China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.

Innocare Pharma Ltd. has signed a licensing agreement with Incyte Corp. for the exclusive rights to the monoclonal antibody Monjuvi (tafasitamab) for hematology and oncology indications in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the deal, Innocare will pay Incyte an up-front fee of $35 million, as well as up to $82.5 million in potential development, regulatory and commercial milestones and tiered royalties.

The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.

Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.

China’s NMPA has given Belief Biomed Inc. the official go-ahead to start testing its investigational gene therapy, BBM-H901, for the potential treatment of hemophilia B in the country, marking the first time an I.V. gene therapy for a rare disease has been approved in China. The company plans to advance the phase I/II trial for the candidate shortly, it said.

Pulse Medical Imaging Technology (Shanghai) Co. Ltd. has raised more than $100 million in a series C funding round to accelerate the R&D, clinical trials and commercialization of its products. “Pulse plans to use the funds to accelerate the commercialization of its fractional flow reserve (FFR) estimating systems,” Xiaojie Lin, marketing director of Pulse, told BioWorld. FFR is a method to measure blood pressure and flow within a coronary artery to check on the possibility that the stenosis impedes oxygen delivery to the heart muscle.

Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.

Cell therapy company Zhuhai Grit Biotechnology Inc. completed a series A+ financing of undisclosed value to advance its lead tumor-infiltrating lymphocyte (TIL) program, GT-101 for advanced solid tumors, into the clinic by year end while also developing other TIL candidates in its pipeline.