Daewoong Pharmaceutical Ltd. has out-licensed greater China rights for its idiopathic pulmonary fibrosis (IPF) candidate, bersiporocin (DWN-2088), to CS Pharmaceuticals Ltd. in a deal worth up to $336 million. Bersiporocin is a prolyl-tRNA synthetase inhibitor being developed by Daewoong for IPF and potentially other fibrotic indications. Read More
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide). Read More
Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau. Read More
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company. Read More
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years. Read More
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022. Read More
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time. Read More
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models. Read More
Just in time for the Chinese New Year, Mabwell Bioscience Co. Ltd. announced that its U.S. subsidiary, Mabwell Therapeutics Ltd., closed a licensing deal with Disc Medicine Inc. worth up to $412 million. Read More
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease. Read More
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery. Read More
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country. Read More
Biopharmas in Asia-Pacific raising money in public or private financings: Asahi Kasei, Biolife Solution, Bristol Myers Squibb, Charles River, Harbour Biomed, HBM Alpha, Iaso, Ivexsol, Kazia. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Aculys, Alterity, Ascletis, Astellas, Beigene, Canbridge, Clinuvel, Dong-A, Dyadic, Everest Medicines, GPCR, Hangzhou Highlightll, Hepagene, Junshi, Keymed, Tevogen. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Affamed, Akeso, Astellas, Catalyst, Concert, Cytomx, Eisai, Eli Lilly, F-star, Genkore, Invox, JW, KSQ, Medigene, Nogra, Novartis, Ono, Recce, Repare, Sab, Sandoz, Senti, Sino, Summit, Sun, Torii. Read More
