Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease. Read More
Hutchmed Ltd., already listed in the U.S. and London, returned to home soil June 30 for a third IPO on the Hong Kong Stock Exchange that reaped HK$4.17 billion (US$537.2 million). The Hong Kong-based company is currently looking to score its first FDA approval to tap the U.S. market after three China approvals. Read More
Beigene Ltd. got the green light for an IPO on the Shanghai Stock Exchange’s Science and Technology Innovation Board, a specialized board known as the STAR Market, that could be worth around $3 billion. It would make Beigene the first biotech company with listings in the U.S., Hong Kong and mainland China. Read More
In a deal that could be worth up to $565 million, Simcere Pharmaceutical Group Ltd. licensed in glutaminyl cyclase inhibitor varoglutamstat (PQ-912) and monoclonal N3pE-antibody PBD-C06, which target the neurotoxic amyloid species N3pE (pGlu-Abeta), from Vivoryon Therapeutics AG to develop and commercialize for Alzheimer’s disease in greater China. Read More
Just five days after raising $105 million in a series E financing round, RNA interference therapeutics specialist Sirnaomics Inc. obtained another IND approval from the FDA for its dual-targeting small interfering RNA (siRNA) inhibitor STP-707 to start a basket study in oncology. Sirnaomics’ CEO Patrick Lu told BioWorld in an exclusive interview that an I.V. administration of STP-707 will be tested to tackle solid cancers that may have metastasized into other potential areas or tissue types in the body. Read More
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd. Read More
As life begins to return to a semblance of normal in many parts of the world, COVAX cautioned countries July 1 against adopting policies that favor specific COVID-19 vaccines. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Aditum, Amyris, Ancora, Astrazeneca, Biophytis, Clover, Codagenix, Dynavax Technologies, Endo International, Glaxosmithkline, Nant Africa, Oyster Point, PYC, Quanta, Simcere, Taisho, TLC, Vir, Vivoryon. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Biontech, Chugai, Direct Biologics, Genentech, HDT, Hutchmed, Ildong, Innocare, Innovent, Junshi, Lupin, Moderna, Pfizer, Roche, Solasia, Yiling. Read More