion Protein…
