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Asieris Pharmaceuticals to Present Phase I Results of APL-1202 Combo at ASCO
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that it will publish the results of a Phase I clinical study at the American Society of Clinical Oncology (ASCO) annual meeting. The study combines Asieris’ APL-1202 with BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab as…
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Antengene’s ATG-022 Earns FDA Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody drug conjugate (ADC), ATG-022, targeting Claudin 18.2, has been granted two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. This brings the…
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Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy. HX009’s Clinical…
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Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as…
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Enhertu, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
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Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been officially launched in the Chinese market. The drug received marketing approval in China in February 2023 and is now available for the treatment of unresectable or metastatic HER2 positive…
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BeiGene’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or…
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Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic…
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Shanghai Junshi Biosciences’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities have accepted for review another indication approval filing for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with paclitaxel (albumin bound) for the treatment of PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic…
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Sino-US Laekna Receives FDA Clearance for LAE102 Clinical Trial in NSCLC
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Sino-US Laekna has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its LAE102 antibody. The drug is set to be assessed as a potential treatment for non-small cell lung cancer (NSCLC). This achievement marks LAE102 as Laekna’s first internally-discovered drug candidate…
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Asieris Pharmaceuticals Secures Exclusive Global Rights to UroViu’s Fluorescent Imaging Cystoscope
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced a strategic collaboration with US firm UroViu Corporation, obtaining exclusive global rights to UroViu’s patented portable single-use cystoscope in the field of fluorescent imaging. Combining Technology for Non-Muscle Invasive Bladder Cancer (NMIBC) ResearchUnder the agreement, Asieris will utilize this patented…
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FibroGen’s Roxadustat Shows Positive Results in Phase III Chemotherapy-Induced Anemia Trial
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US-based FibroGen Inc. (NASDAQ: FGEN) has announced positive topline data from a Phase III trial for roxadustat, a treatment for anemia in patients receiving chemotherapy. The study, which focused on 153 patients in China (NCT05301517), showed that detailed results will be presented at a future industry conference. Roxadustat’s Efficacy and…
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Betta Pharmaceuticals Initiates Phase I/II Study for First-In-Class BsAb BPB-101
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China’s Betta Pharmaceuticals (SHE: 300558) has announced the enrollment of the first patient in a Phase I/II clinical study for its first-in-class bispecific antibody (BsAb), BPB-101. The molecule is currently being assessed for the treatment of advanced malignant solid tumors. BPB-101: A Trifunctional IgG1 Subtype Humanized AntibodyBPB-101 is a trifunctional…
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Antengene’s First-in-Class CD24 mAb ATG-031 Gets US FDA Approval for Phase I Study
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Antengene Corp., Ltd (HKG: 6996) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its first-in-class CD24 monoclonal antibody (mAb), ATG-031. The Phase I PERFORM study is designed to assess the safety, tolerability, pharmacological properties, immunogenicity,…
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BioRay Pharmaceutical’s Zuberitamab Approved by NMPA for CD20 Positive DLBCL Treatment
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BioRay Pharmaceutical Co., Ltd has announced that its drug zuberitamab has been approved by the National Medical Products Administration (NMPA) to treat CD20 positive diffuse large B-cell lymphoma, non-specific (DLBCL, NOS) in adults. The approval is for the use of zuberitamab in combination with standard cyclophosphamide, doxorubicin, vincristine, and prednisone…
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CARSgen Therapeutics Initiates Phase II Study for CT041 in Advanced Gastric Cancer
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China-based chimeric antigen receptor (CAR)-T cell specialist CARSgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of patient enrollment for a Phase II clinical study of its CT041 in advanced gastric cancer/esophageal gastric junction adenocarcinoma (GC/GEJ) with positive CLDN18.2 expression that has previously failed at least second-line treatment. CT041:…
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HitGen Inc. Enters Research Agreement with ARase Therapeutics to Discover Oncology Inhibitors
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China-based HitGen Inc. (SHA: 688222) has announced a research agreement with ARase Therapeutics, Inc. Under this collaboration, HitGen will leverage its DNA-encoded library (DEL) technology platform, which specializes in the design, synthesis, and screening of DELs, to identify novel inhibitors of ARase’s validated oncology targets. HitGen will also provide support…
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Antengene Submits Market Approval Filing for Xpovio in Indonesia for Multiple Myeloma and Lymphoma
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Antengene Corp., Ltd (HKG: 6996) has announced a market approval filing in Indonesia for its drug Xpovio (selinexor). The company is seeking approval for the treatment of relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Background on Xpovio and Its ApprovalsDiscovered…
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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…
