Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
Australians with mantle cell lymphoma (MCL) will now have subsidized access to Beigene Ltd.’s BTK inhibitor, Brukinsa (zanubrutinib), as of March 1, marking the company’s first drug to be listed on Australia’s Prescription Benefits Scheme (PBS). Read More
Everest Medicines Ltd. has acquired rights to develop and commercialize Nefecon (budesonide) for the treatment of primary IgA nephropathy in South Korea from Calliditas Therapeutics AB. Read More
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd. Read More
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China. Read More
Inxmed Co. Ltd. has raised $50 million in a series B round to support clinical trials of its lead candidate, IN-10018, for the treatment of multiple cancers in both the U.S. and China. Inxmed plans to use the funds to invest in trials of IN-10018, bring more stroma-targeting candidates into clinic trials, and improve the firm’s R&D capabilities. Read More
Salubris Biotherapeutics Inc. has raised $32 million in financing from its parent company, Shenzhen Salubris Pharmaceuticals Co. Ltd., for the development of its cardiovascular candidate. Funds will be used to continue efforts in an ongoing phase Ib trial and to initiate two additional phase Ib studies in 2022, as well as to expand the company’s pipeline. Read More
Bridge Biotherapeutics Inc. has signed an exclusive option-to-license agreement for Cellionbiomed Inc.’s preclinical ion channel modulator, BBT-301, thus adding a second idiopathic pulmonary fibrosis (IPF) candidate to its fibrotic diseases portfolio. The company hopes to enter the clinic with the drug in the U.S. by the end of 2022.
Nec Corp. has acquired all of Vaximm AG’s neoantigen program assets. Tokyo-based Nec will conduct the acquisition via its subsidiary, Nec Oncoimmunity AS.
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year. Read More
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA). Read More
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Chimeric, Eucure, Gan & Lee, Geovax Labs, Incannex, Kintor, Moderna, Noxopharm, Pfizer, Prestige, Recce, Taiwan Liposome, Telix, Transcenta. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aeterna Zentaris, Altamira, Angiotensin, Ascletis, Bridge, Calliditas, Cellionbiomed, Cipher, Depymed, Elixirgen, Everest Medicines, Immunoprecise Antibodies, Insilico Medicine, KBI, Moderna, Nuclixbio, Oragenics, Pharmabcine, Prestige, Sun, Taisho. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Akeso, Altamira, Antengene, Bayer, Beigene, Biogen, Immunome, Immutep, Orion, Pharmazz, Samsung Bioepis, Sanbio, SCG Cell Therapy, Valneva. Read More
