Navigation Links
3SBio Signs Exclusive Patent License Agreement with DiNonA for Leukotuximab
Date:8/7/2014

SHENYANG, China, Aug. 7, 2014 /PRNewswire/ -- 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive license with DiNonA Inc. for the development, manufacturing and marketing of Leukotuximab, an anti JL-1 antibody for acute leukemia (AL), including acute myelocytic leukemia (AML) and acute lymphoblastic leukemia (ALL), in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and the Middle East (excluding Cyprus, Egypt, Israel and Turkey).

In addition to an upfront payment, milestone payments will be made after completion of technology transfer, approval of Investigational New Drug (IND) application by the China Food and Drug Administration (CFDA), completions of Phase I to Phase III clinical trials and marketing approval in China. 3SBio will also pay DiNonA a sales-based royalty. Additional terms of the license are not being disclosed.

The incidence rate for AML is 1.6 per 100,000 annually; the incidence rate for ALL is 0.4 per 100,000 annually. In China, there are about two to three million existing AL patients. Among them, between 30,000 and 40,000 patients are newly diagnosed each year. Patients are currently treated with traditional chemotherapy and bone marrow transplant, both of which have major side effects.

Researchers from DiNonA have developed Leukotuximab, an anti-leukemic agent for JL-1+ acute leukemia. This antibody is targeting JL-1 Ag, an epitope of human CD43 extracellular domain. JL-1 is expressed on tumor cells of T, B, and myeloid lineages in more than 80% of acute leukemia patients, but not on mature peripheral blood cells or other normal tissues. Since the expression of JL-1 is highly associated with hematopoietic malignancies and is selectively expressed on the surface of human leukemic cells, anti-JL-1 mAb can be an excellent targeted reagent for treatment of the leukemia.

Leukotuximab showed significant improvement in survival in leukemia animal models. Also, no evidence of toxicity was observed in study animals. An open label and dose-escalating Phase I clinical trial in Korea started at June 2014 and is expected to finish in late 2015.

"We are pleased to collaborate with DiNonA and look forward to moving Leukotuximab into clinical trials in China," Dr. Jing Lou, CEO of 3SBio commented, "3SBio continues to seek opportunities to support novel biologics, especially mAb candidates for blood cancer and other unmet medical needs, particularly in 3SBio's core therapeutic areas of oncology, nephrology and hematology."

"Leukotuximab is a drug candidate with great potential to treat acute leukemia," Dr. Hyung-Geun Song, CEO of DiNonA commented, "3SBio is an established industry leader in the innovative biological field in China, which makes them an ideal partner for long-term collaboration. We are looking forward to working with 3SBio to maximize this opportunity and benefit tens of thousands of Chinese patients suffering for acute leukemia and other severe diseases."

About DiNonA Inc.

DiNonA Inc. is a leading biotechnology company in Korea. DiNonA is focused on medication development for therapeutic antibodies, laser medical devices, and diagnosis/research agents. Leukotuximab, the leading candidate in its pipeline, has entered into Phase I trial in Korea. There are several other mAb candidates also under pre-clinical development.

About Leukotuximab

Leukotuximab is an anti-leukemic monoclonal antibody for JL-1+ Acute Leukemia. The anti JL-1 antibody is targeting JL-1 Ag, an epitope of human CD43 extracellular domain. JL-1 is expressed on tumor cells of T, B, and myeloid lineages in >80% of acute leukemia patients, but not on mature peripheral blood cells or other normal tissues. Since the expression of JL-1 is highly associated with hematopoietic malignancies and is selectively expressed on the surface of human leukemic cells, anti-JL-1 mAb can be an excellent targeted reagent for treatment of the leukemia.

About 3SBio Inc.

3SBio is a fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China. Since its founding in 1993, 3SBio's R&D efforts have resulted in four NDAs for biological medicines, including TPIAO, the first rhTPO approved worldwide. Pipeline candidates include Uricase PEG-20, a modified pegylated recombinant uricase from Candida utilis for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase 1 trials; NuPIAO, a long-acting erythropoiesis-stimulating agent (ESA) for anemia associated with renal failure or chemotherapy and peri-operative blood cell mobilization which has received CFDA approval to initiate clinical trials; and SSS07, an anti-TNF monoclonal antibody for treating rheumatoid arthritis, psoriasis, and potentially other inflammatory diseases. A new state-of-the-art mammalian biological manufacturing facility in Shenyang is the first and only rhEPO facility in China that conforms to both Chinese and European pharmacopeia standards. Planning is underway to develop monoclonal antibody manufacturing capabilities. 3SBio is China's leading specialist in nephrology and oncology supportive care with more than 600 sales professionals covering over 3,000 hospitals in key cities supported by a nationwide network of 120 distributors and logistics providers. EPIAO has been the top selling rhEPO product in China since 2002 with a market share over 40%. Please see www.3sbio.com for additional information.

Business Development Contacts

Tan Bo

Chief Financial Officer

3SBio Inc.

B-13, Grand Place

5 Huizhong Road

Chaoyang District

Beijing, China 100101

Tel: +86 10 8489 2211

Fax: +86 10 8489 2951

Email: tanbo@3sbio.com

Jiang Fei, PhD

Director, Business Development
3SBio Inc.

Shenxin Building 801-802

200 Ninghai Dong Rd

Huangpu District

Shanghai, China 200021

Tel: +86 186 4022 0510

Fax: +86 21 6374 4922

Email: jiangfei@3sbio.com

Tom Folinsbee

Director, Corporate Development

3SBio Inc.

Unit 402 Fairmont House

No.8 Cotton Tree Drive

Admiralty

Hong Kong

Tel: +852 8191 6991

Fax: +852 3007 9376

Email: tomfolinsbee@3sbio.com

Donald Wyatt

VP, Business Development &
Alliance Management

3SBio Inc.

No. 3 A1, Road 10

Shenyang Economy &
Technology Development Zone,
Shenyang, China 110027

US Tel: +1 425 516 7491

China Tel: +86 138 1816 5538

Email: donaldwwyatt@3sbio.com

 


'/>"/>
SOURCE 3SBio Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. 3SBio Inc. Schedules Unaudited First Quarter 2012 Results
2. 3SBio Inc. To Present at the DB Access Asia Conference 2012
3. 3SBio Obtains SFDA Approval to Join Global Phase III Trial for Voclosporin
4. 3SBio Inc. Schedules Unaudited Second Quarter 2012 Results
5. 3SBio Inc. Announces Changes to Its Board of Directors
6. Apexigen Announces the Filing of an IND by its Partner, 3SBio
7. 3SBio Inc. to Hold 2012 Annual General Meeting on October 10, 2012
8. 3SBio Inc. Announces Receipt of "Going Private" Proposal at $15 Per ADS
9. 3SBio Independent Committee Selects Legal Counsel in connection with Going Private Proposal
10. 3SBio Inc. Announces Unaudited Third Quarter 2012 Results
11. 3SBio Inc. Schedules Unaudited Fourth Quarter and Full Year 2012 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... LONDON , Feb. 9, 2016 Hearing ... amount of sound energy transmitted to the inner ear. ... and hearing bands. These devices are recommended for users ... eight hours. Earplugs refer to HPD that are inserted ... attenuation earplugs are designed to provide more natural sound ...
(Date:2/9/2016)... -- Increasingly, health care professionals are enhancing patient care and ... With the Vios Monitoring System from Vios Medical, health ... problems before they become serious by continuously tracking and ... the United States . --> ... --> The Vios Monitoring System connects patient-worn sensors, ...
(Date:2/9/2016)... -- The new report "Global Anti-Bacterial Drugs Market Assessment & Forecast: ... reveals that the North America continued to ... 2014 that translated into revenues worth US$ 16,907.3 million. ... Asia-Pacific , Latin America , ... The global anti-bacterial market is inclined towards North America ...
Breaking Medicine Technology:
(Date:2/9/2016)... ... ... The Journal of Pain Research has published the commentary “ Terminology of ... Dr John F. Peppin says “Terminology matters, yet little attention has been paid to ... cancer pain’ and ‘chronic non-cancer pain’ are replete in the literature; however, the distinction ...
(Date:2/9/2016)... , ... February 09, 2016 , ... ... The guide will ensure lab personnel have a basic understanding of the techniques ... measurement protocols. Enhanced understanding will help them reduce waste and rework to create ...
(Date:2/9/2016)... , ... February 09, 2016 , ... ... cleaning and sealing company , is proud to announce that many of their ... levels of customer service. The hard surface restoration franchises received customer recognition through ...
(Date:2/8/2016)... PLAINSBORO, N.J. (PRWEB) , ... February 08, 2016 , ... ... on cancer patients, has officially launched the Multiple Myeloma Heroes Awards event , ... (MM) or in the lives of patients with MM. The MM Heroes Awards ...
(Date:2/8/2016)... ... February 08, 2016 , ... Stephanie ... celebrates the beginning of a new charity campaign. As part of their ongoing ... Advocates (CASA). In the belief that children deserve a voice, and in the ...
Breaking Medicine News(10 mins):