Alteogen与Novartis签署最高32.23亿美元ALT-B4皮下注射平台授权协议

Alteogen (196170) has signed a technology licensing agreement with Novartis worth up to 4.4 trillion won.
Alteogen said on the 2nd that it entered into an option and license agreement with Novartis for the development and commercialization of subcutaneous (SC) formulations based on ALT-B4, which applies the company's Hybrozyme technology. Under the agreement, Novartis has secured exclusive rights to develop and commercialize SC formulations for multiple products using ALT-B4.
The deal is the second-largest technology licensing agreement by value in Alteogen's history and its fourth this year. If Novartis exercises all options and all development and commercialization milestones are met, Alteogen will receive up to $3.223 billion, or about 4.4165 trillion won. The company will separately receive royalties based on net sales after commercialization. Alteogen's largest deal to date is its agreement with Merck (MSD) of the United States to convert Keytruda to an SC formulation, valued at up to $4.317 billion.
Chun Tae-yeon, chief executive of Alteogen, said Novartis is a world-class pharmaceutical company leading the global healthcare industry. The CEO called the partnership a meaningful achievement that once again validates the technological strength and commercial viability of Alteogen's Hybrozyme platform.
Subcutaneous Delivery for Blockbusters, With Possible Expansion to RNA
The agreement is Alteogen's fourth licensing deal this year. Analysts say the pace shows that global pharmaceutical majors regard ALT-B4 as a core technology as they prepare for patent expirations on existing products and seek to maintain product competitiveness. Attention is also turning to the platform's scalability, with the possibility raised that Novartis may apply ALT-B4 to new modalities beyond antibodies and antibody-drug conjugates (ADCs).
According to the pharmaceutical and biotech industry on the 2nd, Novartis plans to use ALT-B4 for multiple drugs. The specific products have not been disclosed, but industry watchers say Novartis may apply ALT-B4 to ribonucleic acid (RNA)-based therapies. Novartis already markets Leqvio, a small interfering RNA (siRNA)-based drug. In February last year, it acquired Avidity Biosciences for $12 billion, adding an antibody-oligonucleotide conjugate (AOC) platform. The three AOC candidates Novartis obtained are being developed for launch before 2030, and all are intravenous (IV) formulations.
Alteogen has also emphasized that ALT-B4 can be applied to RNA therapies. Chun said that ahead of signing the agreement, the two companies evaluated ways to apply ALT-B4 to various modalities to convert them into SC formulations. At the 2026 BIO International Convention held in San Diego in June, the CEO said cooperation was under discussion in the RNA field and that positive results were emerging even in areas that had not been attempted before.
No hyaluronidase has been applied in the RNA field to date, according to industry accounts. Alteogen had mainly signed deals to convert antibody-based biologics such as Dupixent, Keytruda and Imfinzi into SC formulations. It then broadened the technology's scope to ADCs for the first time in the industry with a 2024 agreement with Daiichi Sankyo to develop an SC version of Enhertu. If the latest deal opens the way to new modalities such as RNA, the technological value of ALT-B4 could rise further.
Some observers say ALT-B4 could be applied to Cosentyx, one of Novartis's flagship blockbuster drugs. With patent expirations scheduled in the United States in 2029 and in Europe in 2030, Novartis needs a strategy to maintain its market position. Cosentyx, an autoimmune disease treatment, posted sales of $6.668 billion last year.
An industry official said Sanofi is already pursuing a plan to apply ALT-B4 to Dupixent, which has already been developed as an SC formulation, to extend the dosing interval to once a month. Cosentyx is also already an SC drug, but the possibility that ALT-B4 will be applied to it cannot be ruled out as the company responds to patent expiration and seeks to improve dosing convenience, the official said. Some analysts note, however, that Cosentyx can already be administered once a month, so gains in convenience may be relatively limited. Other potential candidates cited include in vivo CAR-T therapies, which generate CAR-T cells directly inside the body.
Alteogen has continued its licensing streak this year. In February, the company signed a deal worth up to $285 million with Tesaro, a subsidiary of GlaxoSmithKline (GSK), followed by an agreement with Biogen worth up to $579 million in March and a $365 million deal with an undisclosed pharmaceutical company in August. Including the Novartis agreement, the company has signed four deals this year with a combined value of $4.452 billion.
The string of deals shows that global pharmaceutical majors are looking to ALT-B4 as a means of maintaining competitiveness, analysts say. ALT-B4 is a recombinant human hyaluronidase developed on Alteogen's Hybrozyme platform that converts IV biologics into SC formulations, allowing faster and more convenient dosing. Adding ALT-B4 to an existing drug can qualify it as an improved new drug, helping to preserve market position even after a patent expires. An Alteogen official said the agreement demonstrates Novartis's continued commitment to innovation in providing patients with innovative treatment options and improving treatment convenience.