Bepirovirsen

Plus, label expansions for two drugs targeting rare diseases, and Genmab scraps a Phase 1 cancer trial: 🧠 Novo’s Parkinson’s cell therapy finds a biotech home: Novo Nordisk has found a home for an early-stage Parkinson’s program after the pharma giant stopped cell therapy research last fall . A Boston-based startup called Cellular Intelligence, formerly Somite AI, announced Monday it has acquired the rights to STEM-PD, an allogeneic Parkinson’s cell therapy. The companies did not disclose financial details. This is Cellular Intelligence’s first clinical-stage program, which the Khosla Ventures-backed company says is ready to enter Phase 2. Eight Parkinson’s patients were treated in a Phase 1 study, where cells were injected into the brain in hopes they will grow into dopamine-releasing neurons. The therapy was started at the University of Cambridge and Lund University. — Andrew Dunn 🇨🇳 GSK gets help on hepatitis B drug in China: The UK pharma has enlisted Sino Biopharm’s subsidiary Chia Tai Tianqing Pharmaceutical to help roll out bepirovirsen in China. The Ionis Pharmaceuticals-derived drug is currently under priority regulatory review in the country. CTTQ will buy the drug from GSK for at least 5.5 years. GSK can also look at early-stage assets from Sino for potential collaboration pacts outside of China. — Kyle LaHucik 💉Argenx wins label expansion for injectable Vyvgart: The biotech said the subcutaneous version of its blockbuster rare disease drug is now approved to treat “all serotypes” of generalized myasthenia gravis. The approval was based on a Phase 3 study comparing the drug to placebo after four weeks. — Max Gelman ✅ FDA expands label for rare cancer drug under Commissioner’s National Priority Voucher: The drug regulator approved Bizengri for previously treated patients with advanced cholangiocarcinoma with an NRG1 gene fusion. The treatment was previously approved for certain lung and pancreatic cancers that bear an NRG1 gene fusion. Merus developed the drug, but licensed it to Partner Therapeutics to market in the US in 2024. Genmab last year bought Merus as part of an $8 billion deal. The FDA said Bizengri’s label expansion marked the seventh approval under the voucher program. — Lei Lei Wu ✂️ Genmab scraps Phase 1 cancer program: The company discontinued development of GEN1057 , a company spokesperson confirmed to Endpoints News . The experimental drug had been in a Phase 1 study for solid tumors. GEN1057 is a bispecific antibody targeting fibroblast activation protein alpha (FAPα) and death receptor 4 (DR4). — Max Gelman

GSK has reached a deal with Sino Biopharmaceutical to help maximize access to an experimental hepatitis B drug thats on the verge of approval in China.Through an agreement announced Monday, a subsidiary of China-based Sino will buy a supply of GSKs therapy, bepirovisen, and distribute and promote it through a network of more than 5,000 medical centers there. That agreement has an initial five-and-a-half year term, but can be extended by both companies.GSK will also get the chance to pick through Sinos early-stage pipeline to evaluate potential partnership opportunities outside of China.Bepirovirsen is currently under regulatory priority review in China for the treatment of chronic hepatitis B infections which, if left unaddressed, can cause cirrhosis and liver cancer. These chronic infections remain a global issue, affecting more than 250 million people worldwide, according to GSK. And theyre a particular problem in China, which accounts for about a third of the global disease burden, according to the World Health Organization.Many patients with chronic hepatitis B end up taking antiviral drugs for life. GSK and its development partner, Ionis Pharmaceuticals, are positioning bepirovirsen as a functional cureinstead. An RNA-based medicine, bepirovirsen has shown the potential in clinical testing to push the virus down to undetectable levels in six months.Bepirovirsen could be approved in the U.S. by Oct. 26. But a regulatory review in China is proceeding as well and, on a recent earnings call, CEO Luke Miels noted that the two countries account for about two-thirds of the expected global market opportunity. Nina Mojas, GSKs president of global product strategy, added on that call that theres a very high desire of treatment in China as there is a stigma associated with the disease there.Sinos subsidiary, CTTQ, has played a significant role in advancing the diagnosis and treatment of hepatitis B in China and will help GSK reach more patients, more quickly, the British drugmaker said in its statement.The deal with Sino is the latest in a series of agreements GSK has struck with companies in China, which has quickly become a go-to source for experimental drugs. Since early 2025, GSK has done three licensingdeals with China-based companies, according to data compiled by BioPharma Dive.It has also acquired multiple startups either based in China, or built around drugs discovered there. '