Genhouse Bio Co. Ltd. closed a series A financing round to raise more than ¥200 million (US$31 million) to support phase I studies of KRAS inhibitor GH-35 and SHP2 inhibitor GH-21 in China. The startup expects to enroll patients in trials testing the two compounds in the second half of this year, CEO Wang Kuifeng told BioWorld in an exclusive interview.
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).
Genhouse Bio Co. Ltd. closed a series A financing round to raise more than ¥200 million (US$31 million) to support phase I studies of KRAS inhibitor GH-35 and SHP2 inhibitor GH-21 in China. The startup expects to enroll patients in trials testing the two compounds in the second half of this year, CEO Wang Kuifeng told BioWorld in an exclusive interview.
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept). The news sent Remegen’s share price (HKEX:9995) up 12.8% in Hong Kong on June 9.
Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature.
Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
China is making strides in cell and gene therapy, notably so with a 61% surge in the number of clinical trials in six years, a new report by Ernst & Young showed. While analysts noted the increasing innovation efforts and cross-border collaborations, concerns remain if quality will be compromised by speed.
