Welcome!

News Feed Item

3SBio Signs Exclusive Patent License Agreement with DiNonA for Leukotuximab

Leukotuximab is a novel, first-in-class Leukemia-specific mAb targeting JL-1

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

 

SOURCE 3SBio Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, will discuss how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved effi...
Sensors and effectors of IoT are solving problems in new ways, but small businesses have been slow to join the quantified world. They’ll need information from IoT using applications as varied as the businesses themselves. In his session at @ThingsExpo, Roger Meike, Distinguished Engineer, Director of Technology Innovation at Intuit, showed how IoT manufacturers can use open standards, public APIs and custom apps to enable the Quantified Small Business. He used a Raspberry Pi to connect sensors...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Father business cycles and digital consumers are forcing enterprises to respond faster to customer needs and competitive demands. Successful integration of DevOps and Agile development will be key for business success in today’s digital economy. In his session at DevOps Summit, Pradeep Prabhu, Co-Founder & CEO of Cloudmunch, covered the critical practices that enterprises should consider to seamlessly integrate Agile and DevOps processes, barriers to implementing this in the enterprise, and pr...
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Data-as-a-Service is the complete package for the transformation of raw data into meaningful data assets and the delivery of those data assets. In her session at 18th Cloud Expo, Lakshmi Randall, an industry expert, analyst and strategist, will address: What is DaaS (Data-as-a-Service)? Challenges addressed by DaaS Vendors that are enabling DaaS Architecture options for DaaS
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, will give users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion w...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
SYS-CON Events announced today that FalconStor Software® Inc., a 15-year innovator of software-defined storage solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. FalconStor Software®, Inc. (NASDAQ: FALC) is a leading software-defined storage company offering a converged, hardware-agnostic, software-defined storage and data services platform. Its flagship solution FreeStor®, utilizes a horizonta...