With a U.S. biotech identified as One Bio, Jiangsu Hengrui Pharmaceutical Co. Ltd. has inked an out-licensing deal potentially worth $1.05 billion for its asthma and chronic sinusitis-targeting drug, SHR-1905. A thymic stromal lymphopoietin monoclonal antibody, SHR-1905 is being investigated for a wide range of conditions related to severe asthma. Hengrui is testing the drug in two separate phase II trials in China, having gained NMPA go-aheads to study SHR-1905 for asthma in May 2021 and for chronic sinusitis with nasal polyps in May 2023. The latest deal gives One Bio exclusive rights to develop, produce and commercialize SHR-1905 worldwide, excluding the greater China territory.

Ipsen stood strong on its ultra-rare bone disease drug while others struggle

There have been plenty of companies chasing the first U.S. FDA-approved treatment for the ultra-rare disease fibrodysplasia ossificans progressiva (FOP), but Ipsen SA stayed the course longer and won that approval Aug. 16 with Sohonos (palovarotene). The disorder causes muscle tissue and connective tissue such as tendons and ligaments to ossify, forming bone outside the skeleton that that can lead to immobility, life-threatening respiratory problems and a total locking of the jaw. Other companies have struggled to develop a treatment for FOP, which affects about 400 people in the U.S. Astrazeneca plc has saracatinib, which was repurposed after disappointing in cancer and was in phase II development for FOP but is no longer listed in its pipeline. Biocryst Pharmaceuticals Inc. also is a competitor with its ALK-2 inhibitor, BCX-9250, which is being prepped for a phase II study of FOP.

Abcuro series B collects $155M for push in muscle disease

Abcuro Inc.’s $155 million series B financing will support the phase II/III registrational trial of ABC-008, a first-in-class anti-killer cell lectin-like receptor G1 (KLRG1) antibody for inclusion body myositis (IBM). Key to the effort is the KLRG1 target, expression of which lets the firm deplete T cells of particular concern in IBM, an inflammatory muscle disorder. If all goes well, Abcuro intends to file a BLA in 2026.

Innovent scores first approval for PCSK9 inhibitor in China

China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody (MAb) to be approved in China. The approval for the injectable anti-PCSK9 MAb is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab also marks Innovent's first cardiovascular drug and the company’s 10th approval.

Wound healing chemokine can improve learning and memory in old mice

Scientists have discovered that a small chemokine protein released by activated platelets, Platelet factor 4 (PF 4), reduced neuroinflammation, and improved cognition in aged mice. The study was published on Aug. 16 in the online edition of Nature.

US Fifth Circuit: Even the FDA has to follow the law

As yesterday’s U.S. appeals court ruling that would restore the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court, the Biden administration continues to insist that the courts have no business overriding the FDA’s scientific, evidence-based decisions. But the U.S. Court of Appeals for the Fifth Circuit found that the agency’s loosening of the restrictions on mifepristone in 2016 and later was not evidence-based. It added that the FDA, like any other government agency, has to follow the law and its own regulations in making regulatory decisions. Otherwise, it said, those decisions are arbitrary and capricious.

BioWorld Insider Podcast – The struggle is real: The first half of 2023 was an uphill climb

Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit.

Also in the news

Aegle, Artiva, Baudax, Biophytis, Bluebird, Boston, Bristol Myers Squibb, Chimerix, Coeptis, CSL, Curevac, Curium, Deverra, Eledon, Elevation, HBC Immunology, Ideaya, Inmagene, Innocan, Mei, Mustang, Pieris, Pluri, Polaris, Seagen, Selecta, Servier, Sonnet, Sparrow, Tonix, US Worldmeds, Valneva, Visiox