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Home » Newsletters » BioWorld Asia

BioWorld Asia

Dec. 7, 2021

View Archived Issues
China-economy-trade.png

Prices for state covered drugs in China to be slashed by an average of 61.7%

Pharmaceutical companies in China will cut the prices for more than five dozen drugs by an average of 61.7% to get them on the latest version of the country’s National Drug Reimbursement List. The National Healthcare Security Administration released the new list on Dec. 3, 2021. The new list includes 74 new drugs, the vast majority of which are branded products without generic versions in China. Only seven of the new drugs on the list have generic versions. Read More
DNA in drug capsules, digital background

After safety troubles, Astellas signs $1.6B deal with Dyno Therapeutics to improve AAV tech

Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle. Read More
China flag and vial

Beigene’s siltuximab gets China nod for multicentric Castleman disease as firm preps $3.5B STAR Market listing

Beigene Ltd. has received approval from China’s NMPA to market Sylvant (siltuximab) for the treatment of patients with multicentric Castleman disease, including HIV-negative and human herpes virus-8-negative disease. The green light comes at a good time as the Beijing-headquartered company is preparing for a $3.5 billion listing on Shanghai’s STAR Market, its third listing. The monoclonal antibody siltuximab previously received regulatory approval in the U.S. and Europe. Read More
Stock chart, upward arrow

Neuren’s stock rockets 91% on positive phase III results for trofinetide in Rett syndrome

PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc. Read More
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Abogen raises $300M in series C+ round for COVID-19 vaccine development

Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market. Read More

Tot Biopharm’s first ADC bevacizumab gets China lung cancer approval

Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer. Read More
Stock chart with falling red arrow

Beyondspring’s CRL rattles its shares

Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency. Read More
World trade illustration

SEC finalizes rules on foreign companies

The U.S. SEC adopted final amendments Dec. 2 to its rules implementing 2020’s Holding Foreign Companies Accountable Act. Read More

Appointments and advancements for Dec. 7, 2021

New hires and promotions in the biopharma industry in Asia-Pacific, including: Anheart, Harbour Biomed. Read More

Financings for Dec. 7, 2021

Biopharmas in Asia-Pacific raising money in public or private financings: Beigene, Bone, Evive, Itabmed, Link Health. Read More

In the clinic for Nov. 30-Dec. 6, 2021

Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: AB Science, Adagene, Anji, Arca, Arch Biopartners, Astrazeneca, Betterlife, Bonus Biogroup, Daiichi Sankyo, First Wave, Hepagene, Humanigen, Hummingbird, I-Mab, Immutep, Insilico Medicine Hong Kong, Kyowa Kirin, Lintonpharm, Longeveron, Lynk, Mei, Merck, Nrx, Ose Immunotherapeutics, Pulmotect, RDIF, Revive, Ridgeback, Starpharma, Zai Lab. Read More

Other news to note for Dec. 7, 2021

Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Arcus, Cellevolve, Chinook, Cocrystal, Codiak, Engeneic, Entos, EOM, Epivax, Everest Medicines, Fusion Antibodies, GB Sciences, Geovax Labs, Glaxosmithkline, Greenlight, Gritstone, Huyabio, IAVI, Immunitybio, Immunocellular, Immunome, Inovio, Jemincare, Merck, Moderna, NLS, Noxopharm, Oragenics, Oramed, Oravax Medical, Otsuka, Pfizer, Phylex, Premas, Providence, QIMR Berghofer Medical Research Institute, Rarestone, Rhythm, RDIF, Sanofi, Sanreno, Sciwind, Shanghai Jemincare, Sinovac, Taiho, Vir. Read More

Regulatory actions for Nov. 30-Dec. 6, 2021

Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Abcellera, ABM, Alphamab, Ascletis, Beigene, Bharat, Biontech, Biotheus, Cybin, Eli Lilly, Eusa, Henlius, Iaso, Immunome, Jacobio, Janssen, Junshi, Legend, Merck, Mingmed, Nabriva, Ocugen, Pfizer, Pharmadrug, RDIF, Redhill, Roche, Tot, Tracon, Valneva. Read More

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