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RemeGen’s Telitacicept Receives Priority Review Status from China’s CDE for gMG Treatment
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another market filing for its drug telitacicept with priority review status. The filing seeks approval for the treatment of generalized myasthenia gravis (gMG), a serious…
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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 75.6% Revenue Surge in H1 2024, Driven by Key Product Sales
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RemeGen (HKG: 9995) has reported a robust performance in its first half of 2024, achieving revenues of RMB 742 million (USD 103.9 million), marking a significant 75.59% increase year-on-year. This growth was primarily fueled by heightened sales of its flagship products, telitacicept and disitamab vedotin. The company’s research and development…
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RemeGen Appoints He Ruyi as Chief Strategy Officer, Transitioning from CMO Role
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has appointed He Ruyi as its new Chief Strategy Officer, a role that marks his transition from Chief Medical Officer (CMO). He will continue to serve as a director of the company. Dr. He Ruyi holds a Bachelor’s degree in Medicine and a…
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RemeGen Scales Back Private Placement to Fund New Drug R&D
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has revised its private placement plan, reducing the funds raised from the initially disclosed RMB 2.55 billion in June to RMB 1.953 billion. The capital will be directed towards the research and development of new drugs, bolstering the company’s pipeline which…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
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Kanghong Pharmaceutical’s Lumitin Approved in Myanmar for Neovascular AMD Treatment
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received marketing approval in Myanmar for its product Lumitin (conbercept) for the treatment of neovascular age-related macular degeneration (nAMD). Lumitin, a fusion protein of VEGF receptor and human immunoglobulin Fc segment, is a…
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RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
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RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
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RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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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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RemeGen’s Q1 2024 Revenues Surge 96.41% YOY, R&D Spending Outpaces Income
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China-based pharmaceutical company RemeGen (HKG: 9995) has reported its financial results for the first quarter of 2024, with revenues reaching RMB 330 million (USD 45.54 million) for the three-month period, marking a significant increase of 96.41% year-on-year (YOY). However, the company recorded net losses of RMB 349 million (USD 48.2…
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RemeGen Plans RMB 2.55 Billion Private Placement to Fund Innovative Drug Development
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China-based RemeGen (HKG: 9995) has announced plans to raise RMB 2.55 billion (approximately USD 280.5 million) through a private placement. The funds will be directed towards supporting clinical studies and the development of innovative therapies, including candidates RC18, RC48, RC28, RC88, RC148, and RC198. With a robust product portfolio featuring…
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RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the…
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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’s Telitacicept Secures FDA Approval for Global Phase III Study in Primary Sjogren’s Syndrome
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RemeGen (HKG: 9995), a China-based pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to proceed with a global multi-center Phase III clinical study for its fusion protein drug telitacicept in the treatment of active primary Sjogren’s syndrome (pSS). This 48-week, multi-center, randomized, double-blinded, placebo-controlled Phase…
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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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Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
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China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of…
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RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
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RemeGen and Akeso Biopharma Initiate Phase II Study for Gastric Cancer Combo Therapy
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China-based RemeGen Ltd (HKG: 9995) is poised to conduct a Phase II clinical study in collaboration with fellow Chinese firm Akeso Biopharma (HKG: 9926). The study will assess the combination of RemeGen’s antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), with Akeso’s bispecific antibody, cadonilimab (AK104), for the treatment of gastric…
