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Changchun High & New Technology Industries Receives US Trial Approval for GenSci120 in Rheumatoid Arthritis
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced its subsidiary GenScipt Biotech Corp. receiving approval to initiate a clinical study for its GenSci120 in rheumatoid arthritis (RA) in the United States. This marks a significant step forward in the development of this innovative biologic product for…
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Accropeutics Closes RMB100 Million Series B+ Round to Advance Inflammatory Disease Pipeline
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Accropeutics Inc., a clinical-stage biotech company with operations in New York, US, and Suzhou, China, announced the completion of a Series B+ financing round, raising close to RMB100 million (USD13.8 million). The round was led by Shenzhen Capital Group (SCGC) and included contributions from Morningside Ventures, Leader Venture Capital, and…
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Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
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Biogen Initiates TRANSCEND Study for Felzartamab in Late AMR Kidney Transplant Patients
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US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical…
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InnoCare Pharma Presents Positive Phase II Results of ICP-488 in Psoriasis at AAD Meeting
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) announced the oral presentation of results from the Phase II study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor ICP-488 in psoriasis vulgaris at the American Academy of Dermatology Annual Meeting (AAD). The results demonstrate significant improvements in patients treated with ICP-488…
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Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing…
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Bio-Thera Solutions Inks Licensing Deal with World Medicine for BAT2206
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China-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with World Medicine, granting the Turkiye-based firm exclusive distribution and marketing rights to its BAT2206, a biosimilar version of Roche’s Stelara (Ustekinumab). Partnership DetailsUnder the agreement, World Medicine will handle the import, regulatory filing, and sales of the drug…
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CARsgen Therapeutics Administers KJ-C2219 in SLE Patient in IIT
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that it has administered its KJ-C2219 at the starting dose specified in the clinical protocol in the first patient with systemic lupus erythematosus (SLE) in an investigator-initiated trial (IIT). Therapy DetailsKJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, was developed via CARsgen’s THANK-u…
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Suzhou Ribo Life Science’s RBD2080 siRNA Drug Receives Australian Clinical Trial Approval
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China-based Suzhou Ribo Life Science Co., Ltd announced that its siRNA drug RBD2080 has received clinical trial approval from Australia’s Therapeutic Goods Administration (TGA). The drug, designed to treat autoimmune diseases, will soon enter a Phase I study in Australia. Trial DetailsThe upcoming trial is a randomized, double-blind, placebo-controlled study…
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Sanofi and Teva’s Duvakitug Hits Key Milestones in UC and CD Study at ECCO Congress
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Sanofi (EPA: SAN, NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA) presented Phase IIb data for duvakitug, their experimental monoclonal antibody targeting TL1A, at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress. The RELIEVE UCCD study evaluated the drug in moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD),…
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Triastek’s 3D-Printed Drug D23 Shows Promise in Treating IgA Nephropathy
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China-based Triastek Inc., a pioneer in pharmaceutical 3D printing, announced positive outcomes from a clinical study of its 3D-printed drug product D23, a budesonide ileum-targeted tablet designed to treat IgA nephropathy (IgAN). The study highlights the drug’s precise intestinal targeting and efficacy in addressing the root cause of the disease.…
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PolyMed Biopharma Licenses HPB-143 to Photys Therapeutics for Global Development
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PolyMed Biopharma, a Hangzhou-based developer of Proteolysis Targeting Chimera (PROTAC) drugs, has entered into a licensing agreement with U.S.-based Photys Therapeutics, Inc. for its HPB-143, a targeted protein degrader (TPD) targeting IRAK4. Under the agreement, Photys will obtain exclusive global development, manufacturing, and commercialization rights to the drug, excluding Greater…
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Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for its ivarmacitinib ointment to the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the drug’s use as a topical treatment for mild to moderate atopic dermatitis (AD) in adults. Drug ProfileIvarmarcitinib…
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Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
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Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in…
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Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is…
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Huahai Pharma Set to Launch IL-17 Antibody HB0017 Clinical Study for HS
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is poised to initiate a clinical study for its interleukin-17 (IL-17) monoclonal antibody (mAb) HB0017 in hidradenitis suppurativa (HS) after receiving approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of novel treatments for…
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Chongqing Genrix’s Xeligekimab Approved for Ankylosing Spondylitis by NMPA
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China-based Chongqing Genrix Bio Pharmaceutical Co., Ltd (SHA: 688443) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication of its in-house developed Category 1 biologic product, xeligekimab. The anti-IL-17 antibody is now approved to treat ankylosing spondylitis (radiologically positive axial spondyloarthritis), following its initial…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1819 Phase II Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its investigational drug SHR-1819. This approval is a significant step forward in the development of SHR-1819, which is…
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MabPharm’s CMAB807 Biosimilar Infliximab Approved in Pakistan
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J, NYSE: JNJ)’s Remicade (infliximab), in Pakistan. This follows similar approvals in Peru and Indonesia last year. The approval encompasses all six indications, which…
