HONG KONG – The revisions for China’s Regulations for Supervision and Administration of Medical Devices, which promise harsher penalties and post-market enforcements, will come into effect on June 1, 2021. The revisions see authorities take a more progressive and aggressive approach to the regulatory enforcement of medical device products in China.
Beigene Ltd.’s PARP inhibitor, pamiparib, won conditional approval from China’s National Medical Products Administration for treating patients with germline BRCA mutation-associated recurrent advanced ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
To encourage more innovative medical devices to enter the market faster, China has revised its regulation to allow third parties to manufacture devices, foreign devices that are not yet approved overseas to be imported to the country, and to shorten the regulatory process. The new regulation will take effect on June 1. The 2021 version of the Regulation on Supervision and Administration of Medical Devices introduced a few important changes, echoing Beijing’s call to spur health care innovation. The last update was in 2014.
Since joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2017, China has approved clinical trials and marketing of drugs a lot faster with simultaneous clinical development at home and abroad, according to China’s National Medical Products Administration officials in a webinar on April 29.
HONG KONG – As it advances into its first full year of commercialization in China, Zai Lab Ltd. raised $857.5 million through the sale of American depositary shares (ADS) and ordinary shares, exceeding its initial aim of $750 million.
HONG KONG – Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $591 million, gaining global rights to develop, manufacture and commercialize gene therapy candidates from Logicbio Therapeutics Inc. for the treatment of Fabry and Pompe diseases. The candidates are based on Logicbio’s adeno-associated virus (AAV) sL65, the first produced from its Saavy capsid development platform.
Cross-border startup Adcentrx Therapeutics Inc., with operations in San Diego and soon in Shanghai, secured $50 million in a series A financing round led by CBC Group to establish its presence in the antibody-drug conjugate (ADC) space.
To honor its part for phase one of the U.S.-China trade deal, China has revised its patent law to establish a drug patent linkage system and provide compensation for lost patent terms.
To honor its part for phase one of the U.S.-China trade deal, China has revised its patent law to establish a drug patent linkage system and provide compensation for lost patent terms, similar to procedures under the U.S. Hatch-Waxman Act. Effective June 1, the new patent law is expected to drive biotech innovation and welcome more foreign drugs to the China market.
HONG KONG – As it advances into its first full year of commercialization in China, Zai Lab Ltd. raised $857.5 million through the sale of American depositary shares (ADS) and ordinary shares, exceeding its initial aim of $750 million. “We continue to execute with speed and excellence across all areas of our platform,” Samantha Du, the CEO of Zai Lab, told BioWorld. That includes business development, clinical development – “we currently have 40-plus ongoing and planned trials this year” – along with commercial expansion and global pipeline advancement.
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