CStone announced new drug approval of precision therapy AYVAKIT® (avapritinib) in Hong Kong, China for the treatment of PDGFRA D842V mutant gastrointestinal stromal tumors (GIST)
AYVAKIT is the first precision therapy approved in Hong Kong, China for the treatment of patients with PDGFRA D842V mutant GIST This is CStone's fifth NDA approval in Greater China this year SUZHOU, China, Dec. 28, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative...
Lunit Obtains MDSAP Certificate, Granted Fast-Track Regulatory Process in Major Countries
Lunit meets MDSAP requirements as a global standard medical AI software manufacturer QMS audit exemption in the US, Canada, Japan, Australia, and Brazil SEOUL, South Korea, Dec. 27, 2021 /PRNewswire/ -- Lunit, a leading AI software company for cancer screening and treatment, announced it has obtained MDSAP (Medical Device...
ChemRar Group announces the Russian Avifavir® drug is effective against variants of COVID-19, including Delta and Omicron
Avifavir® is effective against various variants of coronavirus, including Delta and Omicron, as it affects the highly conservative and mutation-resistant replication systems of RNA virus (RdRp). The virus is incapable of developing resistance to favipiravir even with long-term exposure on infected cells, as has been confirmed in clinical trials. This provides Avifavir®...
I-Mab Announces IND Approval from China NMPA for Phase 2 Clinical Trial of Enoblituzumab in Combination with Pembrolizumab in Solid Tumors
SHANGHAI and GAITHERSBURG, Md., Dec. 27, 2021 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved I-Mab's IND submission for the initiation of...
Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19
SUZHOU, China, Dec. 27, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection (NCT04870606). Statistical criteria were not met at an interim analysis of the phase III outpatient study, designed for...
Brii Bio Doses First Patient in Phase 2a/2b Clinical Trial of BRII-179 (VBI-2601) for the Functional Cure of Chronic Hepatitis B
DURHAM, N.C. and BEIJING, Dec. 27, 2021 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, has dosed the first patient in a Phase 2a/2b clinical trial for BRII-179 (VBI-2601) in...
Documentary Zhong Nanshan/ZNS Aired on Discovery Channel in Southeast Asia
GUANGZHOU, China, Dec. 27, 2021 /PRNewswire/ -- On December 28, 2021, the single-episode character documentary Zhong Nanshan/ZNS, jointly produced by Guangdong Radio and Television and the pioneering global entertainment document provider, Discovery Inc., was broadcast on Discovery Channel in Southeast Asia. With a unique perspective and an audience-friendly approach, the documentary demonstrated to the international audience how a character...
Innovent Announces NMPA of China Acceptance of a Supplemental New Drug Application for TYVYT® (Sintilimab Injection plus Bevacizumab Biosimilar Injection and Chemotherapy in Patients with EGFR-mutated Non-squamous Non-small Cell...
SAN FRANCISCO and SUZHOU, China, Dec. 24, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for...
Laekna Presents Vision and Strategy at NewYorkBIO/NYSE Emerging Company Showcase
SHANGHAI and WARREN, N.J., Dec. 24, 2021 /PRNewswire/ -- Laekna was invited by NewYorkBIO and the New York Stock Exchange (NYSE) to present, as an emerging biotech company at the "Emerging Company Showcase" that was held earlier this month in New York. Dr. Guy Rosenthal, Vice President, Head of Corporate and Business Development of Laekna represented the company and spoke...
Convidecia™ Phase III Results Published in The Lancet
96.0% effective against severe disease 14 days post-vaccination for population aged 18 and above. Single-dose vaccine received approvals in at least 10 markets including China, Mexico, Ecuador, Chile, Argentina, Hungary, Kirghizstan, Pakistan, Indonesia and Malaysia. TIANJIN, China, Dec. 24, 2021 /PRNewswire/ -- CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that The Lancet published...
