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  • Samyang Holdings Biopharmaceuticals Division 2021.09.03
    Samyang Biopharm USA and Spanish National Research Council to Conduct Joint Research on Mechanism of New Drug Candidates
    Samyang Biopharm USA and Spanish National Research Council to Conduct Joint Research on Mechanism of New Drug Candidates

      - Joint research on the mechanism of NK cell activation of SYB-010, an immunotherapy drug candidate - Activation of NK cells activation by binding MIC-A/B and exosomes containing MIC-A/B - Confirmation of immuno-oncology effects through animal experiments, such as increased survival rate, and reduction of tumor growth and metastasis   ▲ Samyang Biopharm USA logo   Samyang Biopharm USA continues to pursue open innovation to develop new immunotherapy drugs.   Samyang Biopharm USA (CEO: Hyun-Jung Helen Lee) announced on September 1 that it has concluded a joint research contract with the Spanish National Research Council (CSIC) to investigate the mechanism of action of SYB-010, an immunotherapy drug candidate under study. CSIC is the largest public research institute in Spain.   Through this joint research, Samyang Biopharm USA and CSIC is scheduled to confirm the mechanism by which SYB-010 treats cancer by activating NK cells. The research team found that SYB-010 not only activates NK cells, but also binds to MIC (MHC class I polypeptide-related sequence) A and B isolated from the surface of cancer cells. It is also expected to bind with MIC-A/B contained in exosomes that are released by cancer cells (nano-unit small cells that plays the role of intercellular signal communication).   MIC-A/B on the surface of cancer cells act as indicators for NK cells, cells of our innate immune system, to recognize cancer. When NK cells recognize MIC-A/B and exosomes separated from cancer cells as cancer and attacks them, the immune action against cancer cells is weakened. When SYB-010 blocks these interfering substances, NK cells recognize the cancer more accurately and attacks the cancer. NK cells are immune cells that destroy abnormal cells, such as virus-infected cells or cancer cells.   CEO Hyun-Jung Helen Lee of Samyang Biopharm USA stated that “SYB-010 has great potential to be developed as a new immunotherapy drug,” and affirmed that “the research collaboration with CSIC, who has extensive clinical trial experience, will be a great opportunity to validate the potential of SYB-010.”   Drs. Valés-Gómez and Reyburn of CSIC Immunology and Oncology Research Group agreed that “this is an important study that will help improve our overall understanding of cell receptors and the ligands that bind to them,” and was optimistic that “through this joint research, we hope that SYB-010 can be developed as a new immunotherapy drug.”   Dr. Sean McKenna, principal investigator of Samyang Biopharm USA stated that “CSIC has various experiences in analyzing the immunomodulatory effects of antibodies based on its specialized scientific technology,” and added that “through this joint research, we will develop an effective and safe immunotherapy drug by clearly identifying the anticancer mechanism of SYB-010.”   SYB-010 is a monoclonal antibody artificially made to bind to a specific protein. As a result of administering SYB-010 in an animal tumor model, SYB-010 was successful in binding to the MIC (sMIC) separated from cancer cells to activate the NK cells and significantly reduce tumor growth. The animal tumor model showed a clear anticancer immune effect, such as reducing the metastasis of cancer and increasing the survival rate. Samyang Biopharm USA was introduced to SYB-010 by CanCure of the United States in 2019 and secured exclusive rights to the global development, manufacture and commercialization of this substance. Currently, study is being conducted with the goal of obtaining IND approval by the US Food and Drug Administration (FDA) in 2022.   At present, Samyang Biopharm USA also signed a three-year research cooperation agreement with Dr. Hyun-Sung Lee of Baylor School of Medicine to investigate the association between sMIC expression and sMIC expression in patients who do not show therapeutic effects of immune checkpoint inhibitors. Samyang Biopharm USA, through research with Dr. Lee, was able to confirm the usage method of sMIC to identify patients who do not show therapeutic effect of existing immune checkpoint inhibitors. Thus, Samyang Biopharm USA strives to use SYB-010 to overcome the limitations of immune checkpoint inhibitors where only partial patients respond to treatment.   Samyang Biopharm USA is an overseas corporation of Samyang Holdings established in the center of the global bio industry at Kendall Square, Boston in August 2018 with the goal of developing innovative oncology drugs and rare disease treatments. Samyang Biopharm USA intends to increase the speed and success rate of biopharmaceutical development by conducting global clinical trials of new oncology drug candidates studied by the headquarters in Korea through the implementation of the open innovation strategy, that aims to introduce and develop new biopharmaceutical technologies and materials at an early stage by making the most of the location. Currently, the company continues to search for new drug candidates targeting immunotherapy and rare disease treatments.  

  • Samyang Holdings Biopharmaceuticals Division 2021.08.26
    Samyang Holdings Biopharmaceuticals Division’s “Croquis” Wins 2021 Red Dot Design Award
    Samyang Holdings Biopharmaceuticals Division’s “Croquis” Wins 2021 Red Dot Design Award

    - Winner of the 2021 Red Dot Design Award, one of the world’s top three design awards - Line drawn product packaging with black lines against a white background displaying brand significance and features - Five different yet unified designs for each product type   ▲ Product packaging of Croquis, a facelift thread brand of Samyang Holdings Biopharmaceuticals Division, which was awarded the 2021 Red Dot Design Award (for brands and communication design). The line drawing method visually depicts the brand significance, aimed at quickly and naturally shaping facial contours. Each design displays uniqueness and creativity, yet a unified look.   Samyang Holdings (CEO: Eum Tae-woong) Biopharmaceuticals Division announced on Aug. 23 that Croquis won the 2021 Red Dot Design Award (for brands and communication design). Croquis is a facelift thread brand of Samyang Holdings Biopharmaceuticals Division.   Since 1955, Design Zentrum Nordrhein Westfalen has led the Red Dot Design Award, one of the world’s top three design awards along with iF Product Design Award and the International Design Excellence Awards. In this award ceremony, the best design is selected annually based on its excellence, creativity, and functionality in three divisions: product design, brands and communication design, and design concept. In 2021, 7,800 artworks were exhibited in roughly 60 countries, and 50 design experts conducted a blind evaluation.   The product packaging of Samyang Holdings Biopharmaceuticals Division’s Croquis was inspired by “croquis,” a rough sketch that brings out the object’s characteristics. It earned high points and awarded as winner for an artistic and visual depiction of the brand identity that resonates with consumers and increases customers’ satisfaction.   Croquis product packaging features a sketch of various facial angles using a “line drawing” technique, marking various black lines against a white background. The brand identity was effectively and naturally conveyed through this technique, as the product quickly and naturally and beautifully shapes facial contours. In addition, five different drawing methods were applied for each design, which was unique yet unified. A spokesperson from Samyang Holdings Biopharmaceuticals Division said, “We made sure the design intuitively displayed the brand significance and features of Croquis at a glance. We will continue to develop designs that are easy for consumers to understand and provide differentiated use convenience.”   Meanwhile, Croquis gained trust from the global cosmetic surgery industry by reasonable, data-based marketing, earning its second-mover advantage. Currently, Croquis is sold in roughly 10 countries, including Germany and the UK, and various promotions and academic marketing are being implemented in each nation through webinars to reach cosmetic surgery medical teams worldwide.

  • Samyang Holdings Biopharmaceuticals Division 2021.08.23
    Samyang Holdings Biopharmaceuticals Division Promotes “Croquis” With Global SAB
    Samyang Holdings Biopharmaceuticals Division Promotes “Croquis” With Global SAB

    - Recruitment of a Swedish plastic surgeon to the SAB to give presentations in global cosmetic surgery conferences and conduct advisory activities - Presentation of the efficacy and safety of Croquis at a cosmetic surgery conference in September - Expansion of the overseas business base with data-based academic marketing activities through collaboration with global health professionals       ▲ Dr. Fredrick Berne, a plastic surgeon from Sweden Dr. Berne will officially start working as a member of Samyang Holdings Biopharmaceuticals Division’s SAB starting in September.     Samyang Holdings Biopharmaceuticals Division has added a global health professional to its Scientific Advisory Board (SAB) to promote the safety and efficacy of Croquis worldwide. Croquis is a face-lift thread brand of Samyang Holdings Biopharmaceuticals Division.   Samyang Holdings (CEO: Eom Tae-woong) announced on August 18 that the company recruited Dr. Fredrick Berne, a plastic surgeon from Sweden, to its SAB.   Dr. Berne has worked as a researcher and advisor for global aesthetic companies based on his extensive experience in cosmetic facial procedures and plastic surgery. He also serves as a advisor for major cosmetic surgery societies, including the one of the world’s top three International Master Course on Aging Science (IMCAS). With Dr. Berne on the SAB, Samyang Holdings Biopharmaceuticals Division now has a total of five cosmetic and plastic surgeons—three international and two domestic.   Dr. Berne will begin his official activities as a member of the SAB with a presentation in the Aesthetic and Anti-Aging Medicine World Congress (AMWC) to show clinical cases demonstrating the efficacy and safety of Croquis and suggesting effective procedure techniques. In addition, he will conduct research together to obtain clinical cases from overseas and develop a standard procedure technique which can improve the effect of Croquis, and serve as a speaker in academic webinars, introducing and demonstrating Croquis-based techniques.   An official from Samyang Holdings Biopharmaceuticals Division said, “To target global markets, it is necessary to obtain various cases with different procedures applied to different races for medical devices like face-lift threads as different races have different anatomical features, such as facial and bone structures, and cosmetic effects vary depending on race. Collaboration with health professionals recognized around the world will serve as a good opportunity to demonstrate the efficacy and safety of Croquis.”   Meanwhile, Samyang Holdings Biopharmaceuticals Division will continue to promote Croquis to international plastic surgeons through a variety of contractless academic marketing activities. In the first half of the year, the company participated in the International Seminar & Workshop in Aesthetic Medicine (IMCAS I-SWAM) and shared the latest Croquis-based face-lift procedure online. Samyang Holdings will focus on strengthening academic marketing through webinars with different countries, and promoting a safe and effective procedure for Croquis.   In addition, Croquis overcame disadvantages as a latecomer with data-oriented and evidence-based marketing, and is earning trust in global aesthetic medicine markets. While traditional aesthetic thread brands only compare and emphasize preoperative and postoperative effects, Croquis aims for evidence-based marketing and is making its best effort to obtain various data to prove a correlation between operative effects by parts of the face and the thread’s physical properties together with dermatologists and plastic surgeons in the US, France and Spain.

  • Samyang Holdings Biopharmaceuticals Division 2021.08.17
    SRDDS MOU Between Samyang Holdings Biopharmaceuticals Division and G2GBIO
    SRDDS MOU Between Samyang Holdings Biopharmaceuticals Division and G2GBIO

    - MOU signed for technical and development cooperation of sustained release injectables that lasts more than a month - Drug wrapped with biodegradable polymer for controlled release in the body - Improvement of drug compliance and convenience through combination of biodegradable polymer technology and microsphere technology from both companies   ▲Samyang Holdings Biopharmaceuticals Division and G2GBIO signed an MOU to develop sustained release injectable products at the Samyang Discovery Center in Pangyo on the 9th. From left, Head of PU Lee Yong-jin (Biopharmaceuticals Division), CEO Eom Tae-woong (Samyang Holdings), CEO Lee Heeyong (G2GBIO), and Managing Director Lee Su-jeong (R&D Center).   Samyang Holdings Biopharmaceutical Division is promoting the R&D and commercialization of sustained release injectables through open innovation using drug delivery technology (DDS). DDS is a technology that effectively delivers drugs into the body to reduce side effects and maximize medicinal effects.   Samyang Holdings (CEO: Eom Tae-woong) Biopharmaceuticals Division announced on the 9th that it had signed a memorandum of understanding (MOU) with the sustained release drug delivery system (SRDDS) developer G2GBIO (CEO: Lee Heeyong) to initiate the development of sustained release injectables. SRDDS is a drug with sustained release of medicinal efficacy for up to several weeks to several months. This helps to improve dosing convenience for patients who have difficulty taking regular medications or chronic disease patients who are required to take daily medications.   According to this MOU, Samyang Holdings Biopharmaceuticals Division will develop and supply biodegradable polymers for medical use, in which G2GBIO will use this to initiate research and development of sustained release injectables by producing microspheres. Microspheres are spherical particles of approximately 10 to 100 µm. Through this MOU, the two companies are scheduled to cooperate in all directions, from market research and development strategies for sustained release injectables to development of commercialization technology and discussions on the distribution rights of the finished products.   SRDDS is based on a technology that controls the drug to be slowly released from the body to maintain a constant concentration by wrapping the drug in biodegradable polymer. The key element of this technology is the biodegradable polymer material. This is because the dissolution of microspheres and the rate of drug release varies depending on the type and dissolution of the biodegradable polymer material.   Since 1993, Samyang Holdings Biopharmaceuticals Division has succeeded in developing biodegradable surgical sutures using biodegradable polymers for the first time in Korea. It has accumulated Korea’s best capabilities for biodegradable polymers and is capable of designing optimal polymers tailored to the required drug properties. In addition, stable raw material supply is possible due to the company’s own factory that is capable of producing biodegradable polymer materials and raw materials.   Another key technology in the development of sustained release injectables using the microsphere-based DDS technology is the production of microspheres in uniformed sizes. This is because the dissolution rate and drug release amount may vary depending on the degree of uniformity of the microsphere size. Although production of uniform sized microspheres can be realized to some extent in the research stage, quality assurance is difficult to achieve in mass production. This is why it is difficult for latecomers to enter this market.   G2GBIO’s patented “Innovative Long Acting Micro Particle” (InnoLAMP) technology is capable of producing uniformed sizes of microspheres through their self-developed microsphere manufacturing technology. In addition, a GMP plant for clinical product production equipped with aseptic facilities is available, in which production facilities more than ten times the size are being prepared. There are only about ten companies worldwide capable of commercial production of sustained release microspheres. Based on the mentioned technology, G2GBIO is focused on research and development for dementia treatment and diabetes treatment with sustained medicinal effect for up to a month, and post-operative pain treatment with sustained medicinal effect for up to a week. CEO Eom stated “Samyang Holdings Biopharmaceuticals Division has a diverse portfolio of biodegradable polymer materials and its own production plant, including polymer synthesis technology, so it is possible to supply substances tailored to the properties of drugs.” He added, “We will strive to improve the convenience of drug administration for patients by developing SRDDS that combines the technologies and infrastructures of both companies beyond simple substance supply.”   CEO Lee stated “Samyang Holdings Biopharmaceuticals Division has excellent technology and is the first in Korea to develop biodegradable surgical sutures.” He added, “Since the role of biodegradable polymers is important for sustained release drugs, we expect that this agreement will enhance product competitiveness and make it easier to enter overseas markets.”   Samyang Holdings Biopharmaceuticals Division has invested heavily in DDS from the beginning of its entry into the pharmaceutical business. In the late 1990s, it launched improved new drugs, such as Genexol® PM Inj. and Nanoxel® M Inj. using DDS technology as well as a DDS through the skin, such as the smoking cessation aid Nicostop® Patch and arthritis treatment Rheumastop® Plaster. Samyang Holdings Biopharmaceuticals Division has developed its own differentiated DDS platform that can be applied to biopharmaceuticals, among others, while also promoting the development of new drugs using the platform. Recently, it signed an MOU with mCureX, a subsidiary of the gene therapy developer OliX Pharmaceuticals, to develop a COVID-19 vaccine, and is researching an mRNA vaccine using stability enhanced nanoshell (mSENS), an independent DDS technology of Samyang Holdings Biopharmaceuticals Division.   Founded in 2017, G2GBIO is a biotech company specializing in the development of long-acting medicines. Currently, an investigational new drug (IND) is in progress for the development of a global improved drug for the treatment of sustained release dementia, and plans to continuously promote technology transfer and joint development in the future. Since its establishment, G2GBIO has secured approximately KRW 21.4 billion in investment attraction so far. Investors include Korea Investment Partners which participated in both Series A and B, QUAD Investment Management, Seoul Investment Partners, Emford Equity Partners, BNK Venture Capital, Industrial Bank of Korea, Arc Impact Asset Management, KDB Bank, CKD Venture Capital, Daedeok Venture Partners, AG Investment, G2G Invest Partners, and Biotoxtech.

  • Samyang Holdings Biopharmaceuticals Division 2021.04.05
    Samyang Biopharmaceuticals Corporation’s Bendalid Inj. Signaling Successful Market Entry
    Samyang Biopharmaceuticals Corporation’s Bendalid Inj. Signaling Successful Market Entry

      - Seeks to enter large hospitals in just 1 month since its launch, and is under review by the DC in 15 hospitals - Ensures safety without injecting nitrogen gas with its independently developed method using drug substances from Germany - Seeks to expand abroad as the only generic launched in both 25 mg and 100 mg bottles   ▲Blood cancer drug Bendalid Inj. successfully localized by Samyang Biopharmaceuticals Corporation   Samyang Biopharmaceuticals Corporation’s blood cancer drug Bendalid Inj. (ingredient: bendamustine) is signaling successful market entry as it seeks to advance into large hospitals in just 1 month since its launch.   Samyang Biopharmaceuticals Corporation (CEO Eom Tae-ung) announced on Mar. 31 that Bendalid Inj. is under review by the drug committee (DC) of 15 university hospitals. The DC procedure intends to determine whether a drug can be prescribed in a hospital.   Bendalid Inj. is a generic drug of Eisai Korea’s Symbenda Inj. and has indications for combination therapy with the target anti-cancer drug rituximab in follicular lymphoma, a malignant tumor in lymphatic tissue, chronic lymphocytic leukemia, a type of blood cancer, and multiple myeloma.   Samyang Biopharmaceuticals Corporation has successfully localized bendamustine, for which the country has solely relied on imports, and launched the first generic in both 25 mg and 100 mg bottles on Mar. 1. Except for the original drug’s company, Samyang Biopharmaceuticals Corporation is the only company that launches bendamustine in both doses of 25 mg and 100 mg.   In particular, Samyang Biopharmaceuticals Corporation’s Bendalid Inj. ensures safety without injecting nitrogen gas with its independently developed low-temperature manufacturing method and uses drug substances from Germany to improve reliability in quality.   An official from Samyang Biopharmaceuticals Corporation said, “Samyang Biopharmaceuticals Corporation is the only company in Korea that can produce both 25 mg and 100 mg bottles of bendamustine. As Pharmaceutical Plant in Daejeon, which produces Bendalid Inj., has been certified for European and Japanese GMP, we will expand abroad.”   Meanwhile, Samyang Biopharmaceuticals Corporation began to expand its cytotoxic anti-cancer injection factory last year to boost its global contract development and manufacturing organization (CDMO) business. Currently, a factory whose expected total capacity covers 5 million vials including 4 million liquid injection vials and 1 million lyophilisation vials is being expanded in Daejeon.

  • Samyang Holdings Biopharmaceuticals Division 2021.03.22
    Samyang Biopharmaceuticals Corporation Hosted Webinar for Oncologists in Southeast Asia
    Samyang Biopharmaceuticals Corporation Hosted Webinar for Oncologists in Southeast Asia

    - Shared the latest trends in anticancer therapy using “Genexol PM” with 200 healthcare professionals from Korea, Vietnam, Malaysia, and Thailand - Exporting drug substances and drug products to 50 companies in 20 countries including advanced ones such as Germany and Japan - “We will continue to host online webinars to share the latest insights on Genexol PM and various anticancer drugs” ▲ Around 200 healthcare professionals attended a webinar hosted by Samyang Biopharmaceuticals Corporation.   Samyang Biopharmaceuticals Corporation shared the latest trends in anticancer therapy based on Genexol PM Inj. with oncologists in Southeast Asia. Genexol PM is an anticancer drug that has improved the shortcoming of Genexol Inj. (active ingredient: paclitaxel) for breast cancer, ovarian cancer, and lung cancer.   Samyang Biopharmaceuticals Corporation (CEO: President Eom Tae-ung) announced on March 15 that the company hosted a webinar under the title of “Breast Cancer Patient Treatment with Genexol PM (export name for Southeast Asia: Paxus PM)” participated by around 200 healthcare professionals from Korea, Vietnam, the Philippines, Malaysia, and Thailand.   In this webinar, Prof. Kim Sung-bae from the Department of Oncology, Asan Medical Center and Dr. Mohamed Ibrahim A. Wahid from Beacon Hospital, Malaysia, gave presentations. Professor Kim, who participated in a Phase III trial of breast cancer, shared the effect and latest clinical cases of Genexol PM Inj. in breast cancer patients.   Genexol PM Inj., to which Samyang Biopharmaceuticals Corporation’s drug delivery system was applied to overcome the shortcoming of paclitaxel which hardly dissolves in water, was launched in 2006 in Korea. While traditional paclitaxel injections have had a limitation in dose due to toxicity/side effects associated with solubilizer, Genexol PM do not include any solubilizer, thus enabling the high-dose administration.   Southeast Asian healthcare professionals attending the webinar asked breast cancer treatment experiences using Genexol PM and showed great interest in Genexol PM.   Samyang Biopharmaceuticals Corporation succeeded in mass production of paclitaxel from plant cell culture for the first time in the world in 1995. After it started exporting drug substances in 2002, the company also began to export Genexol Inj. drug products since 2003. Currently, Samyang Biopharmaceuticals Corporation is exporting various anticancer drug substances and products to 50 companies in about 20 countries around the world including advanced ones such as Germany and Japan.    In partnership with “Kalbe International,” Samyang Biopharmaceuticals Corporation exports Genexol and Genexol PM under the name of Paxus and Paxus PM to Indonesia, Vietnam, the Philippines, Malaysia, and Thailand. The company will soon export them to Myanmar as well. Kalbe International is a subsidiary responsible for exporting and importing pharmaceuticals under the Kalbe Group, the largest pharmaceutical group in Indonesia.   An official from Samyang Biopharmaceuticals Corporation said, “From this webinar, we have confirmed that there was a lot of interest regarding Genexol PM among healthcare professionals abroad. Once we obtain additional clinical data including more indications and methods of administration, Genexol PM can be used in more various ways. We will continue to host online webinars to share the latest insights on Genexol PM and other anticancer treatment with healthcare professionals in Korea and abroad.”  

  • Samyang Holdings Biopharmaceuticals Division 2021.02.05
    Samyang Biopharmaceuticals Corporation’s croquis Initiating Its Entry into the Southeast Asian Market with Participation in i-SWAM
    Samyang Biopharmaceuticals Corporation’s croquis Initiating Its Entry into the Southeast Asian Market with Participation in i-SWAM

    - Introduced the facelift thread brand croquis to healthcare professionals by participating in i-SWAM hosted in Indonesia - Director Choi Ho-sung at Piena Clinic demonstrated croquis… shared the latest facelift procedure - Promote the safety and efficacy of croquis to customers around the world through non-contact academic marketing   ▲ Samyang Biopharmaceuticals Corporation participated in International Seminar & Workshop in Aesthetic Medicine (i-SWAM) hosted in Jakarta, Indonesia from and shared the latest procedure based on its facelift thread brand croquis.   Samyang Biopharmaceuticals Corporation (CEO & President Eom Tae-ung) is promoting its facelift thread brand croquis in the Southeast Asian cosmetic surgery market.   Samyang Biopharmaceuticals Corporation announced on Jan. 28 that it participated in International Seminar & Workshop in Aesthetic Medicine (i-SWAM) hosted in Jakarta, Indonesia from Jan. 5 and shared the latest procedure based on its facelift thread brand croquis. The name croquis originates from a drawing technique that quickly sketches the outlines of a model and fittingly, the product promotes its ability to lift up the facial outlines quickly and naturally.   i-SWAM, which marks the 11th anniversary this year, is a Southeast Asian cosmetic surgery conference attended by 3,500 officials in cosmetic surgery and medicine around the world. This year, it can only be attended online until Jan. 30 due to COVID-19.   In this real-time streaming webinar, Samyang Biopharmaceuticals Corporation demonstrated a croquis-based procedure and promoted the advantages of croquis to healthcare professionals in cosmetic surgery and medicine around the world. This lecture featuring a procedure performed by Director Choi Ho-sung at Piena Clinic introduced the basic procedure with croquis to obtain the optimal effect in each part of the face, the latest procedure reflecting facelift thread trends, and other various thread lift procedures.   An official from Samyang Biopharmaceuticals Corporation said, “Indonesia is being highlighted for its high growth potential in the Southeast Asian cosmetic surgery market. Starting with Indonesia this year, we are planning to actively promote the safety and efficacy of croquis to customers around the world through non-contact academic marketing.”   Meanwhile, Samyang Biopharmaceuticals Corporation’s croquis is earning trust in the global aesthetic medicine market with data-oriented marketing, despite its disadvantages as a late comer to the market. Samyang Biopharmaceuticals Corporation aims for evidence-based marketing and is making its best effort to obtain various data to prove a correlation between operative effects in each part of the face and the thread’s physical properties, unlike traditional aesthetic thread brands that only compare and emphasize before and after effects of the operation.  

  • Samyang Holdings Biopharmaceuticals Division 2021.01.05
    Samyang Biopharmaceuticals Corporation successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company
    Samyang Biopharmaceuticals Corporation successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company

    - Obtained marketing authorization for its myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg and 150 mg - To begin export to 17 EU countries including Germany in the first quarter of the next year and take strategy differentiating with two doses - Improved international credibility with authorization from rigorous drug regulatory authorities in Germany to expand globally   ▲ Samyang Biopharmaceuticals Corporation’s myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg (left) and 150 mg (right)   Samyang Biopharmaceuticals Corporation, a biomedical affiliate in the Samyang Group, successfully launched its anti-cancer treatment drug Azacitidine Injection in the EU for the first time as a Korean company.   Samyang Biopharmaceuticals Corporation (CEO & President Eom Tae-ung) announced on December 28 that the company obtained marketing authorization for two doses of its myelodysplastic syndrome (MDS) drug Azacitidine Injection 100 mg and 150 mg from German drug regulatory authorities. MDS is a type of rare incurable blood cancer caused by abnormalities with the process of producing blood in marrow, which decreases the numbers and functions of blood cells such as red blood cells, white blood cells, and platelets below a normal level.   With this authorization, Samyang Biopharmaceuticals Corporation will begin exporting to Germany and expand its exports to 16 countries in Europe in the first quarter of the next year (France, Spain, Italy, Sweden, Austria, Norway, Denmark, Finland, Ireland, Netherlands, Poland, Iceland, Malta, Czech Republic, Bulgaria, and Slovakia). Under the decentralized procedure (DCP), a company is given the authority to export to EU member states after it completes the national phase. The national phase checks whether translation is correct and accurate in the label and package insert.   Samyang Biopharmaceuticals Corporation has launched two doses—100 mg and 150 mg—in an effort to differentiate itself from other competitors only currently providing 100 mg in the European market. The dosage of the anti-cancer drug is determined based on the patient’s body surface area, reducing a financial burden for the patient and making it easier for health professionals to prepare the drug.   Azacitidine Injection is a MDS drug (local Korean drug name: Vidaza Injection) developed by the multinational pharmaceutical Celgene. According to IQVIA, a global pharmaceutical market research firm, the azacitidine market in the EU last year was about KRW 500 billion. The MDS Foundation also estimates that the world has 87,000 new patients annually.   An official from Samyang Biopharmaceuticals Corporation said, “We obtained authorization from drug regulatory authorities in Germany whose authorization process is rigorous even within the EU, and this has improved our international credibility. Samyang Biopharmaceuticals Corporation is recognized in the global market as the only Korean company certified with both EU and Japanese GMP (good manufacturing practice) for cytotoxic anti-cancer injections.”   Samyang Biopharmaceuticals Corporation obtained EU GMP for drug substances in 2005 and finished products in 2014 and has maintained the practice up until today. In 2010, the company acquired GMP certification from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Last year, the company received review by the German Ministry of Health and Consumer Protection (Behörde für Gesundheit und Verbraucherschutz; BGV) in Hamburg, Germany, renewed EU GMP for 4 injections—Paclitaxel, Oxaliplatin, Docetaxel, and Pemetrexed—and acquired new authorization for Azacitidine Injection.   Meanwhile, Samyang Biopharmaceuticals Corporation began to expand its cytotoxic anti-cancer injection factory last year to boost its global contract development and manufacturing organization (CDMO) business. Currently, a factory whose expected total capacity covers 5 million vials including 4 million liquid injection vials and 1 million lyophilisation vials is being expanded in Daejeon.  

  • Samyang Holdings Biopharmaceuticals Division 2020.11.16
    Samyang Biopharmaceuticals Corporation Targeting the Korean Market by Localizing an Antibacterial Biodegradable Suture
    Samyang Biopharmaceuticals Corporation Targeting the Korean Market by Localizing an Antibacterial Biodegradable Suture

    - Successfully developed a biodegradable suture coated with an antibacterial material for the first time in Korea - Passed an international standard test for antibacterial activity and proved its effectiveness in a clinical study in Korea - Samyang Biopharmaceuticals Corporation, improving its brand awareness and market share in Korea with its premium biodegradable suture   ▲ Samyang Biopharmaceuticals Corporation has launched Korea’s first antibacterial biodegradable suture Neosorb Plus.   Samyang Biopharmaceuticals Corporation is promoting its brand in the Korean suture market with biodegradable finished product. A biodegradable suture absorbs in the human body after a certain period of time and is used in surgery to stitch up organs or mucous membranes where it is difficult to remove seams.     Samyang Biopharmaceuticals Corporation (CEO & President Eom Tae-ung) announced on November 12 that the company launched Korea’s first antibacterial biodegradable suture “Neosorb Plus.” The antibacterial biodegradable suture is a biodegradable suture coated with antibacterial substance called chlorhexidine. When a suture is coated with an antibacterial material, bacteria do not proliferate even if they come into contact with the suture, reducing the risk of infections in the surgery site.     Samyang Biopharmaceuticals Corporation’s Neosorb Plus completed an international standard test for its antibacterial effect and proved equivalence to conventional biodegradable sutures in terms of user convenience and treatment effectiveness.     The company is launching it in 3 types depending on the use: general, removable (RM), and needleless. The RM type removes a needle only with hands without scissors and improves efficiency and convenience during surgery.   The release of Neosorb Plus enabled the localization of the antibacterial biodegradable suture for the first time, which were all imported thus far. Samyang Biopharmaceuticals Corporation is planning to supply the products starting mid-November through its designated domestic distributor BTK.     With this launch of the new product, Samyang Biopharmaceuticals Corporation is planning to enter the domestic biodegradable suture market by offering premium suture products. Despite the long history of Samyang Biopharmaceuticals Corporation, which successfully developed a biodegradable suture for surgery in 1993 for the first time in Korea and has started commercial production since 1996, the company has focused on targeting the global market with suture yarn. Last year, Samyang Biopharmaceuticals Corporation accounted for the largest share in the global suture yarn market worth USD 70 million dollar as it exported USD 40 million of suture yarn annually. 200 companies from 40 countries including the U.S., Japan, Europe, Southeast Asia, and Latin America are using Samyang Biopharmaceuticals Corporation’s biodegradable suture yarn.     An official from the company said, “While our suture is recognized internationally to the extent that 90% of Samyang Biopharmaceuticals Corporation’s suture revenue comes from overseas, our brand awareness in Korea is relatively lower. By localizing an antibacterial biodegradable suture, which has been completely dependent on imports so far, we will improve Samyang Biopharmaceuticals Corporation’s brand awareness and share in the domestic biodegradable suture market with our premium products.”     Meanwhile, Samyang Biopharmaceuticals Corporation is also producing and selling medical devices originally developed based on biodegradable materials such as hemostat, anti- adhesive, and surgical mesh in addition to sutures. The company launched the cosmetic surgery thread brand “Croquis” last year. Croquis is a biodegradable suture used in a facelift procedure designed to improve skin elasticity and wrinkles. Along with cosmetic surgery threads newly being approved in China and Europe, etc., strengthened scientific evidence and data are required as well. In line with the market demand, Samyang Biopharmaceuticals Corporation is conducting research with dermatologists and plastic surgeons in the U.S., France, and Spain to obtain various data that prove a relationship between the thread’s physical properties and its treatment effect on facial parts.

  • Samyang Holdings Biopharmaceuticals Division 2020.11.13
    Samyang Biopharmaceuticals Corporation’s Croquis Put Forward a New Landscape in Facelift Procedures in an International Conference
    Samyang Biopharmaceuticals Corporation’s Croquis Put Forward a New Landscape in Facelift Procedures in an International Conference

    - Participated in AMWC, one of the two biggest aesthetic medicine conferences, to demonstrate and publish study outcomes for facelift thread brand Croquis - Combined the advantages of non-fixed and fixed procedures…reducing side effects and improving facelift effects at the same time - Praised by global researchers for “Croquis’s best retention among other threads studied so far”   ▲ Samyang Biopharmaceuticals Corporation participates in Aesthetic and Anti-aging Medicine World Congress (AMWC) 2020 to raise global brand awareness for its facelift thread brand Croquis.     Samyang Biopharmaceuticals Corporation (CEO & President Eom Tae-ung) announced on November 6 that the company participated in the Aesthetic and Anti-aging Medicine World Congress (AMWC) 2020 to raise global brand awareness for its facelift thread brand Croquis. Croquis comes from a drawing technique of the same name which quickly sketches the outlines of a model, and has a meaning of lifting the facial outlines quickly and naturally.   AMWC is one of the two biggest aesthetic medicine conferences and marks its 18th anniversary this year. While it was originally scheduled in April but delayed due to COVID-19, AMWC is live-streamed virtually around the world from November 5 to 7 in Monaco, Europe.     From November 5 to 6 (based on local time), the company will be promoting Croquis by demonstrating and publishing study outcomes online with healthcare professionals from Korea and abroad. On November 5, the first day of AMWC, Dr. Kang Seung-hoon, the CEO of the Four Seasons Skin Clinic, will demonstrate how to use Croquis along with a procedure video. With this, Dr. Kang will be presenting a paradigm from the view of facial tissue rearrangement such as thread insertion or tissue fixation to obtain the optimal effect for different parts of the face.     Meanwhile on November 6, Drs. Hema Sundaram and Henry Delmar, medical practitioners in the US and France, will give a presentation about the interim results of Croquis’s global case studies. Since last year, Samyang Biopharmaceuticals Corporation has conducted clinical studies with dermatologists and plastic surgeons in the US and France with the aim of obtaining data on properties—such as thread strength, elasticity, and tension—required to obtain the desired effect for different parts of the face. Together they focused on demonstrating whether a Croquis-based non-fixed facelift procedure creates an effect equivalent to or higher than a fixed procedure. Although the fixed procedure fixes a facelift thread in the subcutaneous tissue around the temple and has a high level of facelift retention, some patients may experience bleeding or pain due to fixation, which takes longer recover time than the non-fixed procedure.     The study showed that Croquis showed a more-than-equivalent facelift retention effect with the non-fixed procedure compared to the fixed one, led to less bleeding, and took shorter time in recovery. The medical practitioners in the case studies evaluated that Croquis has the best retention among other non-fixed threads they studied so far. Samyang Biopharmaceuticals Corporation is planning to put together the results of the ongoing case studies and officially publish them in January next year.     An official from the company said, “Croquis was manufactured under strict quality control and shows a high level of efficacy and safety on non-fixed procedures. In the rest of our case studies, we will obtain the thread's data for properties required to obtain the optimal effect for different parts of the face, demonstrate its outstanding effect, and publish the results in various global conferences.”   Meanwhile, Samyang Biopharmaceuticals Corporation’s Croquis overcame disadvantages as a late comer with data-oriented and evidence-based marketing strategies and is earning trust in the global aesthetic medicine market. While traditional aesthetic thread brands only compare and emphasize preoperative and postoperative effects, company aims for evidence-based marketing, collects and analyzes case studies with key opinion leaders (KOL) in Korea and abroad, and obtains clinical evidence for a safe and effective facelift procedure.    

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