The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd. to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
Keymed Biosciences Inc. debuted on the Hong Kong Stock Exchange (HKSE) on July 8, raising HK$2.94 billion (US$378.48 million) in the process. The company will use the funds raised for the R&D and commercialization of key pipeline candidates.
PERTH, Australia – Amaroq Therapeutics Ltd., a spinout out of the University of Otago in Dunedin, New Zealand, has launched after securing NZ$14 million (US$9.7 million) in seed funding to develop long non-coding RNAs to treat breast, colorectal and liver cancer.
I-Mab Biopharma Co. Ltd. announced collaborations with mRNA biotech company Immorna (Hangzhou) Biotechnology Co. Ltd. and AI-enabled R&D company Neox Biotech Co. Ltd., gaining access to transformative technologies to discover and develop oncology therapeutics.
Fresh from showcasing preliminary evidence for the tolerability and potential benefits of LVGN-6051 at ASCO’s annual meeting in June, Lyvgen Biopharma Holdings Co. Ltd. is gearing up to move its CD40 agonist LVGN-7409 to clinical trials in China after initial U.S. patient dosing.
PERTH, Australia – Following a AU$85 million (US$64.41 million) capital raise, Qbiotics Group Ltd. is progressing its oncology clinical program for lead candidate tigilanol tiglate, a natural product that is isolated from the seed of the Australian rainforest native shrub Fontainea.
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
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