The cumulus-corona-oocyte complex, composed of cumulus granulosa cells embedded in a matrix of hyaluronan oligosaccharide chains cross-linked by hyaluronan binding proteins and proteoglycans, surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved using enzymatic digestion of the matrix with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed with the intent of circumventing the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. In order to compare the effect of Cumulase with that of the bovine enzyme on the rates of normal fertilization and oocyte damage, a retrospective study using four experienced practitioners was performed. In 2006, using Cumulase, a significantly increased rate of normal fertilization (P = 0.0003) and a significantly decreased rate of oocyte damage (P < 0.0001) were observed compared with 2005, during which time bovine-derived hyaluronidase was predominantly used. This study indicates that Cumulase is safe and effective for use in the removal of the cumulus-corona-oocyte complex prior to ICSI, and may have several distinct advantages over the animal-derived form of the enzyme in terms of safety and efficacy.

项与 Recombinant hyaluronidase (Alteogen) 相关的新闻（医药）

2024-07-08

·PRNewswire

Alteogen Receives Ministry of Food and Drug Safety (MFDS) Approval for Tergase®

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.

临床1期上市批准

2023-09-05

·PRNewswire

Alteogen's Tergase® (Novel Recombinant Human Hyaluronidase Injection) Shows Excellent Immunogenicity Profile

Alteogen expects Tergase® will replace commercially available animal-derived hyaluronidase products and their significant disadvantages. Compared with other commercially available hyaluronidase products, Tergase® showed no incidence of anti-drug antibodies (ADA). The occurrence of ADA is known to adversely affect the safety and efficacy of a drug. DAEJEON, South Korea, Sept. 5, 2023 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170), a Korean biotech company announced that their recently concluded clinical trial of Tergase® showed zero incidence of ADA (including neutralizing antibodies). Tergase® is Alteogen's first proprietary product currently under pharmaceutical approval process by the Korean Ministry of Food and Drug Safety. Tergase® is a stand-alone hyaluronidase product that can be used for the treatment of various medical conditions, such as pain relief, edema treatment, and hyaluronic acid filler removal. In particular, compared to commercially available animal-derived hyaluronidase products in the market, it is a highly purified product of high-quality with very few impurities and an excellent side effect profile. As a Novel Recombinant Human Hyaluronidase, Alteogen expects that Tergase® will be applicable to new indications which are currently not available to existing animal-derived products. The presence of ADA is known to induce unwanted side effects. Therefore, regulatory authorities have very closely scrutinized products for the presence of ADA, using data from immunogenicity safety studies. ADA are also intimately related to drug efficacy and duration of drug action. As Tergase® is a genetically modified human recombinant protein generated by domain s technology between two subtypes of human hyaluronidases, the low incidence of ADA was expected. Thus, Alteogen believes the outcome of zero ADA incidence in the clinical trial with 244 healthy volunteers make Tergase® a highly competitive product in the market due to its high quality. Dr. Soon Jae Park, CEO of Alteogen said, "we believe that in this market, there is a strong need for differentiated products, from the stability and safety perspective, since existing animal-derived products cannot be widely used due to their side effect profiles. When compared with the one and only commercially available human recombinant hyaluronidase from Alteogen's competitor, Tergase® may be superior in many aspects and we expect this will help us gain significant market share in various fields." Previously, literature review showed 3~12% ADA incidence in the competitor's recombinant hyaluronidase product. Even more impressive is that a 4~20 fold more dosing of Tergase®, compared with dosage used for the competitor's product, resulted in significantly less ISR (Injection Site Reactions) occurrence. Currently, Tergase® is undergoing pharmaceutical approval process by the Ministry of Food and Drug Safety, and it is expected to obtain product approval between the end of 2023 and the beginning of 2024 at the latest, depending on the schedule for additional supplementary data requirement. 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 injection. 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.

临床结果上市批准

100 项与 Recombinant hyaluronidase (Alteogen) 相关的药物交易

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