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, according to China’s National Medical Products Administration officials in a webinar on April 29.
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.
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.
HONG KONG – Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $581 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.
HONG KONG – Beijing Stonewise Technology Co. Ltd., a med-tech firm that uses artificial intelligence (AI) to aid in the discovery of small molecule drugs, closed series B and B+ financing rounds that added $100 million to its pocket. The company intends to use the proceeds to upgrade its AI-enabled drug discovery platform.
Cross-border startup Scineuro Pharmaceuticals Ltd., which focuses on central nervous system (CNS) diseases, inked a deal with Eli Lilly and Co. to license in the greater China rights of alpha-synuclein-targeted antibody therapies to follow the global drug development trend in this space.
Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.