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CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational antibody-drug conjugate (ADC) SYS6040. The trial will focus on evaluating the safety and efficacy of SYS6040 in patients with advanced solid tumors. Promising Pre-Clinical…
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Elevation Oncology Halts EO-3021 Development After Poor Phase 1 Data
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US-based Elevation Oncology, Inc. (NASDAQ: ELEV) has announced the decision to terminate development of EO-3021 following disappointing Phase 1 data, which caused its stock price to plummet 41% before trading. EO-3021’s Background and Licensing DealEO-3021, a Claudin 18.2-targeted antibody drug conjugate (ADC) originated by China’s CSPC Pharmaceutical Group Ltd (HKG:…
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Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. Drug…
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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
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CSPC Pharma’s JMT108 Receives NMPA Clinical Approval for Advanced Malignant Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced clinical approval from the National Medical Products Administration (NMPA) for JMT108, an anti-PD-1/IL-15 bi-functional fusion protein. The targeted indication for this novel therapy is advanced malignant tumors, marking a significant step forward in the development of innovative cancer treatments in China.…
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CSPC Pharmaceutical’s Sirolimus Receives BTD for Malignant PEComa Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its sirolimus (albumin-bound) as a monotherapy for malignant perivascular epithelioid cell tumor (PEComa). Drug ProfileSirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor.…
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CSPC Pharmaceutical Initiates Phase III Trial for Ammuxetine in Depression Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced the start of a Phase III clinical trial for its Category 1 chemical drug ammuxetine at the Shanghai Mental Health Center, a top-tier Class 3A mental hospital. Drug ProfileAmmuxetine, a small molecule SNR inhibitor discovered by the Chinese Academy of Military Medical…
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CSPC Pharma Licenses SYS 6005 to Radiance Biopharma for Global Markets
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced a licensing agreement with Radiance Biopharma, Inc., granting the US firm exclusive development and commercialization rights to its SYS 6005 in multiple countries, including the United States, European Union, United Kingdom, Switzerland, Australia, and Canada. Deal TermsUnder the agreement, CSPC Pharma will…
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CSPC Pharmaceutical’s SYH2039 Wins FDA Clinical Approval for Advanced Tumors
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China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has approved clinical trials for its Category 1 chemical drug candidate SYH2039, a selective phosphodiesterase 4B (PDE4B) inhibitor, for advanced malignant tumors. The drug is also under study in China for interstitial lung diseases.…
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CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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CSPC Pharmaceutical’s mRNA Vaccine SYS6017 Gains NMPA Approval for Herpes Zoster Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its mRNA vaccine SYS6017. The trial will focus on herpes zoster, a painful condition caused by the reactivation of the varicella zoster virus (VZV).…
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Alphamab and CSPC Gain NMPA Approval for JSKN003 Phase III Trial in HER2-Positive Breast Cancer
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Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in…
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CSPC’s SYS 6043 Receives FDA Approval for Clinical Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its in-house developed SYS 6043 has obtained clinical trial approval from the US Food and Drug Administration (FDA). This approval marks a significant step forward in the development of innovative treatments for advanced/metastatic solid tumors. Clinical Trial Scope and ObjectivesThe…
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CSPC’s Prusogliptin Approved in China for Type 2 Diabetes Treatment
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China’s National Medical Products Administration (NMPA) has granted marketing approval to CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) for its drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The approval is for the drug’s use in improving blood sugar control among adult patients with type 2 diabetes (T2D). Mechanism of ActionPrusogliptin…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
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10th National VBP Round Results Announced: Contracts Worth Over RMB1.3 Billion
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The national Volume-Based Procurement (VBP) authorities have released comprehensive details regarding the 10th VBP round, including volumes and regions awarded to winning bidders. According to Fineline Info & Tech‘s calculations, the full round, covering 196 companies with winning bids, was valued at over RMB1.3 billion (USD 178 million) in contracts.…
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CSPC Pharmaceutical Group Receives NMPA Approval for SYH9016 Clinical Study in Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its GnRH receptor agonist, SYH9016, in the treatment of solid tumors. SYH9016: A Modified Leuprorelin Product for Solid TumorsSYH9016 is a novel modified…
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Sichuan Biokin’s BL-M08D1 and CSPC’s SYS6010 Eye Breakthrough Therapy Designations in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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CSPC Pharmaceutical’s SYH2062 Receives NMPA Clearance for Hypertension Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, SYH2062. SYH2062: A Novel siRNA Therapy for HypertensionSYH2062 is an N-acetyl-galactosamine (GalNAc)-conjugated small interfering RNA (siRNA) that targets the inhibition of…
