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Everest Medicines (HKG: 1952), a China-based biopharmaceutical company, has declared the successful completion of patient enrollment in a multi-center Phase III clinical trial for etrasimod in Asia, specifically targeting the treatment of moderate-severe active ulcerative colitis (UC). This development follows Everest’s acquisition of development rights to etrasimod in Greater China…
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced the receipt of another clinical trial approval for its drug candidate SHR0302, which is intended for the treatment of graft versus host disease (GVHD). SHR0302: A Selective JAK1 Inhibitor with Oral Solution PotentialSHR0302 is recognized as a highly…
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its tetravalent influenza virus split vaccine, VaxigripTetra, has been granted market approval by the National Medical Products Administration (NMPA) in China. This approval extends the vaccine’s usage to include individuals aged three years and above, building on the earlier approval for…
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The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN) Beyfortus (nirsevimab) is on course to be awarded priority review status for its use in preventing lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants who are about to enter…
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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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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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China-based biotech Transcenta Holdings Ltd (HKG: 6628) has announced encouraging Phase I clinical study results for TST002, a drug designed to address decreased bone density in Chinese patients. Phase I Study Design and FindingsThe randomized, double-blind, placebo-controlled, dosage escalation Phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity…
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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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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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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that the results of three clinical studies for its Category 1 drug jacktinib in myelofibrosis have been shortlisted for the European Hematology Association (EHA) annual meeting this year. Phase III Study: Jacktinib vs. Hydroxyurea in MyelofibrosisA randomized, double-blind Phase III study…
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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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China-based Lynk Pharmaceuticals Co., Ltd announced positive results from the Phase II clinical study of its drug candidate LNK01001 in treating rheumatoid arthritis (RA). The study demonstrated a statistically significant efficacy difference in terms of primary and key secondary endpoints, along with a favorable safety and tolerability profile. LNK01001: A…
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Skyline Therapeutics has reached a significant milestone with the completion of the first patient dosing in its clinical study for SKG0106 intraocular injection solution. This in-house developed ophthalmology gene therapy was approved for clinical trials in China in December 2022. The open, dosage escalation study is designed to evaluate the…
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Gracell Biotechnologies Inc., (Nasdaq: GRCL), a China-based biopharmaceutical company, has announced the start of an investigator-initiated trial (IIT) in China for its therapeutic candidate GC012F. This candidate is an autologous FasTCAR therapy aimed at treating refractory systemic lupus erythematosus (SLE). The therapy is distinctive as a dual B cell maturation…
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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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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1002. This small molecule is a complete agonist of the GLP-1 receptor with oral activity, known for its…
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that the clinical trial filing for its EYP-1901 intravitreal implant, co-filed with EyePoint Pharmaceuticals, Inc (NASDAQ: EYPT), has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended to be assessed as a potential treatment for pathological myopia…
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The Center for Drug Evaluation (CDE) website has indicated that Wuhan Institute of Biological Products Co., Ltd’s oral hexavalent reconstituted rotavirus live vaccine (Vero cells) is on course for priority review. This priority status is granted for the vaccine’s use in preventing acute gastroenteritis caused by rotavirus in infants and…
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the conclusion of a randomized, double-blind, placebo-controlled Phase II clinical study for its drug candidate KX-826 (pyrilutamide) in the US for the treatment of male patients with androgenetic alopecia (AGA). The study demonstrated that KX-826 can promote hair growth, with statistically and…
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The China National Intellectual Property Administration (CNIPA) has released the latest batch of completed patent linkage cases, following the new legal framework introduced with China’s amended Patent Law, which came into effect from July 2021. Decisions on Generic and Originator PatentsThe decisions covered 9 molecules and 19 patent challenge verdicts,…