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SciClone Pharmaceuticals Licenses Eisai’s Tasurgratinib for China
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China-based SciClone Pharmaceuticals Inc. announced a licensing agreement with Eisai Co., Ltd (TYO: 4523), securing exclusive development and commercialization rights to the Japanese firm’s tasurgratinib succinate (E7090) in China. Drug ProfileTasurgratinib, an orally available selective inhibitor of FGFR 1-3, was approved in Japan in September of last year. It is…
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SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
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China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical Products Administration (NMPA). The approval allows its Vibativ (telavancin) to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by sensitive isolates of Staphylococcus aureus. Drug DetailsVibativ is a rapidly bactericidal glycopeptide antibiotic with bactericidal activity…
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SciClone and Menarini Submit NDA for Vaborem in China
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China-based SciClone Pharmaceuticals Inc and its Italy-based strategic partner Menarini have announced the submission of a New Drug Application (NDA) for Vaborem (meropenem vaborbactam) to the National Medical Products Administration (NMPA). The sought-after indication is complex urinary tract infections, including pyelonephritis. This submission marks a significant step in making this…
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Shanghai Pharmaceutical Co., Ltd Secures Multiple Partnerships at CIIE
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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SciClone Pharmaceuticals Gets NMPA Approval for Phase III Study of First-in-Class SERD Orserdu
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SciClone Pharmaceuticals Inc. (HKG: 6600), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III bridging study for its drug Orserdu (elacestrant), the world’s first selective estrogen receptor degrader (SERD) originally developed by Eisai. The Phase III study, which is randomized,…
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GL Capital and SciClone Pharmaceuticals Agree to Privatization and Delisting
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GL Capital and SciClone Pharmaceuticals Inc (HKG: 6600) have jointly announced an agreement to privatize the Chinese firm and delist it from the Hong Kong Stock Exchange. SciClone, an integrated biopharmaceutical company, is engaged in both product development and commercialization with a focus on oncology and severe infections. The company’s…
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SciClone and Menarini File for Import License of Antibacterial Drug Vaborem in Macau
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that its Italy-based strategic partner Menarini has submitted an import drug pre-license filing for Vaborem (meropenem vaborbactam) in Macau. The company is seeking regulatory approval for the new antibacterial drug to treat complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and complicated complex urinary…
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SciClone Pharmaceuticals Teams Up with SPH Health and Hi Dr to Launch Internet Hospital in China
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SciClone Pharmaceuticals Inc., (HKG: 6600), a prominent player in China’s pharmaceutical industry, has joined forces with SPH Health Commerce Co., Ltd and Hi Dr to establish an Internet hospital. The tripartite partnership aims to leverage digital healthcare solutions, although no financial details of the agreement have been disclosed. SciClone, known…
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SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
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SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer. Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO:…
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SciClone Pharmaceuticals Secures Exclusive Rights to Menarini Group’s Orserdu in China
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China’s SciClone Pharmaceuticals Inc., (HKG: 6600) has entered into a licensing and cooperation agreement with the Italy-headquartered Menarini Group. This agreement grants SciClone exclusive development and commercialization rights to Menarini’s Orserdu (elacestrant) in China. SciClone will be responsible for conducting clinical trials, regulatory filings, and marketing and distribution of Orserdu…
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SciClone Pharmaceuticals Partners with Shanghai Pharmaceutical and Menarini Group
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China’s SciClone Pharmaceuticals Inc. (HKG: 6600) has entered into a collaborative agreement with Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) and Italy-headquartered Menarini Group. While specific details of the partnership remain undisclosed, this alliance marks a significant step for all parties involved. Focus on Oncology and Infectious Diseases SciClone is dedicated…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
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SciClone Pharmaceuticals’ Danyelza Officially Launched in China for Neuroblastoma Treatment
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) has reached a significant milestone with the first prescription of Danyelza (naxitamab) in China, signifying its official commercial launch. Danyelza, a GD2-targeted monoclonal antibody, was originally developed by Y-mAbs Therapeutics Inc. and was fast-tracked for marketing approval in China in November 2020. Licensing Agreement and…
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SciClone Pharmaceuticals’ Vaborem Approved for Phase III Clinical Trial in China
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that a clinical trial filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been approved by the National Medical Products Administration (NMPA). This approval allows the drug to enter a Phase III clinical study in China. Study Objectives and DesignThe Phase…
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SciClone Partners with Cowell Health to Enhance Cancer Treatment Accessibility
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has struck a partnership with Cowell Health, Hillhouse Capital’s healthcare-focused wholly-owned subsidiary. The collaboration aims to enhance the accessibility and affordability of high-quality drugs and services, explore a new full-course management model for cancer patients,…
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SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
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SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative…
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SciClone Pharmaceuticals’ Vaborem IND Filing Accepted by NMPA
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SciClone Pharmaceuticals Inc (HKG: 6600) has announced that an Investigational New Drug (IND) filing for its Vaborem (meropenem vaborbactam), a new antibacterial drug, has been accepted for review by the National Medical Products Administration (NMPA). The IND application covers a Phase III clinical study to evaluate the efficacy and safety…
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SciClone’s Danyelza Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs…
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SciClone Pharmaceuticals Reports 10.8% Revenue Growth in 2022 Interim Results
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SciClone Pharmaceuticals Inc., formerly a US-based and Nasdaq-listed company that became China-based after going private in 2017, has released its 2022 interim report. The company generated RMB 1.475 billion ($204.2 million) in revenues during the first half of this year, up 10.8% year-on-year (YOY). Operating profits grew by 8.4% YOY…
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SciClone Pharmaceuticals Doses First Patient in RRx-001 Phase III Study for SCLC
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China-based SciClone Pharmaceuticals Inc. (Nasdaq: SCLN) announced that the first patient has been dosed in the Phase III regulatory REPLATINUM study in China for its RRx-001, a next-generation small-molecule immunotherapy targeting CD47/SIRPα (signal-regulatory protein alpha). The drug, in-licensed from US firm EpicentRx Inc. in July 2020, is being evaluated as…
