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Eli Lilly Licenses OliX Pharma’s OLX75016 for MASH and Cardiometabolic Diseases
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Eli Lilly & Co. (NYSE: LLY) has signed a licensing agreement with OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a South Korea-based RNAi therapeutics developer, to jointly develop and commercialize OLX75016, an investigational drug targeting metabolic-associated steatohepatitis (MASH) and other cardiometabolic indications. Drug ProfileOLX75016, derived from a genome-wide association study (GWAS), is…
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Lion TCR’s Liocyx-M00 Therapy Receives FDA Clearance for HBV-Related HCC Study
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Singapore-based clinical-stage biotechnology company Lion TCR, backed by Chinese investors, has received clearance from the US Food and Drug Administration (FDA) to initiate a global, multi-center Phase II study for its Liocyx-M00 therapy. The treatment involves autologous T-cells transfected with mRNA encoding hepatitis B surface antigen (HBsAg) specific toll cell…
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Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895…
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J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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Degron Therapeutics’ DEG6498 Receives FDA Clearance for Clinical Trials
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China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and Drug Administration (FDA) has granted clinical clearance for DEG6498, its molecular glue degrader (MGD) targeting human antigen R (HuR). The drug will enter early-stage trials to assess its safety and efficacy in solid tumors. Drug…
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Bio-Thera Solutions’ BAT1006 Wins NMPA Approval for HER2+ Breast Cancer Trial
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China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006, its recombinant humanized monoclonal antibody, in combination with trastuzumab and chemotherapy for HER2-positive unresectable or metastatic breast cancer patients previously treated with antibody-drug conjugates (ADCs). Drug ProfileBAT1006 targets the extracellular…
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China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Stason Pharmaceuticals Inc.’s Purinethol (mercaptopurine). The drug, classified as a Category 2.2 chemical drug, is now approved for the treatment of children with…
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Henlius Biotech’s HLX99 Receives FDA Approval for ALS Clinical Study
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial for its small molecule drug HLX99 in amyotrophic lateral sclerosis (ALS). The trial will assess the drug’s potential to treat this neurodegenerative disease through neuroprotective mechanisms. Drug ProfileHLX99 is an…
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Henlius Biotech Doses First Patient in HLX43 Phase II Study for Esophageal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II study of HLX43, its antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. The drug, designed for advanced/metastatic solid tumors, has no comparable approved products…
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Bayer Files for Eylea 8 mg EMA Approval to Extend AMD, DME Treatment Intervals
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Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for Eylea 8 mg (aflibercept 8 mg), seeking to extend anti-VEGF injection intervals to 6 months in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The filing builds on positive data from the PULSAR…
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Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating…
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CSPC Pharmaceutical’s SYH2039 Wins FDA Clinical Approval for Advanced Tumors
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China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has approved clinical trials for its Category 1 chemical drug candidate SYH2039, a selective phosphodiesterase 4B (PDE4B) inhibitor, for advanced malignant tumors. The drug is also under study in China for interstitial lung diseases.…
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Boehringer Ingelheim’s Nerandomilast Hits Primary Endpoint in PPF Phase III Study
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German pharma giant Boehringer Ingelheim announced positive topline results from the Phase III FIBRONEER-ILD study of its investigational phosphodiesterase 4B (PDE4B) inhibitor nerandomilast, demonstrating a statistically significant improvement in forced vital capacity (FVC) at week 52 versus placebo in patients with progressive pulmonary fibrosis (PPF). Study DetailsThe trial met its…
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CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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Kelun-Biotech to Present SKB264/MK-2870 Data for Urothelial Carcinoma at ASCO-GU 2025
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China’s Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) will present efficacy and safety data from the Phase I/II KL264-01/MK-2870-001 study of its TROP2-targeted antibody-drug conjugate (ADC) sacituzumab tirumotecan (SKB264/MK-2870) at the ASCO-GU 2025 conference. The drug is being evaluated in patients with unresectable, locally advanced, or metastatic urothelial carcinoma (UC)…
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Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
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Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was…
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Changchun GeneScience’s GenSci120 Receives NMPA Approval for Rheumatoid Arthritis Trials
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China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its GenSci120 in rheumatoid arthritis (RA). The monoclonal antibody (mAb) was previously approved for studies in adult systemic lupus erythematosus, adult primary Sjogren’s syndrome, and inflammatory bowel…
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CARsgen’s Allogeneic BCMA CAR-T Therapy Achieves sCR in First Patient
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the first patient treated with its allogeneic BCMA chimeric antigen receptor (CAR)-T therapy, developed on the THANK-u Plus platform, achieved a stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment. Patient Background and TreatmentThe patient, diagnosed…
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Beijing Luzhu Submits BLA for LZ901 Herpes Zoster Vaccine to NMPA
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a human vaccine and therapeutic biologics manufacturer, announced that it has submitted a Biologic License Application (BLA) for its LZ901 to the National Medical Products Administration (NMPA), which has been accepted for review. Vaccine DetailsLZ901 is a recombinant herpes zoster vaccine developed based…
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Hainan Boao Lecheng Pilot Zone Implements Baclofen Intrathecal Therapy
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The Hainan Boao Lecheng Pilot Zone Management Bureau announced the implementation of Baclofen Intrathecal Sintetica, a special treatment for severe spasms, at the Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine and Hainan Boao Research Hospital. This therapy is suitable for patients with severe spinal cord-derived chronic spasticity (related…
