The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
Financings are on the rise in Hong Kong as a number of Chinese pharmaceutical companies announced capital raisings, including Simcere Pharmaceutical Group Ltd., Qyuns Therapeutics Co., Ltd., Harbour Biomed Ltd. and Cutia Therapeutics.
Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.
Minghui Pharmaceutical Ltd. announced it is raising $131 million in a pre-IPO financing round Aug. 7. The funds will be used to advance its cancer and inflammatory disease pipeline, which include a PD-1/VEGF bispecific antibody, antibody-drug conjugates (ADCs) and a topical Janus kinase inhibitor.
Innogen Pharmaceutical Group announced an $86 million IPO on the Hong Kong Stock Exchange that will see the company advance its lead product, Diabegone (efsubaglutide alfa), an ultra-long-acting glucagon-like peptide-1 receptor agonist into new global markets for type 2 diabetes as well as other metabolic diseases.
Lepu Biopharma Co. Ltd. has out-licensed two preclinical T-cell engagers to Shanghai-based newco Excalipoint in a deal worth $857.5 million plus equity interest. Under the deal terms, Excalipoint gains an exclusive global license to CTM-012 and CTM-013, developed by Lepu’s Topabody T-cell engager platform. In exchange, Lepu will receive $10 million up front and up to $847.5 million in development and commercial-based milestones, plus tiered royalties on sales.
Chinese vaccine company Ab&B Bio-tech announced an IPO listing on the Hong Kong Stock Exchange (HKEX:2627) under which it hopes to raise up to HK$518.36 million (US$66 million) to commercialize its influenza and human rabies vaccines in China and internationally.
Madrigal Pharmaceuticals Inc.’s long-awaited business development pact became reality by way of an exclusive global license agreement that could be worth more than $2 billion with CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, for SYH-2086. The candidate is a preclinical oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist and orforglipron derivative.