Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research. Read More
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system. Read More
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. Read More
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment. Read More
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint. Read More
Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Read More
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax. Read More
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23. Read More
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA.
After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs). Read More
Innovent Biologics Inc. has acquired exclusive rights to commercialize Eli Lilly and Co.’s oncology drugs Cyramza (ramucirumab) and Retsevmo (selpercatinib) in mainland China, where it will be responsible for the pricing, importation, marketing, distribution and sales of the two products. Read More
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout. Read More
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works. Read More
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer. Read More
New hires and promotions in the biopharma industry in Asia-Pacific, including: Laekna Therapeutics Shanghai, Mesoblast, Orum, Shouti, Sosei Group. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Aptatargets, Canbridge, Carsgen, Clarity, Icosavax, Moderna, Novavax, Ribomic, Servatus, Telix, Urovant Sciences, Vivavision, Windtree, Zai Lab. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Abionyx, Apirx, Biondvax, Bristol Myers Squibb, Chugai, Eqrx, Halozyme, Incannex Healthcare, Insilico Medicine, Moderna, Oragenics, Pfizer, Phylex, Transcenta, Vaxxas. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ascentage, Astrazeneca, Cansino Biologics, Eli Lilly, Henlius, Innovent, Kyowa Kirin, Mei, Neuren, Novavax, Takeda, Xcovery. Read More
