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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…
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MSD Discontinues Vibostolimab and Keytruda Combo Trial in High-Risk Melanoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced its decision to cease development of the anti-TIGIT antibody vibostolimab in combination with its anti-PD-1 drug Keytruda (pembrolizumab) as an adjuvant treatment for resected high-risk melanoma. This strategic move follows an interim analysis that failed to meet the primary endpoint of…
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HutchMed’s HMPL-306 Advances to Phase III Trial in R/R AML Patients
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the commencement of the RAPHAEL study, a pivotal multi-center, randomized, open-label, regulatory Phase III trial. The study aims to evaluate the efficacy and safety of HMPL-306 in patients with recurrent/refractory (R/R) acute myeloid leukemia (AML) featuring isocitrate dehydrogenase (IDH) 1 or…
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Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
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NMPA Accepts Jiangsu Yahong Meditech’s Application for Cervical HSIL Treatment Cevira
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Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for Cevira (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) of the cervix, excluding in…
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Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
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Huadong Medicine’s EGFR Inhibitor Mefatinib for NSCLC Accepted by NMPA for Review
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Huadong Medicine Co., Ltd (SHE: 000963), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its filing for market approval of mefatinib. The drug is proposed as a first-line treatment for locally advanced or metastatic non-small cell lung cancer…
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Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the Health Sciences Authority of Singapore for its enoxaparin sodium injection in four specifications: 0.2ml:20mg, 0.4ml:40mg, 0.6ml:60mg, and 0.8ml:80mg. The approval is valid for a period…
