Nuance Pharma Co. Ltd. signed a licensing deal with Denmark’s Bavarian Nordic A/S for rights to its MVA-BN RSV vaccine for respiratory syncytial virus (RSV) in the Chinese mainland, Hong Kong, Macau, Taiwan, South Korea and certain Southeast Asian countries. Shanghai-based Nuance plans to run its own phase I and phase III trials in China to support regulatory approval of MVA-BN RSV in China, which will be conducted separately from Bavarian Nordic's own phase III trial planned to begin in the first half of 2022.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23.
Edigene Inc. has obtained nonexclusive, global rights to technology from Boston Children’s Hospital for technology related to increasing fetal hemoglobin levels by disrupting B-cell lymphoma/leukemia 11A (BCL11A) expression at the genomic level to treat hemoglobinopathies.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China.
Sihuan Pharmaceutical Holdings Group Ltd.’s subsidiary Beijing Meiyan Kongjian Biology Medicine Co. Ltd. has acquired an 80% equity stake in Shenzhen Yimei Medical Technology Co. The deal is to be completed via a mix of capital and equity transfers. Sihuan Pharmaceutical is interested in Shenzhen Yimei’s two-in-one patented technology of collimated ultrasound and superficial focused ultrasound.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform Beijing Meiyan Kongjian Biology Medicine Co. Ltd. The certification is for three scar repair products, four medical dressing and patch products, as well as three skin repair products.
Edigene Inc. has obtained nonexclusive, global rights to technology from Boston Children’s Hospital for technology related to increasing fetal hemoglobin levels by disrupting B-cell lymphoma/leukemia 11A (BCL11A) expression at the genomic level to treat hemoglobinopathies.
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China. Though already approved for several indications, they’re seeking to position it as a first-line treatment of advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). The final data largely confirmed interim findings from the study, first reported in August 2021.
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