Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance.
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.
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.
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.
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).
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.
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.
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.
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.
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