The death of a 6-year-old girl after receiving an experimental brain-directed gene-editing therapy at the Xinhua Hospital in Shanghai has reopened debate over how regulators should oversee first-in-human personalized gene therapies.

New drug approvals, financings and deals were seen across the Asia-Pacific biotech sector this week, with China’s National Medical Products Administration (NMPA) granting clearances to Takeda Pharmaceutical Co. Ltd.’s oral orexin receptor 2 agonist oveporexton for narcolepsy, as well as Haisco Pharmaceutical Group’s ciprocopan (HSK-39297) for paroxysmal nocturnal hemoglobinuria.

Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. said its IND application was approved in China for SKB-565, its dual-payload antibody-drug conjugate (ADC), for the treatment of advanced solid tumors.