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AstraZeneca’s Nirsevimab on Track for Priority Review for RSV Prevention in Infants
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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 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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Transcenta Holdings’ TST002 Shows Positive Phase I Results for Bone Density in China
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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’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’ Jacktinib Studies Selected for EHA Annual Meeting
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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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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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Lynk Pharmaceuticals’ LNK01001 Demonstrates Efficacy in Phase II Rheumatoid Arthritis Study
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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 Initiates Clinical Study with First Patient Dosing of SKG0106 for wAMD
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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 Initiates Trial for GC012F in Refractory SLE with Dual-Target FasTCAR Therapy
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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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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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Huadong Medicine’s HDM1002 Receives FDA Approval for Clinical Trials
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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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Betta Pharmaceuticals and EyePoint Pharmaceuticals Submit EYP-1901 for NMPA Review
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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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Wuhan Institute’s Hexavalent Rotavirus Vaccine on Track for Priority Review by CDE
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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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Kintor Pharmaceutical’s KX-826 Shows Promise in Phase II Study for Male Androgenetic Alopecia
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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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CNIPA Releases Patent Linkage Decisions, Paving Way for Generic Drugs in China
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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,…
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Guangdong Taienkang’s CKBA Ointment for Vitiligo Accepted for Review by China’s NMPA
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Guangdong Taienkang Pharmaceutical Co., Ltd, (SHE: 301263), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a Phase II clinical trial filing for its CKBA ointment in the treatment of vitiligo. The Category 1 chemical drug is also currently undergoing a Phase IIa clinical…
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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…
