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Press Releases

Press Releases

Samsung Biologics and TG Therapeutics Expand Collaboration for the Large Scale Manufacture of Ublituximab

TG_Samsung_Partnership_Image.jpg
 

Expanding upon an existing contract manufacturing deal first entered into in 2018; collaboration will further enable global manufacturing of ublituximab 

 

Incheon, S. Korea and New York, April XX, 2021 – Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization and TG Therapeutics (NASDAQ: TGTX), today announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.

 

“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” John Rim, CEO of Samsung Biologics, commented. Rim added, “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.”

 

Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.” 

 

In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients.

 

ABOUT UBLITUXIMAB

Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

TG_Samsung_Partnership_Image.jpg
 

Expanding upon an existing contract manufacturing deal first entered into in 2018; collaboration will further enable global manufacturing of ublituximab 

 

Incheon, S. Korea and New York, April XX, 2021 – Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization and TG Therapeutics (NASDAQ: TGTX), today announced an expansion of a large-scale contract manufacturing deal for the supply of TG Therapeutics’ ublituximab, an investigational anti-CD20 monoclonal antibody. TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, in combination with UKONIQTM (umbralisib), TG Therapeutics’ oral once-daily inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with CLL, based primarily on the positive results from the UNITY-CLL Phase 3 trial. Ublituximab was also the subject of two successful Phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS) and a BLA is currently being prepared for this indication.

 

“We are very glad to be able to flexibly accommodate our client’s expanded needs through our facilities,” John Rim, CEO of Samsung Biologics, commented. Rim added, “By supporting TG Therapeutics in this partnership, we are contributing to bringing needed treatments to patients around the world and getting a step closer to our vision of bringing about a better life for humanity.”

 

Michael S. Weiss, Executive Chairman and CEO of TG Therapeutics, stated, “Samsung is the global leader in biologics manufacturing and we are happy to have them as our partner as we look forward to the potential commercialization of ublituximab across both oncology and autoimmune indications. With the recent positive ULTIMATE I and II MS Phase 3 studies, we re-evaluated our supply needs and were very pleased we were able to secure the long-term capacity we believe we will need to meet the potential global demand for ublituximab. This is an important next step in our long-standing relationship with Samsung.” 

 

In order to support all its current and potential clients around the world, Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion of the said plant in 2023, Samsung Biologics will hold 620,000 liters of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally. The company provides contract manufacturing, contract development, and testing services all from a single location, offering end-to-end services for its clients.

 

ABOUT UBLITUXIMAB

Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth or function of B-cells.

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Effective Date: [30Dec2019]

This Privacy Policy illustrates how Samsung Biologics ("we", “our”, “us”) use and protect information you provide through your use of this website (the "Website") or our customer inquiry and recruitment services (collectively the “Services”).

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When you fill out the “Contact Us Form” on our Website, we may collect the following types of information:

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When you submit your application via “TalentPool” on our Website, we may collect the following types of information:

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    Recruitment infomation include Category, Information we may collect from you.
    Category Information we may collect from you
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    Optional Any additional information you provide including but not limited to personal profiles on SNS
    Application Form
    (in Korean)
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    Education History (Name of School, Major, Enrollment Year/Month, Graduation Year/Month, Location), Employment History (Employment Period, Company, Job Title, Job Scope, Major Task), Language, Miscellaneous (Military Status, Reason for Exemption, Veteran Status)
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1.Customer Inquiry

We may use the information we collect from you to conduct certain services or activities such as replying to inquiries, maintaining business records, and conducting market research.

2.Recruitment

In order to proceed with recruitment process and communicate status/result of job application(s).

Sharing information with third parties

We will not disclose your information to third parties for their marketing or business purposes without your consent. However, notwithstanding the above, we may disclose your information to the following entities for recruitment purposes:

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  • Service providers.
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  • Other parties when required by law or as necessary to protect our rights.
    There may be instances where we disclose your information to other parties:
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  • Other parties with your consent or at your direction.
    In addition to the disclosures described in this Privacy Policy, we may disclose information about you to third parties when you consent to or request such disclosure.
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To the extent permitted under applicable law(s), you may ask us to return, destroy, or correct any inaccuracies regarding your personal information. You may also ask us to restrict or limit our use of your personal information unless such restriction or limitation prevents us from complying with applicable law(s) or meeting a legal obligation.

However, your rights above may be limited in cases where your request would disclose personal information of a third party or where such a request would infringe the rights of a third party (including our rights) or if you ask us to delete information which we are required by law to preserve or have legitimate interests in retaining. Other relevant exemptions may exist under the GDPR and national laws. We will inform you of the relevant exemptions when responding to your request. To make such a request concerning your rights set forth herein, please refer to the Contact Us section below.

International Transfer of Information

We are a company based in Korea, and your use of our Website and Services will involve the transfer, storage, and processing of your personal information in Korea. Please note that the information protection laws and other applicable laws of countries outside the European Economic Area (“EEA”), to which your information may be transferred, might not be as comprehensive as those in your country. We will take appropriate measures, in compliance with applicable law, to ensure that your personal information remains protected. Such measures include the use of EU Standard Contractual Clauses to safeguard the transfer of information outside of the EEA or other methods. For more information, please contact us at privacy.bio@samsung.com.

Data Retention

We will retain your personal information for a reasonable period of time that enables us to communicate with you, to provide you with Services, to maintain business records for audit purposes, to meet recordkeeping requirements under applicable law(s), to defend or bring any legal claims and to deal with any queries or complaints you may have.

Keeping Your Information Secure

We have put in place reasonable measures to safeguard the information we collect in connection with the Services. However, please note that although reasonable steps will be taken to protect your information, no website, internet transmission, computer system or wireless connection is 100% secure from any and all potential threats.

Personal Information – Children under the age of 13

The Services are designed for general audience and are not intended or directed to children.

For US Residents Only

In connection with the Services, we will not knowingly solicit or collect personal information from children under the age of 13. In the event we do collect such personal information inadvertently or unknowingly and we later learn about it, we will promptly delete such information. If you believe that children under the age of 13 may have provided personal information to us, please contact us using the Contact Us section of this Privacy Policy.

If You are an individual resident in the EU

We process your personal information on the legal grounds that the processing is :

  • Necessary for the performance of contractual obligation(s) between you and us, for example if we’re providing service(s) that you have requested;
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If you do not provide certain information to us, we may, in some circumstances, be unable to comply with our obligations or provide you with the services that you request. We will inform you of the implications of not providing certain information.

As set forth in the “Your rights” section, you are entitled, in accordance with applicable law, to object to or request restriction of processing your personal information, and to request access to, correction of, or deletion of your personal information. When we use your information on the basis of your consent, you have the right to withdraw such a consent at any time. Any requests should be submitted in writing to the address listed below in the “Contact Us” section. You also have the right to file a complaint with data protection authorities.

Contact Us

If you have any questions about this Privacy Policy, please contact us using the details below.

- Contact : 032-455-9829

- Email : privacy.bio@samsung.com

Changes to this Privacy Policy

We may update this Privacy Policy from time to time. When we update the Privacy Policy, we will revise the “Effective Date” above and post the new Privacy Policy with a new date. We recommend that you review the Privacy Policy each time you visit our Website to stay informed of our most current practices and policies.

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