Alteogen Inc.
South Korean biopharmaceutical company focused on the development and commercialization of novel biologics including antibody-drug conjugates (ADCs), biobetters, and biosimilars; best known for its subcutaneous formulation platform.
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6
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成立时间
2008
已完成
6
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- Alteogen signed an exclusive option and license agreement with Novartis for its hyaluronidase ALT-B4, with maximum payments reaching $3.223 billion if all options and milestones are achieved. - Novartis secured multiple options to develop and commercialize subcutaneous formulations of biopharmaceuticals using ALT-B4, choosing it over Halozyme's Enhanze platform. - ALT-B4's patent protection extends into the early 2040s, while Halozyme's core composition-of-matter patents expire between 2027 and 2029, reinforcing Alteogen's long-term exclusivity position.
- Alteogen signed an option and licensing agreement with Novartis worth up to 4.4 trillion won ($3.2 billion) to develop and commercialize subcutaneous formulations using its ALT-B4 technology. - Novartis gains exclusive rights, through multiple options, to develop and commercialize SC formulations for multiple products, with Alteogen also receiving royalties on net sales after commercialization. - ALT-B4 is a recombinant human hyaluronidase that converts intravenous biologic drugs into subcutaneous formulations, shortening administration time and improving patient convenience. - The deal marks Alteogen's fourth ALT-B4 licensing agreement with a global pharmaceutical company this year, with major SC conversion projects expected to commercialize sequentially from 2029.
- Global pharma M&A activity reached $106 billion in H1 2025, the most active period since 2019, driven by looming patent cliffs in the late 2020s. - GSK acquired NewValent for $10.6 billion at a 40% premium, gaining two lung cancer drugs under FDA review, reflecting the scarcity value of validated late-stage assets. - Korean biotech firms predominantly out-license at Phase 1, structurally missing late-stage premiums, while Chinese companies advance to Phase 3 using faster and cheaper clinical trials. - China's share of global technology deals surged from 8% to 30% in two years, and Korea's global clinical trial ranking fell from fourth to sixth place in 2024.
- Alteogen reported first-half 2026 sales of 140.5 billion won, a 37% year-on-year increase, with net profit more than doubling to 101.3 billion won. - Keytruda Qlex, the first commercialized SC product using ALT-B4, posted Q2 sales of $463 million, a 262% jump from $128 million in the prior quarter. - The company secured ALT-B4 platform license agreements with Tesaro (GSK) and Biogen in Q1 and is in final-stage negotiations for additional deals. - Alteogen plans to shift from upfront/milestone revenue toward a product sales-based growth model as commercial momentum accelerates.
- Alteogen secured Korean regulatory approval for Eyenefy Injection (ALT-L9), a biosimilar of Bayer and Regeneron's blockbuster ophthalmology drug Eylea (aflibercept). - The approval covers all indications of the original drug including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion-related visual impairment. - The biosimilar demonstrated therapeutic equivalence and safety to Eylea in global phase 3 clinical trials conducted across 12 countries including Europe, Korea, and Japan. - Alteogen expects the launch to provide import substitution effects and expanded patient access in Korea's import-dependent ophthalmic treatment market while reducing healthcare costs.
- Alteogen CEO Jeon Tae-yeon announced the company is in advanced negotiations with approximately 10 pharmaceutical companies for its ALT-B4 subcutaneous injection platform, with another major deal potentially worth billions imminent. - The Korean biotech has already secured licensing agreements worth over $1.7 billion combined with companies including AstraZeneca ($1.35 billion) and MSD ($432 million) for its proprietary hyaluronidase enzyme technology. - ALT-B4 enables large-volume subcutaneous delivery of drugs traditionally administered intravenously, reducing administration time from seven to eight hours to just minutes. - The company plans to commercialize six or more products over the next five to six years as its technology platform gains traction in the global pharmaceutical market.
- A Munich Regional Court issued a preliminary injunction preventing Merck from distributing its new subcutaneous formulation of Keytruda in Germany due to patent infringement claims by Halozyme Therapeutics. - The dispute centers on the berahyaluronidase alfa component developed by Alteogen, which Halozyme claims infringes its European patent on MDASE platform technology for drug delivery. - German patients retain access to the original intravenous Keytruda formulation, while the subcutaneous version offers reduced treatment time from 30 minutes to just a couple of minutes. - The patent battle extends beyond Germany, with both companies also engaged in litigation over subcutaneous Keytruda in the United States, where it was recently approved as Keytruda Qlex.
- Korean pharmaceutical and biotech companies achieved record technology export deals worth 18.111 trillion won ($13.5 billion) in 2024, surpassing the previous 2021 record of 13.8 trillion won. - Platform technologies from companies like ABL Bio, Alteogen, and LigaChem Biosciences accounted for approximately 13 trillion won of these deals, demonstrating their ability to license to multiple global partners. - ABL Bio's blood-brain barrier platform secured major deals with GSK (4.1 trillion won) and Eli Lilly (3.8 trillion won), while Alteogen's subcutaneous injection technology attracted partnerships with AstraZeneca, Merck, and Daiichi Sankyo. - Industry experts note that platform technologies offer "low risk, high return" potential compared to single drug development, requiring less R&D investment while generating early-stage licensing revenue.
- Alteogen announced that its aflibercept biosimilar Eyluxvi (ALT-L9) received a positive opinion from the European Medicines Agency's CHMP committee, marking a decisive step toward European approval. - The positive recommendation is based on Phase 3 clinical trial results from 431 wet age-related macular degeneration patients across 12 countries, demonstrating therapeutic equivalence and safety compared to Eylea. - Eyluxvi targets the blockbuster ophthalmology market, with Eylea generating annual sales of $9.5 billion for treating conditions like wet age-related macular degeneration and diabetic macular edema. - This represents Alteogen's second biosimilar product following its Herceptin biosimilar ALT-L2, positioning the company for global pharmaceutical market expansion with expected approval by 2025.
- Merck's subcutaneous pembrolizumab with berahyaluronidase alfa demonstrated noninferior pharmacokinetics compared to intravenous KEYTRUDA in a pivotal Phase 3 trial for metastatic non-small cell lung cancer treatment. - The subcutaneous formulation, administered in approximately two minutes versus standard IV infusion, reduced patient chair time by nearly 50% and healthcare professional active time by 45.7%, potentially improving treatment efficiency. - FDA review of the subcutaneous pembrolizumab application is underway with a target action date of September 23, 2025, which could make it the first subcutaneous checkpoint inhibitor available across all KEYTRUDA's approved solid tumor indications.
