China’s ongoing efforts to tighten regulations across the board is hitting medical device companies. Two companies that issued shares in Hong Kong for the first time over the past week saw their shares tumble right out of the gate. Acotec Scientific Holdings Ltd. (HK: 6669) shares fell more than 25% on their first trading day on the Hong Kong Stock Exchange on Aug. 24 amid regulatory changes in China’s health care industry.
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA. The development marks the first oncolytic viral candidate developed by a Chinese company to win a go-ahead for trials abroad, it said.
Beyondspring Inc. and Jiangsu Hengrui Pharmaceuticals Co. Ltd. entered a ¥1.3 billion (US$200 million) deal to commercialize and co-develop the former’s selective immunomodulating microtubule-binding agent plinabulin in greater China.
Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day.
Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs.
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector.
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.
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