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RemeGen’s 2024 Revenue Soars 58.54% on Strong Product Sales and R&D Growth
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China-based biotech RemeGen Co., Ltd (HKG: 9995, SHA: 688331) released its 2024 financial report, recording RMB 1.717 billion (USD 236.3 million) in revenues, a 58.54% year-on-year (YOY) increase. Product sales reached RMB 1.699 billion (USD 233.9 million), up 61.9% YOY. The annual loss decreased by 2.8% YOY to RMB 1.468…
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RemeGen’s Taitaxipu Receives CDE Acceptance for New Indication Application in China
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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a new indication application for its Claudin18.2-targeted antibody, Taitaxipu (Telitacicept), in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. This…
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RemeGen Reports 40% Revenue Growth in 2023, but Net Losses Widen Amid Pipeline Investments
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RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a China-based biotech firm, has unveiled its 2023 financial results, reporting revenues of RMB 1.083 billion (USD 150 million), reflecting a 40.26% year-on-year increase. This growth was primarily driven by its core products: the fusion protein drug telitacicept and the HER2-targeted antibody drug…
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RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
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RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
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RemeGen Secures Fast-Track Designation for RC88 in Platinum-Resistant Ovarian Cancer
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China-based biotech RemeGen Co., Ltd (HKG: 9995; SHA: 688331) has received fast-track designation (FTD) from the US FDA for its pipeline candidate RC88, a mesothelin (MSLN)-targeted antibody-drug conjugate (ADC). This designation recognizes RC88’s potential as a treatment for platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. Developed in-house,…
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RemeGen Ltd Receives FDA Clearance for MSLN-Targeting ADC RC88 in Gynecological Tumors
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) RC88, which targets mesothelin (MSLN) in gynecological tumors. This approval paves the way for global multi-center Phase II clinical trials to…
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RemeGen’s Telitacicept Shows Positive Phase III Results in Rheumatoid Arthritis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced positive results from the China Phase III clinical study for its telitacicept in the treatment of rheumatoid arthritis (RA). Following these results, the company has submitted a supplementary New Drug Application (sNDA) to the Center for Drug Evaluation (CDE). Previously,…
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RemeGen Ltd Reports 20.56% YOY Revenue Growth in H1 2023 Financial Results
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has released its financial report for the first half of 2023, recording revenues of RMB 422 million, an increase of 20.56% year-on-year (YOY). The company has also ramped up its research and development (R&D) costs to RMB 540 million, marking a 20.19% YOY…
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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of…
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RemeGen’s Telitacicept Set for Breakthrough Therapy Designation in Myasthenia Gravis
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The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune…
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RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles. Study Design and ResultsThe multicenter,…
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RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
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China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD) status from the US FDA for its fusion protein drug telitacicept in myasthenia gravis (MG). This designation highlights the potential of telitacicept in treating this rare and chronic autoimmune disease. The drug previously concluded a…
