China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development.
Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone. “The detailed results of Orient-31 will be released in 2021, and Innovent will file for the new drug application for that indication around early 2022,” Ronnie Ede, chief financial officer and executive director at Innovent, told BioWorld.
Innovent Biologics Co. Ltd.’s phase III Orient-31 trial for sintilimab in EGFR-mutated nonsquamous non-small-cell lung cancer (nsqNSCLC) met its primary endpoint. In combination with anti-VEGF antibody Byvasda (bevacizumab biosimilar injection) and chemotherapy, the treatment improved progression-free survival vs. chemotherapy alone.
Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
Beigene Ltd., which in 2019 parlayed exclusive rights to distribute and promote Abraxane (paclitaxel) in China into more than $111 million in revenue, is contesting Celgene parent Bristol Myers Squibb Co.’s cancellation of the deal in arbitration proceedings at the International Chamber of Commerce.
Abbisko Cayman Ltd. has raised $226 million through an IPO in Hong Kong, where it launched with an initial price of HK$12.46 (US$1.60) per share. The company, doing business as Abbisko Therapeutics, plans to use about a third of the proceeds for research and development of its lead candidate, ABSK-091, as a potential treatment for multiple solid tumors.
In a deal that could be worth more than $450 million, Olix Pharmaceuticals Inc. and Hansoh Pharmaceutical Group Co. Ltd. have agreed to discover, develop, and commercialize siRNA therapeutics for various liver-based targets implicated in cardiovascular, metabolic, and other indications.
Baidu Inc.’s preclinical studies showed the mRNA vaccine sequences for COVID-19 designed using its Lineardesign algorithm outperformed the benchmark sequences designed by traditional algorithms in terms of stability, protein expression and immunogenicity. The firm teamed up with Stemirna Therapeutics Co. Ltd., which specializes in the R&D of mRNA vaccines and drugs, to test seven mRNA COVID-19 vaccine sequences designed using Lineardesign.
Oncology genomic testing company Berry Oncology Corp.’s latest research results showed promising data for its Hifi platform-based technology, its CEO Jun Zhou said during the first International Biopharma Industry Week held in Shanghai. With the Hifi liquid biopsy test, users can receive early screening of six cancers, including liver cancer, lung cancer, gastric cancer, colorectal cancer, esophageal cancer, and pancreatic cancer, with an overall sensitivity of 87.6%, specificity of 99.1%, and overall tissue of origin precision in 82% of positive cancers.
