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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,…
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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 (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’ (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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China-based Innovent Biologics Inc., (HKG: 1801), has announced that a Phase II clinical study assessing the higher dose (9mg) of mazdutide (IBI362) in Chinese adults with obesity has achieved its 24-week primary endpoint. This milestone marks a significant step forward in the development of this potential treatment for obesity. Study…
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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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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 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 (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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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,…