BioInvent International
10.12.2021 13:18:53 CET | ACCESS Newswire | Press release
LUND, SE / ACCESSWIRE / December 10, 2021 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV) , a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA), China's medical product regulator, has approved a Clinical Trial Application (CTA) submitted by BioInvent's licensee in China, CASI Pharmaceuticals (CASI). The CTA is for the initiation of two clinical trials of BioInvent's novel anti-FcyRIIB antibody, BI-1206, in patients with non-Hodgkin's Lymphoma (NHL) in China.
BI-1206 is BioInvent's lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors, and the other in combination with rituximab for the treatment of non-Hodgkin's lymphoma.
CASI is planning Phase 1 trials of BI-1206 as a single agent with the aim to evaluate the PK profile and in combination with rituximab in NHL (mantle cell lymphoma, marginal zone lymphoma and follicular lymphoma) to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in China and associated markets. The studies are expected to start in H1 2022.
BioInvent and CASI have an exclusive licensing agreement for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau in both liquid and solid cancers, with CASI responsible for commercialization in China and associated markets. BioInvent is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206.
"We are very pleased to see the first fruit of our development collaboration with CASI on BI-1206. As BioInvent develops the drug candidate across Europe and the US, our partnership with CASI focusing on China, Hong Kong, Macau and Taiwan, adds significant shareholder value to the company. Our expanding pipeline of first-in-class immunotherapies creates multiple development and commercial opportunities for the company and its partners." said Martin Welschof, CEO of BioInvent.
"We are excited to be able to accelerate the development of BI-1206 in China and contribute to its global development. The collaboration has been open, fast, efficient and professional. We believe BI-1206 has great potential to improve NHL treatment in China and elsewhere." said Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer.
About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase l/ll trials for the treatment of hematological cancer and solid tumors, respectively and a fifth program just initiating clinical development. The Company's validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company's own clinical development pipeline or for additional licensing and partnering.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com .
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. (NASDAQ:CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd. ("CASI China"), which is located in Beijing, China. The Company has built a commercial team of over 100 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com .
For further information, please contact:
Cecilia Hofvander
Senior Director Investor Relations
+46 (0)46 286 85 50
cecilia.hofvander@bioinvent.com
BioInvent International AB (publ)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com
SOURCE: BioInvent International
View source version on accesswire.com:
https://www.accesswire.com/676974/BioInvent-and-CASI-Pharmaceuticals-Announce-CTA-Approval-for-Clinical-Studies-of-BI-1206-in-NHL-in-China
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
Tech "Talent Wars" Are Over as More Companies Prioritize Upskilling, General Assembly Report Finds25.2.2026 15:00:00 CET | Press release
83% of tech recruiters believe company success is more dependent on upskilling employees for AI versus hiring new talent, according to The State of Tech Talent 2026 NEW YORK CITY, NY / ACCESS Newswire / February 25, 2026 / Nearly all technology recruiters (96%) say technical roles are still at least a bit difficult to fill, as most (83%) believe their company's success is now more dependent on upskilling their existing employees for AI rather than hiring external talent, according to The State of Tech Talent 2026, the fourth annual report from AI training provider General Assembly, an LHH brand. "The AI skills gap is growing too fast for companies to hire their way out," said Daniele Grassi, CEO of General Assembly. "Continuous, incremental and role-specific learning is the only way to keep up with the pace of technology change. Growing investment in upskilling reflects leaders' realization that their existing employees bring the business context, institutional knowledge and cultural n
Around Half of Firms' Revenue Depends on Winning RFPs, but Many Lack Scalable Proposal Management Processes, QorusDocs Study Finds25.2.2026 15:00:00 CET | Press release
63% report higher RFP volumes - but up to 20% go unfinished due to resource constraints as proposal teams see 25 to 50% workload spikes SEATTLE, WA / ACCESS Newswire / February 25, 2026 / As B2B buying has become more structured, consensus-driven and risk-averse, proposals and RFPs have moved from a back-office task to a primary driver of revenue at professional services firms, according to new research from QorusDocs, a leader in AI-powered value and proposal management software. Once viewed as a downstream support function, proposal management, now directly shapes pipeline health, win rates and revenue outcomes. As AI disrupts the traditional billable-hour model and prompts corporate clients to question fees, proposal operations have emerged as a critical lever to protect margins and capture growth. However, growing RFP volumes have driven a 25 to 50% workload spike for proposal teams at most organizations. "Time, not intent, has become the primary constraint for modern proposal team
Assembly Chosen to Power Global Paid Media and Amazon Growth for Jabra24.2.2026 15:50:00 CET | Press release
LONDON, GB / ACCESS Newswire / February 24, 2026 / Assembly, the global omnichannel agency built to make brands perform, has been appointed by Jabra, world leading brand in audio, video, and collaboration solutions, as its global paid media agency and lead partner for Amazon services following a competitive pitch process. Assembly's remit spans full-funnel paid media across search, social, display, video, and retail media, alongside Amazon strategy and marketplace operations, to fuel Jabra's next phase of global growth. Pitch Consultants, Tuffon Hall Consultancy, commented: "This was an exceptionally competitive process, and Jabra's new move towards a direct-to-consumer model marks a major shift for the business. Assembly impressed with a powerful proposition, using their proprietary platform STAGE to create a true intelligence engine for Jabra that supports smarter, more connected growth." Why Jabra chose Assembly Assembly was selected for its ability to connect brand and performance,
GA-ASI Develops Long-Range Weapons Capabilities for MQ-9B23.2.2026 13:10:00 CET | Press release
Industry Leading UAS Expands Mission Roles To Include Naval Strike SAN DIEGO, CA / ACCESS Newswire / February 23, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) is developing the addition of long-range standoff weapons to its top-of-the-line MQ-9B SkyGuardian® and SeaGuardian®. Demand continues from naval and air warfighters for platforms that can hold targets at risk from great ranges, especially over the expanses of air and water in the Western Pacific. That's why GA-ASI engineers have begun the work of adapting MQ-9B's payload, stability, range and other features to accommodate the new generation of extended-range precision weapons. "MQ-9B continues to impress in the field and we keep adding to our global customer list," said GA-ASI President David R. Alexander. "We want to continue to build value in the aircraft by expanding into more missions. MQ-9B features extraordinary payload capacity, so it only makes sense to add to our mission sets with the ability to carry long
GA-ASI and USAF Demonstrate Manned-Unmanned Teaming With F-22 and MQ-20 In Joint Autonomy Exercise23.2.2026 13:05:00 CET | Press release
SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 23, 2026 / In collaboration with the U.S. Air Force, General Atomics Aeronautical Systems, Inc. (GA-ASI) conducted its latest demonstration performing an autonomous mission out of Edwards Air Force Base in Southern California using its MQ-20 Avenger® unmanned jet and an F-22 Raptor equipped with the latest government reference autonomy software. The test, which showcased Manned-Unmanned Teaming between the F-22 and MQ-20, leveraged autonomy and the tactical data link to enable coordination between the platforms. The mission included a live engagement between the MQ-20 and the F-22 as the command aircraft flown by an onboard human pilot, highlighting the ability to receive and execute teaming commands. "We appreciate the flawless execution of this mission using the government's advanced autonomous systems," said GA-ASI President David R. Alexander. "This demo featured the integration of mission elements and the ability of autonomy to ut
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom