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).

韩国大田，2024年7月8日/PRNewswire/--Alteogen Inc.（KOSDAQ:196170）宣布，韩国食品和药物安全部（MFDS）批准了Tergase®（重组透明质酸酶）的新药申请（NDA）。

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.

Tergase®是利用Alteogen专有的Hybrozyme™技术开发的重组人透明质酸酶。去除皮肤填充物是主要的产品应用，但它也可以用于各种目的，包括用于眼科手术的局部麻醉溶液和整形外科疼痛管理。市场上主要有纯度较低的牛或绵羊来源的透明质酸酶，而由于其重组来源，Tergase®的纯度超过99%，免疫原性较低。

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..

鉴于优越的产品概况和相对优势，预计产品应用将扩展到传统上不使用动物源性透明质酸酶的领域。。

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.

NDA提交得到了一项多中心，双臂，随机，双盲，安慰剂对照的关键性1期临床试验的支持，该试验涉及244名健康受试者，用于评估安全性，耐受性和药代动力学特征。主要终点-皮内给药期间的药物过敏反应-得到满足，因为试验组的过敏反应率明显低于美国。

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.

MFDS对Tergase®的批准标志着Alteogen转变为商业阶段公司并实现为患者提供更好生物制剂的目标，这是Alteogen的一个关键里程碑。

'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.'.

Alteogen首席执行官Soon Jae Park博士说：“我们很高兴报告这一重要里程碑，并期待着扩大我们在Tergase®商业化方面的合作伙伴关系。”与市场上的动物源性透明质酸酶产品相比，Tergase®具有优异的安全性，有望在不久的将来成为全球透明质酸酶市场上有前途的替代品，预计将达到10亿美元左右。

About Tergase®

关于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.

Tergase®（开发代码名称ALT-BB4）是一种源自人透明质酸酶PH20的独立重组透明质酸酶，正在进行广泛的应用研究。用途包括指示为佐剂的组织渗透性调节剂，以通过皮下或皮内注射增加其他注射药物和表面麻醉剂的分散和吸收。

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..

旨在实现功效和安全性之间的最佳平衡，它由专有的不含人血清白蛋白的液体制剂组成，每瓶1500 IU/mL。。

About Alteogen Inc.

关于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.

Alteogen Inc.是一家总部位于韩国的生物制药公司，专注于新型生物制剂的开发和商业化，例如抗体-药物偶联物（ADC），生物制剂和生物仿制药。Alteogen的产品组合包括临床阶段长效治疗蛋白和下一代ADC，分别由其专有的NexP™fusion和NexMab™平台技术开发。

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)..

它还利用Hybrozyme™技术开发了一种专有的重组人透明质酸酶，该酶能够大量皮下注射通常作为IV输注给药的药物。该公司成立于2008年，在KOSDAQ（196170 KQ）上市。。