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North China Pharmaceutical’s Ormutivimab Approved for Pediatric Use in China
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North China Pharmaceutical Group Corporation (SHA: 600812) has announced that it has received approval from the National Medical Products Administration (NMPA) for a new indication for its Category 1 therapeutic biologic, ormutivimab. The drug, a recombinant humanized rabies virus monoclonal antibody (mAb), is now approved for use in children aged…
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HutchMed’s Sovleplenib Phase III Results to be Showcased at EHA 2024
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HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013), a biopharmaceutical company based in China, is preparing to unveil the topline and subgroup results from the Phase III ESLIM-01 study at the European Hematology Association’s (EHA) 2024 annual conference. Additionally, the company will present updated clinical data for its hematological malignancy therapies…
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Shanghai UniCAR-Therapy’s Innovative CAR-T Therapy Targets Breakthrough Designation with IL-6 Silencing
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Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the…
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Bayer’s 225Ac-PSMA-Trillium Therapy Begins Early-Stage Clinical Trial for mCRPC
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Bayer AG (ETR: BAYN), a multinational pharmaceutical company based in Germany, has this week commenced an early-stage trial for its targeted radionuclide therapy, 225Ac-PSMA-Trillium. The trial is focused on treating advanced metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic candidate incorporates a PSMA-targeting small molecule designed to deliver an alpha…
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Roc Rock Biotechnology Secures Ethical Approval for CAR-M Therapy in Ovarian Cancer
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China-based Roc Rock Biotechnology Co., Ltd. has announced that it has received ethical approval from the Medical Ethics Committee of the Affiliated Hospital of Xuzhou Medical University for its chimeric antigen receptor macrophages (CAR-M) therapy in the treatment of ovarian cancer. This marks a significant step forward for the company…
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Olymvax Biopharmaceuticals Gets Green Light for Tetravalent Influenza Vaccine Clinical Trial
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Olymvax Biopharmaceuticals Inc. (SHA: 688319), a leading vaccine specialist headquartered in Chengdu, China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its tetravalent influenza virus split vaccine (MDCK cells). This vaccine is designed to prevent influenza caused by…
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Insilico Medicine’s ISM8207 Enters Phase I Clinical Trial for Lymphoma and Solid Tumors
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China’s generative artificial intelligence (AI)-driven biotech firm, Insilico Medicine, has announced the first patient dosing in a Phase I clinical study for ISM8207, a potential first-in-class drug candidate co-developed with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196). The open-label, multi-center Phase I study aims to evaluate the…
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Everest Medicines Commences Commercial Sales of Nefecon in China Post-Launch
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Everest Medicines (HKG: 1952), a leading pharmaceutical company based in China, has announced the official commercialization of Nefecon (targeted-release formulation budesonide) in China, marking a significant milestone with the issuance of the first prescription in the country. Nefecon is a patented oral, delayed-release formulation of budesonide, a corticosteroid with significant…
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Fosun Pharmaceutical Advances Lasofocine Clinical Trials for Breast Cancer after NMPA Nod
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct two clinical studies for lasofociene. The first trial is a Phase I study in healthy subjects, while the second is a global multi-center Phase…
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Zai Lab Advances Vygart Hytrulo for CIDP with sBLA Filing in China
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced the filing of a supplemental Biologics License Application (sBLA) in China for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). The sBLA seeks to expand Vygart’s indication to include the treatment of chronic inflammatory demyelinating polyneuropathy…
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Jiangsu Hengrui’s SHR-2173 Gets Green Light for Clinical Trial in IgA Nephropathy
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SHR-2173, an investigational biologic, in patients with IgA nephropathy. Developed in-house, SHR-2173 is designed to target abnormally…
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ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
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GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at…
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Tonghua Dongbao Pharmaceuticals Begins Clinical Trial for Xultophy Biosimilar
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase I clinical study for its insulin degludec and liraglutide combination drug. This molecule is a biosimilar version of Novo Nordisk’s Xultophy, the first compound preparation to combine a basal insulin…
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Novo Nordisk’s Wegovy Shows Durable Weight Loss and Heart Health in Extended Trials
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At the 31st European Congress on Obesity (ECO), Denmark’s pharmaceutical giant Novo Nordisk (CPH: NOVO-B) presented findings from two studies on its weight loss therapy Wegovy (semaglutide). The data indicated that Wegovy’s weight loss effects can be sustained for up to 4 years, along with cardiovascular benefits, irrespective of the…
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RemeGen’s Telitacicept Achieves Full Enrollment in Phase III Primary Sjogren’s Syndrome Trial
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the completion of patient enrollment in a Phase III clinical study for its drug candidate telitacicept in primary Sjogren’s syndrome (pSS) in China. The study aims to evaluate the efficacy and safety of telitacicept in pSS, with a total of 381 patients…
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Bayer’s Q1 2024 Report Shows Slight Dip in Sales Amid Pharmaceutical Unit’s Growth
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Germany-based Bayer (ETR: BAYN) has released its financial report for the first quarter of 2024, showing a slight 0.6% year-on-year (YOY) decrease in group sales to EUR 13.8 billion (USD 14.9 billion), excluding portfolio and exchange rate effects. The pharmaceuticals business segment reported a 3.9% increase in sales, reaching EUR…
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Novo Nordisk’s Bispecific Antibody Mim8 Achieves Milestone in Haemophilia A Trial
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Novo Nordisk (CPH: NOVO-B), a pharmaceutical company based in Denmark, has announced that its bispecific antibody (BsAb) Mim8 has successfully met the primary endpoints in a late-stage trial for haemophilia A. The trial focused on the reduction of treated bleeding episodes, with once-weekly and once-monthly doses of Mim8 showing reductions…
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Novo Nordisk’s Mim8 for Haemophilia A Exceeds Endpoints in Late-Stage Trial
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Denmark-based healthcare company Novo Nordisk (CPH: NOVO-B) has announced positive results from a late-stage trial of its bispecific antibody (BsAb) Mim8, used for the treatment of haemophilia A. The trial successfully met its primary endpoints, which focused on the reduction of treated bleeding episodes. The study demonstrated that once-weekly and…
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Roche and Genprex Initiate Phase I Trial Combining Tecentriq and Reqorsa for ES-SCLC
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Switzerland-based Roche (SWX: ROG) is advancing the evaluation of its anti-PD-L1 drug, Tecentriq (atezolizumab), in combination with Genprex’s (NASDAQ: GNPX) gene therapy, Reqorsa (quaratusugene ozeplasmid), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Genprex has initiated the dose escalation phase of a Phase I clinical trial, with the…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
