Altos Biologics Co., Ltd.

DAEJEON, South Korea I July 1, 2024 I Alteogen Inc. (KOSDAQ: 196170) announced on July 1 st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar ALT-L9, developed by Alteogen. The Phase 3 clinical trial for ALT-L9 commenced with initial clinical trial approval in 2022, involving over 400 subjects across 12 countries. The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet Age-related Macular Degeneration. Conducted in Europe, South Korea, and Japan, the trial evaluated changes in Best-Corrected Visual Acuity (BCVA) over an 8-week period as the primary endpoint. The study demonstrated therapeutic equivalence between ALT-L9 and Eylea®, prompting the submission of the Marketing Authorization Application. Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide. Dr. Soon Jae Park, Chief Executive Officer of Alteogen, emphasized, “The submission of Marketing Authorization Application for ALT-L9, developed by Alteogen and clinically tested by Altos Biologics, mark significant milestones in commercializing our proprietary products and gaining global clinical experience.” He added, “This represents a crucial moment for Alteogen’s growth as a global pharmaceutical company.” “Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea,” added Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics. Altos Biologics also aims to leverage its expertise gained from this trial in ophthalmic diseases to develop a novel multi-specific fusion protein therapeutic incorporating Tie2 regulators, in addition to anti-VEGF mechanisms similar to Eylea®, aimed at stabilizing blood vessels. This initiative aims to position the company as a leading developer of Best-in-Class treatments in the expanding market driven by aging demographics and related eye conditions. 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). SOURCE : Alteogen

DAEJEON, South Korea, July 1, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ: 196170) announced on July 1st that its subsidiary, Altos Biologics Inc. has submitted Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for an aflibercept biosimilar ALT-L9, developed by Alteogen. The Phase 3 clinical trial for ALT-L9 commenced with initial clinical trial approval in 2022, involving over 400 subjects across 12 countries. The study compared efficacy, safety, and immunogenicity against Eylea® in the indication of wet Age-related Macular Degeneration. Conducted in Europe, South Korea, and Japan, the trial evaluated changes in Best-Corrected Visual Acuity (BCVA) over an 8-week period as the primary endpoint. The study demonstrated therapeutic equivalence between ALT-L9 and Eylea®, prompting the submission of the Marketing Authorization Application. Altos Biologics expects to receive approval from EMA by 2025, aligned with the substance patent expiration, and intends to negotiate License Agreements with potential distributors worldwide. Dr. Soon Jae Park, Chief Executive Officer of Alteogen, emphasized, "The submission of Marketing Authorization Application for ALT-L9, developed by Alteogen and clinically tested by Altos Biologics, mark significant milestones in commercializing our proprietary products and gaining global clinical experience." He added, "This represents a crucial moment for Alteogen's growth as a global pharmaceutical company." "Following the European Marketing Authorization Application for ALT-L9, we plan to pursue product approvals in target markets including Korea," added Dr. Hyi Jeong Ji, Chief Executive Officer of Altos Biologics. Altos Biologics also aims to leverage its expertise gained from this trial in ophthalmic diseases to develop a novel multi-specific fusion protein therapeutic incorporating Tie2 regulators, in addition to anti-VEGF mechanisms similar to Eylea®, aimed at stabilizing blood vessels. This initiative aims to position the company as a leading developer of Best-in-Class treatments in the expanding market driven by aging demographics and related eye conditions. 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). Contacts Altos Biologics: Issac Hwang U.S. Attorney Phone: +821024007530 E-mail: [email protected] Alteogen: Tae-Yon Chun, Ph.D., J.D. Corporate Alliance Officer Phone: +820428678861 E-mail: [email protected] SOURCE Alteogen Inc.

Altos Biologics, a subsidiary of Alteogen, is actively engaged in Eylea® Biosimilar (ALT-L9) clinical development and licensing-out discussions. Early 2024 projected for Phase 3 completion and product launch in Europe expected after obtaining approval in the first half of 2025. DAEJEON, South Korea, Feb. 22, 2023 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) ("Alteogen"), a leading biotechnology company based in South Korea, provided a patient enrollment update for the company's ongoing Phase 3 study of ALT-L9 for the treatment of neovascular age-related macular degeneration (wet AMD). ALT-L9 Phase 3 trial (EudraCT: 2021-004530-11) is a randomized, double-masked, parallel group, multicenter study to compare the efficacy and safety of ALT-L9 versus Eylea® in 431 patients with wet AMD. Full recruitment of study volunteers refers to the 431st patient identified as an eligible subject and subsequently enrolled in the trial. In line with schedule set forth in trial protocol, study volunteers go through the process of investigational product administration and observation by investigators. "Patient recruitment process has been further expedited as Altos Biologics closely communicated with trial collaborators at the local level," said an Alteogen official familiar with the study. "We plan to complete the product approval by the first half of 2025 as biologics license application (BLA) will be submitted to the relevant health authorities in early 2024. Altos Biologics is also making great strides in licensing-out efforts and companies possessing marketing capabilities and a proven track record would be prime candidates in forging partnerships." The study builds upon earlier Phase 1 study (NCT: 04058535), which successfully demonstrated similar safety and efficacy profiles to the originator product and evaluated pharmacokinetic characteristics. Additionally, filing and registration of formulation patents related to higher thermal stability and process patents, enabling efficient drug substance manufacturing, further bolster the product's competitiveness from an intellectual property stance. Eylea® is a leading treatment indicated for diabetic retinopathy and macular degeneration. In 2021 alone, the product clocked $5.8 billion in U.S. sales and worldwide, the revenue stood at $9.2 billion, making it one of the so-called blockbuster products. In an attempt to effectively capture Eylea® biosimilar market, Altos Biologics is pursuing licensing-out opportunities in each region. About ALT-L9 ALT-L9 is an investigational compound intended to be a biosimilar formulation of aflibercept (product name Eylea®), an anti-vascular endothelial growth factor (VEGF). Alteogen intends to develop ALT-L9 for the same use as the reference product with respect to route of administration, posology, and therapeutic indications. One vial of ALT-L9 contains 11.12 mg of aflibercept (concentration of 40 mg/mL), and the layers of physicochemical and biological assays support the similarity of ALT-L9 to the reference product. About Alteogen Inc. Alteogen Inc. is a South Korea-based biotechnology company that focuses on the development and commercialization of biologics such as novel human hyaluronidase (ALT-B4), Antibody-Drug Conjugates (ADCs), biobetters and biosimilars. The company was founded in 2008 and listed in KOSDAQ (196170). Contacts US: Vivek Shenoy, Ph.D., MBA Chief Business Officer of Alteogen Phone: +18055708998 E-mail: vivek_shenoy@alteogen.com ROW: In Young Han General Manager, Business Development of Altos Biologics Phone: +82 2 2039 9520 (ext. 235) E-mail: iyhan@altosbio.com Company Codes: Korea:196170