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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
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Acotec Scientific Receives NMPA Approval for Innovative Cardiovascular Devices
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for two of its innovative products: the coronary hypertension balloon dilation catheter wing extension and the microcatheter Vericor-RS. The coronary…
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Sanofi Launches KiDS Program in China to Boost Health Literacy in Schools
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Olivier Charmeil, Executive Vice-President for General Medicines at France-based Sanofi S.A. (NASDAQ: SNY), visited China this week to launch KiDS (Kids & Diabetes in Schools), a program aimed at enhancing health literacy in school environments. Charmeil, who previously served as Sanofi’s China region head, also spoke to local media platform…
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WuXi Bio Reports 2023 Revenue Growth Amid COVID-19 Business Loss and Geopolitical Tensions
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WuXi Bio (HKG: 2269), a leading Contract Research, Development, and Manufacturing Organization (CRDMO) based in China, has released its financial report for 2023, showing a year-on-year (YOY) increase of 11.6% in revenues to RMB 17,034.3 billion (USD 2.35 billion). The company’s net profits reached RMB 3.57 billion (USD 495 million),…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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NMPA Mandates Electronic Permits for Anesthetic Drugs and Psychotropic Substances
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The National Medical Products Administration (NMPA) has issued a new notification aimed at enhancing the management of import and export licenses for anesthetic drugs and psychotropic substances. Effective immediately, applicants for such permits are required to submit their application materials and supplementary materials in electronic form, eliminating the need for…
