Alteogen, Inc.

Tergase® poised to capture a fair share of the global hyaluronidase market. DAEJEON, South Korea, July 8, 2024 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170) announced that the Ministry of Food and Drug Safety (MFDS) of Korea approved its New Drug Application (NDA) for Tergase® (recombinant hyaluronidase). Tergase® is a recombinant human hyaluronidase developed utilizing Alteogen's proprietary Hybrozyme™ Technology. Dermal filler removal is the main product application, but it can also be used for various purposes, including local anesthetic solution for eye surgery, and orthopedics pain management. Mainly bovine or ovine-derived hyaluronidases with lower purity levels are available on the market, whereas owing to its recombinant source, Tergase® exhibits over 99% purity with lower immunogenicity. Given the superior product profile and comparative advantages, it is expected that the product applications will be extended to fields where animal-origin hyaluronidases have not been traditionally used. The NDA submission is supported by a multicenter, 2-arm, randomized, double-blinded, placebo-controlled pivotal Phase 1 clinical trial involving 244 healthy subjects for the assessment of safety, tolerability, and pharmacokinetic characteristics. Primary endpoint - drug allergy response during intradermal administration – was met as the allergic response rate in the test group was significantly lower than the U.S. Food and Drug Administration (USFDA) recommendation as well as zero incidence of anti-drug antibodies (ADA) found. MFDS approval of Tergase® marks a key milestone for Alteogen as it transitions to become a commercial-stage company and achieves its goal of delivering better biologics for patients. "We are pleased to report this important milestone, and look forward to expanding our partnerships in commercializing Tergase®," said Dr. Soon Jae Park, Chief Executive Officer of Alteogen. "And having excellent safety profile compared to animal-derived hyaluronidase products on the market, Tergase® stands to emerge as a promising alternative in the global hyaluronidase market estimated to be around $1 billion in the near future." About Tergase® Tergase® (development code name ALT-BB4) is a stand-alone recombinant hyaluronidase derived from human hyaluronidase PH20, being investigated for a wide range of applications. Usage includes tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected drugs and topical anesthetics by subcutaneous or intradermal injection. Designed to achieve optimal balance between efficacy and safety, it is comprised of proprietary, human serum albumin-free liquid formulation with the presentation of 1,500 IU/mL/vial. 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 US: Vivek Shenoy, Ph.D., MBA Chief Business Officer Phone: +18055708998 E-mail: [email protected] ROW: Tae-Yon Chun, Ph.D., J.D. Corporate Alliance Officer Phone: +820428678861 E-mail: [email protected] SOURCE Alteogen Inc.

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.