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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced positive high-level results from the Phase III WAYPOINT study for Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The drug, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) co-developed with US firm Amgen (NASDAQ: AMGN),…
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart…
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate, KYS202004A, in the treatment of psoriasis. KYS202004A: A Dual-Targeted Fusion Protein for PsoriasisKYS202004A is an…
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Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its therapies Darzalex Faspro (daratumumab and hyaluronidase-fihj) to the US Food and Drug Administration (FDA) and for the subcutaneous (SC) formulation of Darzalex (daratumumab) to the European Medicine Agency (EMA). The company is seeking new indication…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for a suite of drugs including HRS-2189, HRS-5041, HRS-1358, HRS-8080, SHR-8068, adebrelimab, and HRS-6209. The company is set to initiate an open, multi-center Phase…
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Alphamab Oncology (HKG: 9966), a China-based biopharmaceutical company, has announced the presentation of the latest results from the Phase I/II study of its investigational drug JSKN033 at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024). The study focuses on patients with HER2-expressing advanced or metastatic…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
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Daiichi Sankyo (TYO: 4568), a leading Japanese pharmaceutical company, has entered into a potentially $300 million agreement with South Korean biotechnology firm Alteogen to develop a subcutaneous injection version of its cancer drug Enhertu, which is also in collaboration with AstraZeneca. This innovative step aims to enhance patient accessibility and…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
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China-based gene sequencing specialist, MGI Tech Co., Ltd, (SHA: 688114) has announced a commercial collaboration with the Human Cell Atlas (HCA) consortium, marking a significant step forward in the human cell mapping initiative. This partnership aims to expand access to MGI’s proprietary products within the HCA network by offering discounted…
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has provided an update to investors regarding the status of Leon Wang, Executive Vice President International and AstraZeneca China President. The company has confirmed that Wang is currently “in detention” in China and was last reported to be “cooperating with…
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a China-based pharmaceutical company, has announced its intention to acquire 100% stakes in Xintrum Pharmaceuticals, Ltd, a biologic drug developer, for a consideration of RMB 270 million (USD 37.7 million). Upon completion of the deal, Xintrum will become a wholly owned subsidiary of…
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Ascletis Pharma Inc. (HKG: 1672), a China-based pharmaceutical company, has announced positive results from a Phase I clinical study for its drug candidate ASC47 in Australia. This in-house developed therapy is designed to facilitate weight loss without the loss of muscle mass, offering a potential new option for obesity management.…
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Nuwacell Biotechnologies Co., Ltd., a specialist in induced pluripotent stem cell (iPSC) technology based in Heifei, Anhui province, has reportedly secured RMB150 million (USD21 million) in the first closing of its Series B financing round. The funding was led by Guangzhou Industry Investment, with significant contributions from China Resources International,…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading Chinese biotech company, has entered into a strategic partnership with AL-TIRYAQ AL-KHALAWI Medical Company (SVAX), a healthcare unit owned by the prominent Fakeeh family in Saudi Arabia, during the 2024 China International Import Expo (CIIE). This collaboration aims to leverage Henlius Bio’s…
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-M17D1, in patients with advanced solid tumors. BL-M17D1’s…
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Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug, HYP-6589, which targets advanced solid tumors. HYP-6589’s Mechanism of ActionHYP-6589 is an in-house developed SOS1 small molecule…