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BMS’s Sotyktu Sustains Clinical Response in Long-Term Psoriasis Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the release of long-term clinical data for Sotyktu (deucravacitinib), the company’s tyrosine kinase 2 (TYK2) inhibitor, used in the treatment of moderate-to-severe plaque psoriasis. The data, which spans a four-year period, indicates that the first-in-class drug has maintained a clinical response rate…
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Jiangsu Hengrui’s SHR1905 Anti-TSLP mAb Gets Green Light for COPD Clinical Trial
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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Innovent Biologics’ IBI311 New Drug Application Accepted for Review by China’s CDE
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company in China, has announced that the New Drug Application (NDA) for its investigational drug candidate IBI311 has been accepted for review by the Center for Drug Evaluation (CDE). IBI311 is a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody developed for…
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Zai Lab and Innoviva Win China Approval for SUL-DUR to Treat Hospital-Acquired Pneumonia
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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Eli Lilly’s Weekly Insulin Efsitora Alfa Matches Daily Basal Insulins in Reducing A1C Levels
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Eli Lilly and Company (NYSE: LLY), a global healthcare company, has announced results from a comparative study on its once-weekly insulin efsitora alfa. The study demonstrated that efsitora alfa is non-inferior in reducing A1C levels compared to daily basal insulins degludec or glargine in adults with type 2 diabetes (T2D).…
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Biotherus Inc. Advances PM8002 Bispecific Antibody to Phase III for Triple Negative Breast Cancer
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China’s Biotheus Inc. has announced the initiation of a Phase III clinical study for its investigational bispecific antibody, PM8002, which targets both PD-L1 and VEGF. The study will evaluate the safety and efficacy of PM8002 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic…
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Jiangsu Hengrui’s Camrelizumab/Apatinib Combo Denied FDA Approval Over Manufacturing Issues
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The US Food and Drug Administration (FDA) has issued a complete response letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, regarding its application for camrelizumab, a programmed death-1 (PD-1) monoclonal antibody (mAb), in combination with small-molecule targeted cancer therapy apatinib. The treatment was being considered…
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ImmuneOnco Biopharmaceuticals’ CD47 Inhibitor Receives NMPA Go-Ahead for Phase III Trial
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for timdarpacept (IMM01), the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy…
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CSPC Pharmaceutical’s βKlotho Monoclonal Antibody JMT202 Receives Clinical Trial Approval from NMPA
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its βKlotho monoclonal antibody (mAb), JMT202. This molecule is intended to reduce triglyceride (TG) levels in patients…
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Roche’s CT-388 Shows Significant Weight Loss in Phase I Clinical Trial for Obesity
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Switzerland-based healthcare giant Roche (SWX: ROG) has announced preliminary results from a Phase I study of its investigational dual GLP-1/GIP receptor agonist, CT-388. The study is assessing the drug’s effects in obese adults, both healthy and those with type 2 diabetes (T2D). Initial data from the healthy cohort showed that…
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Eisai to Support Grassroots Healthcare in China with Significant Pariet Donation
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced its commitment to donate 100,000 boxes of the gastresophageal reflux disease (GERD) medication Pariet (rabeprazole) to the Beijing Health Alliance Charitable Foundation. This initiative is designed to support a new program aimed at enhancing the capabilities of grassroots health care…
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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…
