Bharat Biotech International Ltd. has successfully developed India’s first indigenous vaccine candidate for COVID-19 to enter human trials. Named Covaxin, the vaccine has been cleared by the Drug Controller General of India (DCGI) and Ministry of Health & Family Welfare for phase I and II trials after the company submitted positive preclinical study results regarding safety and immune response.
BEIJING – China this week approved both the country’s first mRNA vaccine candidate and its first recombinant protein subunit vaccine to begin clinical trials to fight COVID-19. China National Biotec Group (CNBG)’s vaccine is also entering phase III trials in Beijing, Wuhan and Abu Dhabi, the United Arab Emirates (UAE).
PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is gearing up to take its Cymerus mesenchymal stem cell (MSC) product candidate, CYP-004, into a phase III trial in osteoarthritis.
BEIJING – Chinese state-backed vaccine developer China National Biotec Group (CNBG), of Beijing, said on June 16 that its inactivated COVID-19 vaccine candidate produced a seroconversion rate of up to 100% in a phase I/II trial that enrolled 1,120 healthy subjects.
BEIJING – Suzhou, China-based Ascentage Pharma Group Inc. said on June 22 that it is working with Astrazeneca plc’s hematology R&D unit, Acerta Pharma, to develop a combination therapy of its Bcl-2 inhibitor, APG-2575, with Acerta's BTK inhibitor, Calquence (acalabrutinib). The first patient has been dosed in the U.S.
HONG KONG – Astellas Pharma Inc. reported positive results from phase III of its DOLOMITES study comparing the efficacy and safety of roxadustat to that of darbepoetin alfa in treating anemia in nondialysis-dependent, stage 3 to 5 chronic kidney disease (CKD) patients.
PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME).
HONG KONG – Takeda Pharmaceutical Co. Ltd. is preparing to take Takhzyro (lanadelumab) to the world stage after announcing its interim results for a phase III hereditary angioedema long-term prophylaxis (HELP) study.
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.