In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
Sciwind Biosciences Co. Ltd.’s oral ecnoglutide (XW-004) produced strong weight loss results after short-term treatments, up to a 6.8% body weight decrease in obese and overweight participants after once-daily dosing for six weeks, according to data from the first four cohorts of the phase I trial.
Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer.
Windtree Therapeutics Inc. is out-licensing China rights for phase III-ready heart failure candidate istaroxime to Lee’s Pharmaceutical Ltd. for $138 million, plus royalties. Lee’s, of Hong Kong, plans to begin a phase III study for istaroxime in acute heart failure in greater China, while Windtree, of Warrington, Pa., will conduct a global trial in cardiogenic shock, a form of sudden heart failure. Windtree reported positive phase II data in April 2022 that tested istaroxime in cardiogenic shock, which happens when the heart cannot pump enough blood and oxygen to vital organs.
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees.
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc.
Boston-based Praxis Precision Medicines Inc.’s shares rose nearly 25% on Jan. 8 after it announced a pipeline update and licensing deal for its tremor drug, ulixacaltamide (PRAX-944), with Shanghai’s Tenacia Biotechnology Co. Ltd.
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