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
GA-ASI Partnering With Spirit Defense For FQ-42 CCA Production23.10.2026 18:00:00 CEST | Press release
SAN DIEGO, CA / ACCESS Newswire / October 23, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI), the world leader in Uncrewed Aircraft Systems (UAS), today is announcing our partnership with Spirit Defense, a Boeing Company, to support airframe production of the new FQ-42 Vengeance Collaborative Combat Aircraft (CCA). In June, GA-ASI won a contract from the U.S. Air Force (USAF) to produce FQ-42. Spirit Defense's role as a fuselage design-build partner brings together the company's engineering and advanced manufacturing capabilities to support the program from design through production. GA-ASI has been the sole manufacturer of its line of UAS - which includes MQ-9A Reaper®, MQ-1C Gray Eagle®, MQ-20 Avenger®, and MQ-9B SkyGuardian®/SeaGuardian - since the company's inception in 1992. For the FQ-42 program, partnering with Spirit Defense is a strength multiplier for the company and the nation, offering manufacturing capacity and industrial depth to scale CCA production faster, w
Study Finds Lower Rates of Overweight Among Vegan-Fed Cats23.10.2026 16:45:00 CEST | Press release
LONDON, UK / ACCESS Newswire / October 23, 2026 / A large-scale survey published in Frontiers in Animal Science has found cats fed vegan diets had lower rates of obesity and related health problems, than those fed conventional meat-based diets. An online survey analysed carer-reported veterinary assessments of 1,305 cats fed either conventional meat-based (90%) or vegan (10%) diets for at least one year. After accounting for factors including age, sex, neuter status, activity and feeding practices, vegan-fed cats had 34% lower odds of being assessed as overweight. However, the difference was not statistically significant, in part reflecting the relatively small number of vegan-fed cats. For several body weight-related problems, no vegan-fed cats were affected. Nevertheless, researchers say the findings show an interesting trend that warrants further investigation. Overweight and obesity are common in domestic cats, with veterinary studies estimating that around 30-60% of cats are overw
Leggett Dynamics's Mid-Class Massage System Wins Gasgoo's Best Technical Practice Award23.10.2026 16:00:00 CEST | Press release
SHANGHAI, CHINA / ACCESS Newswire / October 23, 2026 / Leggett Dynamics today announced that its Mid-Class Massage System (MCM) received Gasgoo's Best Technical Practice Award during a ceremony held at the 14th annual Automotive & Environment Innovation Forum in Shanghai. The Gasgoo Best Technical Practice Award honors automotive technologies that have proven innovation, production readiness and measurable customer value in real-world vehicle applications. The judging panel cited MCM's innovation that achieves affordable, premium-level comfort for mid-class vehicle programs. About Leggett Dynamics' Mid-Class Massage System Leggett Dynamics' MCM is a comfort innovation that expands premium massage technology beyond the luxury vehicle segment. Already in serial production with a leading global OEM and generating strong interest from multiple global automakers, the innovation delivers a premium massage experience while reducing system cost and complexity through the intelligent use of pre
New Global Initiative Seeks to Modernize Health Workforce Mobility22.10.2026 17:00:00 CEST | Press release
PHILADELPHIA, PA, TORONTO, ON AND GRONINGEN, NETHERLANDS / ACCESS Newswire / October 22, 2026 / TruMerit® and Centennial College, with support of the Groningen Declaration Network (GDN Network), have unveiled a new vision for the future of global health workforce mobility, introducing a framework designed to help health professionals carry trusted, verifiable records of their qualifications and competencies across borders. The initiative is detailed in a newly published paper titled "Toward a Global Digital Credential Mobility Ecosystem for Migrating Health Professionals." As healthcare systems worldwide face persistent workforce shortages, internationally educated health professionals often encounter lengthy, duplicative, and inconsistent credential recognition processes that can delay entry into practice. The paper proposes a new approach centered on a Global Competency Record (GCR). This portable digital record could securely bring together verified evidence of a professional's educ
P&G, Nestlé, Mars, AstraZeneca, ITC and Bekaert win OMP Supply Chain Awards22.10.2026 15:00:00 CEST | Press release
ANTWERPEN, BE / ACCESS Newswire / October 22, 2026 / OMP, a leader in AI-powered supply chain solutions, recently honored six global brands at its conferences held earlier this month in Singapore and Shanghai. The recognized companies - Procter & Gamble (P&G), Nestlé, Mars, AstraZeneca, ITC, and Bekaert - were celebrated for driving decision velocity, co-innovation, and impactful business results. Supply Chain Innovation & Excellence Award: Nestlé and Bekaert Nestlé, one of the world's largest food and beverage companies, and Bekaert, a global market and technology leader in material science of steel wire transformation and coating technologies, received OMP's Supply Chain Innovation & Excellence award for their breadth of deployment and depth of co-innovation.Nestlé aligns its supply network at the strategic, tactical, and operational levels on OMP's Unison Planning™ platform, connecting forecasting, planning, and replenishment end-to-end. As more routine work becomes touchless, plann
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