Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year. A self-developed dual targeted TACI-Fc fusion protein, telitacicept is the second innovative biologic to treat SLE approved in China. Read More
Kintor Pharmaceutical Ltd. said its androgen receptor (AR) antagonist, proxalutamide, reduced mortality risk by 92% and shortened median hospital length stay by nine days vs. standard of care, based on a preliminary analysis of phase III data from 590 hospitalized COVID-19 patients in Brazil. The company expects to have final data ready by the end of this month or early April, Chief Financial Officer Lucy Lu told BioWorld. Read More
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease. Read More
Chinese eye disease specialist Arctic Vision Biotechnology Co. Ltd. raised more than $100 million in a series B financing round. The clinical-stage company will use the funds to initiate a phase III trial for its core asset, ARVN-001 (triamcinolone acetonide suprachoroidal injectable suspension), for uveitic macular edema in China this year. Read More
HONG KONG – Privately held Wugen Inc. of St. Louis has inked an exclusive deal with Shanghai-based Alpha Biopharma Ltd. to manufacture, develop and commercialize allogeneic cell products in Asia. Read More
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization Director-General Ngozi Okonjo-Iweala said at the Global C19 Vaccine Supply Chain and Manufacturing Summit. Read More
After working 24/7 to develop a COVID-19 vaccine in a historic timeframe and scale up manufacturing at an unprecedented rate, some vaccine manufacturers are now facing what appears to be a concerted Russian misinformation campaign akin to those used in the last two U.S. presidential campaigns. Read More
A large-scale metabolomics study of blood samples from 11,000 people has identified common biological links among a number of chronic non-communicable diseases, opening up the possibility of countering multiple diseases simultaneously. Read More
In the “The World for Asia, Asia for the World” panel discussion at the virtual Wuxi Healthcare Forum, investors and executives took note of the region’s digital capabilities for reducing R&D costs and timelines, while also calling for more harmonization on the regulatory front to empower R&D in Asia. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Affibody, Alphamab, Astellas, Eisai, Eli Lilly, Huya, Inmagene, Johnson & Johnson, Melior, Pharmaessentia, RDIF, Takeda. Read More
