Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases. Read More
After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications. Read More
Medicxi has made its first ever investment in China – and its biggest single commitment to date – putting $40 million into D3 Bio Inc. The investment by the London-based venture capital firm will accelerate development of D3’s lead program D3S-001, a second generation KRAS G12C inhibitor, which is in phase II development in advanced solid tumors. Read More
A day after investing $40 million in China’s D3 Bio Inc., London-based venture capital firm Medicxi is investing $25 million to co-found a new U.K.-based company called Petalion Therapeutics Ltd. that will focus on an early stage oncology asset from Australia’s Starpharma Holdings Ltd. to develop novel dendrimer-based treatments. Read More
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. Read More
China’s Visen Pharmaceuticals (Shanghai) Co. Ltd. is targeting an IPO on the Hong Kong stock exchange with three rare endocrine disease therapies licensed-in from Denmark’s Ascendis Pharma A/S, including U.S. FDA-approved Skytrofa (lonapegsomatropin). Read More
“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea.
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing. Read More
The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Daiichi Sankyo, Innocare, Ractigen, Samsung Bioepis, Yoltech. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Ascletis Pharm, CNX Therapeutics, Cytomx, Dsm-Firmenich, Eisai, Mina Therapeutics, Oz Medicann, Nippon Shinyaku, Noxopharm, Roivant Sciences, Sumitomo Pharma. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, D&amn;D Pharmatech, Eisai, Eilean, Innovent, Partner, Remegen. Read More
