Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.

UCB SA is divesting its mature neurology and allergy business in China, selling those products to CBC Group and Mubadala Investment Co. for $680 million so it can refocus on innovation and partnerships in China. The deal includes UCB’s manufacturing site in Zhuhai in Guangdong province.

Simcere Zaiming Pharmaceutical Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SIM-0508, a small-molecule inhibitor of DNA polymerase θ (POLθ), allowing initiation of clinical trials in locally advanced or metastatic solid tumors.

Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.

Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.

China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.

TYK Medicines Inc. made a strong debut on the main board of the Hong Kong Stock Exchange (HKSE), raising HK$579 million (US$74.32 million) to commercialize its lead compound, EGFR inhibitor TY-9591, now in pivotal trials in patients with EGFR mutation-positive lung cancer.

China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.

Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.