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J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
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The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for its IL-23p19-subunit inhibitor Tremfya (guselkumab) as a potential treatment for moderately to severely active ulcerative colitis (UC). The regulatory body will now review data from a late-stage study that…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Everest Medicines’ Velsipity NDA Accepted in Macau, Poised for First Asian Approval
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Everest Medicines (HKG: 1952), based in China, has announced that its New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC) has been accepted for review by the regulatory authority in Macau. This marks Macau as the first region in Asia, within Everest’s licensed…
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Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
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Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
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Sichuan Biokin and Bristol-Myers Squibb Activate $800 Million ADC Licensing Deal
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has officially activated its licensing and cooperation agreement with U.S. pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) for the development of Biokin’s BL-B01D1 antibody-drug conjugate (ADC) candidate, effective February 8, 2024. As of March 7, the company confirmed receipt of the USD 800…
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Simnova Secures RMB 200 Million in Series A+ Funding to Advance CAR Therapy Pipeline
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Simnova, a Shenzhen-based developer of chimeric antigen receptor (CAR) adoptive cell therapies, has successfully raised RMB 200 million (approximately USD 27.8 million) in a Series A+ financing round. The round was led by Youshan Capital, with participation from SIP Oriza Seed Fund, PagodaTree Partners, and Triwise. The company’s pipeline features…
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ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
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Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
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BeiGene Launches Legal Action Against Sandoz and MSN Over Brukinsa Patent Infringement
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BeiGene Ltd. (NASDAQ: BGNE; HKG: 6160; SHA: 688235), the China-based biotech firm, has initiated patent infringement proceedings against two generics manufacturers: Switzerland’s Sandoz Inc. (OTCMKTS: SDZNY) and U.S.-based MSN Pharmaceuticals. This legal action follows notifications received from both companies regarding their Abbreviated New Drug Applications (ANDAs) submitted to the U.S.…
