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Ping An Life Insurance Reports Q3 Results, Advances Healthcare Strategy
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Ping An Life Insurance Company of China Ltd released its 2022 Q3 financial report, showing a 6.3% year-on-year (YOY) decrease in net profits to RMB 76.46 billion (USD 10.59 billion). The decline was attributed to the short-term impact of pandemic disruptions and a volatile capital market. However, the company’s operational…
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Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
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Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to conduct a Phase III clinical study evaluating the efficacy and safety of its programmed death-1 (PD-1) inhibitor, Serplulimab (HaiSiZhuang). The study will assess the drug in combination with chemotherapy (carboplatin/cisplatin-etoposide) in patients with limited stage…
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Daiichi Sankyo Initiates Global Phase II Study of DS7300 for Small-Cell Lung Cancer
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced the first patient dosing in a global pivotal Phase II clinical study (S7300-127) assessing the efficacy and safety of its DS7300 (DS7300a), a potential first-in-class antibody drug conjugate (ADC), in patients with extensive small-cell lung cancer (SCLC) in China. DS7300 is an…
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Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a Phase Ib/II clinical study in China for its SHR-A1811 combined with SHR-1701 in patients with HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). This approval marks a significant step forward in the development of…
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AIM Vaccine Receives CDE Approval for Serum-Free Rabies Vaccine Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its investigational lyophilized human rabies vaccine (serum-free Vero cells). This approval marks a significant step forward in the company’s efforts to develop and commercialize innovative rabies vaccines. Vero Cells…
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Zhiyi Biotechnology Receives FDA Clearance for SK10 in Chemotherapy-Induced Diarrhea
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Guangzhou-based Zhiyi Biotechnology has announced receiving clearance from the US FDA for a clinical study of its SK10 (inactivated Bacteroides fragilis) in chemotherapy-induced diarrhea (CID). This marks a significant milestone in the development of live biotherapeutic products (LBPs) for addressing unmet medical needs. First-in-Class IND ApprovalNotably, this is the world’s…
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Abogen Biosciences Receives UAE Clinical Trial Approval for Omicron BA.4/5 mRNA Vaccine
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China’s Abogen Biosciences Co., Ltd, a developer of messenger ribonucleic acid (mRNA) drugs, has announced receiving clinical trial approval in the United Arab Emirates (UAE) for its mRNA COVID-19 vaccine targeting the Omicron BA.4/5 variants. This approval marks a significant step in the global fight against the evolving COVID-19 pandemic.…
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Gracell Biotechnologies Initiates Phase II Dosing for GC007g in B-ALL Patients
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China-based Gracell Biotechnologies Inc. has announced the first patient dosing in the Phase II portion of its registrational Phase I/II clinical study assessing GC007g for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. This milestone marks a significant step forward in the development of innovative treatments…
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Henlius Biotech Gains NMPA Approval for Phase I Trial of HLX60 in Solid Tumors and Lymphomas
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. This marks a significant step forward in the development of innovative treatments for these challenging…
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Grand Pharma’s TLX591-CDx Approved for Prostate Cancer Diagnosis in China
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Investigational New Drug (IND) filing for TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the National Medical Products Administration (NMPA). This approval marks a significant step forward…
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Genor Biopharma Initiates First Patient Dosing for GB263T in China
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a Phase I/II clinical study for its pipeline candidate GB263T in advanced non-small cell lung cancer (NSCLC) and other solid tumors in China. The drug was first administered in a first-in-human trial in Australia in May…
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Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
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China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), in combination with its anti-CD73 monoclonal antibody (mAb) AK119 for…
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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
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NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
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China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting HIV drug candidate CL-197 has been approved by the National Medical Products Administration (NMPA). CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by simulating endogenous purine nucleotides, thus having potential…
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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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Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
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Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
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Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). Phase II Clinical Trial DesignThe…
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Transcenta’s TST004 Receives FDA IND Clearance for IgAN Treatment
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for TST004, a best-in-class, humanized monoclonal antibody targeting MASP2. The drug is set to be evaluated as a potential treatment for immunoglobulin A nephropathy (IgAN).…
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Kira Pharmaceuticals Gets FDA Green Light for Phase II Study of KP104 in SLE-TMA
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Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus…
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Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
