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.
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.
HONG KONG – The Biden administration’s support for a TRIPS waiver of COVID-19 vaccine patents has already met a chorus of resistance from Western companies. In Asia, skepticism about how it would be achieved and what it will cover, is widespread.
China saw $28.5 billion invested in its life sciences sector in 2020, which was double the previous year’s amount and sets a five-year high. Partnering activities and IPOs also grew exponentially over the last five years to set records.
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 – 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.
