India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others. Read More
China’s NMPA has approved JW Therapeutics Co. Ltd.’s relmacabtagene autoleucel, an autologous chimeric antigen receptor T (CAR T) therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. It marks the first CAR T product to be independently developed in China and approved as a category I biologic product there, as well as the sixth approved CAR T product globally. The anti-CD19 therapy, sometimes called relma-cel, will be marketed as Carteyva. Read More
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity. Read More
Innovent Biologics Inc. has inked a $312 million licensing deal for the development and commercialization of Genfleet Therapeutics Inc.’s KRAS G12C inhibitor, GFH-925, in mainland China, Hong Kong, Macau and Taiwan. Innovent also has additional option-in rights for global development and commercialization. Read More
Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function. Read More
Bristol Myers Squibb Co.’s Opdivo (nivolumab) is now the first and only immunotherapy for the first-line treatment of advanced gastric cancer in China. Read More
For the last few years, Hong Kong has been the preferred financial hub for many Chinese health care companies to go public and raise money from global investors. “Biotechnology is today the fastest-growing IPO market segment,” said Nicolas Aguzin, CEO of HKEX, during the Hong Kong Exchanges and Clearing Ltd. (HKEX) Biotech Summit 2021. Read More
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs. Read More
New hires and promotions in the biopharma industry in Asia-Pacific, including: Hummingbird, Insilico Medicine Hong Kong, Jubilant Biosys, Sumitomo Dainippon. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Bioaegis, Brickell, Celsion, Genfleet, Hebecell, Innovent Biologics, Jacobio, Oragenics, Preveceutical Medical, RDIF, Regencell, Sorrento, Voronoi. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Advaccine, Beigene, Biontech, Coherus, Cstone, Eli Lilly, Entos, Eqrx, Gloria, Harbour, Huya, Innocare, Inovio, Junshi, Ligand, Moderna, Neuren, Pfizer, Suzhou Genhouse. Read More
