Berahyaluronidase alfa

DAEJEON, South Korea, Nov. 10, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced today that the company has entered into an exclusive license agreement with Daiichi Sankyo (TSE: 4568). Under the terms of the agreement, Daiichi Sankyo will acquire world-wide rights to use ALT-B4, Alteogen's novel hyaluronidase utilizing Hybrozyme™ Technology, to develop and commercialize a subcutaneous version of ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC) that has been jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. Alteogen will receive an upfront payment and is eligible to receive milestone payments upon Daiichi Sankyo's achievement of specified development, regulatory and sales milestones. Additionally, Alteogen will be entitled to receive tiered royalties on the sales of the commercialized product. Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Daiichi Sankyo. "Our collaboration with Daiichi Sankyo is groundbreaking in the ADC field, being the first to use hyaluronidase for a subcutaneous ADC marks a significant milestone in the oncology field, and we look forward to our collaboration with Daiichi Sankyo in bringing this product to the market." said Dr. Soon Jae Park, Chief Executive Officer of Alteogen. About ALT-B4 ALT-B4 is Alteogen's proprietary human recombinant hyaluronidase enzyme developed utilizing Hybrozyme™ technology. ALT-B4 can enable the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. ALT-B4 does this by temporarily hydrolyzing hyaluronan in the extracellular matrix. About Alteogen Inc. Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV infusion. The company was founded in 2008 and listed in KOSDAQ (196170.KQ). About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit . Contacts US: Vivek Shenoy, Ph.D., MBA Chief Business Officer Phone: +1 805 570 8998 E-mail: [email protected] ROW: Tae-Yon Chun, Ph.D., J.D. EVP/Corporate Alliance Officer Phone: +82 042 867 8861 E-mail: [email protected] SOURCE Alteogen Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Daiichi Sankyo has entered into an exclusive licence agreement worth up to $300m with Alteogen to develop a subcutaneous version of its AstraZeneca-partnered antibody-drug conjugate (ADC) Enhertu (fam-trastuzumab deruxtecan-nxki). The deal gives Daiichi Sankyo the worldwide rights to use Alteogen’s hyaluronidase-utilising hybrozyme technology, ALT-B4, to develop and commercialise the new formulation. Under the terms of the agreement, Alteogen will receive an upfront payment of $20m and will be eligible for up to $280m based on Daiichi Sankyo’s achievement of specified development, regulatory and sales milestones, plus tiered royalties. ADCs are a new class of cancer therapies designed to precisely target and kill tumour cells while sparing healthy ones. Enhertu, administered as an intravenous (IV) infusion, is specifically directed at HER2, a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body. In some cancers, HER2 expression is amplified or the cells have activating mutations, and HER2 protein overexpression is often associated with aggressive disease and poor prognosis. The therapy already holds approvals for a range of indications, including certain cases of breast cancer, non-small cell lung cancer and gastric cancer. It was also recently granted accelerated approval by the US Food and Drug Administration to treat a subset of patients with advanced solid tumours. Alteogen’s ALT-B4 can enable the large volume subcutaneous administration of drugs that are typically administered as an IV infusion by temporarily hydrolysing hyaluronan in the extracellular matrix, according to the South Korea-based biopharma. Soon Jae Park, Alteogen’s chief executive officer, said: “Our collaboration with Daiichi Sankyo is groundbreaking in the ADC field, being the first to use hyaluronidase for a subcutaneous ADC marks a significant milestone in the oncology field, and we look forward to our collaboration with Daiichi Sankyo in bringing this product to the market.” The announcement comes less than two months after Daiichi Sankyo and Merck & Co – known as MSD outside the US and Canada – shared positive results from a late-stage trial of their HER3-directed ADC patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated NSCLC who have previously received EGFR tyrosine kinase inhibitor treatment.