China’s National Medical Products Administration (NMPA) has issued a guidance for human factors engineering (HFE) of medical devices, a document that by some accounts aligns fairly well with guidance from the U.S. FDA. However, Yvonne Limpens, manager of the human factors program at Emergo by UL, said NMPA may push for domestic HFE testing on imported devices because of a perception that device usability may be different in China than in other nations, thus adding to the cost of doing business in the world’s second most populous nation.
Suzhou, China-based Kintor Pharmaceutical Ltd. reported positive findings from a phase II study of GT-20029, a topical therapy for male androgenetic alopecia, on April 21 – boosting both the company’s stock and its chances of a late-stage clinical study in China and the U.S.
Genfleet Therapeutics Inc. has entered the KRAS G12C inhibitor race in the U.S. as it gears up to begin phase III trials of GFH-925 (IBI-351) in patients with refractory metastatic colorectal cancer (CRC) following FDA clearance. GFH-925 was the first KRAS G12C inhibitor to receive breakthrough therapy designation from China's National Medical Products Administration for previously treated advanced CRC.
China’s CAR T market is expected to grow from $72 million in 2022 to $342 million over the next decade. There are currently more than 400 CAR T therapies in the pipeline in China, and most of these are being developed by specialized Chinese biotechs. Research by Clarivate plc, BioWorld’s parent company, indicates that a notable proportion of CAR T-cell therapies in late-phase development in China are being developed through strategic partnerships and joint ventures between multinational corporations and domestic companies, including Johnson & Johnson and Nanjing Legend Biotech Corp., Juno Therapeutics Inc. and Wuxi Apptec Co. Ltd., and CASI Pharmaceuticals Inc. and Juventas Cell Therapy Ltd.
China’s National Medical Products Administration has cleared Immuneonco Biopharmaceuticals Co. Ltd.’s’ IMM-01 (timdarpacept) to enter a pivotal phase III trial in combination with Beigene Co. Ltd.’s PD-1 inhibitor, tislelizumab, in relapsed or refractory classical Hodgkin lymphoma patients who relapsed or progressed after treatment with PD-1 inhibitors.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
Sino Biopharmaceutical Ltd. and Boehringer Ingelheim International GmbH are partnering to develop innovative cancer therapies in mainland China. They will jointly develop and commercialize three clinical Boehringer assets, including brigimadlin, zongertinib, BI-764532, and other unnamed early stage assets.