Shenzhen Xzing Technology Co. Ltd.’s Endofresh disposable upper gastrointestinal (GI) endoscope has granted the NMPA’s class II approval. The company said the approved product is used for upper gastrointestinal GI endoscopy, diagnosis and treatment.
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs).
Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd., a company developing an oral a urate anion exchanger 1 inhibitor for the potential treatment of chronic gout, said results of a phase IIa trial show that its lead candidate, ABP-671, reduced serum uric acid levels to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL for hyperuricemia, or excess of uric acid in the blood, which leads to gout.
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.
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