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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a strategic partnership with Germany’s Boehringer Ingelheim (BI) to introduce BI’s innovative cancer therapies to the mainland China market. Under the terms of the agreement, Sino Bio will provide support for the co-development and co-commercialization of several clinical-stage drugs, including brigimadlin, zongertinib, and…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the presentation of favorable results from two clinical studies on sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), at the American Association for Cancer Research (AACR) 2024 annual meeting. The drug is under global co-development with Merck, Sharp &…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for Elahere (mirvetuximab soravtansine), the company’s antibody drug conjugate (ADC) that targets folate receptor α (FRα). The study will evaluate Elahere as a…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
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Denmark-based biotech Genmab A/S (NASDAQ: GMAB) has announced a significant all-cash acquisition of Sino-US biotech Profound Bio, targeting its antibody drug conjugate (ADC) pipeline in a deal valued at $1.8 billion, set to close in the first half of 2024. The agreement has received approval from the boards of both…
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The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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Gilead Sciences (NASDAQ: GILD) has announced an in-licensing agreement with fellow US biotechnology company Xilio Therapeutics (NASDAQ: XLO) to acquire an early-stage tumor-activated interleukin 12 (IL-12) for the treatment of solid tumors. Gilead will pay an initial sum of USD 43.5 million for the exclusive development and global commercialization rights…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…