The spate of recent deals involving antibody-drug conjugates (ADC) continues in a field composed of record-breaking agreements in 2023. South Korea’s Dong-A ST Co. Ltd. is expanding into the space by acquiring Abtis Co. Ltd. and its Abclick platform for ADC drug development. Dong A-ST said the buyout helps it secure a new R&D growth engine while expanding its contract development and manufacturing organization business to ADCs. Terms of the acquisition were not disclosed. Also, GSK plc entered a license deal for the exclusive rights for clinical development and commercialization of Hansoh Pharmaceutical Co. Ltd.’s B7-H3-targeted ADC, HS-20093. Hansoh is getting $185 million up front and could receive up to $1.525 billion in milestones. HS-20093 is being developed to treat lung cancer, sarcoma, head and neck cancers and other solid tumors in phase I and II trials in China.

Phase III miss in pemphigus with efgartigimod dents Argenx shares

Argenx SE shares (NASDAQ:ARGX) were trading midday at $340, down $112.58, or 24%, on top-line results from the phase III Address study testing subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus. Results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids was not significantly different between efgartigimod and placebo. Amsterdam-based Argenx is quitting pemphigus development of the drug, approved by the U.S. FDA as Vyvgart two years ago. It’s a neonatal Fc receptor blocker indicated for generalized myasthenia gravis in adults who are anti-acetylcholine receptor-antibody positive.

Explainable AI finds new class of antibiotics

Researchers have used explainable artificial intelligence (explainable AI) to find structurally new antibiotics with minimal toxicity. They reported their findings online in Nature on Dec. 20, 2023. In animal testing, compounds identified via the method showed that they had activity against drug-resistant gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA), one of the most serious bacterial public health threats.

Top Trends of 2023: European biopharma survives capital crunch, look ahead to investment rebound in 2024

A catastrophe was averted over the weekend of March 11-12, 2023, when the U.K. government and the Bank of England orchestrated the rescue of the U.K. arm of Silicon Valley Bank, after its U.S. parent was shut down by the receiver. While that saved dozens of small biotechs with large deposits at the bank – they would have been eligible to get only £85,000 (US$108,000) of their money if SVB UK had been declared insolvent – it signified the fragile economic environment during the year, compounded by wider geopolitical frictions, with a market described by Chris Hollowood, CEO of Syncona Investment Management, as “the worst in my career.”

Top Trends of 2023: After decades of R&D, two RSV vaccines hit the market 

A safe and effective vaccine for preventing respiratory syncytial virus (RSV), a common and sometimes serious respiratory infection, had eluded biopharma for decades. But in 2023, the world saw the first – and second – vaccine hit the market.

Top Trends of 2023: Asia continues to slash drug prices as pressure mounts to include innovative drugs to formularies

In 2023, Japan has faced mounting criticism from the pharma industry for its annual price reductions. Ahead of the G7 summit hosted in Japan in May 2023, a delegation of 24 CEOs from the Biopharmaceutical CEO Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan. Meanwhile, in 2023, China agreed to add 126 drugs to its National Reimbursement Drug List, in a negotiation process that has become more transparent and predictable than ever before. South Korea faces drug pricing reform, while Australia’s government has started an overhaul of its health technology assessment process.

EMA, FDA offer help with challenges of expedited drug programs

Given the challenges of generating chemistry, manufacturing and control information on the compressed timelines used in the EMA’s Priority Medicines scheme and the U.S. FDA’s breakthrough therapy designation program, the two regulators published a joint question-and-answer document discussing quality and good manufacturing practice aspects of applications for both programs, which are aimed at speeding development of innovative products to address unmet medical needs.

Canada launches new drug agency

In an effort to standardize prescription practices across Canada, help Canadians afford their medicines and improve access to health data, the government is investing an additional $89.5 million over the next five years to establish the Canadian Drug Agency (CDA). The new agency will be built from the existing Canadian Agency for Drugs and Technologies in Health and in partnership with the country’s provinces and territories.

BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024

One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.

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